About This Role:
As the Clinical Pharmacology Lead you will provide strategic leadership for Clinical Pharmacology activities across the West Coast Hub (WCH) Transplant portfolio, with primary accountability for Clinical Pharmacology strategy, execution, and regulatory deliverables supporting late-stage development and registration activities. This role will serve as the Clinical Pharmacology Lead for transplant programs, including leadership of Clinical Pharmacology activities supporting BLA submissions, regulatory interactions, labeling strategy, and lifecycle management. The successful candidate will be expected to operate independently, influence program-level decisions, and provide Clinical Pharmacology leadership for high-priority development programs. Candidates with hands-on experience leading the Clinical Pharmacology components of at least one major marketing application, such as a BLA or NDA, through filing preparation, health authority review, responses to information requests, and approval-stage interactions are strongly preferred. Reporting to the Head of Clinical Pharmacology and Pharmacometrics, WCH, this role will work closely with Pharmacometrics, Biomarkers, Clinical Development, Regulatory, Biostatistics, and other cross-functional partners to ensure Clinical Pharmacology strategies are scientifically rigorous, regulatory defensible, and aligned with overall program objectives.
What You'll Do:
Represent Clinical Pharmacology on program and study teams as well as in governance forums, influencing key program decisions, contributing to the strategic direction of the Clinical Pharmacology function beyond transplant portfolio.
Develop and execute integrated Clinical Pharmacology strategies that support dose selection and justification, benefit-risk assessment, regulatory approval, and lifecycle management.
Lead preparation of Clinical Pharmacology components of major regulatory submissions, including BLAs, supplemental filings, briefing packages, information requests, and regulatory responses.
Provide strategic leadership for regulatory interactions and represent Clinical Pharmacology in meetings with health authorities.
Drive Clinical Pharmacology contributions to filing readiness activities and proactively identify and mitigate regulatory risks.
Lead and oversee Clinical Pharmacology analyses, including exposure-responses assessments, population PK analyses, intrinsic and extrinsic factor evaluations, immunogenicity impact assessments, and Model-Informed Drug Development approaches.
Partner closely with Pharmacometrics and other quantitative functions to ensure analyses support regulatory and development objectives.
Provide mentorship and technical leadership within the Clinical Pharmacology function and contribute to the advancement of Clinical Pharmacology capabilities across WCH Development as well as providing scientific and strategic leadership that influences broader organization.
Maintain expertise in evolving Clinical Pharmacology science, regulatory expectations, and development precedents relevant to transplant and immunology programs.
Who You Are:
You are a visionary leader with a deep understanding of Clinical Pharmacology, equipped to drive strategic decisions and influence program development. Your ability to operate independently and mentor others reflects your commitment to advancing the Clinical Pharmacology function. You thrive in cross-functional environments and possess the interpersonal skills to unite diverse teams toward shared objectives. Your proven track record in regulatory submissions and health authority interactions highlights your expertise and dedication to the field.
Qualifications:
PhD, PharmD, MD, or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics, Clinical Pharmacology, or a related discipline.
8+ years of relevant industry experience, including substantial experience supporting late-stage development, regulatory submissions, and health authority interactions.
Demonstrated experience serving as a Clinical Pharmacology Lead for development programs with accountability for strategy and execution.
Proven track record authoring and defending Clinical Pharmacology sections of BLAs, NDAs, supplemental applications, or equivalent regulatory submissions.
Experience leading Clinical Pharmacology strategy for registration-enabling programs and supporting regulatory agency interactions.
Deep expertise in dose justification, exposure-response evaluation, immunogenicity assessments, and Model-Informed Drug Development approaches.
Strong knowledge of Clinical Pharmacology regulatory guidance and expectations for biologic products.
Experience in transplant, nephrology, immunology, or related therapeutic areas.
Ability to influence cross-functional teams and drive strategic decisions in a matrix environment.
Excellent written, verbal, presentation, and interpersonal skills.#LI-TD1Job Level: Management
Additional Information:
The base compensation range for this role is: $209,000.00-$287,750.00
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 familiesphysical, financial, emotional, andsocial 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. VEVRAA Federal Contractor.
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
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