SciPro has been engaged with to support on a search for a (M.D) Vice President Medical Affairs to join an exciting organization who will be responsible for defining Medical Affairs strategy and building a Medical Affairs organization to support the launch of my client's product portfolio and emerging therapies. Reporting directly to the CMO, the position will be a key member of the leadership team who will be work closely with other departments including but not limited to Clinical Development, Regulatory Affairs & Commercial Operations.
Responsibilities of this role will include, but are not limited to, the following:
- Develop an overall medical affairs strategy
- Build a medical affairs organization to support strategy globally
- Lead development of medical strategy, including publication strategy, congress strategy, and LCM) strategy
- In collaboration with the project team(s), develop publication plan(s), contribute to the development of key publications (abstracts, manuscripts, posters, presentations, etc)
- Lead development of non-regulatory-mandated clinical phase IIIb/IV, disease registries, epidemiological studies, outcomes surveys, etc.
- Provide Health Economics and Outcomes Research strategy (via use of external providers)
- Provide input on labeling and regulatory strategy
- Act as a senior company representative with KOLs, policy makers, patient advocacy groups and/or regulatory authorities
- Collaborate with thought leaders to develop clinical therapeutic concepts, identify messages for scientific communications based on preclinical or clinical data, and gain feedback on strategies to support medical affairs plan for pre launch and marketed products
- Set the scientific strategy for MSL field activities and KOL advocacy plans to build and maintain critical relationships
- Support Medical Safety colleagues in the provision of Medical Information
- Anticipate queries that may arise with new product launches and establish high quality and timely training
- Serve as a key medical resource on disease areas and on specific products Closely monitors and evaluates medical literature for potential impact on products and initiatives
- Provide medical review and approval of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process
- Lead design and execution of medical affairs-accoutnable clinical studies, including phase IIIb/IV trials, disease registries, epidemiological studies, and outcomes surveys.
- Collaborate with Legal/Compliance and Regulatory affairs and ensure understanding and adherence to external policies and regulations
- Provide disease and product training in collaboration with key internal stakeholders
- Develop and maintain knowledge of pharmaceutical regulations, guidelines, codes of practices
- Ensure appropriate medical input and review on promotional material/activities as member clients promotional material review team
- Ensure appropriate medical input and review on business development and relevant clinical programs as needed
Experience / Qualifications:
- MD with experience in leading Medical Affairs for a product launch or marketed product
- Experience in rare disease or specialty indications required
- Experience in pre-registration clinical trials highly preferred
- A passion for addressing patients' needs and a solid understanding of the industry's complex regulatory and compliance requirements with an absolute commitment to competing on the highest ethical level are essential
- Strong management and team building skills
- Ability to build and maintain key external relationships across key stakeholders
- Ability to present effectively to groups and manage through others to ensure adherence to the highest quality standards, with the ability to collaborate and drive for results
- Flexible, entrepreneurial by nature, a collaborative team player who works well with patients, physicians, providers, payers, regulators, scientists and peers
- Outstanding presentation, written and oral communication skills required. A clear communicator who can influence effectively both internally and externally.