Clinical Scientist

Role 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.

Responsibilities

• 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.

Qualifications

• 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.
• Required: Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development.
• Required: Practical knowledge of the day-to-day medical monitoring of clinical trials required (e.g., review of safety parameters, etc.).
• Required: Great analytical skills and a passion for “search and find” among complex data generated in clinical studies.
• Required: Collaborative, effective writing skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization.
• Required: 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.
• Required: 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
• Required: 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.
• Required: Desire to develop personal and communication skills through several complex tasks and challenges.

Education

• 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.

Additional Requirements

• Physical Demands: 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. 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.