Medical Director, Clinical Research, Endocrinology

This is a fully remote position, open to applicants in California.

📋 Description

• Assist in the development and implementation of Crinetics' endocrinology portfolio within a multidisciplinary development team.

• Contribute to the creation of a concise clinical development plan (CCDP).

• Aid in the design and execution of clinical trials within designated therapeutic areas.

• Provide medical and scientific insights for publications.

• Support Medical Affairs initiatives.

• Represent Crinetics in interactions with academic, regulatory, and patient organizations.

• Collaborate with the cross-functional team to formulate a concise Clinical Development Plan (CCDP) for the relevant indication, building consensus for Executive Team approval and ensuring its maintenance over time.

• Lead the design, planning, and execution of clinical trials in alignment with the CCDP.

• Offer scientific and clinical direction for the development of clinical protocols, as well as early-stage clinical trial outlines (CTOs) and synopses, amendments, and related documentation (e.g., informed consent).

• Work alongside Medical Writing to ensure the accuracy and medical integrity of content.

• Provide medical monitoring for clinical studies in partnership with CRO medical monitors.

• Ensure the conduct of clinical trials adheres to GCP and all relevant regulatory requirements.

• Supply clinical and scientific input to HEOR-led Patient Reported Outcome research across studies.

• Offer medical and scientific oversight to support enrollment feasibility and protocol-driven eligibility.

• Participate in ongoing and formal data analyses and reviews for CSR completion and planned/actual filing activities.

• Contribute to the creation of clinical sections in regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, and responses to queries from Health Authorities.

• Lead trial-related advisory boards, investigator meetings, and protocol training meetings.

• Collaborate with Medical Affairs and Commercial teams to develop strong working relationships with key investigators, opinion leaders, and patient advocates to enhance the scientific quality and innovation of clinical study design, execution, reporting, and publication.

• Provide medical and clinical expertise in the planning and drafting of publications.

• Oversee clinical programs throughout the planning, execution, and completion of clinical trials, ensuring compliance with all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs in collaboration with Clinical Operations.

• Attend conferences and stay updated on relevant therapeutic area information.

• Act as the external clinical representative of Crinetics in engagements with development partners and lead clinical discussions at advisory boards when necessary.

⛳️ Requirements

• MD degree with a minimum of 5 years of clinical research experience in industry or academia.

• Board certification in endocrinology subspecialty is preferred.

• Comprehensive understanding of clinical medicine, clinical pharmacology, and related fields (e.g., biostatistics, data management, medical writing).

• Profound knowledge of the strategic and operational aspects of clinical research and product development.

• Strong familiarity with FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development.

• Experience with regulatory agency interactions (FDA and/or EU), whether through direct involvement or support of submission activities.

• In-depth knowledge and high-level expertise in the daily medical monitoring of clinical trials is required (e.g., addressing questions about patient eligibility; reviewing safety parameters; managing and processing SAEs, including the composition of SAE narratives).

• Exceptional leadership abilities and capability to operate effectively in a fast-paced, high-accountability environment.

• Outstanding interpersonal skills with a focus on collaboration and influence, supported by excellent presentation capabilities.

• Strategic thinker, team leader, and individual contributor able to thrive in a high-growth, dynamic, science-driven environment.

• Ability to develop and implement innovative approaches to clinical development while prioritizing patient safety and comfort.

• Capable of being a self-starting individual contributor who enjoys engaging in details; demonstrates rigorous attention to detail and data while maintaining a broader perspective and adaptability.

• Collaborative leadership skills, with the ability to cultivate and sustain strong interpersonal relationships, earning trust and confidence from all levels both within and outside the organization.

• Ability to inspire and gain the respect of the leadership team, Board members, regulatory authorities, the investment community, colleagues, and staff.

• Respectful of the insights and experiences of all members of the Crinetics team.

• Ethical, upholding the highest standards of integrity, understanding that we are the creators of hope for our patients and the healthcare professionals who support them, as well as stewards of our shareholders' investments.

🏝️ Benefits

• Health insurance plans for employees and their families, including medical, dental, vision, and basic life insurance.

• 20 days of paid time off (PTO).

• 10 paid holidays.

• Winter company shutdown.

• Discretionary annual target bonus.

• Stock options.

• 401k match.