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Medical Director

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

Job Description:

Medical Director/Senior Medical Director, Hematology Company: Agios Pharmaceuticals

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Medical Director/Senior Medical Director, Hematology LocationAgios Pharmaceuticals HQ Job Code 1129 # of openings 1

Medical Director/Senior Medical Director Hematology, ClinicalDevelopment

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.

The Medical Director will be responsible for Agios’ clinicaloncology programs in Hematology and will be responsible fordeveloping and implementing clinical strategies. The MedicalDirector will play a lead role in the study execution andsupervision of pivotal clinical programs that are currentlyunderway. This individual will be responsible for ensuring that allclinical studies operate to the highest ethical and safetystandards and in compliance with Company, GCP and regulatoryrequirements.

The Medical Director will play a key role in contributing to thestrategic research and development objectives of the company. Thisindividual will serve as a liaison between Agios and clinicalinvestigators, and establish and maintain relationships withopinion leaders, trial physicians, and key global regulatoryagencies.

Specific Functional Responsibilities

Provide medical input and expertise into the strategy, planningand implementation of Agios’ programs in clinical development.

Supervise and monitor all phases of clinical trial conduct byworking closely with external medical monitors, investigators andsites to ensure the successful medical oversight and consistency ofconduct of trials.

Work closely with all functions of the organization and externalpartners to manage trial logistics; work closely with the projectmanagement representative(s) to track trial status.

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

Contribute clinical expertise to data review activities toensure integrity of clinical databases and data analyses.

Monitor and evaluate safety signals relevant to clinicalprograms.

Write and provide editorial comments for clinical study reportsand external presentations of data including manuscripts.

Travel to scientific meetings, meeting with regulatory agencies,investigators, clinical experts and other meetings related toduties as described above

Specific Strategic Responsibilities

Follow developments and trends in the scientific literature anddevelop/maintain contacts with opinion leaders to gain strategicinsights into the further development and positioning of studieswithin an overall program(s).

Cultivate relationships and work closely with investigators andacademic experts to ensure the scientific and clinical basis ofprograms and projects; identify opportunities for externalcollaboration to optimize translational and clinicalstrategies.

Critically analyze data: to develop clinical programs andstudies

for discussion with Regulatory Agencies

to develop abstracts and manuscripts for publication

Support qualification of pharmacodynamics/translationalbiomarker studies for assessing efficacy.

Provide clinical assessments during disease/target evaluation,prioritization and selection; identifying novel therapeuticopportunities and evaluating study design and executionchallenges

Requirements

M.D. with postgraduate training, ideally board certified oreligible in oncology and/or hematology

1+ years of industry experience with experience in oncologyand/or hematology drug development preferred

Strong clinical intuition and excellent problem solving skillsrequired

Excellent ability to review and analyze clinical data andsynthesize and communicate key messages required

Demonstrated ability to mentor and teach others required

Experience working in environments with co-development orpartnership arrangements with other companies preferred

Excellent interpersonal and public speaking skills are required;demonstrated ability to present data clearly, concisely and with aclear purpose and ability to tailor to the intended audience

Demonstrated ability to work with cross-functional teams

Strong collaborative skills and ability to influence othersthrough effective partnerships

Excellent written communication skills. Experience draftingexternal clinical data presentations (abstracts, manuscripts, etc)strongly preferred.

Keywords: Agios Pharmaceuticals, Cambridge , Medical Director/Senior Medical Director, Hematology, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Medical Director, Other , Cambridge, Massachusetts

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