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Research Associate I/Research Associate II, Pharmacology
Company: Carmot Therapeutics`
Location: East Bay
Posted Mar 13, 2024
<p>Carmot Therapeutics Inc is a clinical stage biotechnology company focused on the discovery and development of innovative drugs for the treatment of metabolic diseases With multiple discovery programs advancing toward candidate selection Carmot is seeking a dedicated and experienced Research Associate with rodent metabolic disease models <p> <p><strong>Position Summary<strong><p> <p>In this position you will assist with the design and execution of in vivo pharmacology experiments in rodents In particular you will be utilizing mouse models of obesity and diabetes to support compound characterization and mechanism of action studies These efforts will support lead discovery and translational biology for clinical compounds The position may also involve in ex vivo and in vitro pharmacology experiments The environment at Carmot is fast paced requiring you to be excellent at multitasking and working within a team to achieve common goals<p> <p><strong>Primary responsibilities<strong><strong><br ><strong><p> <p> Evaluate lead molecules using acute subchronic and chronic in vivo models<p> <p> Conduct experiments in relevant rodent models and optimize variety of approaches to model disease processes and to characterize drug candidates<p> <p> Generate high quality experimental data to meet strict timelines and project goals<br ><p> <ul><ul><ul><ul><p> Develop in vivo assays to assess the mechanism of action of newly identified compounds<p> <p> Investigate and validate mechanism of action of drug leads by conducting in vivo ex vivo and in vitro pharmacology experiments<p> <p> Effectively communicate important results to team members and collaborators<p> <p> Familiar with relevant scientific literature Understand and apply relevant scientific knowledge to solving problems arising from the project involved<p> <p> Maintain meticulous notes and records of work <span>performed<span><p> <p><strong>Required experience and skills<strong><p> <p> BSc MSc in pharmacology biology or related field with 15 years of postgraduate relevant experience Title and responsibilities will be based on experience<p> <p> Extensive experience in nonterminal and terminal blood sampling and harvesting tissues<br ><p> <p> Experience with rodent handling and various routes of drug administration intravenous intraperitoneal intramuscular and subcutaneous<p> <ul><ul><ul><ul><ul><ul><ul><ul><ul><ul><ul><ul><p> High level of proficiency in drug delivery utilizing all standard methods<p> <p> Experience with rodent models preferably rodent models of metabolic diseases<p> <p> Familiarity with documenting graphing and presenting data<p> <p> Highly motivated selfdriven comfortable working independently or as a team in a fast paced environment<p> <p> Strong communications and a cando attitude<br > <br > Willingness to learn new techniques and skills and be adaptable to changing priorities for multiple projects<p> <ul><ul><ol><ol><p><strong>Preferred experience and skills<strong><br ><p> <p> Experience analyzing in vivo samples ELISA MSD etc<p> <p> Flexible work schedule with ability to contribute to frequent evening and weekend efforts<p> <p> Demonstrated ability to work independently with minimal supervision<p> <p> Ability to contribute to multiple projects while remaining well organized<br ><p> <p>This position is onsite in Berkeley CA We will be prioritising local candidates<br >Must be authorised to work for any employer in the US without sponsorship<p> <p>Annual base salary range<br >RA I 70k80k<br >RA II 80k90k<br >Carmot Therapeutics Inc is committed to equal employment opportunity regardless of age ancestry colour disability mental and physical exercising the right to family care and medical leave gender gender expression gender identity genetic information marital status medical condition military or veteran status national origin political affiliation race religious creed sex includes pregnancy childbirth breastfeeding and related medical conditions and sexual orientation<p>
Sr. IT Systems Analyst - ScriptMed Remote
Company: Prime Therapeutics
Location: Remote
Posted Mar 12, 2024
<p>Our work matters We help people get the medicine they need to feel better and live well We do not lose sight of that It fuels our passion and drives every decision we make <p> <p><strong><b>Job Posting Title<b><strong> <p> <p>Sr IT Systems Analyst ScriptMed Remote<strong><b>Job Description<b><strong> <p> <p>The Sr IT Systems Analyst is responsible for utilizing various delivery methodologies employed by Prime and assist in the communications interface between IT and the business community in the investigation identification and documentation of business application requirements and technical solutions based on applicable technologies within Prime for either the enhancement of existing applications or to foster the development of new applications <p> <p><b>Responsibilities<b> <p> <ul><li>Interview stakeholders to elicit and document highly complex business needs for modifications to system application and define functional highlevel and detailed system requirements for requested software changes<li> <li>Define components and groupings to be assigned to other Systems Analyst IT resources and analyze and recommend features for phased execution as needed<li> <li>Crosstrain assigned Systems Analyst IT resources for system requirements phase of project and monitor and report project status issues and risks to project leadership<li> <li>Serve as subject matter expert and mentor for more junior members of Systems Analyst IT team<li> <li>Participate in project work and IT estimation process<li> <li>Other duties as assigned<li> <ul><p><b>Minimum Qualifications<b> <p> <ul><li>Bachelors degree in Computer Science or related area of study or equivalent combination of education andor relevant work experience High School Diploma or GED equivalent required<li> <li>Experience with specific domain relevant to team<li> <li>5 years of experience proficient in performing data analysis using tools such as SQL Excel etc to extract insights from large datasets and identify trends patterns amp anomalies system requirements andor supporting key business applications <li> <li>Must be eligible to work in the United States without need for work visa or residency sponsorship<li> <ul><p><b>Additional Qualifications<b> <p> <ul><li>Capable and willing to receive work direction from direct and indirect leadership<li> <li>Strong analytical and technical problemsolving skills<li> <li>Ability to develop decision criteria and unbiased technology comparisons<li> <ul><p><b>Preferred Qualifications<b> <p> <ul><li>ScriptMed application knowledge<li> <li>Understanding of Google Cloud Platform and any API integrations with GCP<li> <li>Experience working in environment with regulatory compliance requirements HIPAA PCI etc<li> <li>Previous experience in PBM health care industry<li> <li>Understanding of security implications of domain<li> <ul><p><b>Minimum Physical Job Requirements<b> <p> <ul><li>Ability to travel up to 5 of the time<li> <li>Constantly required to sit use hands to handle or feel talk and hear<li> <li>Frequently required to reach with hands and arms<li> <li>Occasionally required to stand walk and stoop kneel and crouch<li> <li>Occasionally required to lift andor move up to 10 pounds and occasionally lift andor move up to 25 pounds<li> <li>Specific vision abilities required by this job include close vision distance vision color vision peripheral vision depth perception and ability to adjust focus<li> <ul><p><b>Reporting Structure<b> <p> <ul><li>Reports to a Manager in the Information Technology department<li> <ul><p>Potential pay for this position ranges from $8720000 $13940000 based on experience and skills Pay range may vary by 8 depending on applicant location <p> <p>To review our Benefits Incentives and Additional Compensation visit our Benefits Page and click on the Benefits at a glance button for more detail <p> <p>Prime Therapeutics LLC is an Equal Opportunity Employer We encourage diverse candidates to apply and all qualified applicants will receive consideration for employment without regard to race color religion sex including pregnancy sexual orientation gender identity or expression genetic information marital status family status national origin age disability veteran status or any other legally protected class under federal state or local law <p> <p>Positions will be posted for a minimum of five consecutive workdays<p>
