Medical Director, Clinical Research, Endocrinology

About the role

The Medical Director, Clinical Sciences will support the development and execution of Crinetics' endocrinology portfolio as part of a multidisciplinary development team. Responsibilities include contributing to the concise clinical development plan (CCDP), supporting the design and conduct of clinical trials across assigned therapeutic areas, and bringing enthusiasm for Phase 1–3 development, including biomarkers and proof-of-concept. The incumbent will also provide medical and scientific input to publications, support Medical Affairs, and help represent Crinetics to academic, regulatory, and patient organizations.

Responsibilities

• Partner with the cross-functional team to shape a concise Clinical Development Plan (CCDP) for the indication of interest, building consensus toward Executive Team approval and maintaining the plan over time.
• Contribute to Strategic Plans and the TPP via focused multidisciplinary internal and external consultation.
• Lead the design, planning and implementation of clinical trials consistent with this CCDP.
• Provide scientific and clinical direction for the development of clinical protocols (and, in early stages, clinical trial outlines [CTOs] and synopses), amendments, and related documents (e.g., informed consent), working with Medical Writing to ensure content accuracy and medical integrity.
• Provide medical monitoring for clinical studies in collaboration with CRO medical monitors.
• Ensure that clinical trials are conducted according to GCP and all applicable regulatory requirements.
• Provide clinical and scientific input to HEOR-led Patient Reported Outcome research across the studies.
• Provide medical and scientific oversight needed to support enrollment feasibility and protocol-driven eligibility.
• Participate in ongoing and formal data analyses and review for CSR completion and planned/actual filing activities.
• Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions.
• Lead trial-related advisory boards, investigator meetings, protocol training meetings.
• Collaborate with Medical Affairs and Commercial members to develop effective working relationships with key investigators, key opinion leaders and patient advocates to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
• Provide medical/clinical expertise to publications planning and drafting.
• Provide oversight of clinical programs across planning, execution, and completion of clinical trials, ensuring compliance with all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs, in partnership with Clinical Operations.
• Attend conferences and remain current with relevant therapeutic area information.
• Serve as the external clinical "face" of Crinetics in interactions with development partners, and leading clinical discussions at advisory boards, as needed.

Requirements

MD degree with at least 5+ years clinical research experience within industry or academia. Endocrinology subspecialty board certification preferred. Equivalent combination of education and applicable job experience may be considered. Thorough knowledge of clinical medicine, clinical pharmacology and associated disciplines (e.g., biostatistics, data management, medical writing). Deep understanding of strategic and operational aspects of clinical research and product development. Solid understanding of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Familiarity with regulatory agency interactions (FDA and/or EU), whether through direct participation or supporting submission activities. Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials required (e.g., responding to questions about patient eligibility; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives).

Qualifications

Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment. Superior interpersonal skills focusing on collaboration and influencing capabilities supported by great presentation skills. Strategic thinker, team leader and individual contributor capable of working in a high growth, dynamic, science-driven environment. Able to conceive and execute innovative approaches to clinical development while taking into account the safety and the comfort of the patient. Can also take the role of a self-starter individual contributor, who enjoys rolling up their sleeves and digging into the details; rigorous attention to details and data, while not losing sight of the bigger picture and remaining flexible. Collaborative, effective leadership skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within and external to the organization. Ethical, with 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.

Skills

Physical Demands And Work Environment: Physical Activities: 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. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. 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.

Benefits

Your recruiter can share more about the specific salary range during the hiring process. Salary Range: $270000 - $298000. 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.