Jobs at Click Therapeutics
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Associate Director, Analytical Science and Technology
Company: Kyverna Therapeutics
Location: Other US Location
Posted Mar 14, 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>Reporting to the Senior Director of Technical Analytical Development the Associate Director of Analytical Science and Technology AD ASampT is responsible for establishing the Analytical Science and Technologies group The group will be responsible for drug product lifecycle management data analytics and analytical operations including the implementation of automation to development lab workflows The AD will work closely with the Tech AD team to build the ASampT function and support the hiring of staff as appropriate The AD ASampT will manage the effective execution of analytical method technology transfer troubleshooting and validation of a range of analytical methodologies at a number of analytical contract testing sites In addition they will work closely as an analytical subject matter expert to support colleagues in our manufacturing quality and regulatory functions to define specifications and development and management of the overall control strategy including inprocess and product characterization strategies as the department subject matter expert in lifecycle management This role will be responsible in collaboration with manufacturing and quality for data collection verification and analysis across the manufacturing landscape The individual will present datadriven recommendations to crossfunctional leadership teams based on their thorough and indepth understanding of the analytical issues involved <p> <p><b>Responsibilities<b> <p><ul><li>Analytical Operations Define and develop team procedures and processes to support analytical operations inhouse testing of PD materials and testing of materials from contract development and manufacturing organizations for process and drug product characterization as well as analytical method development <li> <li>Data Analytics Support and manage data analytics collection verification automation visualization for drug product characteristics release characterization inprocess testing across the portfolio <li> <li>Life Cycle Management Support the establishment of control strategies for lentiviral vector and CART cells to support release and characterization testing of both autologous and allogeneic drug products <li> <li>Work closely with Quality Manufacturing and Regulatory team members to ensure appropriateness of release specifications assay controls characterization panels and control of raw materials for the development stage of each program <li> <li>Work closely with both internal and external subject matter experts to ensure successful analytical method technology transfer <li> <li>Support and manage outsourced analytical methods across a global network of vendors for clinical stage lentiviral vector and drug product manufacturing <li> <li>Support the strategy and effectively guide and direct the execution of assay validation transfer optimization and development appropriate to support clinical manufacturing <li> <li>Work closely with Quality and Manufacturing colleagues in support of and to analyze data relating to lot release testing inprocess testing stability testing stability analysis characterization and assay qualificationvalidation <li> <li>Help prepare and review CMC documentation for analytical sections of regulatory filings to multiple agencies to support Kyvernas global regulatory strategy <li> <li>Work with cross functional teams to meet company goals <li> <li>Analyze and trend testing results Prepare and present clear datadriven presentations and propose solutions based on these data <li> <li>Author and review clear and concise technical reports development plans technical protocols and other documentation <li> <li>Other duties as assigned <li> <ul><p><b>Requirements<b> <p><ul><li>PhD in biochemistry biology immunology genetics or related area with at least 7 years of relevant pharmaceutical biotech experience or BSMS with a corresponding equivalent number of years of relevant experience at least 4 of which include analysis of genetically modified cells or gene therapies <li> <li>Experience with management of contract analytical work in CAR T or other exvivo cell therapeutic discipline andor lentiviral vector including analytical method development technology transfer and validation <li> <li>Broad experience in analytical techniques used to interrogate exvivo cell therapies CART and LVV including but not limited to molecular techniques ddPCR qPCR NGS flow cytometry cellbased methods bioassays luciferasebased reporter systems killing assays imaging techniques <li> <li>Experience establishing and managing analytical control strategies for LVV transduced cell therapies or similar modalities during multiple stages of the product development lifecycle <li> <li>Experience effectively managing teams in a fastpaced high stakes environment <li> <li>Significant experience with analytical development method fit for purpose assessments including validation and assay troubleshooting in advanced therapy medicines lentiviral vector gene therapies and exvivo cell therapies Experience should span several or all of molecular cytometry immunoassay residuals and cellbased assay methodologies <li> <li>A strong scientific mindset and ability to effectively interrogate data to build and communicate an understanding of assay and product behavior and to justify datadriven proposals and recommendations <li> <li>An understanding of the cGMP requirements of analysis of exvivo CART cell therapies <li> <li>Familiarity with statistical analysis and statistical process control <li> <li>Effective written and oral communication skills <li> <li>Proven track record of effectively working with others to achieve group goals while contributing at a high level to solve problems and effectively manage time and priorities <li> <li>Occasional travel to support vendor management activities will be expected for this position <li> <ul><p> <p><p><span>The base salary range for candidates residing in California for this position is $170000 $205000 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 relevant experience tenure skills and abilities geographic location 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>