IT Manager / Sr. Manager
Company: Celldex Therapeutics
Location: Other US Location
Posted Mar 12, 2024
<p><strong>Overview<strong> <p> <p>Celldex is looking for an experienced IT ManagerSenior Manager to join a high performing team of IT staff and consultants This key role will partner with clinical and regulatory teams to evaluate ongoing business needs and help identify and implement computerized solutions to meet those needs This individual will also be responsible for providing IT support primarily to Celldexs New Haven CT office and act as liaison with other IT staff to oversee and support the the operation maintenance and administration of clinical regulatory research lab and enterprise systems as well as networking equipment <p> <p><strong>Responsibilities<strong> <p> <ul><li>Coordinate and oversee IT projects and provide project management business analysis and documentation support to implement new or changes to software systems and technologies with a focus on systems used by Clinical and Regulatory teams This may include validation or qualification of systems<li> <li>Manage and administer clinical regulatory RampD systems<li> <li>Provide training on systems and onboarding of new employees as needed<li> <li>Work with users as a first line of support for New Haven CT related help desk requests and work as part of the overall IT Team to support users working remotely or at other sites<li> <li>Liaise with IT staff to determine necessary technology advances and educate employees on the use of software and hardware used in daytoday operations<li> <li>Liaise with IT staff to support onsite networking equipment and systems and troubleshoot issues <li> <li>Set up laptops desktops and peripherals for new users and replacements<li> <li>Assist with reviewing and updating IT policies and procedures eg Disaster Recovery Plan and Business Continuity Plan and development of SLAs<li> <li>Assist with budget process and planning assist departments and users with evaluation of solutions requests quotes and estimates generate project plans and recommend solutions<li> <ul><p><strong>Qualifications<strong> <p> <ul><li>Highly communicative consultative in nature and demonstrated excellent written and verbal communications skills<li> <li>Excellent interpersonal skills and ability to communicate clearly effectively and professionally<li> <li>Strong analytical skills with demonstrated ability to solve complex problems resolve issues and make practical recommendations and plans<li> <li>Takes ownership of enduser issues and is proactive when interacting with end users to resolve issues<li> <li>Maintains a high degree of customer service for end user requests while adhering to all IT policies and SOPs<li> <li>Be diligent and selfmotivated with an eagerness to learn and excel in a highpaced environment<li> <li>Be flexible and adjust to changing priorities or timelines<li> <li>Must be able to move hardware devices among communications and server racks<li> <li>Be willing to travel occasionally to other Celldex offices in Massachusetts and New Jersey offices<li> <ul><p><strong>EducationExperience<strong> <p> <ul><li>4+ years of experience working in an IT or businessrelated discipline<li> <li>Minimum of BA or BS in scientific field or Information Technology<li> <li>Working knowledge of terminal services remote desktop connection and other remote access support tools<li> <li>Experience working in life sciences field especially with Clinical Regulatory andor Research Lab teams or systems a plus<li> <li>Knowledge of Good Clinical Practices GCP a plus<li> <li>Experience with regulatory filing systems regulatory management systems clinical trial or clinical data management systems part 11 esignature solutions a plus<li> <ul><ul><li>Hybrid work is ok but must be able to work in the office a minimum of 3 days a week<li> <ul><p>Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity equity and inclusion We are committed to promoting a diverse environment through development recruiting and community outreach<p>
Forecast Analyst Sr - Remote
Company: Prime Therapeutics
Location: Remote
Posted Mar 12, 2024
<p>Our work matters We help people get the medicine they need to feel better and live well We do not lose sight of that It fuels our passion and drives every decision we make <p> <p><strong><b>Job Posting Title<b><strong> <p> <p>Forecast Analyst Sr Remote<strong><b>Job Description<b><strong> <p> <p>The Senior Forecast Analyst is responsible for providing complex financialdata modeling forecasting revenue projections and analysis for various functional areas throughout Prime as well as for the Pricing and Analytics team This role is responsible for creating and developing new methodologies reports and analytical models and provide critical analysis related to Requests for Proposals RFPs and structure of client guarantees <p> <p><b>Responsibilities<b> <p> <ul><li>Provide indepth comprehensive analysis and recommendations for the RFP process as Prime seeks to grow the business with purpose and bring in new groups and Blues plans<li> <li>Lead development and implementation of financial modeling changes to improve accuracy<li> <li>Consult with management andor senior leadership to analyze and troubleshoot data analysis andor forecasting issues for variety of complex projects<li> <li>Create enhance and maintain various forecasts and financial models including but not limited to drug trend generic discount projections revenue forecasting and RFPs provide recommendations based on forecasts and analysis<li> <li>Mentor coach and provide work direction to more junior analysts on various work efforts<li> <li>Other duties as assigned<li> <ul><p><b>Minimum Qualifications<b> <p> <ul><li>Bachelors degree in Finance Math Economics or related area of study or equivalent combination of education andor relevant work experience HS diploma or GED is required<li> <li>5 years of experience in detailed analytical work in financial insurance pharmacy benefits management reporting amp analytics benefits consulting healthcare industries or related field<li> <li>Must be eligible to work in the United States without need for work visa or residency sponsorship<li> <ul><p><b>Additional Qualifications<b> <p> <ul><li>Ability to work independently while maintaining accuracy and attention to detail and meet deadlines<li> <li>Excellent verbal and written communication and presentation skills to senior levels of leadership<li> <li>Proficiency in Microsoft Excel andor database programming environment<li> <li>Demonstrated organization with the ability to balance multiple projects and meet competing deadlines<li> <li>Strong interpersonal skills with the ability to develop partnerships with internal clients<li> <ul><p><b>Preferred Qualifications<b> <p> <ul><li>Extensive analysis and modeling experience with pharmacy medical insurance andor financial data<li> <li>Experience using SAS Enterprise Guide SQL or other related database programming environments<li> <li>Salesforce experience<li> <li>Previous work experience with model creation and maintenance<li> <ul><p><b>Minimum Physical Job Requirements<b> <p> <ul><li>Constantly required to sit use hands to handle or feel talk and hear<li> <li>Frequently required to reach with hands and arms<li> <li>Occasionally required to stand walk and stoop kneel and crouch<li> <li>Occasionally required to lift andor move up to 10 pounds and occasionally lift andor move up to 25 pounds<li> <li>Specific vision abilities required by this job include close vision distance vision color vision peripheral vision depth perception and ability to adjust focus<li> <ul><p><b>Reporting Structure<b> <p> <ul><li>Reports to Manager Principal Director or Sr Director in Pricing amp Analytics department<li> <ul><p>Potential pay for this position ranges from $8560000 $12840000 based on experience and skills Pay range may vary by 8 depending on applicant location <p> <p>To review our Benefits Incentives and Additional Compensation visit our Benefits Page and click on the Benefits at a glance button for more detail <p> <p>Prime Therapeutics LLC is an Equal Opportunity Employer We encourage diverse candidates to apply and all qualified applicants will receive consideration for employment without regard to race color religion sex including pregnancy sexual orientation gender identity or expression genetic information marital status family status national origin age disability veteran status or any other legally protected class under federal state or local law <p> <p>Positions will be posted for a minimum of five consecutive workdays<p>
