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Sr. Manager, Supply Chain Planning
Company: Corcept Therapeutics
Location: Peninsula
Posted Mar 12, 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>As Sr Manager Supply Chain Planning you will be responsible for developing end to end supply plans to ensure continuous drug supply for Corcepts global clinical trials This position will report to the Sr Director Supply Chain <p> <p><strong>Essential Duties and Responsibilities<strong><p> <ul><li>Develop supply plans for all Corcept clinical studies<li> <li>Perform scenario planning to support decisionmaking<li> <li>Provide clinical supply and risk mitigation recommendations<li> <li>Oversee inventory management of study drug and comparators at depots<li> <li>Maintain supply dashboards eg monthonhand and KPIs<li> <li>Work crossfunctionally to ensure supply plans are feasible<li> <li>Provide product costs to support international shipments<li> <li>Develop and implement appropriate Supply Chain SOPs<li> <ul><p><strong>Requirements<strong><p> <ul><li>BSBA degree in Life Science or a closely related field<li> <li>68 years of experience in a pharmaceutical or biotechnology company<li> <li>ASCM CPIMCSCP certifications preferred<li> <li>Working experience with global clinical trials and IRT systems is a must<li> <li>Working knowledge of cGMPs and familiarity with US and EU regulations<li> <li>Working knowledge of drug development process Phase IIV<li> <li>Excellent interpersonal verbal and written communication skills are essential in this collaborative fastpaced dynamic environment<li> <li>Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines<li> <li>Strong attention to detail with excellent followup<li> <li>Proficient in Microsoft Outlook Word Excel PowerPoint<li> <ul><p>The pay range that the Company reasonably expects to pay for this headquartersbased position is <span><span>$165000 $185000<span><span> the pay ultimately offered may vary based on legitimate considerations including geographic location jobrelated knowledge skills experience and education<p> <p>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 Principal Analyst, Clinical Programming
Company: Cerevel Therapeutics
Location: Boston, MA
Posted Mar 11, 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 Biometrics Department is seeking an Analyst of Clinical Programming to report to Director of Clinical Programming who will support statistical programming activities across all Cerevel clinical trials while also working closely with externally managed CROs and functional service providers FSPs The Analyst will contribute to the development and implementation of a highly efficient programming ecosystem to enable seamless production across internalexternal sourcing models and the delivery of timely high qualityCDISCcompliant and submissionready SAS programs SDTM ADaM and summary tables figures and listings This position requires a extensive knowledge of SAS and CDISC standards and a broad understanding of the pharmaceutical drug development process Strong organizational skills innovative problemsolving capabilities the agility to respond promptly and completely to timecritical tasks as well as strong communication skills are required<span><p> <p><b>Key Responsibilities <b> <p><ul><li>Work independently in executing statistical programming tasks and delivering high quality timely results<li> <li>Exercise independent judgement in selecting methods techniques and evaluation criteria for obtaining results <li> <li>Apply broad expertise and knowledge in highly complex disciplines of clinical trials data processes and safety and efficacy analysis generation<li> <li>Support integrated summaries ISEISS CSR conferencespublications adhoc analyses and regulatory deliverables<li> <li>Contribute to the development of standards best practices within the Biostatistics functional area that are consistent with highest industry standards Be recognized internally as a subject matter expert through significant contributions to the development of the functional area capabilities <li> <li>Build strong collaborations with Clinical Operations Data Management and Pharmacovigilance Provide thought leadership and work on broader organization projects<li> <ul><p><b>Required Qualifications<b> <p><ul><li>MS degree with 7+ years of experiences or BS degree with 10+ years of experiences in statistical programming in the in the CRO or Pharmaceutical Industry with mastery of SAS programming concepts across SASBase SASSTAT SASGraph SASIML and SASSQL<li> <li>Experiences with CDISC SDTM and ADaM models and complex clinical trial data <li> <li>Strong collaboration skills ability to work smoothly within the function and with crossfunctional teams<li> <li>Strong interests in all data elements of clinical trials<li> <li>Good understanding of the roles and responsibilities of related disciplines including Biostatistics Clinical Operation Clinical Data Management and Pharmacovigilance<li> <li>Strong verbal and written communication skills ability to clearly and effectively present information<li> <li>Familiarity with safety data and MedDRA and WHO drug coding dictionaries<li> <ul><p><b>Desired Qualifications<b> <p><ul><li>Experience or knowledge working in the CNS therapeutic area<li> <li>Regulatory filing experiences <li> <li>Ability to program in R Python SQL<li> <li>Familiarity with AIML technologies such as regression supervisedunsupervised machine learning<li> <ul><p><b>Education<b> <p><ul><li>BSMSMA in Statistics Biostatistics Computer Science Mathematics or related area<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>
Software Engineer - REMOTE
Company: Prime Therapeutics
Location: Minneapolis–Saint Paul, MN
Posted Mar 11, 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>Software Engineer REMOTE<strong><b>Job Description<b><strong> <p> <p>The Software Engineer IT is responsible for developing testing deploying and maintaining technology solutions This position analyzes designs and develops tests and testautomation This position collaborates crossfunctionally with team members to achieve innovative businessdriven technology solutions <p> <p><b>Responsibilities <b> <p> <ul><li>Design develop test deploy and maintain technology solutions and ensure solutions meet nonfunctional requirements assist with solution design<li> <li>Analyze design and develop tests and testautomation suites<li> <li>Use test driven development in an agile environment<li> <li>Leverage and contribute components for the continuous integration and continuous deployment pipeline for technology solutions<li> <li>Collaborate crossfunctionally with team members to achieve innovative businessresults driven technology solutions<li> <li>Consistently apply best