Director, Medical Research

Company: Alnylam Pharmaceuticals
Location: Somerville
Posted on: January 12, 2021

Job Description:

Job Description - Director, Medical Research (200091)Job Description Director, Medical Research(Job Number: 200091)Description Director, Medical ResearchOverviewAlnylam is the world---s leading RNA interference (RNAi) company. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development. SummaryReporting to VP, Medical Affairs, Director, Medical Research will collaborate with Global and Country Medical Directors in the planning and execution of evidence generation supporting all Alnylam products from early phase to LOE, including registries, studies, investigator-initiated studies (IIS) and phase 4 studies. The successful candidate will have primary responsibility for registry and phase 4 studies oversight including managing a team and day to day responsibility of management of the post-marketing studies. The successful candidate will ensure that all studies within the program are executed in accordance with US, EU and other governmental regulations as applicable, as well as with appropriate ICH/GCP guidance. This person will manage cross functional relationships with internal and external stakeholders and will be extremely hands on fostering relationship development with KOLs. This is a high visibility position with great impact potential.Primary ResponsibilitiesProvide oversight of the Medical Research team including overseeing the conduct of registries/phase 4 studies and IIS process Partner with Medical Directors to plan and execute on Alnylam---s clinical and real world evidence generation plans ranging from natural history disease registries to phase 4 studiesActively participate in strategic planning activities including budgeting, resource management and vendor identification/managementEnsure adequate resources for medical research operations including overseeing operational plans, tactical execution of registries, protocol preparation, report writing, regulatory submissions, etc.Ensure alignment of activities/decisions affecting all trials within the programsOversee CROs and external vendors on a day to day basis including issue tracking/resolution, timeline/budget managementPartner with Medical Directors in the cross-expertise medical affairs study review, including defining review framework, coordinating Medical Affairs Review Board (MARB) review of all medical affairs studies, internally sponsored or investigator-initiated, tracking of study requests, review and decision, as well as study execution milestones. Collaborate closely with Clinical Operations and Biometrics group as needed to support the planning and execution of medical affairs studiesRequirementsThe Director, Medical Research will be part of a very active team within a dynamic, fast-paced, high-profile biotechnology company. The successful candidate will possess the following capabilities and characteristics.BS, MS, PharmD, PhS with experience in clinical operations and/or managing post-marketing studies7-10 years of demonstrated study operations experience ideally managing post-marketing studiesAbility to lead a highly skilled workforce Prior experience selecting and managing CROsProven excellence in study operations strategy including oversight of multiple trials simultaneouslyAbility to foster effective relationships with vendors, investigators and colleaguesStrong written and verbal communication skills as well as strong interpersonal skillsAbility to execute and deliver within timelinesProven planning and organizational skills with experience managing multiple priorities; ability to prioritize in a shifting environment with a sense of urgencyTravel will be requiredClear alignment with Alnylam Core ValuesCommitment to PeopleInnovation and DiscoverySense of UrgencyOpen CulturePassion for ExcellenceAlnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.LI-JR1

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