Senior Project Manager (CMC)
Company: Kyverna Therapeutics
Location: Other US Location
Posted Mar 13, 2024
<p><span>Kyverna Therapeutics is a clinicalstage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases Be at the forefront of cell therapy innovation by joining scientists industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated<span><p> <p><br ><p> <p><span>This position will partner with functional subteam leaders to lead project management activities for a cell therapy program subteam guiding the subteam through preclinical and clinical development This is a crossfunctional role that will integrate functional subteam plans with the overall program plan in partnership with the program manager The candidate may work on any functional sub team depending on need including CMC Clinical Research or Regulatory The role may also help build overall project management capabilities at Kyverna This position will report to the Director of Program Management <span><p> <p><span> <span><p> <p><span>This is an opportunity to join a growing company working on transformational therapies for autoimmune disease This is a high visibility role that will work with various groups in the company advancing innovative science in cellular and genetic therapies You will have the opportunity to work on research and development help build the project management organization and build relationships with external partners If you are a program or project management professional that wants to work on exciting science with a dynamic team and are looking to grow your career this may be the role for you <span><p> <p><b>Respoinsibilities<b> <p><ul><li>Manage one or more highly complex RampD project andor highprofile partnerships <li> <li>Serve as the Project Management Leader for a functional program subteam or core team for candidate cell therapy <li> <li>Develop and maintain integrated project plans to identify interdependencies critical path activities key milestones and understand best case and base case scenarios <li> <li>Use appropriate project management tools to focus teams facilitate decision making manage risk and ensure all are tracked and communicated clearly within teams and to external stakeholders <li> <li>Partner with finance to manage program budgets and guide resourcing decisions <li> <li>Effective communication and stakeholder management with the project team senior leadership and other key stakeholders <li> <li>Manage the interfaces between functional areas to ensure effective handoff and communication between program functional subteams to execute on important program milestones <li> <li>Partner with peer program and project managers to ensure project plans are integrated across functions <li> <li>Help build the program management function by creating project management tools processes and templates <li> <ul><p><b>Requirements<b> <p><ul><li>A minimum of a BABS + 6 years of experience in a scientific discipline is required while an advanced degree PhD MS MD andor PMP Certification is preferred <li> <li>The ideal candidate will have at least 6 years of multidisciplinary experience in the biotechpharmaceutical industry with at least 2 years of direct project management in drug development <li> <li>Experience applying the principles concepts practices and standards of project management for drug development <li> <li>Ability to understand and communicate scientific and business elements associated with Kyvernas engineered T cell therapies <li> <li>Excellent interpersonal skills ability to develop relationships with key stakeholders good conflict management skills <li> <li>Strong communication skills in person and written word and the ability to interact with a diverse group of individuals <li> <li>Proven ability to proactively identify risks and drive resolution of issues <li> <li>Proven success in goal setting prioritization and time management <li> <li>Results and detailoriented selfmotivated ability to work with minimal supervision <li> <li>Ability to perform and be adaptive in a fastpaced environment under tight deadlines <li> <li>Strong analytical and problemsolving capabilities <li> <li>Some understanding of FDA regulatory processes and clinical trials is preferred <li> <li>Experience with gene or cell therapy development programs is a plus <li> <li>Experience in a CMC discipline is preferred <li> <ul><p> <p><p><span>The salary range for this position is from $145000 $175000 USD annually This salary range is an estimate of what we reasonably expect to pay for this posted position and the actual salary may vary based on various factors including without limitation individual education experience tenure skills and abilities as well as internal equity and alignment with market data This position is also eligible for bonus benefits and participation in Companys stock option plan<span><p> <p><br ><p> <p><br ><p> <p><span>Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race religion color sex gender identify sexual orientation age nondisqualifying physical or mental disability national origin veteran status or any other legally protected status EOEAAVets<span><p> <p><p>
Desktop Support Technician
Company: Scribe Therapeutics
Location: East Bay
Posted Mar 12, 2024
<p>Scribe Therapeutics is a molecular engineering company focused on creating bestin<br >class in vivo therapies that permanently treat the underlying cause of disease Founded<br >by CRISPR inventors and leading molecular engineers Benjamin Oakes Brett Staahl<br >David Savage and Jennifer Doudna Scribe is overcoming the limitations of current<br >genome editing technologies by developing custom engineered enzymes and delivery<br >modalities as part of a proprietary evergreen CRISPR by Design™ platform for CRISPR<br >based genetic medicine<p> <p><br >We are seeking a highly creative passionate and motivated individual to join us in our<br >quest to develop the next generation of CRISPRbased therapeutics The current role is<br >for a Desktop Support Technician to join our team and advance our platform The<br >candidate should have a passion for working collaboratively with biologists and<br >bioengineers to enable building the necessary tools for meeting the new frontier of<br >CRISPRbased therapeutics Additionally the candidate would bring expertise in<br >providing routine guidance for users of the IT systems components and applications<br >running in Scribe Therapeutics by maintaining an understanding of IT concepts and<br >staying updated with the latest trends<br > <br >The candidate will have numerous opportunities for professional growth in a rapidly<br >growing biotechnology startup which includes growing into a leadership role of<br >increasing responsibilities and the ability to publish highly impactful work in peer<br >reviewed journals <p> <p><br >Key Responsibilities<br >● Receives and processes user complaints<br >● Resolves computer problems and errors<br >● Responsible for managing employee accounts amp security access<br >● Sets up and configures new computer instruments and internet equipment<br >● Updates computer application software and operating systems<br >● Manages SaaS o365Azure AWS and Google cloud services<br >● Manages Data Protection activities such as Backup amp Recovery and log<br >monitoring<p> <p>● Serves as an escalation point for junior IT team members<br >● Effectively collaborate with members within a fully integrated team to facilitate<br >execution on projects within established timelines<br >● Foster a driven fastpaced dynamic and fun environment in which to do<br >rigorous science<br >Required Skills and Background<br >● At least 35 years of prior experience working in the helpdesk support role with a<br >proven track record of handson experience resolving end user problem tickets<br >● Proficient in MS Office and ITrelated applications including o365 amp Google Suite <br >● Effective timemanagement skills<br >● Excellent communication and coordination skills<br >● Ability to work both independently and collaboratively in a fastpaced<br >interdisciplinary