Senior Medical Director, Clinical Development

Biogen•Cambridge, MA

23h

About The Position

The Senior Medical Director specializing in Immunology is a pivotal member of the Clinical Development team. The role integrates scientific rationale, regulatory requirements, product development plans, and commercial goals to shape strategic clinical development initiatives. The position develops and implements Clinical Development Plans for clinical pipeline and research assets, and leads clinical development of early-stage assets through registration and post-approval. The role provides clinical insights for early development assets, including assets that have not completed R2D transition, and contributes clinical expertise to partnerships and in-licensing activities, including due diligence. The Senior Medical Director acts as an R&D Project Lead accountable for an asset throughout development and serves on the functional leadership team, influencing organizational strategy and senior cross-functional counterparts. The position engages significantly with global regulatory authorities and collaborates with MSIDU leadership, the Immunology Franchise, and external innovation partners.

Requirements

MD or MD, PhD, with training or experience in immunology; examples include general medicine with a fellowship in rheumatology or dermatology, with pulmonary, infectious disease, and gastroenterology also considered.
3–5 years of clinical development experience within pharma or biotech.
Experience leading registration-stage programs and/or early clinical development programs, including experience filing INDs.
Significant interaction with global regulatory authorities.
Business development experience, including due diligence.

Nice To Haves

Experience in rare indications.
Ability to function as a Research and Development Project Lead.

Responsibilities

Develop and implement Clinical Development Plans for clinical pipeline and research assets.
Lead and oversee clinical development of early-stage assets through registration and post-approval.
Provide clinical insights for early development assets that have not completed R2D transition.
Provide clinical input for partnered assets and in-licensing activities.
Act as Research and Development Project Lead, ensuring accountability for an asset throughout development activities.
Serve as a member of the functional leadership team and provide insights on broader strategy.
Influence senior cross-functional counterparts across research, development, medical business, and commercial functions.
Engage significantly with global regulatory authorities.
Lead registration-stage programs and/or early clinical development programs, including experience filing INDs.
Participate in business development activities, including due diligence.
Collaborate closely with MSIDU leadership, the Immunology Franchise, and external innovation partners.

Benefits

Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
At least 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid maternity and parental leave.
401(k) program with company-matched contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Employee Resource Groups participation.
Short-term and long-term incentives, including cash bonus and equity incentive opportunities.