Medical Director/ Senior Medical Director

Role Summary

Medical Director/Senior Medical Director responsible for leading and executing early- and late-stage clinical trials in type 1 and type 2 diabetes and obesity. This role designs and plans clinical trials, oversees medical aspects of trial execution, interprets study results, and supports data disclosures and scientific communications. The position involves collaboration with Medical Affairs, Scientific Communications, Safety and Pharmacovigilance, and Clinical Operations, as well as engagement with key opinion leaders, advisory boards, and patient advocacy groups. On-site in San Carlos, CA.

Responsibilities

• Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
• Assist with the strategy and creation of the clinical development plans for one or more programs.
• Work collaboratively with other clinical staff in trial execution and oversight (e.g., Biostatistics, Clinical Operations, Scientific Communications).
• Act as Medical Monitor for company-sponsored trials.
• Support project teams with therapeutic area specific information.
• Perform ongoing clinical data review during study execution to ensure integrity of accruing study data and appropriate safety follow-up.
• Collaborate with internal departments in analyzing and reporting of safety data from clinical trials.
• Support writing and review of investigator brochures, protocols, statistical analysis plans and clinical study reports.
• Provide scientific input into clinical study reports and regulatory submissions.
• Analyze and interpret clinical trial data and prepare reports for regulatory agencies and publication.
• Interact with key opinion leaders and investigators in relevant disease-specific areas.
• Ensure consistency of scientific and development strategies for diabetes and obesity products in development.
• Collaborate with groups within the organization to successfully execute key opinion leader strategy, advisory boards, scientific activities at scientific conferences, and other medical affairs-related activities.
• Maintain the highest level of scientific and clinical knowledge in relevant disease areas.
• May supervise employees, both directly and indirectly through a dotted line structure.

Qualifications

• MD with board certification or eligibility in Endocrinology, Diabetes and Metabolism required.
• At least five years of drug development experience in biotechnology or pharmaceutical industry.
• Proven hands-on experience in the design, execution, and reporting of controlled clinical trials in diabetes mellitus (type 1 and type 2).
• Knowledge of ICH and Good Clinical Practice and familiarity with global and regional regulations.
• Experience in the assessment of adverse events and safety of patients participating in clinical trials.
• Strong interpersonal skills and the ability to function in a team environment.
• Ability to lead by example, build interdependent partnerships, and foster a collaborative culture.
• Able to prioritize and manage several projects simultaneously.
• Ability to work in a fast-paced and evolving environment with diverse, multi-functional teams.
• Outstanding verbal, written, and presentation skills for communicating complex ideas clearly.
• Exceptionally organized with keen attention to detail and the ability to adapt under deadlines.

Education

• MD with board certification or eligibility in Endocrinology, Diabetes and Metabolism.