Associate Director, Evidence Generation - Neuropsychiatry (US Medical Affairs)

Role Summary

The Associate Medical Director, Evidence Generation - Neuropsychiatry is part of the US Medical Team, serving as a strategic partner to inform medical practice in the neuropsychiatry space. You will lead the development, support, and execution of a cross-functionally accepted Evidence Generation plan, delivering a cross-portfolio plan with a balance of technical expertise, therapeutic knowledge, project management, and communication skills. This individual contributor role supports the full portfolio of US marketed and pipeline products and reports to the Head of Evidence Generation.

Responsibilities

• Coordinate or lead the development of quality, impactful evidence generation activities, including clinical studies, real-world evidence generation, payor/managed care collaborative RWE studies, etc., used by field medical or commercial teams to educate HCPs, patients, PAGs, or other customers.
• Ensure studies are conducted in compliance with relevant SOPs and applicable internal, external, regulatory requirements; inform study teams and stakeholders of progress against goals, major study risks/opportunities, and agree to contingency/mitigation plans as needed.
• Communicate clearly, confidently, and credibly; engage in new opportunities for collaboration; develop solutions quickly to take advantage of emerging opportunities; take calculated risks and learn from failure.

Qualifications

• Required: MD, PhD, PharmD, DNP or comparable advanced degree in a scientific/clinical discipline.
• Required: Minimum 5 years’ experience in the healthcare/pharmaceutical sector with 2+ years’ experience in Evidence Generation roles, including Real World Evidence (RWE).
• Required: Strong proficiency in RWE disciplines such as comparative effectiveness study design, prospective study design, PRO survey design, RWD analyses and what payers consider strong evidence; ability to manage multiple studies and present them to stakeholders within and outside Biogen.
• Required: High knowledge of the US healthcare landscape, public health and industry trends, and regulatory and payer environment to identify key issues and develop evidence generation strategies and plans.
• Required: Clinical experience and subject matter expertise in one or more therapeutic areas; Neuropsychiatry preferred.
• Preferred: Prior experience collaborating within alliances or partnerships.
• Preferred: Experience with medical launch as well as products at different lifecycle stages; strong working knowledge of US regulations relevant to Medical Affairs.
• Required: Demonstrated ability to lead and collaborate with global, regional, and/or affiliate medical to ensure regional activities align with global medical strategy and address insights and needs.
• Required: Ability to manage projects and take initiative to solve complex problems.
• Required: Excellent written and oral communication skills, including presentations.

Skills

• Evidence generation planning and management
• Clinical study design and interpretation
• Real-world evidence (RWE) methodology and analysis
• Regulatory, payer, and healthcare landscape knowledge
• Strategic thinking and cross-functional collaboration
• Effective communication and presentation skills

Education

• MD, PhD, PharmD, DNP or comparable advanced degree in a scientific/clinical discipline.