New · posted Nov 4
Biogen · Biotechnology
Senior Medical Director, Clinical Development
- Cambridge, MA
- On-site
- Full-time
- Director
The 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 need
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.
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.
Preferred Skillsnice to have
- Experience in rare indications is a plus.
- Ability to function as Research and Development Project Lead.
Job Level: Management
Skills named in this posting
- MD or MD, PhD with immunology training
- 3-5 years clinical development in pharma/biotech
- Clinical Development Plan strategy
- Leading registration-stage or early clinical programs
- IND filing experience
- Interaction with global regulatory authorities
- Business development and due diligence
- R&D Project Lead capability
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.
Pay and benefits
$274,000 – $376,750 a year
Employer providedAdditional 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.
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
Medical, dental, vision and life insurance
401(k) with company match
Employee stock purchase plan
Paid vacation, holidays and sick time
Paid maternity and parental leave
Tuition reimbursement up to $10,000
Where you'll work
Cambridge, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Cambridge, MA
From the posting
About Biogen
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.
Equal opportunity, accessibility and legal noticesBiogen's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% above the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in Massachusetts64 roles publishing pay
Director roles in the US215 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $274,000 | — | $376,750 |
| Massachusetts (middle half) | $255,000 | $300,000 | $320,875 |
| All US (middle half) | $260,000 | $300,000 | $334,250 |
This role: Biogen's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 277 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Biogen's own promotion track.
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
Company hiring pulse
Biogen on Regulatory Jobs
- 23
- Open roles
- 23
- Distinct roles
- 4
- Locations
By discipline
- Clinical13 57%
- Quality7 30%
- Regulatory3 13%
By level
- Director7 30%
- Senior & Principal7 30%
- VP & Executive5 22%
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Senior Medical Director, Clinical Development at Biogen
Open until filled. $274K–$377K a year, employer provided.