Clinical Scientist

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 Clinical Scientist will be working within a multi-disciplinary team focusing on a Clinical Development Program. This individual will provide clinical expertise and scientific insights to help elaborate a protocol for phase 1 - 3 studies then monitor, track, and analyze subjects’ data in these studies. 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:

• Conduct data analyses before and during clinical studies to support medical decision making, create presentation slides, and prepare for development division discussion meetings.
• Perform high quality clinical data review to identify events of special interest from data within the EDC system for further investigations.
• Collaborate with biometrics and pharmacovigilance to review periodic data listings (e.g. adverse events, protocol deviations, concomitant medications) to discussion with clinical team.
• Perform regular trend analysis in ongoing clinical trials.
• Lead periodic Medical Review meetings.
• Use the findings and other analyses to 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 preparation for safety review committees, DSMBs/DMC incl. data review and development of presentations
• Collaborate with Medical Affairs and Patient Advocacy to support effective working relationships with key investigators, key opinion leaders and patient advocates.
• Participate in research site identification and relationship building with CROs in this space.
• Track progress, take notes and plan meetings for the protocol discussion group (Biometrics and Clinical Research, plus ad hoc functions).

• Other duties as assigned.

Education and Experience:

Required:

• MD, Ph.D., Pharm. D., MPH (Master of Public Health), MSN or RN with 8 years of industry related experience with a minimum of 2 years clinical research experience in clinical development within a biopharmaceutical company.
• Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development.
• Practical knowledge of the day-to-day medical monitoring of clinical trials required (e.g., review of safety parameters, etc.).
• Great analytical skills and a passion for “search and find” among complex data generated in clinical studies.
• 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.

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:

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 Range

The salary range for this position is: $150000 - $180000.

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.