Director, Medical Research
Company: Alnylam Pharmaceuticals
Location: Somerville
Posted on: January 12, 2021
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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
Keywords: Alnylam Pharmaceuticals, Somerville , Director, Medical Research, Executive , Somerville, Massachusetts
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