Senior Clinical Scientist
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Job Description
Senior Clinical Scientist working to monitor and analyze clinical data in phases 1-3 studies for Crinetics. Collaborating with a multidisciplinary team to enhance therapies for endocrine diseases.
Responsibilities:
- Provide clinical expertise and scientific insights to help monitor, track, and analyze subjects’ data in phase 1 - 3 studies
- Collaborate with the Medical Lead and groups involved in Clinical Development such as Pharmacokinetics, Clinical operations, Biometrics, Pharmacovigilance, and Medical Affairs
- Monitor, analyze, and review safety and efficacy data for events of interest
- Review laboratory parameters, patient profiles, data listings, summary tables
- Collaborate with clinical leads and medical directors on scientific content and program strategy
- Support authoring and review of various clinical and regulatory documents
- Address scientific and protocol related issues from investigators
- Contribute to safety narratives, manuscripts, and scientific presentations
- Support preparation for safety review committees
- Review protocol deviations to identify cause and resolution
- Participate in Database lock activities and represent CR at internal meetings
- Contribute to the development of regulatory documents in collaboration with Medical Affairs and Patient Advocacy
- Participate in research site identification and relationship building with CROs
Requirements:
- M.D., Ph.D., Pharm. D., MPH, MSN or RN with 8-10 years industry related experience
- 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
- 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
- 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 they are the creators of hope for patients and healthcare professionals.
Benefits:
- 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
- Discretionary annual target bonus
- Stock options
- ESPP
- 401k match
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