Senior Medical Director, Alzheimer’s Disease & Dementia, Clinical Development

Role Summary

Senior Medical Director, Alzheimer’s Disease & Dementia, Clinical Development. Lead and oversee clinical development activities across early and late-stage programs within Biogen's ADD portfolio, developing Clinical Development Plans to ensure timely progression from discovery to regulatory approval and post-market surveillance. Influence strategy, partnerships, and due diligence within a cross-functional leadership context.

Responsibilities

• Lead the strategic framework for clinical development plans, aligning scientific rationale, regulatory requirements, product development, and commercial objectives.
• Implement and manage the Clinical Development Plan for the ADD clinical pipeline and research assets.
• Guide clinical development from early-stage assets through to registration and post-approval phases.
• Offer clinical expertise for early development assets during the research phase, supporting the transition from research to development (R2D).
• Provide clinical insights for partnered assets and support due diligence for potential external assets.
• Serve as the Development Lead for an asset.
• Be an active member of the functional leadership team, contributing to broader strategy discussions and influencing senior cross-functional counterparts.
• Engage with global regulatory authorities and foster relationships that facilitate the clinical development process.

Qualifications

• Required: MD or MD/PhD with specialization in neurology, neurodegeneration, geriatric neurology, neurocognitive disorders or movement disorders.
• Required: Minimum of 5 years of experience in the pharmaceutical industry.
• Required: Proven track record of leading clinical programs to regulatory submission and approval stages.
• Required: Demonstrable experience with filing Investigational New Drug applications (INDs).
• Required: Extensive interaction with global regulatory authorities.
• Required: Proficiency in business development and due diligence activities.
• Preferred: Strategic thinking and exceptional problem-solving skills.
• Preferred: Strong leadership and team management abilities.
• Preferred: Excellent communication and interpersonal skills, capable of fostering collaborative relationships.

Education

• Not specified

Additional Requirements

• Travel or physical demands not specified as essential.