practices and drive for continuous improvement<li> <li>Actively participate in Agile ceremonies<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>2 years of experience with application development or packaged software implementations<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>KotlinJava<li> <li>Spring BootWebSecurityData JDBC<li> <li>Monarch PCF or Tanzu<li> <li>Gradle GitHub<li> <li>Data Streaming Kafka RabbitMQ<li> <li>Security Spring Security OAuth2 Client and Resource Server<li> <li>Ability to be flexible and willing partner with and learn from more senior team members<li> <li>Ability to speak up to address opportunities<li> <li>Strong problemsolving and analysis skills<li> <li>Ability to drive innovation and be forward thinking<li> <li>Strong desire to learn<li> <li>Excellent documentation skills<li> <ul><p><b>Preferred Qualifications<b> <p> <ul><li>Experience working in environment with regulatory compliance requirements HIPAA PCI etc<li> <li>Previous experience working an in AgileProduct Delivery model<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>Ability to work a flexible schedule including weekends and shifts outside of Primes core business hours of 900 am to 300 pm as needed for technical support andor project needs<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>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>
Supply Chain Planner (Manager – Senior Manager)
Company: Karuna Therapeutics
Location: Boston, MA
Posted Mar 11, 2024
<p><strong>Position Supply Chain Planner Manager Senior Manager<strong><p> <p><br ><p><p><strong>Position Summary<strong><p> <p>Karuna is seeking an experienced and motivated Manager Senior Manager Supply Chain to join our rapidlygrowing organization Reporting to the Associate Director CMC Supply Chain this critical position will be responsible for the creation and maintenance of the US Supply Plan for all products from all external Third Party vendors within the portfolio to ensure the correct supply and stocking levels to support sales and operations This role with interface with a diverse team across Commercial Manufacturing Regulatory Quality and external partners to support key tasks related to planning of API DP and FG manufacturing and supply We are looking for a professional who has extensive experience in the biotechpharmaceutical industry and who has specific experience in GMP inventory management and planning experience in an ERP system<p> <p><br ><p><p><strong>Responsibilities<strong><p> <ul><li>Development and execution of robust supply plans to maintain adequate inventory levels to meet commercial demand<li> <li>Drive longterm supply chain strategy development and implementation across External Manufacturing amp Supply Operations in alignment with business and functional strategy goals<li> <li>Develop implement and control the Master Production Plan considering demand capacity and inventory constraints<li> <li>Interact with internal and external customers and suppliers to accomplish project objectives including packaging labeling shipment inventory management and drug return logistical activities<li> <li>Establish update and maintain policies and procedures required to maintain good manufacturing practices GMP and good distribution practices GDP compliance in the storage distribution and returns of commercial product<li> <li>Monitor inventory levels and provide feedback to Commercial Program leads and their direct Manager regarding expiry and resupply needs across inventory<li> <li>Regularly monitor API and drug expiry and the appropriate inventory levels at CMOs and 3PLs<li> <li>Support return and destruction of materials or finished goods from CMOs or sites<li> <li>Perform inventory checks and manage inventory levels and cycle count at the vendor yearly<li> <li>Provide accurate finished goods inventory availability dates to Commercial team<li> <li>Team with supply chain and operations to align market and financial requirements with manufacturing capabilities<li> <li>Complete inventory analyses as needed including tracking against targets estimated depletion and EampO risk<li> <li>Review challenge amp ensure execution of operational planning in collaboration with central planning functions<li> <li>Proactively identify analyze amp respond to potential issues affecting raw material planning production planning or supply chain overall<li> <li>Collaborate closely with suppliers amp internal stakeholders to optimize schedules amp production plans<li> <li>Identify amp resolve materialrelated issues<li> <li>Work closely with Supply Chain Sales Marketing Quality Regulatory Finance and Procurement to ensure effectiveness of the Supply Chain Processes in meeting overall service inventory and cost objectives<li> <li>Support the SampOP process by providing key metrics and product supply data as needed<li> <li>Drive to meet critical Customer Service Level targets On Time in Full<li> <li>Monitor Inventory ShortDate and BackorderOOS and develop risk mitigation plans via crossfunctional collaboration for solutions as needed<li> <li>Work with Procurement to ensure that suppliers are aligned to the latest strategic initiatives and adhere to the appropriate business technical and quality agreements<li> <ul><p><strong> <strong><p> <p><strong>Required Qualifications<strong><p> <ul><li>BS in a scientific field<li> <li>APICS CSCPCPIM certification is a plus<li> <li>Minimum 35 years of relevant experience<li> <li>Experience with Advanced Planning Systems eg JDE Oracle SAP APOSCM<li> <li>Proven experience with inventory management distribution and supply chain planning<li> <li>Commercial Supply Chain planning experience is a plus<li> <li>Specific experience in the areas of Supply Planning Materials Management Inventory Management Demand Planning and Sales Operations Planning<li> <li>Current knowledge of Good Manufacturing Practices cGMP Food and Drug Administration FDA and other regulatory requirements<li> <li>Experience in implementing Supply Chain Planning Execution Systems and Processes within an ERP environment including design and implementation<li> <li>Experience and strong understanding of cGMP andor cGCP and Pharmaceutical Development<li> <li>Must possess exceptional communication skills selfmotivated exposure andor knowledge of software programs including Microsoft Project Power Point and excel<li> <li>Experience working with thirdparty CRO and CMO clinical supply operations is a plus<li> <li>Excellent verbal and written skills allowing for an open and effective dialogue throughout the company<li> <li>Attention to detail and quality are critical to success<li> <li>Able to command respect from peers and capable of highly independent work as well as being a team player and role model<li> <li>Highly motivated decisive and resultsoriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company<li> <li>Proven ability to manage multiple projects identify and resolve issues<li> <ul><p><br ><br ><p><p><u>The successful candidate will also embody our values<u><p> <p><strong> <strong><p> <p><strong>Our purpose is to create value for those we have the privilege to serve<strong><p> <ul><li>We take pride in our work<li> <li>We keep our promises and deliver<li> <li>We are driven to meaningfully innovate<li> <li>We succeed through inclusion and teamwork<li> <ul><p><br ><p><p>Karuna 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<p> <p><br ><br ><br ><br ><br ><br ><p><p>LIHybrid<p>
