Medical Director, Medical Affairs

MEDICAL DIRECTOR, MEDICAL AFFAIRS

Position Summary:

The Medical Director, Medical Affairs will be a key member of the Medical Evidence team and will help set strategy for both internal Company programs and external facing interactions. The Medical Director is responsible for the design and execution of Phase 3b/4 studies, Externally Sponsored Research Collaborations, Expanded Access Programs, and Product Registries. The Medical Director will work closely with investigators and KOLs to ensure studies will address the needs of providers and patients. The Medical Director, Medical Evidence will report directly to the ED, Medical Evidence.

Essential Duties and Responsibilities:

• Develop protocols and serve as medical monitor of Medical Affairs sponsored studies
• Coordinate with Company Outreach and Patient Advocacy Team on interactions with community advocates and patient support groups
• Design, execution, and interpretation of Phase 3b/4 studies, Expanded Access Protocols, product registries, and other sources of medical evidence in collaboration with internal colleagues, clinical centers, vendors, and other external partners. Lead development of study protocols, CRF design and database development, ICF/patient authorizations, site initiation and data entry activities and development of analysis plans. Support development of physician and patient engagement plans, including web portals, advisory boards, and novel tools to enable long-term data collection
• Partner with Patient Advocacy to develop studies to understand the patient and caregiver perspective around burden of disease and treatment outcomes
• Support the development of criteria and processes for Externally Sponsored Research (ESR) studies; collaborate with Field Medical Affairs and investigators to provide input on study design and budgets
• Collaborate with external study investigators, patient groups, and other consortia to maximize synergies in development of and access to complementary data-sets
• Collaborate with colleagues in Medical Affairs to ensure all communications are aligned with the medical strategy to facilitate patient access to treatments

Qualifications:

• Minimum of 9-14 years' clinical experience in an academic or research institution
• M.D. degree is required
• Hematology clinical training preferred
• Solid understanding of drug development and life-cycle development of a product
• Ability to function independently to progress key projects with minimal direction and oversight 
• Demonstrated ability to work effectively in teams with a commitment to cross-functional risk sharing, collaboration and learning that facilitates partnership, collective accountability and prompt, informed decision-making
• Maintain clinical and technical expertise through review of the scientific literature and attendance at key scientific meetings
• Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building
• Demonstrated ability to deliver on commitments, to lead by example, and to enable others to effectively contribute

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company's facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.