Manager, Safety Operations
Company: Cerevel Therapeutics
Location: Boston, MA
Posted Mar 15, 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> <p><b><span><u>Role Summary<u><span><b><p> <p><br ><p> <p>We are looking for an experienced Drug Safetypharmacovigilance professional who will be an integral member of the Safety Operations and Compliance group within the Global Drug Safety GDS department This individual will be responsible for supporting the GDS Director in overseeing all aspects of safety vendor management including case workflow regulatory submissions and compliance management across all Cerevel clinical study protocols Previous experience in endtoend safety case management of collectable safety events serious adverse events adverse events of interest pregnancy from clinical studies Additional experience sought includes end user experienceconfiguration of safety database managing vendor to vendor communications regulatory reporting proficiency and compliance audit metrics experience Uptodate knowledge of current global regulations and industry guidelines governing pharmacovigilance is critical This role reports to the GDS Director of Safety Operations and Compliance but requires the ability to work independently and collaboratively with associated departments within the Clinical Medical Organization <p> <p><b>Key Responsibilities<b> <p><ul><li>Participates in the daily management operational oversight and execution of delegated operational safety tasks for all Cerevel clinical programs<li> <li>Represents GDS Operations and Compliance GDS Operations Lead within clinical development teams as required<li> <li>Provide Sponsor oversight of delegated safety responsibilities outsourced to safety vendor including the timely and accurate execution of the processes defined within the applicable Safety Management and Safety Reporting plans <li> <li>In conjunction with others in GDS Operations team oversee case workflow case receipt through submission between safety vendor and Cerevel Safety Medical Reviewer<li> <li><b><u>Additional tasks include<u><b><li> <li>Overseesensures safety case queries are resolved as per defined processes interfacing with clinical operations team and clinical vendors as required<li> <li>Monitors performance metrics other reports of the safety vendor and the quality output of the ICSRs provides appropriate feedback and training<li> <li>As required present safety reporting processes according to study protocol at Investigator Meetings or to other required audience<li> <li>Ensures safety cases are closed within required timelines with resolution of required queries<li> <li>Supports safety data reconciliation activities and ensures safety vendor responsibilities are completed within the required timelines <li> <li>Monitoring of reporting and quality compliance through case oversight and quality metrics report review ensures the implementation of effective corrective and preventative action plans are in place for any quality issues<li> <li>Collaborates with Quality department to effect vendor inspections and internal department audits in effort to maintain a state of high PV inspection readiness for the organization<li> <li>Competency in clear written and oral communication and excellent attention to detail and resolution of tasks and objectives<li> <ul><p><b>Required Qualifications<b> <p><ul><li>3+ years of clinical safety End to End case processing in small biotechpharma andor CRO<li> <li>Pharmacovigilance project management experience<li> <ul><p><b>Desired Qualifications <b> <p><ul><li>Safety vendor management and oversight experience<li> <li>Safety database configuration and end user experience<li> <ul><p><b>Education<b> <p><ul><li>BS or MS in Scientific Discipline<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>
Patent Agent / Counsel
Company: ReCode Therapeutics
Location: Peninsula
Posted Mar 14, 2024
Excellent writing, communication, organizational, problem-solving, and analytical skills. A PhD degree in a biotech-related discipline, such as cell or molecular biology, genomics, microbiology, immunology, biochemistry, bioinformatics, chemistry, or cancer biology. Excellent organizational skills. ReCode Therapeutics is an Equal Opportunity Employer. Preferred Qualifications: Experience managing outside counsel. Advanced degree preferred. Build strong, collaborative relationships with stakeholders across internal teams, including R&D, pre-clinical and clinical teams, BD, and legal. Experience with LNPs and mRNA therapeutics J.D. Self-directed and proactive, and comfortable executing on multiple projects independently and in collaboration with others. Application and knowledge in any of the areas of life science tools, molecular biology assays, genomic analyses.
