Sr. Medical Director, Immunology, Clinical Development
About The Position
About This Role: As the Sr. Medical Director specializing in Multiple Sclerosis and Immunology, you will be a pivotal member of our Clinical Development team. This role integrates scientific rationale, regulatory requirements, product development plans, and commercial goals to construct a strategic framework for our clinical development initiatives. You'll be responsible for developing and implementing the Clinical Development Plan (CDP) for both our clinical development pipeline and research assets. Leading and overseeing the clinical development of early clinical stage assets through to registration and post-approval is a core aspect of this position. You will provide critical clinical insights for early development assets, working alongside our research function. Your expertise will also be crucial in partnerships and in-licensing activities, where you will offer clinical input and participate in due diligence for potential external assets. This role not only demands deep clinical knowledge but also strategic acumen to influence broader organizational goals. What You’ll Do: Develop and implement the Clinical Development Plan for clinical pipeline and research assets. Lead and oversee the clinical development of early-stage assets through to registration and post-approval. Provide clinical insights for early development assets that have not completed R2D transition. Offer clinical input for assets in partnership with external partners and/or for 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, providing 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 with experience filing INDs. Participate in business development activities, including due diligence. Collaborate closely with MSIDU leadership, Immunology Franchise, and external innovation partners. Who You Are: You are a visionary leader with a robust background in immunology and a passion for driving clinical development forward. Your ability to integrate scientific and commercial perspectives allows you to build comprehensive strategic frameworks. You thrive in a collaborative environment, influencing and inspiring cross-functional teams towards a common goal. Your strategic insights and experience with regulatory authorities position you as a key player in advancing our clinical assets. You approach challenges with a solution-oriented mindset, always aiming to enhance our clinical development processes.
Requirements
- MD or MD, PhD, with training/experience in immunology, such as general medicine with a fellowship in rheumatology or dermatology, also considering pulmonary, ID, and GI.
- At least 5 years in the pharmaceutical industry.
- Experience leading registration-stage programs and/or early clinical development programs with experience filing INDs.
- Significant interaction with global regulatory authorities.
- Business development experience, including due diligence.
Nice To Haves
- Experience in rare indications is a plus.
- Ability to function as Research and Development Project Lead.
Responsibilities
- Develop and implement the Clinical Development Plan for clinical pipeline and research assets.
- Lead and oversee the clinical development of early-stage assets through to registration and post-approval.
- Provide clinical insights for early development assets that have not completed R2D transition.
- Offer clinical input for assets in partnership with external partners and/or for 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, providing 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 with experience filing INDs.
- Participate in business development activities, including due diligence.
- Collaborate closely with MSIDU leadership, Immunology Franchise, and external innovation partners.
Benefits
- 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 end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
