Senior Medical Director, Clinical Development

Biogen; Cambridge (MA); Presencial; USD 274.000 - 377.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Paid vacation and holidays

Pension and equity incentive programs

Tuition reimbursement

Descripción de la vacante

Biogen seeks a Sr. Medical Director in Immunology to drive the clinical development program from early assets through to registration and post-approval. You will shape the Clinical Development Plan, contribute to external partnerships, and interface with global regulators.

You will lead cross-functional teams, provide immunology insights, and contribute to business development efforts while collaborating with MSIDU leadership and external partners to advance pipelines.

Formación

• MD or MD, PhD with training/experience in immunology.
• 3-5 years in clinical development within pharma/biotech.
• 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.

Responsabilidades

• 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.

Conocimientos

Immunology training

Clinical development

IND filings

Regulatory interactions

Business development

Educación

MD/PhD in Immunology

Descripción del empleo

About This Role

As the Sr. Medical Director specializing in 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.

About This Role

As the Sr. Medical Director specializing in 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.

Required Skills

• 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.
• 3 - 5 years in clinical development within pharma/biotech.
• 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.

Preferred Skills

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

Job Level: Management

Additional Information

The base compensation range for this role is: $274,000.00-$376,750.00. 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.

Benefits

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 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.