Software Engineer
Company: Click Therapeutics
Location: New York City, NY
Posted Mar 14, 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 >We are looking for a motivatedSoftware Engineer with exceptional ability to build scalable frontend applications This role will be supporting an expanding list of mobile applications that meet the needs of patients in innovative ways Currently our focus is on expanding our platform to provide quality efficiency and consistency for our existing therapeutic applications We have a growing list of public private and privileged digital therapeutics and our software meets our patients on our mobile applications iOS and Android which are supported by APIs hosted within our secure virtual private cloud We are investing in our quicklyexpanding data science and analytics prediction and personalization services and strive to greatly advance realtime machine learning to provide a personal user experience to each patient We are looking for candidates who share our focus and care for the success of our product and business as well as driving lifechanging outcomes for our patients<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>Learn and collaborate in a fastmoving and dynamic environment<li> <li>Participate in the planning and estimation of the implementation of product requirements<li> <li>Participate in code reviews pairing sessions demos and tech talks<li> <li>Implementation of mobile applications component libraries API services and design systems<li> <li>Partner closely with product owners engineering leads managers and UX designers to build experiences users will love<li> <ul><p> <br ><strong>Qualifications<strong><br ><p><ul><li>BS in Computer Science or related field<li> <li>4+ years of experience building front end applications or mobile applications<li> <li>Experience in development with JavaScript and strong understanding of fundamentals of the modern stack<li> <li>Strong knowledge and experience using JavaScript ES6+ CSS 3 and HTML 5 Experience with preprocessors such as SASS and styled components is a big plus<li> <li>Experience with frameworks such as React Native preferred or extensive experience with React or other similar frameworks and desire to learn React Native<li> <li>Experience writing automated tests with tools such as Jest<li> <li>Experience creating component libraries or Design Systems with React to build and contribute to our component library<li> <li>Comfortable integrating and troubleshooting backend services within the system<li> <li>Familiarity with AWS Kubernetes Docker CircleCI npm yarn and Github<li> <li>Comfortable working in an Agile development environment as well as interfacing with cross functional partners such as Design and Product<li> <ul><p> <br ><strong>Compensation<strong><br >The base salary range for this position is between $147500 $173500 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 | 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>
Sr. Manager, Translational Sciences Project Management
Company: Scribe Therapeutics
Location: East Bay
Posted Mar 14, 2024
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status. The offered pay range will depend on internal equity and the candidate’s relevant skills, experience, qualifications, training, and market data. Excellent interpersonal, influencing and communication skills. Foster a driven, fast-paced, dynamic, and fun environment in which to do rigorous science. We will provide an intellectually stimulating, collegial and fast-paced environment. Visit us at www.scribetx.com. Create and maintain project and department documentation including agenda, minutes, action items, dashboards, goals and milestones. At the time of posting, the base pay wage range for this role is $150,000-190,000 per year. Participate in study team, cross-functional and Translational Sciences meetings. Develop presentations to update stakeholders on scenarios, progress and timelines.
