Job Description
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
Position Summary: The Vice President of Nonclinical Drug Safety and Toxicology is responsible for providing strategic and operational leadership for the toxicology group across the Crinetics portfolio of discovery, early development, and late development programs. This includes scientific, technical, operational, and financial oversight.
Essential Job Functions and Responsibilities: - Create a long-term global toxicology strategy in alignment with the company's vision and objectives, including multi-year scientific and operational plans.
- Lead scientific direction for global regulatory toxicology including safety pharmacology.
- Lead scientific direction for safety assessments of discovery and early development programs, aligning with program objectives and regulatory strategies.
- Oversee toxicology findings and provide advice to project teams and senior management on potential impact of results on program goals and probability of success.
- Collaboratively design and implement external 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 leaders and external parties including development partners, consultants, CROs and approved vendors based on a balance of quality, timeliness, and cost.
- Hire, lead, and direct the scientific and operational toxicology teams to effectively meet deadlines and organizational objectives.
- 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, as needed.
- Communicate toxicity study results to discovery program and development teams, and to Crinetics executive management and Board of Directors, as needed.
- Actively participate in regulatory meetings.
- Other duties as assigned.
Education and Experience: - PhD in toxicology or related discipline with at least 15 years of experience, (an equivalent combination of experience and education may be considered) with at least 14 years of leadership/supervisory experience.
- Preferred 10 years of experience managing and developing a drug safety/toxicology team.
- DABT certification strongly preferred.
- Experience in defining and implementing scientifically relevant and compliant nonclinical toxicology strategies and contingency plans addressing both theoretical and identified nonclinical safety issues.
- Collaborative mindset capable of excelling within multi-discipline discovery and development teams
- Proven track record of interfacing with global regulatory authorities, and the design and interpretation of safety studies for regulatory submissions, including INDs and NDAs.
- Deep knowledge of FDA and EMA requirements and guidance for nonclinical safety submissions.
- Strong communication (written and oral) and interpersonal skills with an ability to effectively function within a matrixed environment.
Technical Knowledge Required: Equipment: PC, e-mail systems, and common office machines, or ability to be trained.
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, Powerpoint), Prism or equivalent statistical and graphing software.
Physical Demands and Work Environment: 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 5% of your time.
Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary Range The salary range for this position is: $306,000 - $383,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
Job Tags
Full time, Local area,