Senior Director, Clinical Science

Senior Director, Clinical Science page is loaded## Senior Director, Clinical Science remote type:
Remote locations:
Remote time type:
Full time posted on:
Posted Yesterday job requisition :
JR000600

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.
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* 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.
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* Education and Experience:

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* Required:

* MD, Ph.D., Pharm.

D., MPH (Master of Public Health), MS, Bachelors degree in Biological Sciences…