Associate Director/Sr. Manager, Clinical Biomarker, Clinical Development Organization

Company: Moderna Therapeutics
Location: Somerville
Posted on: January 14, 2021

Job Description:

The Role:Moderna is seeking a Clinical Biomarker Lead to develop and drive biomarker plans across clinical stage Infectious Disease programs. This position reports to Moderna---s Director of Clinical Biomarkers. The Associate Director/Sr. Manager will work collaboratively across several clinical teams (internal, external CROs) to ensure planning, execution and data delivery of biomarker lab data for clinical trials conducted by Moderna.Here---s What You---ll Do: Evaluate technologies to identify, define and implement the biomarker strategy to support the clinical development of Moderna---s vaccines.Develop biomarker plans with input from the research and clinical leads.Manage biomarker assay labs complete appropriate development, qualification or validation studies in order to execute the clinical biomarker plan on time and with good quality.Ensure the timely and efficient delivery of all biomarker operational aspects across vaccine clinical trials: accountable for planning, coordinating, and overseeing all operational activities required to manage the flow of biomarker samples from planning, collection, analysis, data delivery and final sample disposition with support from the Biosample Operations ManagerDevelop and provide operational input and recommendations into all study related documentation (including protocol, lab manual, informed consent form, and amendments) and processes, and ensure collection, delivery and analysis of biosamples in compliance with these documents as well as GCP/ICHServe as a single point of contact for biomarker operations across vaccine teams, and with collaborators, assay labs and CROs.Responsible for the identification and selection of biomarker vendors in collaboration with the Translational Science/Research leadsManage the development and oversight of the biomarker analysis timelines, budget, risk and quality plansAttend operations team meetings and monitor training, CRO kick-off meetings, as applicable, to deliver trainings on biomarker activitiesParticipate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collectionHere---s What You---ll Bring to the Table:MS (with at least 8 years pharmaceutical/biotechnology experience) or PhD (with at least 2-4 years of pharmaceutical or biotechnology experience) in a related science focus (i.e. immunology, molecular biology, biotechnology).Experience in Infectious disease programs (Ex: Human respiratory viruses / Human herpes viruses / HIV / Human Flaviviruses ) is highly desirable.Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure.Diagnostic assay development and testing experience is desirable.Solid experience in the application of biomarkers during development of assets is preferred, including experience with clinical translational research, validation and implementation.Experience in managing third party assay laboratories, collaborations and budget management.Strong communication and project management skills.Here---s What We---ll Bring to the Table: On-site subsidized cafeteria or catered lunchesCompany-provided iPhoneFree parking, monthly subway pass or a subsidized commuter rail passFree annual corporate membership to BluebikesHighly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSPFlexible Spending Accounts for medical expenses and dependent care expenses16 weeks of 100% paid parental leave for all new parents 16 weeks 100% paid family caregiver leave20 weeks 100% paid medical leaveEligible for ---Moderna Month--- (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)Adoption assistance and discounts to local childcare centers, as well as access to care.com401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediatelyA suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disabilityVoluntary legal assistance plan15 days--- vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)About Moderna:Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body---s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company---s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit .Our Mission:Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person---s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. LI-AK1- Full time

Keywords: Moderna Therapeutics, Somerville , Associate Director/Sr. Manager, Clinical Biomarker, Clinical Development Organization, Executive , Somerville, Massachusetts