Director / Senior Director, Head of Nonclinical Development

Location
South San Francisco, CA
Posted
Sep 14, 2021
Ref
5541380002
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

We Are Genetic Navigators bringing together passionate, creative and dedicated professionals to join a rapidly growing biotech in our mission to translate novel genetic insights into lifesaving medicines.

 We are seeking an experienced Head of Nonclinical Development who will be accountable for all regulated nonclinical activities for Maze development compounds across the pipeline beginning from nomination of a development compounds through NDA/BLA and any post-approval commitments. This individual must have the ability to work in a fast-paced, team-oriented, start-up environment to oversee all aspects strategic planning and oversight of nonclinical activities. The successful candidate will play a cross-functional and highly visible role requiring an ability to be a liaison with project teams, functional management, and technical leaders in drug discovery, research, and clinical development. To lead nonclinical, the Head will have deep expertise in toxicology, specifically small molecule GLP studies.

The position will report to the Chief Medical Officer and will be a key member of the development leadership team.

Your Navigation Tools:

  • Design, manage and oversee regulatory compliant nonclinical activities required to support IND submissions, clinical development, NDA/BLA including all GLP in vitro and in vivo toxicology, safety pharmacology, and carcinogenicity studies, bioanalytical assay development, and sample analysis across all Maze programs
  • Serve as company advisor on timing of initiation of key nonclinical activities within small molecule programs and other modalities including gene therapies Serve as foundation to nonclinical function and prepare to build internal and external capabilities to support advancing pipeline programs from preclinical development through approval and life cycle management
  • Serve as primary internal subject matter expert on toxicology findings, advise on dose selection and dose escalation plans for early development programs, and update the company on regulatory trends in nonclinical development activities
  • Identify, select, and oversee key vendors and CROs to support nonclinical studies and bioanalytical assay development, technology transfer, and sample analysis as needed
  • Serve as the primary author on all key nonclinical/GLP regulatory documents and/or oversee and approve such documents generated by more junior employees
  • Participate in due diligence activities for potential in-license assets and support intelligence activities for competitor assets
  • Partner with functional leaders in DMPK, pharmacology, and translational development in the design of drug discovery research experiments
  • Lead coordination and integration of timelines to harmonize with other development functions
  • Develop fit-for-purpose departmental SOPs, work instructions, and other processes and ensuring appropriate training and adherence in collaboration with quality affairs colleagues
  • Proactively identify nonclinical risks to Maze programs and develop risk mitigation plans
  • Contribute to the development and maintenance of a positive team-focused company culture and champion Maze values through sharp and thoughtful leadership

Your role in Navigating The Maze:

  • PhD in Toxicology or related field or DVM with a minimum of 8 years of relevant industry experience
  • DABT certification is highly desired
  • Experience with successful preparation and submission of nonclinical sections of INDs, NDAs, BLAs, and/or MAAs
  • Track record of toxicology leadership on multiple programs at early and late stages of development
  • Direct experience developing the toxicology strategy and data package supporting the clinical development of small molecule is required; experience in other therapeutic modalities (gene therapy, monoclonal antibody, oligonucleotide) is preferred
  • Firm understanding of pharmacokinetics and modeling human dosing as well as experience in bioanalytical vendor oversight and management
  • Proven track record of conducting drug safety assessment studies, and ability to make sound risk assessments and representing toxicology perspectives on project teams and external stakeholders
  • Management experience, particularly in areas team building, professional development, and mentorship of more junior staff
  • Strong leadership and communication skills to translate corporate objectives into action plans that effectively and consistently deliver high quality data on time and on budget
  • Ability to adapt quickly to changing environments and priorities
  • Positive and enthusiastic disposition and high personal and ethical standards in approaching corporate goals
  • Ability to travel domestically and internationally for vendor visits, industry conferences, regulatory meetings, and as required