Job Summary
The Vice President, Medical Affairs is responsible for leading the development and execution of strategic and tactical plans for Headquarter (HQ) and Field medical affairs teams pre-launch, launch, and post approval for biosimilars and biologic products. This leader is an active and collaborative member of the Biosimilar Leadership Team (BLT). Leads local and collaborates on global product and business development activities. Serves as strong medical lead working with cross-functional counterparts regionally and globally to ensure strong execution against corporate goals and objectives in line with federal, state and company compliance requirements. Strong, motivational leader who builds and leads medical affairs team to ensure high quality, compliant execution against medical affairs performance goals.
*While this position may be worked remotely, qualified candidates must be permanently authorized to work in the U.S., and must work inside the U.S.
Responsibilities
Develop and ensure execution of impactful medical affairs strategy and tactics for HQ and Field teams to support product development, pre- and post-launch activities as aligned with the SVP, Chief Medical Officer.
Collaborate with direct reports and MSL Senior Managers/Field Directors to align on and oversee MSL onboarding, training, resource development and impactful execution of in-field territory plans across oncology and immunology.
Lead HQ team to ensure impactful strategic and tactical execution of key medical affairs initiatives including: IIT evaluation, study design/execution, evidence generation, multi-channel medical communication/education, consulting, MRL review and Medical Information.
Maintain a high level of professional expertise by staying abreast of the current medical landscape with regard to key therapeutic areas (e.g., oncology, immunology) and related products.
Work with broader Medical Affairs team to identify, build relationships with, and provide insights from, KOLs, decision makers and influencers in the HCP community.
Medical expert for US to review, develop, and approve clinical summaries in support of BLA, NDA, and ANDA applications.
Medical expert who provides, and trains others in the organization to provide, scientifically accurate, fair-balanced, clear, concise (yet comprehensive) medical information targeted to appropriate audiences regarding disease state, business landscape and key product information to external and internal customers.
Serve as a US medical expert/point person providing due diligence on business development opportunities for products in development as well as potential acquisition targets.
Train and facilitate other members of the team to train staff regarding current knowledge of disease/treatment landscape, applicable local and global regulations, standard operating procedures, and guidelines.
Responsible for writing, and/or training team to write/review relevant Standard Operating Procedures (SOPs) as needed.
Job Requirements
Medical/clinical professional degree required (PharmD, MD, PhD).
15+ years of experience in the pharmaceutical industry (predominantly in a medical affairs or clinical development role) required (supporting Biosimilars or Biologics preferred). Clinical experience will also be considered (7+ years preferred).
Pharmacology (PK/PD) knowledge and ability to communicate key concepts and study findings required.
Ability to understand and interpret the regulatory requirements under which drugs are developed, reviewed, and supported after approval.
Experience with the clinical drug development process.
Significant experience leading larger teams including HQ and/or Field required.
Clinical and scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents.
Ability to understand and interpret FDA BLA (351 (a), (k)), NDA, and ANDA submission requirements.
Knowledge of PC systems and Microsoft Office Suite (Word, Excel) is required.
Up to 50-60% travel required.
Base salary range: $280,000-330,000
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
