Offer summary

Qualifications:

Ph.D., DVM, or equivalent in toxicology, pharmacology, or related field., Minimum of 12 years of experience in the biotech/pharma industry with a focus on biologics., Proven leadership in toxicology strategy for IND-enabling studies and clinical-stage biologics., Strong communication skills and certification as a Diplomate of the American Board of Toxicology (DABT)..

Key responsibilities:

Develop and execute non-clinical safety and toxicology strategies for biologic programs.

Oversee GLP and non-GLP toxicology studies at CROs, including various study types.

Collaborate with cross-functional teams to integrate toxicology findings into program development.

Prepare toxicology sections for regulatory submissions and represent the company in health authority interactions.

Job description

Position: Senior/Executive Director of Toxicology
Department: Translational Science
Location: Remote (PST Zone) with up to 20% global and domestic travel
Reports To: SVP, Head of Translational Science

Position Summary

Angitia Biopharmaceuticals, a science-driven biotech company dedicated to developing breakthrough therapies for musculoskeletal diseases, is seeking an experienced and strategic Senior/Executive Director of Toxicology to lead and shape our nonclinical safety strategy. This role is critical in advancing our preclinical pipeline, ensuring all toxicology efforts are scientifically robust, compliant with regulatory requirements, and aligned with corporate objectives. The ideal candidate will bring deep expertise in biologics toxicology and regulatory requirements, along with strong leadership skills to build high-performing teams and drive cross-functional initiatives.

Responsibilities

Lead Toxicology Strategy:Develop and execute non-clinical safety and toxicology strategies for early- and late-stage biologic programs.
Study Oversight:Design, commission, and oversee GLP and non-GLP toxicology studies conducted at CROs, including single- and repeat-dose, DART, juvenile, genetic, and safety pharmacology, and carcinogenicity studies.
Cross-Functional Leadership:Collaborate closely with discovery, pharmacology, regulatory, and clinical teams to integrate toxicology findings into overall program development.
Regulatory Support:Prepare toxicology sections for regulatory submissions (IND/CTA, BLA/MAA, briefing documents), and represent the company in interactions with health authorities (e.g., FDA, EMA).
Risk Assessment:Interpret and communicate complex toxicology data to executive leadership and project teams, providing guidance on risk/benefit profiles.
Team Building:Build and lead a high-performing toxicology function, including managing internal staff and external consultants/CROs.
Innovation and Trends:Stay abreast of emerging trends and technologies in biologics toxicology and integrate innovative approaches where appropriate.

Qualifications

D., DVM, or equivalent in toxicology, pharmacology, or related field with a minimum of 12 years of experience in the biotech/pharma industry with a strong focus on biologics.
Proven leadership in toxicology strategy for IND-enabling studies and clinical-stage biologics.
Deep understanding of regulatory toxicology requirements (FDA, EMA, ICH) and experience with global regulatory submissions.
Experience managing CROs and external partnerships.
Strong communication skills with ability to influence cross-functional teams and executive stakeholders.
Certification as a Diplomate of the American Board of Toxicology (DABT).

Salary Range: $240,000 to $280,000

About Angitia

Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis (Phase 2), osteogenesis imperfecta (OI) (Phase 1), and spinal fusion (Phase 3). Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group.

Learn more at www.angitiabio.com.

Benefits:

Medical, dental, and vision coverage for employees and their eligible dependents
401(K) Retirement Plan with Company match
Company paid Long Term Disability Coverage
Company-paid life Insurance & AD&D Coverage
Voluntary Life Insurance & AD&D Coverage
Employee Assistance Program (EAP)
Company-paid Holidays
Vacation
Paid Sick Leave
Telecommunication Monthly Stipend
Work-From-Home Equipment Reimbursement