Scientific Director, Development Toxicology

About this role

Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives. We apply a deep understanding of human biology and leverage different therapeutic modalities to advance first-in-class treatments or therapies that deliver superior outcomes to patients. We are looking for a motivated and passionate individual to join us as a Director, Development Toxicology, with a focus on enabling the delivery of transformative and safe drugs to patients. You will provide non-clinical safety expertise for our diverse portfolio which contains a broad range of indications and drug modalities. This high-impact role supports the advancement of the pipeline by designing, conducting and interpreting toxicology studies, assessing safety risks, and contributing to project strategy across all phases of Drug Development and for our marketed products. The position is based in a collaborative, multidisciplinary environment within the Nonclinical Safety function.

What you'll do:

• Accountable for all aspects of the nonclinical safety and regulatory strategies for their development programs and marketed products
• Responsible for ensuring the effectiveness of their Nonclinical Safety sub-teams (represented by toxicology, pathology, study management, DMPK, and CMC) which manage the operational execution of the nonclinical safety strategy for each program
• Collaborate with other functional groups (study management, pathology, clinical, regulatory, research, translational sciences, DMPK, clinical safety, CMC, etc.) and external partners on program-related tasks and objectives
• Leads initiatives to improve/modernize processes, develop best practices guidelines, validate new methods and technologies, and optimize partnerships to facilitate portfolio advancement.
• Represents Biogen on external scientific committees and industry working groups in the areas of drug development and regulatory toxicology.
• Provides mentorship to less experienced toxicologists and scientists within and outside of the Nonclinical Safety Department
• Serve as a subject matter expert within their field of sub-specialization to provide input on other programs and studies, including external partnerships and due diligence reviews for in-licensing and business development opportunities.

Who you are

An experienced toxicologist with a strong track record of developing and executing on nonclinical safety strategies for programs at all phases of drug development, making data-informed decisions that enable safe and effective therapies to reach patients.

Qualifications

• Ph.D. in Toxicology, or closely related field with 12+ years of regulatory toxicology and drug development experience in the biopharmaceutical industry.
• Toxicology board certification preferred.
• In-depth knowledge and expertise with both GLP and non-GLP compliant in vitro and in vivo toxicology study design, conduct, reporting and regulatory submissions.
• A high degree of familiarity with applicable regulatory guidelines (ICH, FDA, GLP, etc.) and experience with regulatory agency interactions.
• Experience working effectively with other leaders and operational staff in a matrixed organization
• Proven leadership, organizational and time management skills, including the ability to lead teams, delegate, and interact effectively with internal/external experts for the conduct of toxicology studies, risk assessment and drug development. Must possess good communication and technical writing skills. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts.

*LI-RD8

Job Level: Management

Additional Information

The base compensation range for this role is: $208,000.00-$286,

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 to 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.