Senior Medical Director, Clinical Research
October 21
Description
• Clinical leader of endocrinology programs • Develop clinical strategy and Clinical Development Plans • Oversee writing of study synopsis, protocol, and amendments • Review data inputs and generate reports • Collaborate with other departments on clinical results • Contribute to regulatory documents preparation • Lead drafting of responses to regulatory authorities • Provide leadership and career management to direct reports
Requirements
• MD degree with at least 13 years' overall experience • 8 years in clinical development within biopharmaceutical and/or pharma companies • 10 years in a leadership role with 3-5 years of people management experience • Experience in clinical practice in internal medicine and/or pediatrics preferred • Experience in designing and executing First-in-Human and Phase 2 studies • Experience with application of biomarkers • Interaction with FDA and/or EU regulatory agencies is a plus • Strong knowledge of GCP, ICH guidelines and regulatory requirements • High-level expertise in medical monitoring of clinical trials • Excellent leadership, project planning, negotiation, and communication skills
Benefits
• Discretionary annual target bonus • Stock options • ESPP • 401k match • Top-notch health insurance plans (medical, dental, vision, life) • 20 days PTO • 10 paid holidays • Winter company shutdown
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