QC Analyst
Company: Beam Therapeutics
Location: Raleigh-Durham, NC
Posted Mar 14, 2024
<p><strong>Position Overview<strong><p> <p>Beam is seeking a highly motivated and energetic Analyst to join our growing QC analytical team The <strong>Quality Control Analyst <strong>will be responsible for performing various analytical methods to evaluate the quality of critical inprocess samples to support cGMP manufacturing operations across multiple site programs This role will also be responsible for daily laboratory operations including reagent receipt and inventory management and equipment maintenance This position will support deviation initiation and investigations as well as implementation of continuous improvements The Analyst will support critical analytical method implementation workstreams in support of program startup and scale up<p> <p>This role will work closely with team members in Quality Assurance Manufacturing MSampT and Analytical Development The position will report to the Senior QC Manager The Analyst I is expected to be an onsite resource at Beams manufacturing facility in RTP North Carolina to support project startup and routine clinical and commercial operations<p> <p><strong>Responsibilities<strong><p> <ul><li>Cultivate Beams culture and our valuesdriven organization focused on people<li> <li>Execute against the mission vision and strategy for Beam internal Quality organization<li> <li>Ensure safety compliance efficiency and sustainability throughout cGMP testing<li> <li>Execution of inprocess analytical methods including flow cytometry cell blood count cell count and viability HPLC and platebased ELISAs<li> <ul><ul><li>Real time documentation within data sheets and LIMS following appropriate test methods SOPs and ALCOA+ principles<li> <li>Responsible for daily and weekly lab tasks to maintain general upkeep of the laboratory such as room cleaning and inventory management<li> <li>Perform QC laboratory instrument maintenance including cleaning calibration and supporting preventative maintenance according to preestablished maintenance schedules<li> <ul><ul><li>Analyze and interpret data within given parameters escalate unexpected results to area manager and provide support for deviation initiation investigation and CAPAs<li> <li>Tracking ordering and stocking of laboratory reagents and materials<li> <li>Clearly and concisely communicate complex issues to peers manager and to other crossfunctional teams<li> <ul><p><strong>Qualifications<strong><p> <ul><li>Bachelors degree required preferably in a chemistry life science or related discipline<li> <li>13 years relevant bioanalytical assay experience including flow cytometry andor ELISA methods<li> <li>Prior GMP experience is preferred<li> <li>Advanced technical writing skills and problemsolving ability<li> <li>Ability to work in a highpaced team environment meet deadlines and prioritize tasks across multiple projects<li> <li>Advanced ability to communicate effectively with peers and demonstrate collaboration across different functional groups<li> <li>Must be able to work onsite daily and willing to have a flexible schedule during peak times which may include supporting critical operations outside of normal work hours as needed<li> <ul>
Associate Director, Pipeline & Portfolio Market Planning
Company: Corcept Therapeutics
Location: Peninsula
Posted Mar 14, 2024
<div> <p>At Corcept Therapeutics we believe the potential impact of cortisol modulation on the future of health has long gone overlooked That is why for twentyfive years we have pushed the boundaries of what is possible driven by fiercely independent science open collaboration and the curiosity to follow the data wherever it leads<p> <p>Our company is committed to building a culture that values diverse perspectives and the unique contributions of every employee Our vibrant community is made up of over 300 peoplemedical practitioners scientists and industry professionalsall with the shared goal of advancing the science of cortisol modulation to treat serious disease<p> <p>Our work has uncovered over 1000 proprietary selective cortisol modulators including our marketed product Korlym® mifepristone the first treatment available for those living with Cushings syndrome a lifethreatening condition caused by excess cortisol activity Today we have a unique opportunity to revolutionize the treatment of severe endocrine oncology metabolism and neurology disorders and aim to deliver better outcomes for the people affected by them<p> <div> <p>The Associate Director Pipeline and Portfolio Market Planning is accountable for developing product strategies including indication selection and sequencing global market and disease understanding competitive landscape assessments patient journey and treatment paradigms target product profiles TPPs product differentiation positioning and value proposition forecasting and market accesspricing dynamics for select pipeline programs The therapeutic area scope will initially focus on oncology with increasing responsibilities across other therapeutic areas<p> <p><strong>Responsibilities<strong><p> <ul><li>Lead programlevel strategy