Medical Director

Precision Medicine Group

1d•Remote

About The Position

The Medical Director serves as the project physician and provides medical and scientific expertise to project teams. The Medical Director’s primary focus of work will be to ensure the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety. This position also participates in the strategic planning and execution of critical development programs for a variety of clients in oncology or autoimmune disease (depending on client and/or program assignment), contributes to the development of Precision’s Medical team, and supports Business Development activities.

Requirements

MD, DO, MBBS, or equivalent medical qualifications
5+ years of clinical experience
Completed an accredited medical residency program.
Completed a fellowship or equivalent relevant to assigned programs (e.g., oncology and/or hematology; rheumatology; allergy & immunology; endocrinology; gastroenterology; nephrology; neurology; or other related subspecialty).
5+ years of experience in oncology or autoimmune disease clinical research (depending on client and/or program assignment).
Demonstrated expertise across the lifecycle of oncology or autoimmune disease drug development, with ability to strategically analyze clinical trial protocols in the assigned therapeutic area.
Availability for domestic and international travel including overnight stays (approximate 30% travel requirement).
Ability to deliver on commitments; understands the service culture.
Strategic thinker who can build strategic drug development solutions associated with novel development programs, study designs, and patient populations.
Demonstrates a high degree of professionalism, as evidenced by punctuality, positive interactions with customers and teammates, including good interpersonal skills.
Communicate both verbally and in written form in an acceptable manner.
Conduct formal presentations to a wide variety of audiences including colleagues.
Strong visual and presentation skills.
Ability to work effectively in a fast-pacing team setting, with minimal supervision.
Proven efficiency in working remotely

Nice To Haves

Drug development experience in oncology or autoimmune diseases (depending on program needs).
Board Certification in Oncology and/or Hematology, or in a relevant medical subspecialty aligned to assigned programs, or equivalent.
Phase I and Phase II clinical trial experience in oncology or autoimmune disease.
Prior CRO experience.
Maintains current scientific and medical knowledge base.

Responsibilities

Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement.
Support Business Development and Proposals teams by participating in the RFP process; prepare medical considerations section for proposals; and support or participate in bid defense meetings.
Write or edit scientific content of deliverables within budget and timelines.
Collaborate with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy.
Provide scientific insight and create content for specified company releases (e.g., white papers and publication manuscripts).
Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications.
Review laboratory values, adverse events, coded adverse event and medication data, and data tables, listings and figures as needed.
Serve as a medical resource for study sites, the project team and clients.
Assist in the preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions.
Assume responsibility for medical and safety monitoring on assigned projects.
Participate in feasibility discussions relating to specific project proposals.
Develop training modules and provide training concentrating on disease states
Participate in process improvement activities.
Collaborate with Senior Vice President, Global Medical and other members of the Medical Science Department to support growth and development activities globally.
And other job duties as assigned by the line manager