Executive Director, Clinical Science and Clinical Research Operations

Crinetics Pharmaceuticals•Headquarters, KY

1d•$253,000 - $317,000•Onsite

About The Position

Crinetics is seeking an Executive Director, Clinical Science and Clinical Research Operations, a senior executive role responsible for setting the strategic direction for clinical science and operational execution across the endocrine clinical development portfolio. This leader will shape the Clinical Scientist operating model, establish enterprise-wide standards, and build organizational capability to deliver programs with excellence and speed. The role involves driving alignment across cross-functional teams, building and developing a high-performing team, and partnering with the Executive Medical Director, Clinical Research Endocrinology, to ensure integrated scientific strategy and operational delivery. The Executive Director is accountable for the performance, culture, and long-term capability of the Clinical Science team.

Requirements

Ph.D., Pharm.D., MPH, or MS in Biological Sciences Life Sciences, Pharmacy, or a related field
13+ years of clinical research experience spanning Phase 1–3 programs in a pharmaceutical or biotechnology company.
Minimum experience of 6 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
Deep command of FDA and EMA regulatory expectations, Good Clinical Practice, ICH guidelines, and clinical drug development; able to engage Health Authorities with confidence and shape submission strategy.
Proven ability to translate operational realities into strategic decisions; understands trial execution at a level that enables credible leadership of clinical teams and CRO partners.
Strong analytical and scientific judgment, with the ability to synthesize complex data and translate findings into clear strategic recommendations for leadership and cross-functional stakeholders.
Exceptional written and verbal communication skills; able to represent the organization credibly to Health Authorities, investigators, and external partners, and to align and influence at all levels of the enterprise.
Track record of executive-level performance in a fast-paced, entrepreneurial biopharmaceutical environment; adept at leading multiple high-priority programs simultaneously, making sound decisions under ambiguity, and driving clarity and momentum across the organization.
Demonstrated ability to build high-performing teams, develop talent, and foster a culture of scientific excellence, accountability, and inclusion; commands credibility and trust across the organization and with external stakeholders.
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.

Nice To Haves

Equivalent combination of education and applicable job experience may be considered

Responsibilities

Lead and develop the Clinical Scientist function, including staff, consultants, and Clinical Research Project Coordinator, by building organizational capability, shaping succession pipelines, and driving a high-performance culture aligned with enterprise priorities.
Define and evolve the Clinical Scientist operating model, establishing standards, processes, and governance to ensure consistent, scalable execution across all clinical development programs.
Serve as the senior leader and decision-maker across Clinical Research and key partner functions (Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Writing), driving alignment on clinical development strategy and resolving cross-functional trade-offs impacting quality, timelines, and risk.
Own clinical data oversight, ensuring clean data, analysis, and interpretation to enable high-quality medical decision-making, regulatory submissions, manuscripts, and internal/external presentations.
Collaborate with Medical Leads and Medical Monitors on clinical data reviews to identify and investigate events of special interest.
Accountable for proactive partnering with Biometrics and Pharmacovigilance in reviewing periodic data listings (adverse events, protocol deviations, concomitant medications, laboratory abnormalities).
Establish and oversee a systematic data quality framework across multiple studies, ensuring early signal detection and timely escalation and resolution.
Represent the organization externally setting the tone for protocol training and site engagement.
Drive the scientific execution of through contribution of key regulatory documents, including IND/CTA/IMPD submissions, protocols and amendments, informed consent forms, clinical study reports, briefing books, safety updates, and responses to Health Authority questions.
Set direction for clinical documentation standards, overseeing development of study documents including feasibility questionnaires, study plans, eCRFs, eCRF guidelines, and other trial-specific materials.
Oversee DSMB/DMC preparation, ensuring high-quality, data presentations that enable independent safety review and informed stopping rule decisions.
Oversee strategic partnerships with CROs, ensuring strong relationships, quality delivery, and alignment with program and company objectives.
Lead data cleaning activities through database lock (DBL), coordinating across Clinical Operations, Biometrics, and Medical Monitoring to deliver a complete, query-resolved dataset; provide the Medical Lead with clean, analysis-ready data to support clinical trial decision-making.
Lead the development, review, and approval of clinical trial startup materials, serving as a primary owner of startup document quality and timeline; ensure all materials meet regulatory standards and are aligned with program strategy prior to site activation.
Identify, escalate, and drive resolution of program and portfolio risks in a timely and structured manner; partner with the team to prioritize activities, reallocate resources, and implement risk mitigation plans that protect program timelines and data integrity.
Drive continuous improvement and transformation initiatives across the Clinical Science team, anticipating future needs and implementing changes that enhance efficiency, quality, and scalability.
Other duties as assigned.