projects and initiatives in support of maximizing portfolio value<li> <li>Synthesize data from various sources including primary market research secondary data and analytics into actionable insights<li> <li>Provide physician patient and payer perspective into clinical strategy and planning<li> <li>Develop amp maintain longrange revenue forecasts and valuations for new programs<li> <li>Develop competitive intelligence tracking tools and analysis to support programs<li> <li>Work crossfunctionally with Commercial teams and Development organization to support integrated planning activities<li> <li>Create and manage target product profiles TPPs for pipeline products working with development team to influence and support clinical development decisions<li> <li>Manage ad hoc strategic projects across portfolio<li> <li>Conduct asset assessments and due diligence for business development opportunities<li> <ul><p><strong>Preferred Skills Qualifications and Technical Proficiencies<strong><p> <ul><li>Ability to master new therapeutic areas across multiple perspectives including scientific clinical commercial and regulatory<li> <li>Solid understanding of market research principles<li> <li>Ability to develop and deliver compelling presentations to senior management<li> <li>Ability to rapidly synthesize information from multiple sources communicate ideas and data both verbally and written in a persuasive manner<li> <li>Ability to lead across a matrixed organization and to integrate crossfunctional thinking into a clear strategy<li> <li>Strong understanding of the drug development process for early through latestage programs<li> <li>Occasional travel required for corporate and industry events<li> <ul><p><strong>Preferred Education and Experience<strong><p> <ul><li>Bachelors degree required Advanced degree preferred MBA MSc PhD PharmD<li> <li>5+ years in product planning preferred with relevant professional experience in new product planning market planning corporate development andor healthcare strategy consulting considered<li> <li>Industry experience within oncology required<li> <li>Experience on a crossfunctional drug development team preferred<li> <ul><p>The pay range that the Company reasonably expects to pay for this headquartersbased position is $204500 $240600 the pay ultimately offered may vary based on legitimate considerations including geographic location jobrelated knowledge skills experience and education<p> <p><strong> <strong>Applicants must be currently authorized to work in the United States on a fulltime basis<p> <p>If you are based in California we encourage you to read this important information for California residents linked here<p> <div> <p>Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs<p> <p><strong> <strong><strong>Please visit our website at httpswwwcorceptcom<strong><p> <p><strong>Corcept is an Equal Opportunity Employer<strong><p> <p><em>Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview Though we use thirdparty tools to help with advertising our jobs please be vigilant in checking that the communication is in fact coming from Corcept<em><p> <p><strong><em> <em><strong><p> <div>
Senior Software Quality Assurance Tester
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 >The Senior Software Quality Assurance Tester will have a role in planning executing and reporting for testing of Clicks innovative Software as a Medical Device SaMD applications in development This individual will be part of the Quality Assurance team in technology and work closely with the Technology Development and alongside Quality Management team Business Operations and external development partners to help ensure that Click delivers an optimal user experience and effective treatment to patients <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>Perform manual execution of functional testing regression testing smoke testing exploratory testing and negative testing across various mobile devices in a dynamic environment with evolving strategy and scope<li> <li>Perform software testing based on business timelines and sprint schedules<li> <li>Create test scripts execute tests and prepare and present reports and metrics to management and development partners <li> <li>Own the process of tracking software defects through the problemresolution process<li> <li>Partner with Technology Development to help reproduce and diagnose issues<li> <li>Identify and recommend new tools and creative solutions to increase test performance and efficiency <li> <li>Assist with the implementation of Clicks Quality Management System processes throughout the organization<li> <li>Work with the Quality Management Team to manage the software release process and prepare technical documentation<li> <li>Support lead by taking ownership of side tasks such as daily reports bug vetting and coaching of new team members<li> <ul><p> <br ><strong>Qualifications<strong><br ><p><ul><li>Bachelors degree in Engineering Computer Science Information Systems or a related STEM field<li> <li>5+ years experience in software testing preferably mobile applications both iOS and Android applications<li> <li>Experience