research team<br >● Remotely or physically assists in computerrelated concerns<p> <p>Preferred Skills and Background<br >● Associate degree in computer science or related field<br >● Prior experience in desktop support technician or similar role preferred<br >● Proficient in MS Office and ITrelated applications including o365 amp Google Suite<br >● Effective timemanagement skills<br >● Detail oriented<br >● Excellent communication and coordination skills<br >● CompTIA A+ certification or CompTIA Cloud+ certification<br >● Microsoft Certified Azure Fundamentals professional<p> <p>Salary will be commensurate with experience We will provide an intellectually<br >stimulating collegial and fastpaced environment If you are ready to engineer the<br >future of therapeutics then we are excited to hear from you Visit us at<br >wwwscribetxcom <p> <p>We are committed to creating a diverse environment and are proud to be an equal<br >opportunity employer All qualified applicants will receive consideration for<br >employment without regard to race color religion gender gender identity or<br >expression sexual orientation national origin disability age or veteran status<br >At the time of posting the base pay wage range for this role is $7000090000 per year The<br >offered pay range will depend on internal equity and the candidates relevant skills<br >experience qualifications training and market data Additional incentives are provided<br >as part of the complete package in addition to comprehensive medical and other<br >benefits<p>
Senior Manager, Global Product Quality
Company: Cerevel Therapeutics
Location: Boston, MA
Posted Mar 13, 2024
<p><b>Company Overview<b><p> <p><br ><p> <p>Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity Our portfolio of precommercial neuroscience assets targets a broad range of central nervous system CNS disorders including schizophrenia epilepsy Parkinsons disease and substance use disorder <p> <p> <p> <p>Headquartered in the Greater Boston area we are bold thinkers deep experts resilient pathfinders and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on peoples lives<p> <p> <p> <p>Cerevel aspires to develop and nurture a culture characterized by trust respect courage curiosity and compassion with a relentless focus on mission and results Our patientcentricity guides our purpose how we treat each other and what we work on every day The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions<p> <p><br ><p> <div><u><b>Role Summary<b><u><div> <p><br ><p> <p>The Senior Manager Global Product Quality will be responsible for both operational and compliance management of GMP and GLP QA activities at Cerevel to support the manufacture packaging testing and supply of materials for use in latephase and commercial operations This individual will provide technical quality expertise and phaseappropriate compliance guidance to crossfunctional teams internally and externally in the development and implementation of cGMP compliant quality systems to ensure product quality data integrity and most importantly patient safety at Cerevel<p> <p><br ><p> <p>In addition this role will be responsible for overseeing a network of global vendors eg CROsCDMOsCMOs and will work closely with the GxP Quality Management functions to support the development and inspection readiness of Global Quality Management Systems which may include but not limited to GxP document management and training deviation and CAPA management change management product quality complaints risk management vendor management internalexternal audits and inspection readiness etc<p> <p><b>Key Responsibilities<b> <p><ul><li>Provide Quality oversight for GMPGLP activities at Cerevel and its global vendors which includes Contract Research Organizations CROs Contract Development Manufacturing Organizations CDMOs and Contract Manufacturing Organizations CMOs <li> <li>Apply cGMP principles and requirements in a phaseappropriate manner to support the development and manufacture of commercial products while ensuring quality and compliance with Cerevels procedures and applicable health authoritys regulations<li> <li>Review and approve GMP documentation including Master Batch Records Specifications Analytical Test Methods Stability ProtocolsReports Validation ProtocolsReports Change Controls and Label Proofs in support of manufacturing testing and packaginglabeling at various vendors<li> <li>Review and approve vendors executed batch records analytical data packaging and labeling records to ensure timely disposition of drug substances drug products and finished goods for use in commercial operations<li> <li>Review approve and track Cerevels andor vendors product quality investigations included but not limited to deviationsnonconformances CAPAs out of trend OOT out of specification OOS product quality complaints associated with manufacturing and analyticalstability testing<li> <li>Work proactively and effectively with vendors and respective Cerevel business functions to identify and mitigate quality risksissues that may arise to maintain compliance and preserve projects timelines<li> <li>Participate in andor support Quality audits internal and external with the support of external quality consultantsauditors Support vendor qualification activities which may include auditing and approving of GMPGLP vendors providing recommendations and following up on audit responses and resolution of CAPAs<li> <li>Ensure Cerevel and vendors are in compliance with US and Global regulations guidelines and industry standards in countries where Cerevel conducts GxP activities Serve as a PersoninPlant PIP at vendors when needed<li> <li>Lead preparation for CDMOCMO inspection readiness when required<li> <li>Review CMC regulatory filings and supporting documentation as needed<li> <li>Develop and oversee GPQ metricsKPIs and report results to Senior Management<li> <li>Serve as GPQ Representative in collaborating with Information Technologies and Quality Management in the selection implementation and maintenance of GxP electronic quality management systems and applications eg Veeva Vault QMS<li> <li>Support the development implementation and maintenance of Cerevels procedures and electronic Quality Management Systems<li> <li>Partner with stakeholders throughout lifecycle of quality systems implementation and continuous improvement from defining business need project planning development deployment and end user adoption and provide ongoing GMP functional oversight for all electronic quality management systems<li> <li>Additional Quality projects and responsibilities may be assigned based on business needs of a growing organization<li> <ul><p><b>Required Qualifications<b> <p><ul><li>8+ years of relevant QA experience in pharmaceutical or biopharmaceutical industry in manufacturing QA or QC role supporting GMP Activities for Investigational Medicinal Products andor Commercial Products<li> <li>Indepth knowledge of GMPGLP QA principles and standards as well as thorough understanding of FDA EMA and ICH quality regulations necessary for daytoday operations of commercial supply operations<li> <li>Experience in working and managing CDMOsCMOs to conduct GMP manufacture testing packaginglabeling andor distribution<li> <li>Experience in authoring and implementing SOPs<li> <li>Experience with RegulatoryHealth Authority Inspections<li> <li>Experience working in electronic quality management systems Veeva or equivalent<li> <li>Experience with electronic Learning Management Systems<li> <li>In depth knowledge of Validation Lifecycle requirements<li> <li>Understanding of GAMP Validation Guidelines and Validation lifecycle requirements<li> <li>Strong understanding of the Drug Development Process ability to partner and build relationship with business function stakeholders and external vendors in order to enable high quality outcomes<li> <li>Technical writing experience writing investigations performing root cause analysis and identifying CAPAs<li> <li>Analytical problem solving and decisionmaking skills<li> <li>Highly motivated flexible and able to respond quickly to shifting priorities and meet deadlines with excellent organizational skills and keen attention to details<li> <li>Strong verbal and written communication skills to effectively communicate with business functions and vendors<li> <li>Ability to travel as needed may be up to 30 domestic travel occasional international travel may also be expected<li> <ul><p><b>Desired Qualifications<b> <p><ul><li>2+ years of supplier quality experience managing GMPGLP Vendors<li> <li>Previous experience working in a commercial Quality role<li> <li>Desire to work in a fastpace dynamic environment<li> <li>Strong team player with a solutionsoriented and customerservice mindset<li> <li>Excellent interpersonal problem solving with high degree of autonomy<li> <li>Organized and efficient delivers highquality work<li> <li>Experienced at leading teams and developing talent<li> <li>Ability to coordinate timelines with internal customers and vendors<li> <ul><p><b>Education<b> <p><ul><li>Bachelors degree in life science or equivalent or engineering field relevant to pharmaceutical development significantly more work experience in the relevant areas may be required for candidates without a bachelors degree<li> <ul><p> <p><p>Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race religion color sex gender identity sexual orientation age nondisqualifying physical or mental disability national origin veteran status or any other characteristic protected by applicable law<span> <span><p> <p><p>
