Biogen · 9 hours ago
Senior Director and Section Head of Clinical Pharmacology & Pharmacometrics
United States
Full-time
Remote
Director/Executive
$242K/yr - $333K/yr
15+ years expBiogen is a global biotechnology company committed to excellence and innovation in drug development. The Senior Director and Section Head of Clinical Pharmacology & Pharmacometrics will lead a team focused on executing clinical development plans and providing scientific leadership in pharmacokinetics and pharmacodynamics. This role involves managing high-profile clinical pharmacology activities, mentoring staff, and engaging in cross-functional collaborations to support Biogen's diverse portfolio.
BiotechnologyHealth CareNeuroscienceTherapeutics
Hiring Manager
Teresa de Leon
Responsibilities
Leads and manages high profile clinical pharmacology activities including training, CDP and study designs with R&D across drug modalities and Biogen disease areas
Leads clinical pharmacology efforts in early and late stage (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results
Ability to represent clinical pharmacology function at governance (DPAC, RDGC, TRC) and external advisory boards
Provides extensive regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents. Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent
Engages in cross-functional activities providing Clinical Pharmacology input and provides a source of Clinical Pharmacology expertise and advice to other functions across the Company. Participates in and provides Clinical Pharmacology perspective to cross-functional committees and activities
Maintains extensive scientific awareness and presence in Clinical Pharmacology, publishes multiple manuscripts and posters, presents at Scientific Conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large
Manages and/or mentors staff within the function and matrix leadership across projects. Develops expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serves as a reference source in these for his peers
Qualification
Required
Ph.D., M.D./Ph.D., or Pharm.D. in Clinical Pharmacology, pharmacokinetics, or a related field
15+ years of direct industry experience in Clinical Pharmacology
Demonstrated experience in leading teams and/or managing professional staff
International recognized expert in Quantitative Clinical Pharmacology
Solid experience in developing Clinical Pharmacology strategy, designing/implementing Clinical Pharmacology studies
Strong knowledge of the drug development process and overall familiarity with the regulatory process. Direct experience in preparing regulatory submissions and responding to health authority questions
Extensive record of publications, presentations, invited lectures, and other scientific activities
Active knowledge of advanced methods for Quantitative Pharmacology and PMx analyses
Experience with use of PK/PD software packages such as -Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
2026-01-16
2026-01-16
2026-01-16
Company data provided by crunchbase