Medical Director/Senior Medical Director
South San Francisco, CA

JOB SPECIFICATION

The Position

The Medical Director/Senior Medical Director, reporting to the Chief Medical Officer, will play a pivotal role in the clinical development of the Company’s compounds. He or she will lead the strategic discussion around trial design, assist in writing the protocols, and then play a vital role in the planning and execution of the clinical trials. He or she will provide clinical expertise to key study plans and processes such as investigator meetings, eCRF design, drafting of informed consents and investigator brochures, data management, study monitoring, data analysis, completion of study reports, and publication of key findings. The Medical Director/Senior Medical Director will work closely with medical consultants and key opinions leaders in infectious disease from around the world to insure that studies are clinically relevant and thoughtfully designed to meet the objectives in the target product profiles and the target labels.

Duties & Responsibilities

• Work with the Chief Medical Officer to plan and implement the clinical development of the Company’s products in a way that is consistent with corporate goals and timelines.
• Play a pivotal role on Product teams and subteams providing clinical expertise to all aspects of trial design and conduct.
• Assist with the development, negotiation and management of budgets for clinical trials
• Plan and execute clinical research and data collection.
• Interpret the findings from clinical research.
• Establish and maintain pertinent standard operating procedures for clinical research
• Ensure that Company-sponsored clinical research is conducted in a manner that is in full compliance with all pertinent governmental regulations.
• Play an important role in discussions, communications, and negotiations with Regulatory authorities, including INDs, meeting packages, teleconferences, and meetings.
• Be responsible and accountable for the clinical aspects of communications with regulatory authorities
• Provide scientific and clinical expertise in support of business development activities as needed.
• Represent the Company in a positive fashion and develop and maintain key relationships with clinical and research communities and key opinion leaders.

Education

• MD required; Strong clinical and science background in infectious disease and/or clinical expertise in infectious disease highly desirable.
• Advanced degree(s) must be from an accredited institution.
• Board certification or eligibility for certification is a plus.

Experience

• Three or more years with direct, industry-related product development experience in pharmaceuticals, biopharmaceuticals or biotechnology industries.
• Solid experience with protocol design, evaluation, and conduct.
• Experience with a small to medium sized biotech strongly preferred.
• Proven management and leadership experience in working with CROs for the execution of clinical trials.
• Willingness to be a “hands-on, roll-up-your sleeves team member” in a lean organization.
• Effective verbal and written communication skills. Experience in presentations to internal and external groups. Strong organizational, interpersonal and computer skills a must.
• Excellent team interaction skills along with demonstrated ability to work in a cross-functional team and influence the decisions of a team.