Senior Director, Clinical Science

Crinetics Pharmaceuticals • Headquarters, KY

1d • $250,000 - $287,000

About The Position

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.

Requirements

• MD, Ph.D., Pharm. D., MPH (Master of Public Health), MS, Bachelors degree in Biological Sciences or RN with minimum 15-20 years of clinical research experience in clinical development (Phase 1 to 3) within a biopharmaceutical company.
• Minimum experience of 5 years in Endocrine therapeutic area and in rare disease clinical development, with an established track record of contributing meaningfully to phase 1-3 clinical trial design, execution and analysis
• Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development.
• Practical hands-on knowledge of the day-to-day clinical trials activities required.
• Excellent analytical skills and attention to detail.
• 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.

Responsibilities

• 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.

Benefits

• In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
• We also provide 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, and a winter company shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Director