Senior Specialist, People Operations
Company: Maze Therapeutics
Location: Peninsula
Posted Mar 12, 2024
<p><strong>The Position<strong><p> <p>Are you ready to dive into a role where every day brings opportunities to shape how we support our employees through HR systems and benefits administration and to champion our culture by infusing our workplace with energy and comradery The Human Resources department is looking for a vibrant Senior Specialist to join our dynamic team Working handin hand and reporting to our Senior Manager of People Operations you will shape policies programs and initiatives to propel our team forward<p> <p>As the Human Resource Information System HRIS lead you will be at the heart of our employee experience by guiding new hires through seamless onboarding and ensuring our HR operations runs with precision and finesse maintaining our essential employee data and records You will also be the central resource for benefits administration driving solutions by educating Maze employees and analyzing new benefit strategies<p> <p>As the heart of our employee experience you will guide new hires through seamless onboarding and bring connection and joy to the workplace by spearheading the culture committee Team Fun<p> <p><strong>Your Impact<strong><p> <ul><li>Benefits Administration<li> <ul><li>Administer Mazes benefits programs including systems communications and enrollment<li> <li>Serve as primary support resource to employees on benefitsrelated matters by interpreting policies and leveraging resources<li> <li>Ensure that leave programs are administered accurately consistently and uniformly in line with established policies and procedures including applicable laws and regulations and serve as the point person for our employee leave of absence concierge<li> <li>Support annual benefits renewal process by analyzing benchmarking data preparing renewal proposals and presentations and lead Mazes open enrollment process<li> <li>Recommend benefits enhancements by staying uptodate on employee and market trends<li> <li>Monitor benefit enrollments terminations changes in coverage and audit as necessary<li> <ul><li>HRIS Data<li> <ul><li>Continuously update and monitor new hires terminations changes in reporting structures and organizational changes and execute through our HRIS platform ADP Workforce Now and internal org chart Pingboard<li> <li>Drive process improvements identify gaps and potential solutions and partner with GampA teams to drive process solutions and implementation<li> <li>Liaise with our finance team to support critical processes such as payroll accounts payable purchasing HR budgeting etc <li> <li>Execute on companywide compliance initiatives and support People Operations related adhoc projects<li> <ul><li>Employee Experience<li> <ul><li>Create a positive onboarding experience by conducting new hire benefits orientation and manage a smooth employee offboarding process<li> <li>Lead Mazes culture committee to build culture and connectiveness by working collaboratively with key stakeholders to execute monthly cultural events and initiatives and oversee the committees budget<li> <li>Support Mazes Learn + Grow program by contributing to the planning and execution of guest speaker presentations and seminars<li> <li>Partner with Sr Manager People Operations to refine operational policies procedures and programs<li> <ul><ul><p><strong>Skills and Qualifications<strong><p> <ul><li>Human Resource experience working in a small to midsized company or startup environment<li> <li>Bachelors degree in Human Resources or related field or equivalent experience<li> <li>Experience administering corporate benefit programs<li> <li>Experienced in HRIS administration and reporting in Bamboo Paylocity ADP or similar systems preferred<li> <li>Meticulous attention to detail with effective organization and communication skills<li> <li>Proven ability to handle sensitive and confidential information with discretion and sound judgement<li> <li>Demonstrated problem solver with a systemsthinking mindset<li> <li>Selfmotivated attitude with a collaborative spirit a team player who has a growth mindset and ability to conduct selfdirected work<li> <li>Demonstrated flexibility and professionalism in managing conflicting priorities and anticipating needs<li> <li>Proficiency in Microsoft Office Suite including Word Outlook Excel and PowerPoint<li> <ul><p><strong>About Maze Therapeutics<strong><p> <p>Maze Therapeutics is a biopharmaceutical company that is harnessing the power of human genetics to transform the lives of patients with a focus on genetically informed therapies for common diseases such as chronic kidney disease Maze applies variant functionalization in tandem with advanced data science methods and a robust suite of research and development capabilities to advance a pipeline of novel precision medicines Maze has developed the Maze Compass PlatformTM a proprietary purposebuilt platform to understand and integrate the critical step of variant functionalization into each stage of drug development Utilizing the Maze Compass PlatformTM Maze is building a broad portfolio of wholly owned and partnered programs Maze is based in South San Francisco<p> <p><strong>Our People<strong><p> <p>Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases We are fostering a culture that encourages vision initiative and the development of talent Our supportive work environment inspires creative thinking and freedom of expression resulting in a stimulating atmosphere where people enjoy coming to work While we have a passion for advanced science and pride ourselves on excellence in execution ultimately everything we do is about patients <p> <p><span><strong>Our Core Values<strong><span><p> <p><span><strong>Further Together<strong><span> <span> Our path is paved with challenges but with resilience and a teamfirst mentality well achieve our mission <span><p> <p><span><strong>Impact Obsessed<strong><span> <span><span> <span>We embrace the bold take calculated risks and learn from our mistakes to improve the lives of others<span><p> <p><span><strong>Stand True<strong><span> <span><span><span> Our integrity is foundational it guides us no matter the obstacle<span><p> <p><span>The expected annual salary range for employees located in the San Francisco Bay Area is $112500 to $137000 Additionally this position is eligible for an annual performance bonus<span><p> <p><span>Maze performs positionbased compensation benchmarking to industry market data to ensure we pay competitive wages Determination of starting salary will depend upon a variety of jobrelated factors which may include professional experience skills and job location The expected salary range for this role may be modified in the future<span><p> <p><span>Maze offers a robust benefits package to our eligible employees including competitive medical dental and vision insurance mental health offerings equity incentive plan 401k program with employer match and a generous holiday and PTO policy<span><p>
