Senior Medical Director, Clinical Research, Endocrinology

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $324k - $360k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Crinetics Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals is a biotechnology company that develops innovative therapies for endocrine diseases. The company is focused on addressing unmet medical needs by creating treatments for conditions such as acromegaly, carcinoid syndrome, ACTH-dependent Cushing’s syndrome, congenital adrenal hyperplasia, and other endocrine disorders. Crinetics is committed to improving the quality of life for patients through cutting-edge science and robust clinical trials. Their pipeline includes promising candidates like paltusotine, which has been accepted by the U. S. Food and Drug Administration for the treatment of adult patients with acromegaly. The company collaborates with healthcare practitioners and stakeholders to ensure that their therapies address real-life problems effectively and build value for investors by entering market niches with significant needs.

📋 Description

• 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) • 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 guidance • Define the scientific rationale and design captured in 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 of the data input in the EDC for events of interest or needing further investigation • Provide senior-level medical monitoring and safety oversight in cooperation with pharmacovigilance • Collaborate with other departments in all topics related to the conduct and analysis of clinical study results • Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings • Support advisory boards, key opinion leader engagement, and external scientific collaborations • Contribute to the development of relevant sections of regulatory documents such as amendments to protocols and responses to Health Authorities questions

🎯 Requirements

• MD degree • 10+ years of experience industry, clinical/medical practice or combination • 5+ years of program management experience • Experience from clinical practice in internal medicine/endocrinology • 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 • Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials

🏖️ Benefits

• Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown • Discretionary annual target bonus • Stock options • 401k match