Medical Director, Clinical Research, Endocrinology

Responsibilities

• Partner with cross-functional teams to develop and maintain Clinical Development Plans (CCDP)
• Lead design, planning, and implementation of clinical trials
• Provide scientific oversight for clinical protocols and related documents
• Conduct medical monitoring for clinical studies in conjunction with CRO medical monitors
• Ensure compliance with GCP and all regulatory requirements during clinical trials
• Collaborate on Patient Reported Outcome research with HEOR teams
• Contribute to clinical sections of regulatory documents and represent the company externally

Qualifications

• MD degree with 5+ years of clinical research experience, preferably in endocrinology
• Board certification in endocrinology is preferred
• Solid understanding of clinical medicine, pharmacology, and associated disciplines
• Solid understanding of FDA/EMA regulations and Good Clinical Practice (GCP)
• Experience with regulatory agency interactions and clinical trial monitoring

Benefits

• Top-tier health insurance plans for employees and families including medical, dental, and vision
• 20 days of paid time off (PTO) plus 10 paid holidays
• Participation in a discretionary annual bonus program
• Stock options and Employee Stock Purchase Plans (ESPP)
• 401k match and company-wide winter shutdown