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Medical Director

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

Job Description:

Medical Director/Senior Medical Director Rare Genetic Diseases Company: Agios Pharmaceuticals

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Medical Director/Senior Medical Director Rare Genetic Diseases(RGD) Location Agios Pharmaceuticals HQ Job Code 1136 # of openings1

Medical Director/Senior Medical Director Rare Genetic Diseases(RGD)

Agios (agios.com) is a biopharmaceutical company committed toapplying our scientific leadership in cellular metabolism totransform the lives of patients with cancer and rare geneticdiseases. We are growing rapidly with an active research anddiscovery pipeline across both therapeutic areas. Agios has twoapproved oncology precision medicines and multiple first-in-classinvestigational therapies in clinical and/or preclinicaldevelopment.

We are currently seeking an innovative Clinical Developmentleader to help drive our rare disease development program .Reporting into our Vice President for Rare Genetic Diseases (RGD),this person will advance Agios’ research activities and pipelinetargeting Inborn Errors of Metabolism (IEMs).

The Medical Director/Senior Medical Director will be responsiblefor the development and execution of clinical research anddevelopment programs for Agios Pharmaceuticals including theleadership of the pivotal trials, NDA and filing activities. Thisrole will give strategic medical and tactical input to the RGDdiscovery teams from early discovery to development candidates toIND submission. This position will serve as a key liaison betweencompany and clinical investigators and establish crediblerelationships with opinion leaders, and regulatory officials.

Specific Strategic and Tactical Responsibilities:

Direct involvement in trial design of Phase I/II/III researchtrials targeting rare or orphan diseases.

Directly supervise and monitor trial conduct as well as workclosely with external medical monitor physicians to assureconsistency of conduct across trials. Work closely with allfunctions of the organization and external partners to manage triallogistics.

Provide medical input to global regulatory plans and regulatorymeetings in partnership with regulatory affairs.

Follow important developments and relevant trends in thescientific literature and develop/maintain contracts with externalexperts to support understanding of the candidate drug effects andto gain strategic insights to the further development and placementof study and overall program.

Develop effective relationships with external providers toensure successful medical oversight of outsourced studies.

Provide clinical assessments during disease/target evaluation,prioritization and selection, identifying novel therapeuticsopportunities as well as critical study design and executionchallenges.

Develop evidence for functional relevance of targets in humandisease.

Support qualifications of pharmacodynamic/disease markers ofassessment of efficacy.

Work closely with the project management representative(s) totrack trial status.

Work closely with study physicians, as well as other projectteam members/functional areas to ensure regulatory compliance.

Review written materials and provide editorial comments forclinical study reports and manuscripts.

Responsible for the scientific quality of all clinical work.

Ensure consistent practices with the highest ethical standardsin compliance with internal SOPs, local regulations and laws.

Qualifications

M.D. or equivalent degree (desirable areas include Genetics orHematology).

Board Certification, Board Eligibility or specialistaccreditation in internal medicine or pediatrics; specificexperience with genetic metabolic disorders desirable.

A minimum of 3+ years of clinical and managerial experiencewithin pharmaceutical trial design and conduct (POC, Phase I/PhaseII) within the pharmaceutical industry CRO or Academia is required.Experience with trials though NDA strongly preferred.

Translational research expertise and experience in rare/Orphandisease development desirable.

Excellent interpersonal and public speaking skills are requiredfor this high visibility position.

Demonstrated ability to work in a matrix environment withcross-functional teams.

Demonstrated leadership experience.

Approximately 10% annual travel (domestic and international) isrequired for this position.

Keywords: Agios Pharmaceuticals, Cambridge , Medical Director/Senior Medical Director Rare Genetic Diseases, Other , Cambridge, Massachusetts

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