Note: The job is a remote job and is open to candidates in USA. Crinetics Pharmaceuticals is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases. The Senior Clinical Scientist will provide clinical expertise and scientific insights to monitor and analyze data in clinical studies, collaborating closely with various teams involved in Clinical Development.
Responsibilities
- Responsible for monitoring, tracking, and analyzing clinical trials subjects’ data, under the supervision of the Clinical Medical Lead. This involves collaborating with investigators, CRO medical monitors, Clinical Operations and the Biometrics team
- Monitor, analyze, and review on a regular basis safety and efficacy data for events of interest or needing further investigation. Review laboratory and other safety parameters, review patient profiles, data listings, summary tables, and review coded terms
- Collaborate closely with clinical leads and medical directors to align on scientific content and program strategy
- Support authoring and review of protocols/amendments, protocol clarification letters, clinical study reports, IBs, ICFs, training documents, charters, lab and pharmacy manuals, newsletters, medical monitoring plans, statistical analysis plans, data management plans, eCRFs, eCRF completion guidelines, and other clinical and regulatory documents
- Address questions regarding scientific and protocol related issues from investigators in consultation with Medical Monitors or the Medical Lead
- Contribute to the preparation and/or review of safety narratives, manuscripts, and scientific presentations
- Contribute to the preparation and/or review of regulatory submissions, responses, and requests for information
- Support preparation for safety review committees, DSMBs/DMC including data review and development of presentations
- In collaboration with Clinical Operations and the Medical Lead, review protocol deviations to identify cause and appropriate resolution
- Participates in Database lock activities as assigned by MM (including data review and cross-checks to ensure quality and consistency) and represents CR at internal data management meetings
- Contribute to the development of relevant sections of regulatory documents such as amendments to protocols, briefing books, safety updates, responses to Health Authorities questions
- 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
- Other duties as assigned
Skills
- M.D. Ph.D., Pharm. D., MPH, MSN or RN with 8-10 years industry related experience with a minimum 3-5 years of 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 skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization
- Ability to inspire and earn respect of the leadership team, colleagues, and staff. Respectful of the ideas and experience of all members of the Crinetics team
- Ethical, with 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
- Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint)
Benefits
- Discretionary annual target bonus
- Stock options
- ESPP
- 401k match
- 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
- Winter company shutdown
Company Overview