Associate Director/Director, Nonclinical Safety Evaluation
Manager: Vice President, Nonclinical
Location: Brisbane, CA or Point Richmond, CA
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our mission. Let’s build a better future together.
The candidate will provide scientific oversight and strategic guidance for nonclinical safety evaluation programs from late-stage research through all phases of the drug development process including market application.
This individual will participate in the pharmacological and toxicological assessment at Sangamo by developing and implementing nonclinical strategies, including creating a best-evidence synthesis of existing knowledge and by designing, executing, interpreting, investigating toxicity relationships and reporting data that elucidates the toxicologic/pharmacologic profile of gene therapy and gene editing/regulating candidates. This individual will work collaboratively with internal and external cross-functional teams, collaborators and consultants to design and efficiently execute nonclinical programs that support clinical development and regulatory submissions. The comprehensive analysis and interpretations of non-GLP and GLP studies will be reported and defended to regulatory agencies in meetings and documents including the IND/CTA, annual reports, investigator brochures, special protocol assessments and market applications. The successful candidate will have an extensive pharmacology/toxicology background, along with biologics and/or gene therapy development experience as well as a strong understanding of Good Laboratory Practices (GLPs) that will provide broad-based support to align the nonclinical efforts with the company’s philosophy on drug development.
Managerial responsibilities may include, but are not limited to, mentorship and supervision of scientific staff.ESSENTIAL FUNCTIONS:
- Develop and implement nonclinical strategies.
- Design, execute, interpret and report nonclinical studies to support cDNA and zinc finger protein and zing finger nuclease-based gene therapy compounds in late-stage research and all stages of nonclinical/clinical development
- Represent the department at Core Teams and provide expert advice and direction on development programs.
- Lead nonclinical development sub-teams and actively support the integration of nonclinical activities in Sangamo’s drug development paradigm
- Provide scientific leadership influence across the organization and support cross-functional strategy initiatives.
- Work closely with scientists and other functions across Sangamo departments and project teams to ensure effective product development efforts.
- Develop target safety assessment and integrated pharmacology/toxicology summaries of investigational gene therapy candidates for internal decisions and regulatory submissions
- Interact with CROs, university laboratories, collaborators and consultants as necessary to ensure timely study completion, report production and progression of Sangamo nonclinical projects
- Communicates effectively cross-functionally to accomplish company goals.
- Represent the company at scientific and professional meetings and conferences.
- Maintain a high level of professional expertise through awareness of current and emerging standard practices and guidelines, and familiarity with scientific literature in toxicology and nonclinical safety evaluation
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Doctorate (PhD) in toxicology or closely related field of study, with a minimum of 8+ years of nonclinical experience in the pharmaceutical and/or biotechnology field
- Preference to candidates with Academic training in toxicology, pathology or related discipline, preferably with advanced degree (Ph.D., D.V.M.) and board certification (DABT, DACVP)
- Strong understanding of drug development
- Extensive experience in the design and conduct of nonclinical pharmacology and toxicology studies to support product registration
- Experience with managing studies conducted at CROs and academic labs
- Familiarity with CDER/CBER/ICH guidelines for new product development
- IND/CTA and NDA/BLA development experience
- Previous leadership and supervisory experience
- Ability to build and foster cross-functional collaborations both internally and externally at Sangamo
- Excellent written and verbal communication skills
- Ability to travel, approximately 10%, both domestic and international
Sangamo is an equal opportunity employer
The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.