Director, Clinical Pharmacology

Biogen; United States; Remote; USD 199,000 - 274,000; Full time

Job summary

A leading biotechnology company is seeking a Director of Clinical Pharmacology to provide strategic leadership throughout the drug development lifecycle. This role involves managing high-profile activities, mentoring teams, and ensuring compliance with regulatory standards. Ideal candidates are Ph.D.-level scientists with extensive clinical experience and a passion for drug development.

Benefits

Medical, Dental, Vision, & Life insurance

Fitness & Wellness programs

Up to 15 days of paid vacation

401(k) program with company match

Tuition reimbursement up to $10,000

Qualifications

• Required Ph.D. or equivalent in Pharmacology, Pharmaceutics, or related.
• 8+ years in Clinical Pharmacology or a related field.
• Extensive experience with clinical study design and regulatory submissions.

Responsibilities

• Lead Clinical Pharmacology initiatives across drug development.
• Manage and mentor junior staff in Clinical Pharmacology.
• Engage in regulatory strategy and documentation.

Skills

Pharmaceutical strategy development

Mentorship

Communication

Pharmacokinetics knowledge

Interpersonal skills

Education

Ph.D. in Pharmacology or related field

Job description

About This Role

As the Director, Clinical Pharmacology, you will serve as the Clinical Pharmacology Lead on multiple development or program teams, providing strategic leadership in the development and execution of Clinical Pharmacology Plans for drug candidates throughout the drug development lifecycle (preclinical through clinical). You will manage and/or mentor less experienced staff and be a respected and visible leader on Clinical Pharmacology issues within the function, for program teams, and across the organization.

This role reports to the Head of Clinical Pharmacology West Coast Hub (WCH).

What You’ll Do

• ·Lead and manage high profile Clinical Pharmacology activities including Clinical Development Plans and study design development across drug modalities and disease areas
• ·Drive the development and execution of the Clinical Pharmacology Plan for multiple assets or development teams
• ·Lead Clinical Pharmacology efforts in early and late stages of development (e.g. study design, protocol/synopsis preparation, data analysis and interpretation, result reporting, recommendation of action) to yield high-value PK/PD insights to inform critical decisions
• Provide Clinical Pharmacology guidance on regulatory strategy and take responsibility for Clinical Pharmacology-related sections of regulatory documents
• Maintain cutting-edge knowledge of best regulatory practices, drug development precedent, and relevant technical advances
• Maintain scientific awareness and presence, presenting and publishing and participating in scientific conferences and forums
• Engage with consultants and advisors in the field as well as the scientific community at large
• Engage in cross-functional committees and activities to provide a source of Clinical Pharmacology expertise and perspective to other functions across the company
• Manage and/or mentor junior staff within the function
• Develop expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serve as a reference source for peers

Who You Are

You are a Ph.D.-level scientist in Clinical Pharmacology or a related field with 8+ years of relevant experience in an industrial or academic setting. You have solid experience developing and implementing Clinical Pharmacology strategy and strong knowledge of the drug development process. You have experience leading teams and enjoy working in a multidisciplinary environment.

Required Skills

• Ph.D., M.D./Ph.D., or Pharm.D. in Pharmacology, Pharmacokinetics, Pharmaceutics or other suitable related fields with 8+ years of relevant industry experience
• Extensive experience developing and implementing Clinical Pharmacology strategy and designing and executing Clinical Pharmacology studies
• Active knowledge of advanced methods for Quantitative Pharmacology and Pharmacometric analyses and ability to design analyses to inform and expedite drug development (e.g. Model-Informed Drug Development)
• Deep understanding of the drug development process and regulatory guidance
• Direct experience preparing regulatory submissions, responding to health authority questions, and participating in interactions with regulatory authorities
• Experience leading teams and/or managing professional staff
• Attention to detail, writing and communication
• Ability to mentor and train junior scientists
• Excellent interpersonal, presentation, and communication skills

Job Level: Management

Additional Information

The base compensation range for this role is: $199,000.00-$274,000.00

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 onto learn more about our DE&I efforts.

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.