working in an Agile development environment alongside other functions as part of a scrum team<li> <li>Ability to coordinate and execute on multiple simultaneous projects <li> <li>Ability to cope under pressure and to work to tight deadlines<li> <li>Strong verbal and written communication skills organizational skills and attention to detail<li> <li>Excellent analytical skills an affinity for problemsolving and the ability to understand complex relationships between product functionality and requirements<li> <li>Experience with common software development tools such as JIRA and test case management Tool such as Zephyr ScaleTest Rail<li> <ul><p> <br ><strong>Preferred Qualifications <strong><br ><p><ul><li>Experience working within FDA 21 CFR 820 andor ISO 13485 medical device quality management system regulations<li> <li>Experience creating medical device technical files or other technical writing<li> <ul><p> <br ><strong>Compensation<strong><br >The base salary range for this position is between $85000 $110000 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>
Research Associate, Flow Analytical Development
Company: Kyverna Therapeutics
Location: Other US Location
Posted Mar 14, 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> Kyverna is recruiting a highly motivated Research Associate Flow Analytical Development to contribute to flow cytometry assay development in its Analytical Development group to help advance its mission to free patients from the siege of autoimmune disease The candidate will be responsible for performing laboratorybased studies and providing technical expertise to design develop optimize validate qualify and tech transfer methods across technologies including cellbased assaysT cell culture potency assay proliferation etcimmunoassays multiplex immunoassays single cellbased proteomics and multicolor flow cytometry <span><p> <p><span> <span><p> <p><span>The ideal candidate will develop methods to characterize monitor and understand the attributes of engineered cells that are part of the Kyverna pipeline using advanced technologies and lead assay qualificationvalidation to support pipeline programs The ideal candidate will contribute to our goals of navigating whats next in gene transfer technologies immunology and cell engineering while living our core values Bring Intellectual Rigor Elevate Each Other and Stay True To Why <span><p> <p><b>Responsbilities<b> <p><ul><li>Support development of robustflow cytometry assays and panels to characterize and phenotype starting material inprocess and engineered cellular products <li> <li>Assist with methods qualification and validation in support of regulatory filing and tech transfer <li> <li>Support inhouse Process Development by providing analytical testing and data analysis <li> <li>Analyze data to support regulatory filings and evaluate new technologies <li> <li>Support operation and management of Technical Development workflows <li> <li>Work with typical biological software such as Benchling FlowJoPrism <li> <li>Organize data for writing test procedures SOPs and protocols <li> <li>Maintain good electronic notebook record of performed studies <li> <li>Collaborate with research and technical development within Kyverna and CMOCRO organizations supporting the business <li> <li>Other duties as assigned <li> <ul><p><b>Requirements<b> <p><ul><li>Bachelors or Masters degree with 1+ years of industry experience in biological sciences such as biochemistry molecular and cell biology or a related discipline T cell biology and immunology background are preferred <li> <li>Experience with multicolor flow cytometry Experience with complex cell phenotyping panels preferred Previous experience using Beckman Coulter Cytoflex flow cytometers a plus but not required <li> <li>1+ years of experience with mammalian tissue culture including both adherent and suspension cells <li> <li>Previous experience with Benchling and flow cytometry analysis programs such as Flowjo or Cellengine strongly preferred <li> <li>Experience with immunostaining and visualization assays such as immunofluorescence staining and microscopy a plus <li> <li>Experience with immunoassays such as ELISA Ella Isoplex MSD and Western blot analysis a plus <li> <li>Ability to execute experiments with minimal technical supervision <li> <li>Ability to multitask work effectively as part of a team and meet deadlines in a fastpaced environment<li> <li>Ability to think critically and demonstrate troubleshooting and problemsolving skills <li> <li>Document laboratory procedures and experiments with great attention to detail and maintain accurate lab records and notebooks <li> <li>Author protocols reports and standard operating procedure documents as needed <li> <ul><p> <p><p><span>The salary range for this position is from $75000 $90000 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>
Marketing Manager (Digital) - Remote
Company: Prime Therapeutics
Location: Remote
