Job Title: Senior Medical Director - NASH & Diabetes
Location: San Francisco, CA
About Us:
A mid-sized biotechnology company at the forefront of innovation in metabolic diseases, specializing in nonalcoholic steatohepatitis (NASH) and diabetes. We are dedicated to transforming patient outcomes through groundbreaking research and development of novel therapeutics. Our team of experts collaborates to advance cutting-edge treatments in endocrinology and metabolic disorders.
Position Summary:
We are seeking a highly experienced and strategic Senior Medical Director with a strong background in endocrinology to lead our clinical development efforts in NASH and diabetes. The ideal candidate will have a minimum of five years of industry experience and be board-certified or board-eligible in endocrinology. This role will be responsible for the strategic oversight of clinical programs, regulatory interactions, and cross-functional collaboration to drive successful drug development.
Key Responsibilities:
Provide strategic leadership and medical expertise for the clinical development of NASH and diabetes programs.
Oversee the design, execution, and interpretation of clinical trials, ensuring alignment with regulatory standards and company objectives.
Serve as a key liaison with regulatory authorities (FDA, EMA, etc.), academic institutions, and external stakeholders.
Collaborate with internal teams, including research, regulatory, medical affairs, and commercial teams, to develop and execute clinical development strategies.
Lead interactions with key opinion leaders (KOLs), patient advocacy groups, and advisory boards to enhance program development.
Support business development activities by evaluating potential partnerships, acquisitions, and licensing opportunities.
Ensure compliance with all regulatory, legal, and ethical standards in clinical research.
Mentor and develop junior medical and clinical team members.
Qualifications & Experience:
MD, DO, or equivalent degree with board eligibility/certification in endocrinology.
Minimum of five years of industry experience in clinical development, with a focus on metabolic diseases, NASH, or diabetes.
Deep understanding of clinical trial design, regulatory requirements, and drug development processes.
Proven leadership and management experience in a biotech or pharmaceutical setting.
Strong analytical and strategic thinking skills with the ability to make data-driven decisions.
Excellent communication and interpersonal skills, with the ability to engage stakeholders across various functions.
Experience leading regulatory submissions and engaging with health authorities.
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