Senior Medical Director

Role Summary

Senior Medical Director on-site in San Carlos, CA, leading and executing early- and late-stage clinical trials in type 1 and type 2 diabetes and obesity. Responsible for design and planning of clinical trials, medical aspects of trial execution, interpretation of study results, and development of scientific methods for protocol design, data collection, and final study reports. Collaborates with Medical Affairs and Scientific Communications to plan and deliver data disclosures and engages in KOL identification, advisory boards, scientific congresses, and relationships with scientific associations and patient advocacy groups. Works with Safety and Pharmacovigilance and Clinical Operations teams, and works on-site three days a week.

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.
• Responsible for performing 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/or Metabolism required.
• At least seven 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 (both type 1 and type 2 diabetes).
• 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, as well as the ability to function in a team environment.
• Ability to lead by example, build interdependent partnerships, and participate in a culture of collaboration and teamwork that fosters open communication.
• Able to prioritize and manage several projects simultaneously.
• Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines.
• Outstanding verbal, written, and presentation skills to enable effective communication at all levels that allows for the presentation of complex and/or new ideas with clarity and simplicity.
• Exceptionally organized with keen attention to detail with the ability to shift focus and priorities, when necessary, under pressure and within deadlines.

Education

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

Skills

• Scientific knowledge in diabetes and obesity; ability to interpret clinical data.
• Medical monitoring and trial oversight experience.
• Strong collaboration and communication skills; experience engaging with KOLs and investigators.
• Proficiency in preparing regulatory submissions and clinical study reports.