Posted Mar 14, 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>Marketing Manager Digital Remote<strong><b>Job Description<b><strong> <p> <p>The Marketing Manager is responsible for driving the development and execution of quality marketing initiatives to meet Prime Therapeutics business needs sales and product objectives This position leads collaborates with cross functional partners to bring an integrated and strategic approach to sales support and communications planning <p> <p><b>Responsibilities<b> <p> <ul><li>Strong understanding of SEO SEM email marketing social marketing and content marketing<li> <li>Ability to conceptualize plan and execute digital marketing campaigns across various channels including web email social media and other digital platforms from ideation to implementation monitoring and optimization<li> <li>Experience with website analytics tools Google Analytics Adobe Analytics<li> <li>Knowledge of CRM systems and marketing automation tools<li> <li>Ability to develop and implement digital marketing strategies<li> <li>Excellent analytical skills and ability to interpret data to make informed decisions<li> <li>Uptodate with the latest trends and best practices in digital marketing<li> <li>Certifications such as Google Ads certification HubSpot certification etc are a plus<li> <li>Proficiency in web content management systems such as WordPress or LifeRay including frontend editing skills and basic HTML coding knowledge with the ability to troubleshoot and make necessary updates independently<li> <li>Collaborate with crossfunctional business partners and stakeholders to understand Primes business objectives product offerings client utilizationadoption and history and intended market positioning<li> <li>Translate business insights into marketing strategies and create messaging that is clear defensible and differentiates Prime and our products and services in the market<li> <li>Other duties as assigned<li> <ul><p><b>Minimum Qualifications<b> <p> <ul><li>Bachelors degree in marketing communications 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 work experience in related marketing roles including B2B marketing product marketing andor communications<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 write and manage communication pieces for a wide variety of audiences<li> <li>Strong interpersonal communication skills including team leadership conflict resolution and listening<li> <li>Ability to work under pressure and manage multiple complex projects simultaneously without compromising quality<li> <li>Ability to work independently and at time work with ambiguity<li> <ul><p><b>Preferred Qualifications<b> <p> <ul><li>Experience in the health insurance or Pharmacy Benefits Management PBM industry<li> <li>Leadership experience<li> <li>Experience designing marketing campaigns for both businesstobusiness and businesstoconsumer audiences<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 a Manager Director or Sr Director in the Marketing 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 Scientist, Bioanalysis
Company: Dyne Therapeutics
Location: Waltham
Posted Mar 13, 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><span>This role plays a critical role in advancing our pipeline of novel treatments through the application of cuttingedge bioanalytical techniques This includes designing developing optimizing and validating bioanalytical in complex biological matrices with a focus on muscle tissue and fluids The person in this role is expected to utilize stateoftheart LCMSMS instrumentation for the quantitative analysis of biomarkers metabolites and therapeutic compounds in preclinical and clinical samples<span><p> <p>This role is based in Waltham MA without the possibility of being a remote role Candidates must be able to relocate<p> <p><strong>Primary Responsibilities Include<strong><p> <ul><li>Provide bioanalytical support for portfolio including complex method development and troubleshooting for PK and immunogenicity assays across several programs<li> <li>Collaborate crossfunctionally with Platform Research and NonClinical teams<li> <li>Design develop andor optimize sensitive quantitative assays to measure Dyne proprietary drugs in different matrices plasma urine tissues and from different species rodents nonhuman primates human<li> <li>Setup and maintain lab instrumentation<li> <li>Evaluate assay performance ability to troubleshoot issues<li> <li>Perform data analysis and interpretation<li> <li>Track progress against project timelines generate regular status updates and communicate progress and issues to management<li> <li>Maintain a welldocumented laboratory notebook<li> <li>Effectively manage workload with minimal supervision<li> <li>Adhere to safe laboratory practices<li> <li>Multitask across several projects and manage time effectively to achieve results<li> <li>Collaborate to identify external vendors CRO for new outsourced projects and request contracts<li> <li>Transfer bioanalytical assays to CROs oversee assay validation and sample testing<strong> <strong><li> <ul><p><strong>Education and Skills Requirements<strong><p> <ul><li>BS or MS in Pharmaceutical sciences with at least 68 years of experience in the pharmaceutical industry or PhD degree with at least 4 years of industry experience<li> <li>Broad and indepth knowledge of FDA bioanalytical guidance to industry<li> <li>Handson assay development experience with different ligand binging assay formats and detection methods required<li> <li>Strong assay troubleshooting data analysis and interpretation skills<li> <li>Excellent verbal and written communication skills<li> <li>Ability to work collaboratively in a teamoriented environment<li> <li>Strong attention to detail organizational skills and ability to multitask<li> <li>Demonstrated ability to troubleshoot and solve problems<li> <ul><p><br ><p><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>
