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Executive Director Epidemiology

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: Sarepta Therapeutics

Location: Cambridge

Posted on: September 12, 2020

Job Description:

The Executive Director Epidemiology will provide leadership forall epidemiology activities in the global pharmacovigilance andrisk management department in Sarepta. This individual will serveas a member of the Safety Evaluation & Risk Management (SERM) groupand supervise epidemiology talent comprising in-house andoutsourced resources. The Executive Director Epidemiology willfunction in a company matrix team environment interacting withseveral key stakeholder groups including; Clinical Development,Medical Affairs, Regulatory Affairs, Quality Assurance,Manufacturing, Commercial, Research and Legal. KeyResponsibilities:

Leads/contributes to integration of Epidemiology into theR&D clinical development process & post-marketing safetyactivities via participation in cross-functional clinical trial,clinical development and global development teams.

Responsible for design and conduct of pharmacoepidemiologystudies: Observational studies with primary safety objectives e.g.post-marketing requirements for observational safety studies tocharacterize a safety concern.

Risk Management Plan safety studies (registry, cohort, surveys,case-control or drug utilization studies).

REMS/RMP Risk Minimization studies (KAB Surveys, Measurement ofEffectiveness studies).

Contributes to product safety evaluation in NDA/BLAs/MAAs.

Responsible for epidemiology information in Core Risk ManagementPlans and REMS.

Leads assessment, interpretation & communication of relevantscientific literature; maintains awareness of internal & externaldata resources & identifies appropriate studies for addressingquestions of interest, independently performs data queries &summarizes epidemiologic information.

Collaborates with other functional groups (Medical Affairs,Commercial, Regulatory Affairs) in preparing documentation forreimbursement agencies or other external organizations.

Contributes to signaling and data mining activities utilizinginternal and external sources of data.

Develops methodologies for establishing thresholds for productsafety signals.

Undertakes risk assessment of extrinsic sources of risk(systems) utilizing methodologies such as root cause analysis orFMEA.

Participates in discussion of product safety issues at theSafety Detection Team and Global Safety Committee.

Contributes to the company labeling management process andLabeling Committee discussions on product core data sheets andcountry package inserts.

Collaborates with Safety Physicians and Safety Scientists inproduction of periodic ADR safety reports e.g. PADER,PSUR/PBRER.

Maintains knowledge & skills on evolving epidemiologicalmethods, tools & data sources.

Leads and grows the Epidemiology group in the GlobalPharmacovigilance Department.

Perform other related duties as needed.

Education and Skills Requirements:

MSc. or Ph.D. or Sc.D. Epidemiology/Pharmacoepidemiology or MPHwith experience in the pharmaceutical industry.

At least ten years’ experience in epidemiology including aminimum of 5 years’ pharmaceutical industry experience in globalpharmacovigilance & risk management.

Experience contributing to or involvement in NDA, BLA, MAAprocess including leading design and implementation of naturalhistory studies and registries in the pharmaceutical industry isrequired.

Experience leading, and supervising talent is required andexperience with rare disease is a plus.

Key Skills, Abilities and Competencies: Ability to use orinterpret analysis results from data mining or signaling softwaretools.

Strategic risk management planning.

Ability to work in a cross-functional team environment.

Works on problems of diverse scope where analysis of situationor data requires evaluation of identifiable factors.

Exercises judgment within generally defined practices andpolicies in selecting methods and techniques for obtainingsolutions.

Receives minimal supervision. Expected to solicit input fromothers in Global Pharmacovigilance, Medical Affairs, Commercial,Regulatory Affairs and Clinical Development and to independentlyimplement existing and new approaches for the design of studies andanalysis of safety data.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation andbenefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Actionemployer and participates in e-Verify.

Posted 16 Days Ago

Full time

R-00171

About Us Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at theforefront of precision genetic medicine, having built a worldleading pipeline for the treatment of Duchenne muscular dystrophy(DMD). The Company has expanded its portfolio to includeLimb-girdle muscular dystrophy (LGMD) and central nervous system(CNS) disorders across several therapeutic modalities, includingRNA, gene therapy and gene editing. If you are interested in anorganization that is collegial, entrepreneurial and driven towardsuccess, we invite you to apply today.

Keywords: Sarepta Therapeutics, Cambridge , Executive Director, Epidemiology, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Executive Director Epidemiology, Other , Cambridge, Massachusetts

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