Medical Director - US Medical Lead - Evenity (Bone)

Role Summary

Medical Director, US Medical Lead. You will support the implementation of US medical strategies, drive local evidence generation and lifecycle management, oversee clinical trial conduct, and engage external key stakeholders. You will contribute to data communication strategies and regulatory interactions, and ensure medical governance and compliance for the US market.

Responsibilities

• Support implementation of US medical strategies.
• Develop and execute the US product medical strategy via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team/Portfolio Governance and alignment with Global strategy.
• Define scientific evidence gaps and develop local evidence generation strategy in coordination with Global.
• Support clinical trial conduct.
• Engage external key stakeholders (often in partnership with other functions).
• Develop data communication strategy (including congress).
• Provide Medical input into label and regulatory interactions, in alignment with global strategy and program clinical trial data.
• Implement Medical governance for the product, which includes:
  • Safety and pharmacovigilance as a key and effective partner with GRAAS
  • Clinical trial conduct
  • US risk management/minimization in collaboration with GRAAS
  • Subject matter appropriateness (medical/scientific) of external interactions (e.g., copy review, multichannel, congresses, 1-1 interactions)
• Ensure appropriate medical support of compliance.

Qualifications

• Required: Doctorate degree and 4 years of medical leadership experience
• Required: Master’s degree and 8 years of medical leadership experience
• Required: Bachelor’s degree and 10 years of medical leadership experience
• Required: At least 4 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. This managerial experience may run concurrently with the above technical experience.
• Preferred: MD plus accredited fellowship, board certified or board eligible
• Preferred: Clinical research/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
• Preferred: Experience with clinical study management and conduct
• Preferred: Familiarity with US health care compliance considerations
• Preferred: Experience with opinion leader interactions
• Preferred: Experience with integrated delivery networks, accountable care organizations, and payers
• Preferred: Broad and formal leadership experience
• Preferred: Pharmaceutical product development, product lifecycle and commercialization process knowledge with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs
• Preferred: Network of customer contacts in therapeutic area
• Preferred: Knowledge of local pharmaceutical industry and legal/health system environment
• Preferred: Finance/budgeting and resource management experience