Senior Medical Director, Clinical Research

$274,000 - $330,000/Yr

Crinetics Pharmaceuticals - San Diego, CA

Full-time - Senior

San Diego, CA

Chemical Manufacturing

About the position

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Responsibilities

• Clinical leader of one or more endocrinology programs, being integral to developing the clinical strategy and plans.
• Member of global project team(s) and development sub team(s).
• Focus on immediate and short-term (<2 years) strategic planning horizon.
• Develop department processes to achieve department and corporate objectives.
• Contribute as the Clinical Research expert to the conception and regular modifications of the Target Product Profile (TPP).
• Lead the development of the Clinical Development Plan (CDP) for each indication being pursued, using the TPP as a guidance.
• Conceive and write the Clinical Study Outline for each study in the CDP.
• Lead the discussions and oversee the writing of the study synopsis, study protocol and its amendments.
• Review or oversee the review on a regular basis the data input in the EDC for events of interest or needing further investigation.
• Prepare, in cooperation with biometrics and pharmacovigilance, periodic data listings and review these for discussion with clinical team.
• Collaborate with other departments in all topics related to the conduct and analysis of clinical study results.
• Contribute to the development of relevant sections of regulatory documents.
• Contribute significantly to the preparation, drafting and finalization of all the clinical sections of NDA and MAA.
• Provide leadership, career management and personal development to direct reports.
• Other duties as assigned to meet business needs.

Requirements

• MD degree with at least 13 years' overall experience with 8 years in clinical development within biopharmaceutical and/or pharma companies.
• A minimum of 10 years in a leadership role with 3-5 years of people management experience.
• Experience from clinical practice in internal medicine and/or pediatrics is preferred.
• Experience in designing, planning, and executing First-in-Human studies, Phase 2 proof-of concept studies and preferably also global phase 3 trials.
• Experience with application of biomarkers.
• Experience interacting with the FDA and/or EU regulatory agencies is a plus.
• Strong general knowledge of GCP, ICH guidelines and regulatory requirements and trial design that apply to clinical drug development.
• Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials.
• Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment.
• Strong project planning, negotiation, and presentation skills.
• Ability to work independently and collaboratively, prioritizing tasks efficiently.
• Strategic thinker, team leader and individual contributor capable of working in a high growth, dynamic, science-driven environment.
• Able to prioritize and parallel process multiple workstreams.
• Self-starter, who enjoys rolling up their sleeves and digging into the details.
• Able to conceive and execute innovative approaches to clinical development.
• Ability to inspire and earn respect of the leadership team, Board members, the investment community, colleagues, and staff.
• Well-developed presentation and written communication skills.
• Ethical, with highest standards of integrity.

Benefits

• Discretionary annual target bonus
• Stock options
• Employee Stock Purchase Plan (ESPP)
• 401k match
• Top-notch health insurance plans for employees and their families (medical, dental, vision, and basic life insurance)
• 20 days of PTO
• 10 paid holidays
• Winter company shutdown