Vice President, Non-Clinical Drug Safety & Toxicology

Vice President, Non-clinical Drug Safety & Toxicology

Categories: Toxicology

POSITION SUMMARY:

The Vice President of Safety and Toxicology is responsible for providing strategic and operational leadership for the toxicology function for the non-clinical development group. This includes scientific, technical, operational, and financial oversite.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

• Create a long-term global toxicology strategy in alignment with the company's vision and goals, including multi-year scientific and operational plans.

• Lead scientific direction for global regulatory toxicology including safety pharmacology

• Oversee toxicology findings and provide advice to project teams and senior management on potential impact of results on the program goals

• Oversee the design and execution of scientific toxicity studies (in vitro and in vivo) required for lead optimization, and development candidate selection

• Develop strategy, plan and budget to effectively manage regulatory toxicity studies (in vitro and in vivo) required for IND and NDA submissions, including general toxicity, juvenile toxicity, genotoxicity, safety pharmacology, reproductive and developmental, and carcinogenicity studies

• Work with internal R&D partners and external parties including development partners, consultants, CRO's and approve vendors based on a balance of quality, timeliness, and cost

• Hire, lead and director the scientific and operational toxicology teams to effectively meet deadlines and organizational goals.

• Develop and manage of timelines related to this function

• Identify and engage experts in the field of toxicology (e.g., consultants) to interpret study results and make recommendations

• Communicate toxicity study results to cross functional program teams and to the management, as needed

• Chairs a global non-clinical safety committee

• Approve nonclinical study proposals and ensure that they fulfill all requirements of the program development plan

• Actively participate in regulatory meetings

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• Ph.D. in toxicology or related discipline with at least 15 years of experience, (an equivalent combination of experience and education may be considered)

• 10 years of experience managing and developing a drug safety/toxicology team

• Experience in defining and executing scientifically relevant and compliant nonclinical toxicology strategies and contingency plans addressing both theoretical and identified nonclinical safety issues

• Proven track record of interfacing with global regulatory authorities.

• Strong communication (written and oral) and interpersonal skills with an ability to effectively function within a matrixed environment

TECHNICAL KNOWLEDGE REQUIRED:

Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained.

Software Knowledge: Windows, MS Office (Outlook, Word, Excel), Prism or equivalent statistical and graphing software.

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

TRAVEL:

Travel may be required up to 15% of your time

ABOUT CRINETICS:

Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine and endocrine-related cancer therapeutics company. Crinetics' benefit package includes health insurance, stock options, 401k, ESPP, paid time off, and the company provides a dog-friendly work environment.