Medical Director-US Medical Affairs- hATTR Franchise
Reporting into the VP, Global Medical Affairs, and serving as a key member of the Medical Affairs leadership team, the Medical Director-US Medical Affairs will be the in-house Medical Affairs professional responsible for the provision of medical insights
and expertise in the development and execution of key medical affairs activities, including supporting partner functions such as development and commercial. Working in alignment with other Medical Affairs functions (Field Medical, Medical Communications, Medical
Information), the Medical Director will be responsible for the development and execution of select components of the brand plan(s), including KOL engagement (in conjunction with field medical), Managed Access program, registry, and Investigator-Initiated Research
(IIR) planning and oversight.
This position will be a HQ position based in Carlsbad, CA.
Primary Position Responsibilities/Tasks
- Lead Medical review of marketing and medical materials on Medical-Legal-Regulatory and medical materials review teams
- Liaise with commercial colleagues and provide expert input into requested and relevant activities and projects including disease state and product materials creation
- Work with market access lead to provide medical insights and assist as required in the preparation and/or review of the product dossiers
- Lead development, execution and oversight of Expanded access program and disease state registry
- Develop, implement and oversee management of IIR processes and strategies
- In conjunction with Field Medical Directors, represent Medical Affairs at congresses, professional association meetings, and other international, national, regional and local events
- Provide strategic and medical input into execution of publication plan, including interfacing with publications lead, medical writer(s) and statisticians to ensure high quality, medically accurate output
- Integrate and align activities and insights with Medical Director(s), Europe to ensure global medical plan execution consistency
- Maintain knowledge of hATTR market place, including knowledge of competitive products, treatment protocols and paradigms, and emerging relevant data and trends
- As required, assist medical writing and medical information in the drafting and finalization of Standard Response Letters (SRLs)
- Interface with regulatory affairs in the development and progression of regulatory documents, including the NDA, NDS, and MAA
- In conjunction with Medical Communications and Field Medical, develop supporting materials (e.g. slide decks) for external medical affairs presentations
- Contribute to the development of internal process for comprehensive collection and analysis of medical and scientific competitive intelligence information. As appropriate, facilitate appropriate internal distribution to medical, legal, regulatory and marketing
- Integrated with Field Medical Directors, interact with Key Opinion Leaders (KOLs) in respective therapeutic area to establish strong scientific presence and value of MA in the medical and academic communities
- Provide expert input in the medical affairs aspects of ongoing and future clinical trials
- Participate in the evaluation of in-licensing opportunities
- M.D. required- Specialization in neurology or internal medicine with experience in transthyretin amyloidosis and/or diseases with sensory neuropathies strong preferred
with clinical experience in respective specialty
- 3+ years of experience working in the Pharmaceutical Industry, preferably within Medical Affairs
- Excellent interpersonal skills with demonstrated ability to work with and effectively support cross-functional teams
- Excellent working knowledge of policies and guidance documents related to compliant medical affairs operations, including information dissemination, continuing medical education, and clinical trials
- Demonstrated success in pre-launch medical affairs brand plan development and execution
- Experience in designing and working with patient registries and Expanded Access/Compassionate use programs
Excellent salary and benefits package offered.
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Akcea Therapeutics is proud to be EEO employer.