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Crinetics Pharmaceuticals · 1 day ago

Clinical Scientist

United States

Full-time

Onsite

Senior Level, Lead/Staff

$144K/yr - $180K/yr

8+ years exp

Crinetics Pharmaceuticals is a pharmaceutical company focused on developing therapies for endocrine diseases. The Clinical Scientist will provide clinical expertise and insights for phase 1-3 studies, collaborate with various teams, and contribute to regulatory document development.

BiotechnologyHealth CarePharmaceuticalTherapeutics

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

Qualification

Clinical research experienceFDAEMA regulationsClinical PracticeData analysisMedical monitoringCollaborative writingAnalytical skillsInterpersonal skillsFlexibilityIntegrity

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