Associate Director/Director, Quality Systems and Document Control
Company: CymaBay Therapeutics
Location: North Jersey
Posted Mar 11, 2024
<p><span><span><span><span><span><b><span>POSITION SUMMARY<span><b><span><span><span><span><span><p> <table><tbody><tr><td valign=top> <p><span><span><span><span>The primary role of the Associate DirectorDirector QA Systems and Document Control is to lead the ongoing development implementation maintenance and evaluation of quality management systems across the organization The successful candidate will possess a strong background in quality management systems regulatory compliance and document control processes This is a hybrid role<span><span><span><span><p> <td> <tr><tbody><table><p><span><span><span><span><span><b><span>ESSENTIAL DUTIES AND RESPONSIBILITIES<span><b><span><span><span><span><span><p> <table><tbody><tr><td valign=top> <ul><li><span><span><span><span><span><span>Continuously improve and implement quality policies procedures and objectives to achieve organizational goals<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Take charge of leading and overseeing Quality Document Control processes<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Analyze and present insights on quality metrics trends and overall performance<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Spearhead initiatives to continually improve quality systems pushing forward a culture of continuous improvement<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Collaborate directly with all levels and departments within CymaBay to reinforce and support quality systems<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Serve as the business system owner for Veeva Quality Docs overseeing validation implementation and configuration changes This includes testing new functionality and content for the quality docs platform<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Ensure alignment with departmental management and the broader company vision<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Facilitate support for regulatory inspections<span><span><span><span><span><span><li> <li><span><span><span><span>Fulfill other responsibilities as assigned<span><span><span><span><li> <ul><td> <tr><tbody><table><p><span><span><span><span><span><b><span>MINIMUM QUALIFICATIONS<span><b><span><span><span><span><span><p> <table><tbody><tr><td valign=top> <ul><li><span><span><span><span><span><span>A minimum of 57 years of pertinent experience in Quality emphasizing quality systems and document control including 3 years in a managerial role<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Previous involvement in managing quality systems encompassing paperbased hybrid and cloudbased systems<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Demonstrated success in initiating and leading process improvement initiatives<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Ability to effectively engage with a diverse multidisciplinary functional group<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Strong change management skills showcasing the capacity to simplify and enhance business processes<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Adaptability to a dynamic fastpaced and intricate business environment<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Proficient verbal and written communication skills in a practical context<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Robust organizational skills coupled with meticulous attention to detail<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Selfmotivated and disciplined with a proactive approach<span><span><span><span><span><span><li> <li><span><span><span><span><span><span>Excellent proficiency in computer applications including MS Word Excel and PowerPoint<span><span><span><span><span><span><li> <ul><td> <tr><tbody><table><p><span><span><span><span><span><b><span>EDUCATION CERTIFICATES LICENSES REGISTRATIONS<span><b><span><span><span><span><span><p> <table><tbody><tr><td valign=top> <ul><li><span><span><span><span><span><span>Bachelor of Science degree<span><span><span><span><span><span><li> <ul><td> <tr><tbody><table><p><span><span><span><span><span><b><span>PHYSICAL DEMANDS AND WORK ENVIRONMENT <span><b><span><span><span><span><span><p> <table><tbody><tr><td valign=top> <p><span><span><span><span><span><span>The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions<span><span><span><span><span><span><p> <p><span><span><span><span><span><span>While performing the duties of this job the employee is regularly required to talk and hear The employee frequently is required to walk and sit The employee is occasionally required to stand The employee must occasionally lift andor move up to 25 pounds <span><span><span><span><span><span><p> <p><span><span><span><span><span><span>The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions<span><span><span><span><span><span><p> <p><span><span><span><span><span><span>The noise level in the work environment is usually moderate<span><span><span><span><span><span><p> <td> <tr><tbody><table><p><span><span><span><span><span><span>The anticipated salary range for AD QA Systems amp Training in Newark California is $170000 $185000 and Director QA Systems amp Training is $185000 $215000 The <span>final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry education etc CymaBay is a multistate employer and this salary range may not reflect positions that work in other states<span><span><span><span><span><span><span><p>
Quality Assurance, CMC (Manager-Senior Manager)
Company: Karuna Therapeutics
Location: Boston, MA
Posted Mar 11, 2024
