Senior Medical Director, Alzheimer’s Disease & Dementia, Clinical Development
BiogenAbout the role
Job Description
About This Role:
As a Senior Medical Director for Alzheimer’s disease & Dementia (ADD) Clinical Development, you will be at the helm of pioneering programs that have the potential to transform lives. You'll lead and oversee clinical development activities across both early and late-stage programs within Biogen's ADD portfolio. This integral role requires a blend of scientific acumen, strategic planning, and leadership to advance clinical assets from discovery through to regulatory approval and post-market surveillance. By developing and implementing robust Clinical Development Plans (CDPs), you will ensure that clinical development timelines are met with precision, incorporating pivotal decision points and critical criteria for progression. As a cornerstone of our clinical development team, your work will not only shape the trajectory of our ADD pipeline but also contribute to the company's mission by providing vital insights into early development of research assets, external partnerships and due diligence activities. Within the wider business structure, you will serve as a lynchpin for cross-functional collaboration, influencing strategy and decision-making at a senior level.
What You’ll Do:
- 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.
Who You Are:
You are a visionary leader with an MD or MD/PhD, ideally grounded in neurodegeneration or movement disorders. Your past five years have been marked by a trail of successes in pharmaceutical clinical development, including leading registration-stage programs and navigating the complexities of global regulatory interactions. You are no stranger to the crucial nature of business development and due diligence processes. Your experience may also extend to rare indications, setting you apart as a specialist in the field. You are known for your strategic mindset and your ability to drive clinical programs to fruition, all while ensuring alignment with broader organizational goals.
Qualifications
Required Skills:
- MD or MD/PhD with specialization in neurology, neurodegeneration, geriatric neurology, neurocognitive disorders or movement disorders.
- Minimum of 5 years of experience in the pharmaceutical industry.
- Proven track record of leading clinical programs to regulatory submission and approval stages.
- Demonstrable experience with filing Investigational New Drug applications (INDs).
- Extensive interaction with global regulatory authorities.
- Proficiency in business development and due diligence activities.
Preferred Skills:
- Strategic thinking and exceptional problem-solving skills.
- Strong leadership and team management abilities.
- Excellent communication and interpersonal skills, capable of fostering collaborative relationships.
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Additional Information
The base salary range for this position is $268,000.00-$369,000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
· Medical, Dental, Vision, & Life insurances
· Fitness & Wellness programs including a fitness reimbursement
· Short- and Long-Term Disability insurance
· A minimum of 15 days of paid vacation and an additional e
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