PBM Project Manager - Remote
Company: Prime Therapeutics
Location: Remote
Posted Mar 13, 2024
<p>Our work matters We help people get the medicine they need to feel better and live well We do not lose sight of that It fuels our passion and drives every decision we make <p> <p><strong><b>Job Posting Title<b><strong> <p> <p>PBM Project Manager Remote <p> <p><b>Job Description Summary<b> <p> <p>Responsible for the management of a variety of projects for corporate andor strategic business unit SBU Provides support through the planning and execution of these projects Support may include establishing deadlines assigning resourcesresponsibilities and monitoring and summarizing progress of projects Prepares reports for upper management regarding status of project Familiar with a variety of the fields concepts practices and procedures <p> <p><b>Job Description<b> <p> <ul><li>Meets with business process owners and key stakeholders to identify the projects goals objectives critical success factors and success measures<li> <li>Develops a detailed project charter to serve as a critical communication tool for key stakeholder buy in and set expectations<li> <li>Creates and executes project work plans and revises as appropriate to meet changing needs and requirements<li> <li>Identifies resources needed and assigns individual responsibilities<li> <li>Manages daytoday operational aspects of a project and scope including meeting facilitation and documentation<li> <li>Reviews deliverables prepared by team before passing to project team members<li> <li>Effectively applies Magellans methodology and enforces project standards using Microsoft Project or other approved toolkit templates<li> <li>Prepares for project reviews and quality assurance procedures<li> <li>Minimizes our exposure and risk on project appropriately raising awareness on atrisk items<li> <li>Ensures project documents are complete current and stored appropriately<li> <li>Keeps project team well informed of changes within the organization and general corporate news that may impact project scope<li> <li>Provides status reporting to stakeholders on a regular basis Apprises management of issues requiring resolution in order to maintain progress on a timely basis<li> <li>Prepares reports andor dashboards for enterprise project activity<li> <li>Delivers engaging informative wellorganized presentations<li> <li>Resolves andor escalates issues in a timely fashion<li> <li>Understands how to communicate difficultsensitive information tactfully<li> <li>Conducts lessons learned to continually improve processes<li> <li>Contributes to implements and maintains best practices and project management policies and guidelines<li> <li>Prepares Business Case and Return on Investment ROI to show impact to the business<li> <li>Assists in the development of resource management and project financial materials<li> <ul><p><b>Responsibilities<b> <p> <ul><li>For clinical project management related roles clinical licensure eg LPN RN LCSW LMSW is preferred<li> <ul><ul><li>Bachelors degree plus 5+ years project management or job related experience in a medium to largescale corporation<li> <li>May consider additional years of experience in lieu of degree 4 additional years in lieu of degree or 2 additional years with an Associates degree<li> <li>Strong working knowledge of Microsoft Product Suite specifically Excel Access and Visio<li> <li>Knowledge of project management practices and methodologies<li> <li>Knowledge of process improvement methodologies<li> <li>Ability to develop and maintain multiple project plans<li> <li>Financial Management knowledge understands basic financial model and budgeting<li> <li>Facilitation and interpersonal skills with the ability to work effectively with crossfunctional teams <li> <li>Basic knowledge of health care management <li> <li>Proven ability to plan organize schedule direct control and monitor project activities<li> <li>5+ years project management or job related experience in a medium to largescale corporation<li> <ul><p><b>Work Experience<b> <p> <p>Work Experience Required <p> <p>ProjectProgram Management <p> <p>Work Experience Preferred <p> <p><b>Education<b> <p> <p>Education Required <p> <p>A Combination of Education and Work Experience May Be Considered Bachelors Business Administration <p> <p>Education Preferred <p> <p>Masters <p> <p><b>Certifications<b> <p> <p>Certifications Required <p> <p>Certifications Preferred <p> <p>LSSGB Lean Six Sigma Green Belt Certification Enterprise Enterprise PMP Project Management Professional Enterprise Enterprise <p> <p>Potential pay for this position ranges from $6080000 $9728000 based on experience and skills Pay range may vary by 8 depending on applicant location <p> <p>To review our Benefits Incentives and Additional Compensation visit our Benefits Page and click on the Benefits at a glance button for more detail <p> <p>Prime Therapeutics LLC is an Equal Opportunity Employer We encourage diverse candidates to apply and all qualified applicants will receive consideration for employment without regard to race color religion sex including pregnancy sexual orientation gender identity or expression genetic information marital status family status national origin age disability veteran status or any other legally protected class under federal state or local law <p> <p>Positions will be posted for a minimum of five consecutive workdays<p>
Senior Manager/Associate Director, Business Development
Company: Click Therapeutics
Location: New York City, NY
Posted Mar 13, 2024
<p><strong>Who We Are<strong><br >Click Therapeutics Inc develops validates and commercializes software as prescription medical treatments for people with unmet medical needs As a leading innovator of Digital Therapeutics™ Click delivers accessible clinically proven FDAregulated prescription treatments to the smartphone in your hand Clicks treatments are defined by a commitment to applying technical and scientific rigor and patientcentric design to the development process This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options Click Therapeutics continuously expands and refines its platform with novel cognitive behavioral and neuromodulatory mechanisms of action and advanced datadriven tools such as artificial intelligence and machine learning The digital therapeutics under development on Clicks platform address diverse areas of therapeutic need including indications in psychiatry neurology oncology immunology and cardiometabolic diseases Consistently named a best place to work Click fosters an inclusive diverse workforce of innovators clinicians scientists researchers designers technologists engineers and more united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics For more information visit wwwclicktherapeuticscom and connect with us on LinkedIn <br ><strong>About the Role<strong><br >In this role you will have the opportunity to drive the execution of Clicks business development strategy Business development plays a critical role in the strategic growth of Click by leading partnering initiatives and executing various types of transactions to shape our pipeline and enable our programs to reach patients The Senior Manager or Associate Director will establish and drive a portfolio of partnering opportunities and collaborate with