<p><strong>Position<strong> <strong>Quality Assurance CMC ManagerSenior Manager<strong><p> <p><br ><p><p><strong>Position Summary<strong><p> <p>Karuna is seeking an experienced and motivated individual to join our Quality Assurance team as ManagerSenior Manager CMC Quality Assurance to support drug development from Phase 1 to commercialization Reporting to our Senior Manager Quality Assurance CMC this position is responsible for managing reviewing and approving quality documents from Contract Manufacturing Organizations and Contract Testing Laboratories for manufacturing testing validation and disposition of clinical and commercial products for human use This position will work closely with CMC Analytical Development and CMC Quality Control Regulatory Affairs and other functional teams<p> <p><br ><p><p><strong>Responsibilities<strong><p> <ul><li>Ensures compliance to cGMP policies and procedures for documentation resulting from manufacturing operations of clinical and commercial small molecule API and drug product<li> <li>Provides Quality Assurance oversight of analytical development and QC activities including method validation method transfers and reference standard qualifications<li> <li>Performs assessments and QA review of Change Controls deviations root cause analyses and product impact assessments and investigations including OOS investigations for commercial and clinical products<li> <li>Reviews product release and stability data<li> <li>Provides Quality oversight of protocols starting material and finished product specifications API and DP manufacturing documentation and analytical and stability reports<li> <li>Ensures corporate readiness towards regulatory CMC inspections<li> <li>Ensures data integrity in GMP documentation from manufacturing and analytical and stability studies<li> <li>Supports disposition activities for manufactured products in support of CommercialClinical Product including Master Batch Record review Executed Batch Record review resolution of commentsissues and Certificate of Analysis review<li> <li>Supports other QA operation or compliance activities as needed<li> <ul><p><br ><p><p><strong>Required Qualifications<strong><p> <ul><li>BSBA in Chemistry Biology Pharmaceutics or other sciencerelated field<li> <li>58 years of experience within the pharmaceutical industry and in a GMP role Laboratory and QA experience is strongly preferred<li> <li>Knowledge of FDA EU ICH requirements for GMP and related areas eg 21 CFR 211 Part 11 Annex 11 ICH Q7 etc<li> <li>Experience in reviewing Specifications MBRs EBRs stability protocols method validation protocols and reports etc<li> <li>Excellent verbal and written skills allowing for an open and effective dialogue throughout the company<li> <li>Attention to detail and quality are critical to success<li> <li>Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts results and attitudes on others<li> <li>Uses teamwork to work cooperatively toward the most effective solutions championing the best ideas of team members and assisting where help is needed yet is capable of highly independent work when efficiency is required<li> <li>Resultsoriented individual who is highly motivated decisive flexible in thought and has the creativity to excel in and contribute to a rapidly growing company<li> <li>Forward thinking mindset with the ability to manage multiple projects and identify and resolve issues<li> <li>Broad experience in an emerging publicly traded company environment is a plus<li> <ul><p><br ><br ><p><p><u>The successful candidate will also embody our values<u><p> <p><strong> <strong><p> <p><strong>Our purpose is to create value for those we have the privilege to serve<strong><p> <ul><li>We take pride in our work<li> <li>We keep our promises and deliver<li> <li>We are driven to meaningfully innovate<li> <li>We succeed through inclusion and teamwork<li> <ul><p><strong> <strong><p> <p>Karuna 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<p> <p><br ><br ><br ><br ><br ><br ><br ><p><p>LIHybrid<p>
Scientist – Analytical Development
Company: Shape Therapeutics
Location: Seattle, WA
Posted Mar 12, 2024
<p><span>ShapeTX® is pioneering the field of programmable RNA medicines to repair the genetic causes of diseases By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities ShapeTX is developing breakthroughs in RNA editing nextgeneration AAVs and disruptive gene therapy manufacturing The ShapeTX platform enables pharma innovators to design treatments across a wide range of diseases including rare genetic disorders as well as debilitating conditions such as Alzheimers Parkinsons and many more You can find us at <span>shapetxcom<span> and on <span>LinkedIn<span> and <span>Twitter<span><span><p> <p><span>At ShapeTX we are a dynamic team of professionals who are dedicated and passionate about making cures a reality Through diversity of thought scientific knowledge professional rigor and focus we are merging cuttingedge science with extensive drug development expertise to unlock cures to many debilitating diseases<span><p> <p><span>Shape Therapeutics is headquartered in Seattle Washington with a satellite site in Boston Massachusetts<span><p> <p><p> <p>We are seeking a Scientist Analytical Development In this position the individual will work within the PampPD team to develop assays that will enable characterization of ShapeTX viral vector and processes This is an exciting opportunity to learn develop and implement cutting edge AAV analysis techniques as well as grow your career in a rapidly evolving market The ideal applicant will have experience analyzing and characterizing protein modalities to evaluate and understand attributes relevant to therapeutic drugs Candidates should be detail oriented with a collaborative spirit and a desire to work in a fastpaced startup environment<p> <p><strong>What Youll Do<strong><p> <ul><li>Lead the development of analytical methods and establish SOPs<li> <li>Lead characterization studies of AAV utilizing relevant protein analytical techniques eg HPLC CEcIEF Biophysical characterization<li> <li>Perform mass spectrometrybased topdown and bottomup analyses<li> <li>Independently follow established protocols analyze and communicate results<li> <li>Work crossfunctionally to identify current and future analytical needs<li> <li>Maintain awareness of current literature and technologies related to AAV analytics<li> <li>Perform various assays to support PampPD experiments<li> <li>Maintain laboratory supplies and reagents<li> <li>Maintain organized and detailed records using an electronic laboratory notebook<li> <ul><p><strong>What you Bring<strong><p> <p>Qualifications<p> <ul><li>PhD in Biochemistry Chemistry or a related discipline with 02+ years of relevant biotechpharmaceutical industry experience OR<li> <li>MSBS candidates with 510+ years of experience in Biochemistry Chemistry or a related discipline<li> <ul><p>Skills and Experience<p> <ul><li>Handson