Director, Clinical Pharmacology Lead

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $209k - $287.8k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Provide strategic leadership for Clinical Pharmacology activities across the West Coast Hub Transplant portfolio • Lead Clinical Pharmacology activities supporting BLA submissions, regulatory interactions, labeling strategy, and lifecycle management • Represent Clinical Pharmacology on program and study teams and in governance forums • Develop and execute integrated Clinical Pharmacology strategies supporting dose selection and justification, benefit-risk assessment, regulatory approval, and lifecycle management • Lead preparation of Clinical Pharmacology components of 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 and identify and mitigate regulatory risks • Lead and oversee exposure-response assessments, population PK analyses, intrinsic and extrinsic factor evaluations, immunogenicity impact assessments, and Model-Informed Drug Development approaches • Partner with Pharmacometrics and other quantitative functions to align analyses with regulatory and development objectives • Provide mentorship and technical leadership within Clinical Pharmacology and advance Clinical Pharmacology capabilities across WCH Development • Maintain expertise in evolving Clinical Pharmacology science, regulatory expectations, and development precedents relevant to transplant and immunology programs

🎯 Requirements

• 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

🏖️ 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 • Short term and long-term incentives, including cash bonus and equity incentive opportunities