functional area leaders internally to drive deals to execution This will require strategic relationship management effective time management creative problem solving and thorough diligence If you have an entrepreneurial spirit are successorientated and you can work independently you may be the right candidate to join our team<br >This position is based out of Clicks headquarters located in Tribeca NYC at the center of one of the fastestgrowing digital health communities We have a hybrid working model that consists of at least 3 days in office each week<br ><strong>Responsibilities<strong><br ><p><ul><li>Identify evaluate and drive new business development opportunities that meet the strategic therapeutic and commercial needs of the organization<li> <li>Partner closely with internal legal and functional area teams to lead negotiations<li> <li>Efficiently manage a pipeline of partnering opportunities and timelines coordinating crossfunctional collaboration and delivering high quality outputs<li> <li>Create presentations and materials to facilitate partnering discussions<li> <li>Cultivate relationships with potential partners in relevant industries<li> <li>Develop business cases opportunity rationale timeline and resources risks and considerations etc required to optimize Clicks partnering strategy<li> <li>Lead due diligence processes<li> <li>Support other prioritized business development initiatives and activities as needed<li> <ul><p> <br ><strong>Qualifications<strong><br ><p><ul><li>Graduate of a 4year degree program from a toptier university with a strong academic track record<li> <li>610 years of business development alliance management or investment banking experience in life sciences<li> <li>Efficient in selfmanaging deadlines prioritizing assignments and delivering outputs with high attention to detail<li> <li>Highly independent selfstarter with high capacity for learning quickly<li> <li>Sophisticated relationship manager<li> <li>Adaptable in dynamic atmosphere of changing requirements and scope<li> <li>Strong written and verbal communication skills<li> <ul><p> <br ><strong>Preferred Qualifications<strong><br ><p><ul><li>Experience working at a lean or startup environment<li> <li>Experience in digital therapeutics or traditional pharmacotherapy<li> <ul><p> <br ><strong>Compensation<strong><br >The base salary range for this position is between $110000 $180000 The final base salary will be dependent upon skills experience and location In addition to the base salary Click Therapeutics offers an annual performancebased cash bonus and a generous equity package<br ><strong>Benefits<strong><br >The role includes great benefits and is an excellent wealthbuilding opportunity at a fastgrowing preIPO company in a nascent and extremely exciting space <br >Competitive Salary with Annual Review | Cash Bonus | Stock Options | 5 401k matching | Medical | Dental | Vision | Life Insurance | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fertility Support | Fitness Reimbursement | Bike Membership | Professional Development Stipend | Lunch Stipends | Parent Benefits | LinkedIn Learning | Industrious Workspaces | Commuter Subsidies | Flexible Work Arrangement | Choice of Mac or Windows | Sponsored Company Events | Office Snacks and Beverages | Much More<br ><strong>Equal Employment Opportunity<strong><br >Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status Click Therapeutics also complies with all applicable national state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act All applicants must have authorization to work for Click Therapeutics in the US In certain circumstances it may be advantageous to Click Therapeutics to support the applications for temporary visa classification andor sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U S For certain classes of temporary visas the resulting work authorization may be specific to Click Therapeutics and the specific job andor work site Click Therapeutics may at its business discretion decide to or refrain from obtaining maintaining andor extending the temporary visa status andor sponsoring a colleague for permanent residency and or employment eligibility considering factors such as availability of qualified US workers and the colleagues longterm prospects for securing lawful permanent residence among other reasons Employment applicants requiring immigration sponsorship must disclose when initial application for employment is made whether or not they are legally authorized to work for Click Therapeutics in the US and if so whether that authorization permits them to work in the job they seek In no case should Click Therapeutics support of a colleagues temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the atwill employment relationship between the colleague and Click Therapeutics<br ><strong>Recruitment Phishing Scams<strong><br >Fake job advertisements and offers are increasingly appearing on the internet If you have encountered a job posting or have been approached with a job offer that you suspect may be fraudulent we strongly recommend you do not respond and report it to the Federal Trade Commission and the FBI at httpswwwic3govHomeComplaintChoice You can also contact our team at recruitmentclicktherapeuticscom to report details of your experience<br >Please be mindful of the following<br ><p><ul><li>Click Therapeutics will only reach out to you through an clicktherapeuticscom email address<li> <li>Other than your email address or telephone number which you may provide via a job application portal Click Therapeutics will never ask you to provide personally identifiable information about yourself such as a Social Security Number or Drivers License Number via a messaging application like that used on the LinkedIn platform or Microsoft Teams<li> <li>Click Therapeutics will conduct interviews facetoface over Zoom<li> <li>All job postings will be listed on the Click Therapeutics official career page If someone contacts you about a job or position that is not listed on the official career page please contact the Click Therapeutics recruitment team at the contact information below<li> <ul><p> <br >If you have any questions regarding the validity of a recruitment inquiry or an interview please contact the Clicks recruitment team at recruitmentclicktherapeuticscom to confirm before proceeding<p>
Senior Quality Assurance Specialist, Global Product Quality
Company: Cerevel Therapeutics
Location: Boston, MA
Posted Mar 12, 2024
<p><b>Company Overview<b><p> <p><br ><p> <p>Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity Our portfolio of precommercial neuroscience assets targets a broad range of central nervous system CNS disorders including schizophrenia epilepsy Parkinsons disease and substance use disorder <p> <p> <p> <p>Headquartered in the Greater Boston area we are bold thinkers deep experts resilient pathfinders and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on peoples lives<p> <p> <p> <p>Cerevel aspires to develop and nurture a culture characterized by trust respect courage curiosity and compassion with a relentless focus on mission and results Our patientcentricity guides our purpose how we treat each other and what we work on every day The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions<p> <p><br ><p> <div><u><b>Role Summary<b><u><div> <p><br ><p> <p><span>The Senior QA Specialist Global Product Quality implements and maintains the quality systems and tools required to manage and monitor the quality and compliance of GMP vendors that are utilized in the manufacturing packaging testing and distribution of Cerevel products<span><p> <p><b>Key Responsibilities<b> <p><ul><li>Ensure GMP compliance for outsourced manufacturing packaging labeling testing amp distribution activities<li> <li>Review GMP documentation such as Master Batch Records Specifications Analytical Test Methods Stability ProtocolsReports Validation ProtocolsReports Change Controls and Label Proofs in support of manufacturing testing and packaginglabeling at various vendors<li> <li>Review executed batch records and analytical data to ensure timely disposition of drug substances drug products and finished goods for use in clinical trials and commercial operations<li> <li>Review product quality investigations including but not limited to quality events deviations CAPAs out of trend OOT out of specification OOS product quality complaints associated with manufacturing and