experience in protein or virus analysis and characterization<li> <li>Handson experience with multiple analytical technologies to characterize proteins ie LC LCMS CE cIEF DLS DSF<li> <li>Familiarity with common data analysis software eg GraphPad Prism JMP<li> <li>Handon experience with mass spectrometric analytical software<li> <li>Ability to troubleshoot and think analytically<li> <li>Strong work ethic and attention to detail<li> <li>Ability to multitask and support multiple projects simultaneously<li> <li>Ability to work collaboratively in a teamscience environment<li> <li>Ability to think creatively and tackle challenges with a problemsolving attitude<li> <li>Excellent written and verbal communication skills<li> <ul><p><span><strong><span>Compensation amp Benefits <span><strong><span><p> <p><span>ShapeTX offers a robust benefits package including but not limited to Medical Dental and Vision coverage for employees and their eligible dependents We provide eligible employees with 12 paid Holidays plus a one week winter break at year end We are proud to offer a competitive paid parental leave benefit an annual employee stipend for employees to use however they choose a Flex Paid Time Off program allowing flexible PTO for vacation sick leave and other purposes and Company paid Long Term Disability Employees are eligible to enroll in our Companys voluntary 401k plan voluntary LifeADampD and Voluntary FSAs <span><p> <p><span><span>The salary range for this role is $96000$144000 <span><span lang=EN xmllang=EN xmllang=EN>The hired applicants placement within the range is based on qualifications and professional experience Additional compensation may include annual target bonus andor signon bonus equity grant and relocation bonus <span><span><p> <p><span>We aspire to <em>Shape Life<em> not only through our science but also through our commitment to foster an inclusive environment that supports diverse perspectives and experiences<span><p>
Translational Scientist
Company: Kyverna Therapeutics
Location: Other US Location
Posted Mar 12, 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 Therapeutics is currently recruiting for a Translational Scientist In this newly created position the incumbent will partner with key internal stakeholders to assess clinical metrics and develop data analytical tools in support of Kyvernas biomarker strategies The Translational Scientist will provides statistical expertise and guidance in the development and validation of analytical assays<span><p> <p><b>Respnsibilities<b> <p><ul><li>Partner with statisticians in writing reviewing and executing statistical analysis plans SAP for biomarkers highlighting the biomarker strategy for clinical drug development<li> <li>Plan and perform relevant and innovative statistical analyses of highdimensional eg gene expression single cell sequencing spatial transcriptomics data generated by cutting edge technologies<li> <li>Create and perform endtoend analyses that include design data gathering processing analysis iteration with stakeholders and presentation of results<li> <li>Accountable for the development of data analytics tools visualization platforms predictive models and emergent insight capabilities that make use of complementary and complex data sets<li> <li>Communicate with internal and external scientific communities bringing forth innovative approaches to biomarkers and drug development<li> <ul><p><b>Requirements<b> <p><ul><li>MS or PhD in Bioinformatics Computational Biology Statistics Biological Sciences Cancer Biology Genetics Genomics Computer Science Physics or similar field<li> <li>MS with 3+ years of experience or PhD with 1+ years of experience in molecular diagnostics or pharmaceutical industry experience will be considered experience performing benchwork preferred<li> <li>Experience with analysis of large scale PKPD genomic and proteomic data sets<li> <li>Experience in modeling methods particularly in their application to Pharmaceutical RampD<li> <li>Experience interpreting biological statistics and translating them to clear relationships of clinical outcomes for clinical and business stakeholders<li> <li>Knowledge of molecular biology understanding of disease pathways and bioanalytical assays<li> <li>Strong problemsolving and collaboration skills and rigorous and creative thinking<li> <li>Strong verbal writing and presentation skills<li> <li>Ability to succeed and thrive in a rapid paced and crossfunctional team environment<li> <li>Experience programming in Python or R is a must Tableau or Spotfire is desirable<li> <p><br ><p> <ul><p> <p><p><span>The base salary range for candidates residing in California for this position is <span> $1470000 USD to $160000 USD annually <span>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>
Senior Manager, SEC Reporting & Technical Accounting
Company: Corcept Therapeutics
Location: Peninsula
Posted Mar 12, 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 Senior Manager SEC Reporting amp Technical Accounting will own the SEC Reporting amp Technical Accounting including preparation of financial statement and technical accounting processes and manage Corcepts equity incentive plan<p> <p><strong>Responsibilities<strong><p> <p><strong><u>SEC External Reporting amp Technical Accounting<u><strong><p> <ul><li>Preparation of supporting schedules for the Companys 10Q 10K 8K Proxy and Section 16 SEC filings<li> <li>Plan for the filings such as preparing the reporting calendar disclosure checklist etc<li> <li>Research relevant US GAAP accounting and disclosure requirements and SEC rules<li> <li>Assist with the external auditors requirements<li> <li>Assist in preparation of BOD and Audit Committee materials<li> <li>Contract review<li> <li>Technical accounting memos<li> <li>Monthend and Quarterend close activities incl leases software capitalization review<li> <li>Prepare monthly investment reports<li> <li>Assist in special projects data gathering and process improvements<li> <li>Ensure compliance with SarbanesOxley SOX controls<li> <li>Manage Census reports<li> <ul><p><strong><u>Stock Administration<u><strong><p> <ul><li>Manage the overall equity transaction process including option exercises initiated in the TD Ameritrade platform and monthly grant processing<li> <li>Support management with the stock administration platform Certent and maintain the Fidelity Net Benefits module<li> <li>Act as an internal equity expert and educate employees on questions relating to equity and stock options<li> <li>Complete yearend reporting needs for Section 6039 reporting for ISO exercises W2 income reporting and 1099Misc on equity income reporting<li> <li>Prepare quarterly treasury stock reconciliations<li> <li>Prepare quarter close reconciliations of restricted stock releases