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. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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 Senior Director, Clinical Science will be working within a multi-disciplinary team and leading a group of Clinical Scientists implementing Endocrine Clinical Development programs. This individual will provide clinical expertise and scientific insights to clinical development activities (phase 1 - 3 studies), including regulatory documents. The incumbent will collaborate with all the groups involved in Clinical Development e.g., Clinical Pharmacology (CP), Clinical Operations, Medical Writing, Biometrics, Pharmacovigilance, Regulatory Affairs, HEOR and Medical Affairs.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Lead and mentor the Clinical Scientist team (including consultants), reviewing their work and supporting their professional development.
- Serve as a scientific liaison between clinical research with multiple departments including clinical operations, regulatory, biostatistics, pharmacovigilance, and medical affairs, ensuring consistency in the clinical development approach across the organization.
- Support data cleaning and analyses of clinical studies to enable high quality medical decision making, presentations at internal and external meetings, manuscripts and regulatory documents.
- Support the Medical Leads and Medical Monitors in clinical data reviews to identify events of special interest that require further investigations.
- Collaborate with Medical Monitors, biometrics and pharmacovigilance to review periodic data listings (e.g. adverse events, protocol deviations, concomitant medications, abnormal lab, etc).
- Perform and supervise systematic evaluation of clinical data for multiple projects in terms of data quality and trend analysis in ongoing clinical trials.
- Participate in periodic Medical Review meetings along with the Medical Leads.
- Contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings.
- Contribute to the development of relevant sections of regulatory documents such as protocols, amendments to protocols, informed consent forms, briefing books, safety updates, responses to Health Authorities questions.
- Contribute to the development of study documents such as feasibility questionnaires, study plans, electronic Case Report Forms (eCRFs), eCRF guidelines and other essential trial specific documents.
- Collaborate in cross-functional meetings (with internal stakeholders and/or external consultants) to develop clinical development plans.
- Support Clinical Operations, CROs, and site staff on study protocol related questions
- Support preparations for safety review committees, DSMBs/DMC incl. data review and development of presentations
- Collaborate with Medical Leads to support effective working relationships with key investigators, and key opinion leaders.
- Participate in research site identification and relationship building with CROs in this space.
- Other duties as assigned.
Education and Experience:
Required:
- MD, Ph.D., Pharm. D., MPH (Master of Public Health), MS, Bachelors degree in Biological Sciences or RN with minimum 15-20 years of clinical research experience in clinical development (Phase 1 to 3) within a biopharmaceutical company.
- Minimum experience of 5 years in Endocrine therapeutic area and in rare disease clinical development, with an established track record of contributing meaningfully to phase 1-3 clinical trial design, execution and analysis
- Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development.
- Practical hands-on knowledge of the day-to-day clinical trials activities required.
- Excellent analytical skills and attention to detail.
- Collaborative, effective writing skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization.
- Ability to thrive and flourish in a fast-paced, dynamic, entrepreneurial small company environment; ability to prioritize and parallel process multiple workstreams, comfortable “changing gears” and remaining flexible, as well as making definitive decisions.
- Ability to inspire and earn respect from the leadership team, colleagues, and staff. Respectful of the ideas and experience of all members of the Crinetics team
- Ethical, with the highest standards of integrity recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders.
- Desire to develop personal and communication skills through several complex tasks and challenges.
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.
Travel:
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range:
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.
Salary RangeThe salary range for this position is: $250000 - $287000.
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.
