临床药理学负责人
Director, Clinical Pharmacology Lead
**关于该职位**
作为临床药理学负责人，您将在西海岸中心（WCH）移植产品组合中为临床药理学活动提供战略领导，主要负责支持后期开发和注册活动的临床药理学策略、执行和监管交付物。
该职位将作为移植项目的临床药理学负责人，包括领导支持BLA提交、监管互动、标签策略和生命周期管理的临床药理学活动。成功候选人应能够独立工作，影响项目层面的决策，并为高优先级开发项目提供临床药理学领导。我们更倾向于选择有实际经验领导至少一个重大市场申请（如BLA或NDA）的临床药理学部分的候选人，包括准备提交、卫生机构审查、对信息请求的回应以及审批阶段的互动。
向西海岸中心临床药理学与药代动力学负责人汇报，该职位将与药代动力学、生物标志物、临床开发、监管、生物统计学以及其他跨职能合作伙伴密切合作，以确保临床药理学策略科学严谨、监管可辩护，并与整体项目目标保持一致。
**您将负责**
- 作为临床药理学代表参与项目和研究团队以及治理论坛，影响关键项目决策，并为移植产品组合以外的临床药理学职能的战略方向做出贡献。
- 制定并执行整合的临床药理学策略，支持剂量选择和论证、获益风险评估、监管批准和生命周期管理。
- 领导主要监管提交物（包括BLA、补充文件、简报包、信息请求和监管回应）中的临床药理学部分的准备工作。
- 为监管互动提供战略领导，并在与卫生机构的会议中代表临床药理学。
- 推动临床药理学对提交准备工作的贡献，并主动识别和缓解监管风险。
- 领导和监督临床药理学分析，包括暴露-反应评估、群体药代动力学分析、内在和外在因素评估、免疫原性等。
查看英文原文
**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-TD1
Job 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 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](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.biogen.com%2Fresponsibility%2Fdiversity-inclusion.html&data=05%7C01%7Cdennis.mercier%40biogen.com%7C67adaf5a6edd4324716208db0dcd2182%7C7b7466bbfe1d47a0b9438ded565c8e54%7C0%7C0%7C638118946897044815%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=p2vFGx6ZWK7lyBEL4wuNIQJcKSVRZD90VuJxcOkjX04%3D&reserved=0) 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.