stock option exercises grants and forfeitures including Blackscholes and stockbased compensation expense calculation<li> <li>Manage ESPP program and purchases<li> <li>Internal reporting of stock ownership by executives directors and financial institutions<strong> <strong><li> <ul><p><strong>Preferred Skills Qualifications and Technical Proficiencies <strong><p> <ul><li>Advanced analytical ability attention to detail strong organizational skills and ability to multitask in a fastpaced environment<li> <li>Good communication skills<li> <ul><p><strong>Preferred Education and Experience <strong><p> <ul><li>Minimum BS BA in accounting or finance CPA preferred<li> <li>5 + years of experience<li> <li>Public accounting experience preferred<li> <li>Strong and current understanding of financial statements US GAAP and SEC reporting rules<li> <li>Experience with XBRL tools a plus<li> <ul><p> The pay range that the Company reasonably expects to pay for this headquartersbased position is <span>$195000 $210000<span> the pay ultimately offered may vary based on legitimate considerations including geographic location jobrelated knowledge skills experience and education<p> <p>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>
Director/Senior Director of DMPK
Company: Genesis Therapeutics
Location: San Diego, CA
Posted Mar 11, 2024
<p><b>Genesis Therapeutics<b> is pioneering artificial intelligence guided rational drug design to address severe unmet medical needs for patients Our lab in San Diego is looking for an experienced motivated and versatile Drug Metabolism and Pharmacokinetics DMPK Director or Senior Director to lead of DMPK team and to help advance our compounds through preclinical and clinical development The successful candidate will provide leadership and guidance in the design analysis and reporting of in vitro and in vivo DMPKADMET studies to support our small molecule drug discovery and early development pipeline The candidate will also participate in data integration best practices for AI ADME predictive model <p> <p>This is a fulltime position in a fastpaced biotech environment with a collegial group of high performing colleagues working towards welldefined goals Full medical and dental benefits flexible work hoursvacation included in this opportunity to learn all aspects of biotech startup<p> <p><br ><p> <p>Learn more about us here httpswwwgenesistherapeuticsai<p> <p><br ><p> <p>And our recent collaboration with Eli Lilly here httpsendptscomgenentechpartneredgenesistherapeuticsinksnewestaidiscoverydealwithelililly<p> <p><b>What You Will Do<b> <p><ul><li>Represent DMPK as an integral member of projectcore teams providing scientific and strategic leadership for all stages of drug discovery and early development<li> <li>Lead the DMPK team 23 scientists and built internal DMPK assay capabilities to support internal programs<li> <li>Effectively manage CROs and DMPK team to design and execute in vitro and in vivo studies aimed at characterizing the DMPKADME properties of small molecule drug candidates<li> <li>Communicate DMPK data and provide interpretation of results to project teams senior management and other stakeholders<li> <li>Oversee the preparation of nonclinical DMPKADME reports and the relevant sections of documents for regulatory submissions<li> <li>Provide input into the pharmacokinetic and design aspects of nonclinical pharmacology and nonclinical toxicology studies<li> <li>Partner with AI engineer on ADME predictive model<li> <li>Be a scientific leader and mentor <li> <ul><p><b>What You Will Bring<b> <p><ul><li>A MSc or PhD in Biological Science Chemistry Pharmacokinetics Pharmacology or related discipline with 10+ years Industrial experience in Drug Discovery amp Development<li> <li>Verifiable track record of drug discovery experience success and leadership with experience in advancing programs through all stages of discovery to IND candidates <li> <li>Thorough knowledge of FDA and ICH guidelines<li> <li>Knowledge of various invitro amp in vivo ADME assays <li> <li>Ability to work effectively in a dynamic environment with diverse team of coworkers<li> <li>Solid written and oral communication skills enthusiasm integrity selfmotivation strong interpersonal skills and attention to detail are necessary<li> <ul><p><b>What We Offer<b> <p><ul><li><b>Competitive Pay<b><li> <li><b>Stock Option Eligibility<b><li> <li><b>401k Plan<b><li> <li><b>Open PTO Policy<b><li> <li><b>Paid Company Holidays<b><li> <li><b>Free lunch and snacks at our offices<b><li> <li><b>Health Care Plan including Medical Dental and Vision fully covered for the employees <b><li> <ul><p> <p><p>Genesis Therapeutics<span> is unifying AI and biotech to discover novel and breakthrough treatments for patients with severe and devastating conditions Genesis was founded on groundbreaking molecular ML research and since has established itself as the industry leader in AI for small molecule drug discovery Our team of accomplished biotech leaders and expert drug hunters joins forces with deep learning researchers and software engineers who are pioneering predictive and generative AI technologies for molecules<span><p> <p><br ><p> <p><span>Our team has created the industrys most advanced molecular AI platform called GEMS Genesis Exploration of Molecular Space to accelerate and optimize small molecule drug discovery and to enable the discovery of novel firstinclass and bestinclass small molecule drugs for challenging andor undruggable targets <span><p> <p><br ><p> <p><span>The company has leveraged GEMS to build an internal pipeline with multiple programs against highvalue targets including datapoor and canonically undruggable targets where GEMS is uniquely advantaged In addition Genesis has two AI platform collaborations across a range of therapeutic areas <span>Eli Lilly<span> signed in 2022 with a $20M upfront payment and a $670M total deal size and <span>Genentech<span> signed in 2020<span><p> <p><span>We raised <span>a $200M series B<span> in August 2023 and have raised over $280M in funding from top technology and biotech investors including Andreessen Horowitz Rock Springs Capital T Rowe Price Fidelity Radical Ventures NVentures NVIDIAs VC arm BlackRock and Menlo Ventures <span><p> <p><br ><p> <p><span>Genesis is headquartered in Burlingame CA with a fully integrated laboratory in San Diego We are proud to be an inclusive workplace and an Equal Opportunity Employer<span><p> <p><br ><p> <p><br ><p> <p><br ><p> <p><b>Finding the best talent is our top priority at Genesis Therapeutics If you are interested in potential partnership on recruitment please reach out to <b><b>recruitinggenesistherapeuticsai<b><b><b><p> <p><p>
Senior Data Manager
Company: 4D Molecular Therapeutics - (4DMT)
Location: Other US Location
