Senior Medical Director (Contractor)

Position Summary:

As a Senior Medical Director, you will play a critical role in shaping the clinical development strategy for our MASH Phase III clinical trials. You will collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Research & Development. Your expertise will drive the successful execution of clinical trials and contribute to the advancement of novel therapies.

Essential Responsibilities:

Clinical Trial Oversight:

• Monitor ongoing clinical trials, ensuring adherence to protocols, safety guidelines, and regulatory requirements.
• Analyze clinical trial data, interpret results, and provide medical insights to inform decision-making.
• Oversee safety monitoring in ongoing clinical studies.
• Review safety events, adverse reactions, and serious adverse events (SAEs).

Collaboration and Leadership:

• Work closely with the Clinical Operations, Regulatory, R&D, and Data Management teams to support clinical trials execution.
• Provide scientific and strategic leadership to clinical trial protocols design, endpoints, and patient selection.
• Collaborate with cross-functional teams to develop scientifically sound clinical trial protocols and study documents that are feasible to execute.
• Contribute to and participate in interactions with regulatory authorities and regulatory submissions.
• Collaborate with study investigators in the preparation, submission, and presentation of scientific data at scientific meetings and congresses.
• Collaborate with R&D team to generate, analyze, and publish research data.

Therapeutic Expertise:

• Focus on MASH (metabolic dysfunction-associated steatohepatitis) therapeutic area.
• Stay abreast of scientific literature, competitor landscape, and emerging trends in MASH research.
• Represent the company at scientific conferences and engage with key opinion leaders.

Education and Experience Requirements:

• Medical degree (MD) with board certification in a relevant specialty (e.g., gastroenterology, hepatology).
• Prior experience in clinical development within the biotechnology or pharmaceutical industry, or clinical research organization.
• Familiarity with clinical trial design, execution, and data analysis.
• Strong understanding of MASH pathophysiology and related research (other disease area understanding is a bonus).
• Awareness of regulatory requirements specific to MASH clinical trials (other disease area understanding is a bonus).
• Ability to provide scientific and strategic leadership.
• Excellent communication skills, ability to collaborate effectively with thought leaders and investigators.
• Strong decision-making skills.
• Willingness to stay informed about emerging trends in MASH research.
• Ability to work in a fast-paced, small company environment with multiple competing responsibilities.
• Position involves 10-20% travel.

The hourly rate for this position is $175-$190. The hourly rate will be based on the experience and qualifications of the selected candidate.