analyticalstability testing<li> <li>Ensure investigations are robust and properly documented including root cause analysis product quality impact assessment CAPA<li> <li>Work proactively and effectively with vendors and respective Cerevel business functions to identify and mitigate quality risksissues that may arise to maintain compliance and preserve projects timelines Escalate issues to Manager in timely manner<li> <li>Work collaboratively with Global Quality staff and other functional area partners to ensure GMP compliance with Cerevel and regulatory requirements<li> <li>Support enhancements to electronic quality management system and other continuous improvement activities<li> <li>Authorupdate Standard Operating Procedures Work Practices and other related documents<li> <li>Additional responsibilities may be assigned based on business needs of a growing organization<li> <ul><p><b>Required Qualifications<b> <p><ul><li>45 years of related experience in pharmaceutical industry in Quality Assurance or Quality Control role supporting GMP Activities for clinical trials andor commercial products<li> <li>Understanding of GMP requirements and the drug development process<li> <li>Technical writing experience writing investigations performing root cause analysis and identifying CAPAs<li> <li>Ability to handle interactions and resolve issues with internal customers and vendors in a tactful professional and effective manner<li> <li>Highly motivated flexible and able to respond quickly to shifting priorities and meet deadlines with excellent organizational skills and attention to detail<li> <li>Strong verbal and written communication skills<li> <li>Experience in authoring and implementing SOPs<li> <li>Experience working in electronic quality management systems Veeva or equivalent<li> <li>Ability to travel as needed may be up to 20<li> <ul><p><b>Desired Qualifications<b> <p><ul><li>Small molecule experience<li> <ul><p><b>Education<b> <p><ul><li>Bachelors degree in life science field or equivalent or engineering field relevant to pharmaceutical development preferred<li> <ul><p> <p><p>Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race religion color sex gender identity sexual orientation age nondisqualifying physical or mental disability national origin veteran status or any other characteristic protected by applicable law<span> <span><p> <p><p>
VP, Program Team Leader
Company: Dyne Therapeutics
Location: Waltham
Posted Mar 12, 2024
<div><b>Company Overview<b> <p>Dyne Therapeutics is a clinicalstage muscle disease company focused on advancing innovative lifetransforming therapeutics for people living with genetically driven diseases With its proprietary FORCE™ platform Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue Dyne has a broad pipeline for serious muscle diseases including clinical programs for myotonic dystrophy type 1 DM1 and Duchenne muscular dystrophy DMD and a preclinical program for facioscapulohumeral muscular dystrophy FSHD For more information please visit httpswwwdynetxcom and follow us on X LinkedIn and Facebook <p> <div> <p><strong>Role Summary<strong><p> <p>The Program Team Leader PTL is a passionate drug developer with a global perspective who brings adaptable leadership strategic product development acumen and relentless pursuit of longterm success for patients and Dynes medicines The PTL is a highly visible leadership role Working with an experienced Program Manager and a crossfunctional team the PTL shapes the Program strategy goals priorities and plans bringing both a futureorientation toward the ultimate goal of broad global commercial access for patients in need and a pragmaticorientation to chart the path mitigate risks cultivate options and lead through complex drug development decisions<p> <p>This role is based in Waltham MA without the possibility of being a remote role <p> <p><strong>Primary Responsibilities Include<strong><p> <ul><li>Lead a highperforming crossfunctional Program Team focusing on both the what such as strategy priorities output and resources and also the how such as maintaining a fulfilling collaborative and sustainable team environment<li> <li>Establish a robust and wellunderstood Program strategy for bringing a lifechanging medicine to patients in need<li> <li>Ensure that research nonclinical clinical regulatory CMC and commercial strategies and plans are aligned with the overall Program strategy<li> <li>Structure and facilitate critical crossfunctional decisions within Program Team and senior leadership team bringing all relevant perspectives to bear while driving to efficient decisions in a fastpaced environment<li> <li>Own Program recommendations across stages of the Program to achieve milestones and timelines<li> <li>Drive preparation and presentation of materials for Board of Directors and Scientific Advisory Board<li> <li>Maintain clear open and proactive communication with the senior leadership team and other stakeholders regarding Program strategy status priorities risks and needs and facilitate appropriate decisionmaking<li> <li>Keep abreast of emerging developments regarding research and development in the fields of muscle diseases and oligonucleotide drug discovery and development<li> <li>Build visible constructive and credible presence within KOL and patient community for relevant disease areas<li> <li>Participate in business development activities as needed including opportunity evaluations and due diligence<li> <li>Provide a motivating leadership example within Dyne more broadly during periods of rapid growth<li> <li>Responsibly steward the Program budget in collaboration with finance and functional leaders<li> <li>Foster a culture of collaboration innovation discovery and cuttingedge research focused on scientific excellence open communication and continual improvement<li> <li>Actively coach team members to achieve their best and support to mitigate gaps in skill or capacity<li> <li>Consider needs of the Program in context of Dyne corporate strategy and priorities as primary advocate for the Program among Dyne senior leadership<li> <li>Lead with Dynes core values at the forefront<li> <ul><p><strong>Education and Skills Requirements<strong><p> <ul><li><strong> <strong>Experience in Phase 13 drug development is required product launchearly commercialization experience a strong plus<li> <li>Proven and respected leader with <ul><li>Advanced degree in Medical or Life Science MD PhD or MBA or equivalent<li> <li>12+ years of experience in pharmaceutical industry in leadership positions in drug development and proven track record in driving Programs through IND early clinical pivotal stages and approval<li> <li>Andor at least 12 years in pharmaceutical industry in significant development andor commercial leadership or general management positions including working with development teams in crossfunctional setting with exceptional track record of delivering on business objectives activitymilestones leading to filing and launching and strong knowledge of neuromuscular diseases<li> <li>Experience in rare genetic diseases preferred<li> <ul><li> <li>Other key traits<li> <li>Entrepreneurial team leader able to shape and communicate the vision for an important therapeutic Program and guiding the development of the product strategy and its execution<li> <li>Insightful people leader supporting and coaching highcaliber functional experts to achieve their absolute best<li> <li>Collaborative corporate leader partnering with other senior leaders to shape and fulfil Dynes overall mission to develop and commercialize transformational therapeutics for people living with serious diseases<li> <li>Orientation towards collective achievement and team credit combined with individual sense of responsibility and accountability for teamwork and product<li> <li>Adept at leading through ambiguity and provide steadiness and consistency among shifting priorities<li> <li>Comfortable with fastpaced and nimble organizational environment<li> <li>Demonstrated experience in building highly effective and motivated crossfunctional teams and in guiding teams and organizations in making complex and highstakes datadriven decisions<li> <li>Proven acumen for crossfunctional leadership and influencing without direct authority both among crossfunctional team members and senior functional leaders<li> <li>Demonstrated scientific knowledge and curiosity necessary for thought partnership across all