Medical Director/Senior Medical Director, Hematology

Agios Pharmaceuticals
Full time Full day
Cambridge, MA

Medical Director/Senior Medical Director Hematology, Clinical Development


Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.


The Medical Director will be responsible for Agios' clinical oncology programs in Hematology and will be responsible for developing and implementing clinical strategies. The Medical Director will play a lead role in the study execution and supervision of pivotal clinical programs that are currently underway. This individual will be responsible for ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with Company, GCP and regulatory requirements.


The Medical Director will play a key role in contributing to the strategic research and development objectives of the company. This individual will serve as a liaison between Agios and clinical investigators, and establish and maintain relationships with opinion leaders, trial physicians, and key global regulatory agencies.


Specific Functional Responsibilities



  • Provide medical input and expertise into the strategy, planning and implementation of Agios' programs in clinical development.

  • Supervise and monitor all phases of clinical trial conduct by working closely with external medical monitors, investigators and sites to ensure the successful medical oversight and consistency of conduct of trials.

  • Work closely with all functions of the organization and external partners to manage trial logistics; work closely with the project management representative(s) to track trial status.

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

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

  • Monitor and evaluate safety signals relevant to clinical programs.

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

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


Specific Strategic Responsibilities



  • Follow developments and trends in the scientific literature and develop/maintain contacts with opinion leaders to gain strategic insights into the further development and positioning of studies within an overall program(s).

  • Cultivate relationships and work closely with investigators and academic experts to ensure the scientific and clinical basis of programs and projects; identify opportunities for external collaboration to optimize translational and clinical strategies.

  • Critically analyze data:

  • to develop clinical programs and studies

  • for discussion with Regulatory Agencies


  • to develop abstracts and manuscripts for publication



  • Support qualification of pharmacodynamics/translational biomarker studies for assessing efficacy.

  • Provide clinical assessments during disease/target evaluation, prioritization and selection; identifying novel therapeutic opportunities and evaluating study design and execution challenges


Requirements



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

  • 1+ years of industry experience with experience in oncology and/or hematology drug development preferred

  • Strong clinical intuition and excellent problem solving skills required

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

  • Demonstrated ability to mentor and teach others required

  • Experience working in environments with co-development or partnership arrangements with other companies preferred

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

  • Demonstrated ability to work with cross-functional teams

  • Strong collaborative skills and ability to influence others through effective partnerships

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

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