Head of Toxicology and DMPK , West Coast Hub
Biogens West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
About This Role:
This role will report to the Head of Clinical Pharmacology WCH or designee and collaborate closely with the Discovery Toxicology, Development Toxicology, and DMPK groups at Biogen HQ.
What Youll Do:
The primary responsibilities of this position are to provide strategic nonclinical safety and DMPK expertise and representation for clinical development programs in the WCH portfolio from discovery through post-marketing, including the following job duties:
Apply a broad understanding of toxicology, pharmacology, drug metabolism/pharmacokinetics (DMPK) and regulatory sciences to design all types of toxicology and DMPK studies required to support clinical development, regulatory strategies and registration of biopharmaceuticals. This may include safety assessment of novel device and delivery systems.
Apply in-depth intellectual and technical expertise in toxicology, DMPK, and drug development to the assigned programs.
Ensure that the preclinical/nonclinical development plan for their programs is aligned with the clinical development plan and program objectives.
Develop risk assessments to inform key decision points and progression of drug candidates through stages of development.
Develop appropriate preclinical and nonclinical safety and DMPK testing strategies that are tailored to the therapeutic modality (e.g., small molecule, biologic), including design and oversight of in vitro and in vivo toxicology studies.
Apply knowledge of applicable regulatory guidelines (ICH, FDA, GLP) to the development of testing strategies and design of appropriate toxicology studies.
Represent DMPK and Preclinical/Nonclinical Safety on programs, projects, initiatives, and due diligences and contribute to team goals and deliverables.
Collaborate effectively with other functional groups (study management, pathology, clinical, regulatory, research, biomarkers, clinical pharmacology, clinical safety, CMC, etc.) on program-related tasks and objectives.
Be able to absorb and synthesize a broad range of data from toxicology, pharmacology, and PK/ADME studies to complete the nonclinical risk assessment and establish safe use conditions in humans for novel therapies.
Prepare high quality regulatory documents for submission to support clinical development and marketing authorizations (e.g. INDs, study reports, BLAs) globally.
Represent the DMPK and preclinical/nonclinical safety functions at country-specific regulatory meetings for their programs.
This position is based in South San Francisco, California and requires frequent onsite presence. Candidates must be within commutable distance or able to self-relocate to be considered.
Who You Are:
Ph.D. in Toxicology, Pharmacology, or closely related field
15+ years of combined toxicology, DMPK, and drug development experience in a biopharmaceutical setting.
Toxicology board certification preferred.
Working knowledge and experience in all phases of research and development for biopharmaceuticals.
A high degree of familiarity with applicable regulatory guidelines (ICH, FDA, GLP, etc.); prior experience with regulatory agency interactions desired.
Demonstrated experience and expertise with both GLP and non-GLP compliant in vitro and in vivo toxicology study design, conduct and reporting.
Demonstrated proficiency in ADME, PK/PD modeling, and DMPK project representation.
Proven leadership, organizational and time management skills, including the ability to lead teams and interact effectively with internal/external experts for the conduct of toxicology studies and regulatory submissions.
Must possess good communication and technical writing skills and be capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts.
Demonstrated ability to mentor less experienced toxicologists and nonclinical safety and/or DMPK scientists.
Biogens West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
About This Role:
This role will report to the Head of Clinical Pharmacology WCH or designee and collaborate closely with the Discovery Toxicology, Development Toxicology, and DMPK groups at Biogen HQ.
What Youll Do:
The primary responsibilities of this position are to provide strategic nonclinical safety and DMPK expertise and representation for clinical development programs in the WCH portfolio from discovery through post-marketing, including the following job duties:
Apply a broad understanding of toxicology, pharmacology, drug metabolism/pharmacokinetics (DMPK) and regulatory sciences to design all types of toxicology and DMPK studies required to support clinical development, regulatory strategies and registration of biopharmaceuticals. This may include safety assessment of novel device and delivery systems.
Apply in-depth intellectual and technical expertise in toxicology, DMPK, and drug development to the assigned programs.
Ensure that the preclinical/nonclinical development plan for their programs is aligned with the clinical development plan and program objectives.
Develop risk assessments to inform key decision points and progression of drug candidates through stages of development.
Develop appropriate preclinical and nonclinical safety and DMPK testing strategies that are tailored to the therapeutic modality (e.g., small molecule, biologic), including design and oversight of in vitro and in vivo toxicology studies.
Apply knowledge of applicable regulatory guidelines (ICH, FDA, GLP) to the development of testing strategies and design of appropriate toxicology studies.
Represent DMPK and Preclinical/Nonclinical Safety on programs, projects, initiatives, and due diligences and contribute to team goals and deliverables.
Collaborate effectively with other functional groups (study management, pathology, clinical, regulatory, research, biomarkers, clinical pharmacology, clinical safety, CMC, etc.) on program-related tasks and objectives.
Be able to absorb and synthesize a broad range of data from toxicology, pharmacology, and PK/ADME studies to complete the nonclinical risk assessment and establish safe use conditions in humans for novel therapies.
Prepare high quality regulatory documents for submission to support clinical development and marketing authorizations (e.g. INDs, study reports, BLAs) globally.
Represent the DMPK and preclinical/nonclinical safety functions at country-specific regulatory meetings for their programs.
This position is based in South San Francisco, California and requires frequent onsite presence. Candidates must be within commutable distance or able to self-relocate to be considered.
Who You Are:
Ph.D. in Toxicology, Pharmacology, or closely related field
15+ years of combined toxicology, DMPK, and drug development experience in a biopharmaceutical setting.
Toxicology board certification preferred.
Working knowledge and experience in all phases of research and development for biopharmaceuticals.
A high degree of familiarity with applicable regulatory guidelines (ICH, FDA, GLP, etc.); prior experience with regulatory agency interactions desired.
Demonstrated experience and expertise with both GLP and non-GLP compliant in vitro and in vivo toxicology study design, conduct and reporting.
Demonstrated proficiency in ADME, PK/PD modeling, and DMPK project representation.
Proven leadership, organizational and time management skills, including the ability to lead teams and interact effectively with internal/external experts for the conduct of toxicology studies and regulatory submissions.
Must possess good communication and technical writing skills and be capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts.
Demonstrated ability to mentor less experienced toxicologists and nonclinical safety and/or DMPK scientists.
Additional Information
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 reimbursemen