Senior Medical Director, Medical Affairs - United States
Want to know company name or location? Company managed [?]
- Our company is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells.
- Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.
- We are on a rapid growth trajectory and have a highly energized and accomplished team.
- Our company is publicly traded with a current market capitalization well over $2 Billion.
- The Senior Medical Director, Medical Affairs provides clinical leadership and input to Vice President, Medical Affairs on clinical program strategies and life cycle management.
- He/she provides Medical Affairs clinical support and works closely with cross-functional groups that include Research, Translational Sciences, Development, Commercial and Clinical Operations to ensure that Medical Affairs scientific and medical strategies are aligned with broader corporate and patient needs.
- He/she is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.
- Partner with opinion leaders (OLs) to gather information on current focused therapeutic area issues and questions.
- Provide clinical leadership in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Development, and Commercial)
- Work closely with Medical Science Liaisons (MSLs) to provide appropriate education and training.
- Provide support, participation and insight in MSL activities, such as KOL interactions.
- Provide medical expertise to the Medical Information group and Medical Communications group; participate in a cross-functional team that identifies and addresses emerging medical inquiries; reviews documents created to support Medical Affairs external communications
- Provide medical support to promotional and legal review committees
- Provide medical support as needed on non-company sponsored studies, non-interventional studies and investigator sponsored studies.
- MD, Board certified hematologist or oncologist preferred
- Strong knowledge of hematology, and in particular, strong depth of knowledge in leukemias and lymphomas
- Working knowledge of biostatistics and pharmacokinetics
- Possess an understanding of applicable US and EU drug development regulations and GCP regulations
- Pharmaceutical clinical research experience
- Ability to work collaboratively in a team-based environment with minimal supervision
- Excellent written and oral communication skills, including presentation skills
- Detail-oriented, with excellent planning, time management and organizational skills, and the ability to work independently while organizing multiple tasks and meeting aggressive deadlines
- Proven ability to develop internal relationships, as well as external relationships with opinion leaders and industry experts
- Ability to engage in positive dialogues, influence outcomes and resolve conflict in a constructive manner
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of the first 200 employees in this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.