Executive Medical Director, Cell Therapy (NY ESO 1) - US Medical Affairs
The Medical Director is accountable for the work of US Medical Affairs for a specific medicine(s) in partnership with the Global Franchise, R&D, US medical matrix team(s) and US medical commercial strategy team(s). The incumbent should be able to contribute to the development and execution of the US Medical Affairs Plan and the medical sections for the strategic plan for one or more medicines integrating US environment and medical voice of customer (patients, providers, payers) into medical affairs strategy. In addition, the candidate must ensure US needs for medical and health outcomes evidence generation are represented and incorporated into the global medical work and recommend scientifically appropriate measures within health outcomes research over the lifecycle of the medicine(s) to meet US reimbursement needs.
- Ensure US external experts are appropriately engaged over the life cycle of the medicine in close collaboration with the field medical organization to gain insights into our medicine(s) and diseases through advisory boards, consultations, scientific meetings, publications and research related activities.
- Provide input to global Integrated Evidence Plan for the medicine(s) and lead the design and delivery of US-focused late phase studies in collaboration with Global Franchises. Act as medical monitor when appropriate and manage US funded investigator sponsored studies.
- Partner with stakeholders to ensure delivery of assigned medical activities to support life cycle management and ensure integrity of scientific content and medical governance.
- Work closely with R&D, Global Franchise, safety, regulatory, and manufacturing to ensure appropriate decisions based on a benefit-risk assessment.
- Serve as the US Medical Affairs point of contact for safety issues and contribute to the copy approval process.
- Up to 20% travel, mostly domestic, may be required.
- Physician (M.D. or equivalent) with board certification and demonstrated experience and interest in treatments for cancer. Active or eligibility for a US Medical licensure (or equivalent previously outside of the US) is required. Subspecialty certification in Oncology/Hematology is preferred.
- In-depth knowledge of Oncology and/or cell therapy, especially related to disease mechanisms, patient care, treatment options, clinical decision making, and key issues and advances in the field. Experience in cancer cell therapies, NSCLC, and/or Sarcoma drug development is strongly preferred.
- Familiarity with key medical/scientific experts in the Oncology and/or cell therapy field with capability of effectively interacting and collaborating with these experts.
- Effective team leadership, with proven ability to motivate, influence, negotiate, and collaborate; strong project management skills; solid planning and organizational skills; strong scientific/analytical problem-solving skills.
- Strong business acumen and communication skills (oral and written), including the ability to identify and articulate the value of clinical and heath outcome data to internal stakeholders and external customers.
- Product lifecycle management experience, including the ability to detect and foresee potential changes in the healthcare, regulatory and competitive environments throughout the product lifespan; to understand the impact of new data on the value / positioning of products in guidelines / formularies; and to proactively identify unmet needs and how to address them.
- Medical affairs experience is preferred.
- Robust knowledge of the US healthcare environment including disease-specific research priorities, public health need, competitor landscape, clinical practice trends and treatment guidelines evolution.
- Clinical research/drug development experience obtained while working in the pharmaceutical industry or substantial clinical trial experience collaborating with pharmaceutical sponsors in either the academic or clinical practice setting is preferred.
- Knowledge and experience in late phase trials, drug development, and FDA guidance to industry.
- Teaching skills: expected to become the educator-in-chief on his/her medicine within the US Medical Affairs group.
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