Posted Mar 11, 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 At 4D Molecular Therapeutics Inc 4DMT we boldly innovate to unlock the full potential of genetic medicines for countless patients We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms<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><span datacontrast=auto>GENERAL SUMMARY<span><span dataccpprops=> <span><p> <p><span datacontrast=auto>The Senior Data Manager will be responsible for performing Data Management activities that support observational clinical programs worldwide They will participate as an active member of a crossfunctional study team to plan lead and execute the Data Management tasks required for all phase 14 studies The Senior Data Manager has a broad fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance<span><span dataccpprops=> <span><p> <p><span datacontrast=auto>RESPONSIBILITIES<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=7 dataarialevel=1><span datacontrast=auto>Lead Data Management of a clinical study or a series of related studies with minimal guidance<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=8 dataarialevel=1><span datacontrast=auto>Manage and monitor the progress of data management activities with CROs vendors and statsprograming groups on assigned studies<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=9 dataarialevel=1><span datacontrast=auto>Review protocols for appropriate data capture including electronic Case Report Form eCRF design<span><span dataccpprops=> <span><li> <ul><ul><li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=1 dataarialevel=1><span datacontrast=auto>Perform a thoroughly detailed review of eCRF data requirements <span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=2 dataarialevel=1><span datacontrast=auto>Lead the development of data edit check specifications and data listings<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=3 dataarialevel=1><span datacontrast=auto>Coordinate the design and testing of Electronic Data Capture EDC systems according to company standards <span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=4 dataarialevel=1><span datacontrast=auto>Develop or lead the development of the Data Management and Data Transfer Plan for a clinical study <span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=5 dataarialevel=1><span datacontrast=auto>Attend study meetings and provide Data Management updates and metrics<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=6 dataarialevel=1><span datacontrast=auto>Review and provide feedback to the clinical team on other study documents eg Clinical Monitoring plans Statistical Analysis Plans and vendor specifications<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=7 dataarialevel=1><span datacontrast=auto>Provide training on the EDC system andor eCRF Completion Guidelines to internal and external study team members as needed<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=8 dataarialevel=1><span datacontrast=auto>Perform or ensure assigned CRO reconciliation of header data from external data sources against the clinical database<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=9 dataarialevel=1><span datacontrast=auto>Perform or ensure assigned CRO completed Serious Adverse Event reconciliation activities according to SOPs and guidelines<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=10 dataarialevel=1><span datacontrast=auto>Lead database upgradesmigrations including performing User Acceptance Testing<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=11 dataarialevel=1><span datacontrast=auto>Maintain data management files eTMF<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=12 dataarialevel=1><span datacontrast=auto>Perform and coordinate database lock and freeze activities <span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=8 datalistdefnprops= dataariaposinset=13 dataarialevel=1><span datacontrast=auto>Other duties as assigned nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time<span><span dataccpprops=> <span><li> <ul><p><span datacontrast=auto>QUALIFICATIONS<span><span dataccpprops=> <span><p> <p><span datacontrast=auto>Education<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=14 dataarialevel=1><span datacontrast=auto>BABS degree or higher preferably in medical or biological sciences<span><span dataccpprops=> <span><li> <ul><p><span datacontrast=auto>Experience<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=15 dataarialevel=1><span datacontrast=auto>Minimum of 6 years of CDM experience in the pharmaceutical industry<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=16 dataarialevel=1><span datacontrast=auto>Minimum 3 years in lead data manager role<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=9 datalistdefnprops= dataariaposinset=17 dataarialevel=1><span datacontrast=auto>Minimum 3 years experience with Medidata Rave iMedidata<span><span dataccpprops=> <span><li> <ul><p><span datacontrast=auto>Skills<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=1 dataarialevel=1><span datacontrast=auto>Excellent written and verbal communication skills and collaborative working style<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=2 dataarialevel=1><span datacontrast=auto>Proven conceptual analytical and strategic thinking<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=3 dataarialevel=1><span datacontrast=auto>Experience standardizing CDM amp data flow processes<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=4 dataarialevel=1><span datacontrast=auto>Demonstrated project management skills<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=5 dataarialevel=1><span datacontrast=auto>Proactively identifies risks issues and possible solutions<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=6 dataarialevel=1><span datacontrast=auto>Displays excellent organization and time management skills excellent attention to detail and ability to multitask in a highvolume environment with shifting priorities andor conflicting deadlines<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=7 dataarialevel=1><span datacontrast=auto>Ability to build a rapport and trust with others through leadership and dependability<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=8 dataarialevel=1><span datacontrast=auto>Extensive knowledge of Clinical Systems eg EDC IXRS and external data vendors eg Central Laboratories<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=9 dataarialevel=1><span datacontrast=auto>Knowledge of GCPFDAICH regulations required<span><span dataccpprops=> <span><li> <ul><p><span>Base salary compensation range<span><p> <p>National $159000 195000<p> <p>Bay Area $174000 219000<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>