Scientific Director, Development Toxicology

Biogen Idec•Cambridge, MA

70d•$208,000 - $286,000

About The Position

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.

Requirements

Ph.D. in Toxicology, or closely related field with 12+ years of regulatory toxicology and drug development experience in the biopharmaceutical industry.
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.

Nice To Haves

Toxicology board certification preferred.

Responsibilities

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.

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