Director, Development Toxicology
Categories: Toxicology
Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. 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. Come join our team as we transform the lives of others.
Position Summary:
The Director Toxicology is responsible for developing and leading the strategic direction for all toxicology efforts. With the support of team members, he/she will be responsible for designing, planning, monitoring and reporting of nonclinical toxicology and safety pharmacology studies. The Director will have broad expertise in toxicology/pharmacology and will support ongoing and late-stage programs and to contribute to a number of preclinical projects as well as. He/she is responsible for the interpretation of nonclinical findings in the perspective of the safety of patients/trial participants and has the talents to accurately communicate this information to the development team, company management and Regulatory Agencies.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Lead strategic scientific direction for regulatory toxicology including safety pharmacology.
- Design, conduct and/or monitor, and interpret exploratory toxicity studies (in vitro and in vivo) in support of lead optimization, and development candidate selection.
- Critically evaluate toxicology findings and provide advice to project teams and senior management on potential impact of results on the program goals
- Plan, budget, design, monitor, and interpret 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
- Design and keep updated Key Event Maps and timelines related to nonclinical activities and integrate this information in the general development program
- Work with experts in the field of toxicology (e.g., consultants, KLOs) to interpret study results and make recommendations where needed
- Communicate toxicity study results to cross functional program teams and management
- Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates, provide input during protocol development and report generation/finalization and monitor study activities to ensure timely and GLP compliant execution of contracted studies
- Review nonclinical study proposals and ensure that they fulfill all requirements of the program development plan. Contribute to ensuring compliance of dossiers to global health authority standards
- Oversee the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.)
- Actively participate in regulatory meetings
- Maintain a current understanding of toxicology literature, methodology, and regulatory requirements
- Other duties as assigned
Education and Experience:
- PhD, DVM, and/or MD Degree with 10+ years of pharmaceutical/biotech experience
- Strong scientific acumen, passionate and persistent with a track-record of success in various phases of drug development
- Extensive knowledge of managing nonclinical Contract Research Organizations (CRO’s)
- Strong leadership skills and ability to develop and maintain effective interactions in matrixed environment; ability to collaboratively influence strategic direction; leadership style creates a balanced culture of mentorship, empowerment and accountability achieving talent growth and program success
- Efficient organizational skills and excellent verbal and written communication skills
- Strong knowledge of preparation of INDs, CTAs, NDAs, and MAAs
- Proven experience interacting with Regulatory Agencies, written, remotely and in person
- Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
- Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
- Solid experience with regulatory processes, risk assessments and ICH guidelines and Good Laboratory Practice (GLP)
- Demonstrated experience and expertise in nonclinical drug development including discovery, development through post-marketing P
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 25 lbs. may be required. The noise level in the work environment is typically 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.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel:
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $190,000 – $219,000
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.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
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
Vaccination requirement:
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasona