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Scientist, Toxicology

Company: Moderna Therapeutics
Location: Somerville
Posted on: September 12, 2020

Job Description:

The Role:The Scientist will lead all aspects of toxicology work for select nonclinical programs to enable drug candidates from research through development and IND enabling studies.-- The senior scientist will design, execute, and interpret nonclinical safety studies conducted in multiple species, and will be heavily involved in regulatory submissions and interactions with various health authorities as well as the internal clinical team. The successful candidate must have the ability to multitask and to function effectively in a fast-paced environment. Be capable of conducting work independently, but also capable of pulling in subject matter experts when necessary to lead the conversation.-- Will maintain extensive scientific awareness and presence in toxicology, publishes manuscripts and posters, presents at scientific conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large.--Here's What You'll Do:In conjunction with program teams and the nonclinical sciences team, develop toxicology strategies and provide expert support to research and development projectsCollaborate on the design of non-GLP investigative and pharmacology studies to support development compounds, as neededReview, summarize and integrate complex data sets across multiple disciplinesManage the preparation and presentation of nonclinical safety data for project teams, portfolio management, internal /external partners and/or scientific groupsProvide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategyLead finalization of toxicology reports and manage the tabular presentation of data in accordance with CTD formatSupport the preparation of national and international regulatory submissions and interactions with health authorities and be capable of effective communications with regulatory authoritiesInteract cross functionally with Research, Regulatory, Clinical and ManufacturingWork closely with clinical to ensure toxicology support for clinical trial designsHere's What You'll Bring to the Table:Doctorate degree 0-2 years of scientific experience OR Master's degree & 5-8 years of scientific experience OR Bachelor's degree & 15 years of scientific experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings Experience working with Contract Research Organizations Ability to develop and deliver clear and concise presentations for both internal and external meetingsOutstanding written and verbal communication skillsAbility to multi-task and change quickly change prioritiesStrong written and oral communication skills and a track record of achievement in publications and/or patent applications Candidate will be curious in exploring new path for drug discovery, bold in proposing creative experimental designs and ideas. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomesHere'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, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past five 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-AK1Full time

Keywords: Moderna Therapeutics, Somerville , Scientist, Toxicology, Other , Somerville, Massachusetts

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