functions<li> <li>Proven ability to establish and maintain credible and trustbased relationships with external stakeholders eg KOLs patient advocacy groups regulators or investors<li> <li>Outstanding sense of urgency and ability to pace the teams work to achieve milestone achievement in highly competitive landscape<li> <li>Excellent communication skills verbal written presentation and ability to clearly communicate complex ideas stakeholders and teams at all levels<li> <li>Natural focus on team dynamics and proven ability to coach and support team members to perform at their best<li> <li>Effective peopleoriented collaboration skills in an environment with cross internal functional teams and thirdparty collaboratorsvendors<li> <li>Team player and mentor who listens effectively and invites response and discussion<li> <li>Collaborator who communicates in an open clear complete timely and consistent manner<li> <ul><p>LIOnsite<p> <div> <p>The statements contained herein reflect general details as necessary to describe the principles functions for this job the level of knowledge and skill typically required and the scope of responsibility but should not be considered an allinclusive listing of work requirements Individuals may perform other duties as assigned including work in other functional areas to cover absences or relief to equalize peak work periods or otherwise balance workload<p> <p>This description is not intended to be constructed as an exhaustive list of duties responsibilities or requirements for the position This position may change or assume additional duties at any time The employee may be requested to perform different or additional duties as assigned All Employees are expected to adhere to all company policies and act as a role model for company values<p> <p><em><span>Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age color disability gender national origin race religion sexual orientation veteran status or any classification protected by federal state or local law<span><em><p> <div>
Human Resources / Talent Acquisition Intern
Company: 4D Molecular Therapeutics - (4DMT)
Location: Other US Location
Posted Mar 13, 2024
<div> <p><em><strong>Attention recruitment agencies<strong> All agency inquiries are vetted through Talent Acquisition No unsolicited resumes will be accepted Agencies must be expressly engaged by the 4DMT talent acquisition team on any requisition Agencies reaching out directly to hiring managers will not be tolerated and may impact your ability to work with 4DMT in the future<em><p> <p><br ><p><p>4DMT is a clinicalstage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines We seek to unlock the full potential of gene therapy using our platform Therapeutic Vector Evolution TVE which combines the power of directed evolution with our approximately one billion synthetic AAV capsidderived sequences to invent evolved vectors for use in our products We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles These profiles will allow us to treat a broad range of large market diseases unlike most current genetic medicines that generally focus on rare or small market diseases <p> <p>We have built a deep portfolio of AVVbased gene therapy product candidates with five product candidates in clinical trials 4D150 for the treatment of wet agerelated macular degeneration wet AMD and diabetic macular edema DME 4D710 for the treatment of cystic fibrosis lung disease 4D310 for the treatment of Fabry disease cardiomyopathy 4D125 for the treatment of Xlinked retinitis pigmentosa XLRP and 4D110 for the treatment of choroideremia In addition we have two product candidates in preclinical studies 4D175 for geographic atrophy GA and 4D725 for alpha1 antitrypsin deficiency<p> <p>Todate we have demonstrated clinical proofofconcept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors We have built a robust and efficient product engine with 6 open Investigational New Drug Applications INDs in the US 1 IND in Taiwan and 1 Clinical Trial Approval CTA in Australia We believe we are positioned to create develop manufacture and if approved effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases<p> <p>In addition to TVE our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material This internal capability and close collaboration between our RampD and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT<p> <p>Company Differentiators <p> <p> Fully integrated clinicalphase company with internal manufacturing<br > Demonstrated ability to move rapidly from idea to IND<br > Five candidate products in the clinic and two declared preclinical programs<br > Robust technology and IP foundation including our TVE and manufacturing platforms<br > Initial product safety and efficacy data substantiates the value of our platforms<br > Opportunities to expand to other indications and modalities within genetic medicine<p> <div> <p><strong><span datacontrast=auto>GENERAL SUMMARY<span><strong><span dataccpprops=> <span><p> <p><span datacontrast=auto>We are seeking an Intern for our Human Resources Department where you will be a member of the Talent Acquisition TA team This role will be based in Emeryville CA at our companys headquarters <span><span dataccpprops=> <span><p> <p><strong><span datacontrast=auto>RESPONSIBILITIES <span><strong><span dataccpprops=> <span><p> <p><strong><span datacontrast=auto>Talent Acquisition 85 of TIME <span><strong><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=3 datalistdefnprops= dataariaposinset=1 dataarialevel=1><span datacontrast=auto>Shadow the team during TA meetings Intake meetings interviews and debrief meetings<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=3 datalistdefnprops= dataariaposinset=2 dataarialevel=1><span datacontrast=none>Attend department meetings and contribute to team discussions<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=3 datalistdefnprops= dataariaposinset=3 dataarialevel=1><span datacontrast=auto>Perform hands on work to <span><span dataccpprops=> <span><li> <ul><ul><li dataleveltext=o datafont=Courier New datalistid=3 datalistdefnprops= new= dataariaposinset=1 dataarialevel=2><span datacontrast=auto>Upload resume books into applicant tracking system<span><span dataccpprops=> <span><li> <li dataleveltext=o datafont=Courier New datalistid=3 datalistdefnprops= new= dataariaposinset=2 dataarialevel=2><span datacontrast=auto>Schedule panel interviews<span><span dataccpprops=> <span><li> <li dataleveltext=o datafont=Courier New datalistid=3 datalistdefnprops= new= dataariaposinset=3 dataarialevel=2><span datacontrast=auto>Be onsite to monitor onsite interviews<span><span dataccpprops=> <span><li> <li dataleveltext=o datafont=Courier New datalistid=3 datalistdefnprops= new= dataariaposinset=4 dataarialevel=2><span datacontrast=auto>Review and edit TA slide decks<span><span dataccpprops=> <span><li> <li dataleveltext=o datafont=Courier New datalistid=3 datalistdefnprops= new= dataariaposinset=5 dataarialevel=2><span datacontrast=auto>Design a weekly social media post highlighting a requisition<span><span dataccpprops=> <span><li> <ul><p><strong><span datacontrast=auto>HR Operations 15 of TIME<span><strong><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=4 dataarialevel=1><span datacontrast=auto>Contribute to monthly newsletter<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=5 dataarialevel=1><span datacontrast=auto>Photograph monthly socials and other activities<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=6 dataarialevel=1><span datacontrast=auto>Additional duties as assigned<span><span dataccpprops=> <span><li> <ul><p><strong><span datacontrast=auto>QUALIFICATIONS<span><strong><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=7 dataarialevel=1><span datacontrast=auto>Senior standing or recent undergraduate Business Administration Human Resources or other relevant course work<span><span dataccpprops=> <span><li> <ul><p><br ><p><p>Base salary compensation range<p> <p>$2200hr for undergraduate <p> <p>$2500hr for Masters <p> <p><br ><br ><p><div> <p>4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race color religion gender sexual orientation national origin age disability genetic information marital status status as a covered veteran and any other category protected under applicable federal state provincial and local laws<p> <p> <p> <p>Equal Opportunity EmployerProtected VeteransIndividuals with Disabilities<p> <div>