Senior Specialist, QA Operations
Company: CRISPR Therapeutics
Location: Other US Location
Posted Mar 14, 2024
<p><b>Company Overview<b><p> <p>Since its inception over a decade ago CRISPR Therapeutics has transformed from a researchstage company advancing programs in the field of gene editing to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies oncology regenerative medicine cardiovascular and rare diseases The Nobel Prizewinning CRISPR science has revolutionized biomedical research and represents a powerful clinically validated approach with the potential to create a new class of potentially transformative medicines To accelerate and expand its efforts CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer and Vertex Pharmaceuticals CRISPR Therapeutics AG is headquartered in Zug Switzerland with its whollyowned US subsidiary CRISPR Therapeutics Inc and RampD operations based in Boston Massachusetts and San Francisco California and business offices in London United Kingdom<p> <p><b>Position Summary<b><p> <p>Reporting to the Associate Director Quality Operations the Senior Specialist is responsible for supporting ongoing GMP operations throughout the facility Some roles to highlight that are covered under this responsibility are Warehouse support and raw material disposition Manufacturing record review and floor support Drug Product disposition and shipment<p> <p><b>Responsibilities<b><p> <ul><li>Supporting routine Warehouse activities including raw material release receipt of critical materials and cold storage movements<li> <li>Assisting the Manufacturing team in completing routine processes such as cleaning equipment logbook review batch record approval vial inspection and maintenance events occurring within the controlled areas<li> <li>Approval of Equipment and Facility lifecycle and maintenance documentation within the Blue Mountain System Some of this work includes discussions around Preventative Maintenance schedules Unplanned events within the facility and Facility shutdown planning and oversight<li> <li>Acting as a QA SME in supporting the development and implementation of processes aimed to support compliant robust and sustainable operations for facilitiesutilities and equipment warehouse logistics shipping manufacturing cleaning and process<li> <li>Authormaintain team SOPs and related documents to ensure compliant processes are continuous within the department<li> <li>Lead the implementation of QA Operations strategies and act as SME to support other departments efforts on site<li> <li>Utilize the QMS system to manage deviations change controls and CAPAs<li> <li>Intake of potential deviation events and assisting in their mitigation from departments supported by this team<li> <li>Supporting supplier qualification efforts<li> <li>Participating in internal audits and regulatory inspections<li> <li>Gathering preparing and reporting relevant Quality Metrics<li> <li>Work with key internal partners including Quality Assurance Manufacturing Facilities Quality Control MSAT and Supply Chain<li> <ul><p><b>Minimum Qualifications<b><p> <ul><li>BS with 57+ years of experience or an advance degree with 46+ years of experience QA operations cell therapy GMP manufacturing supply chain or compliance in a highly regulated GMP environment<li> <li>Experience in the development execution and approval of SOPs and batch records<li> <li>Experience in raw material receipt disposition and warehouse operations<li> <li>Proficiency working within a GMP warehouse or similar environment<li> <li>Experience with gowning into a Grade B cleanroom and knowledge of proper etiquette when working within one<li> <li>Experience with the use of electronic systems to ensure compliance<li> <li>Excellent written and verbal communication skills with the ability to communicate crossfunctionally<li> <li>Innovative and strategic compliance skills including identification and implementation of best practices<li> <li>Ability to organize and prioritize workload to meet deadlines and companys objectives<li> <li>Ability to work independently and within crossfunctional teams<li> <li>Ability to mentor less experienced staff members<li> <ul><p><b>Preferred Qualifications<b><p> <ul><li>Prior experience working in cell or gene therapy<li> <ul><p><b>Competencies<b><p> <ul><li>Collaborative Openness One Team<li> <li>Undaunted Fearless Cando attitude<li> <li>Results Orientation Delivering progress toward our mission Sense of urgency in solving problems<li> <li>Entrepreneurial Spirit Proactive Ownership mindset<li> <ul>