Senior Director, Clinical Development - Antibacterials, Antifungals, CMV & Covid 19

The Senior Director has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving investigational or marketed drugs in the infectious diseases therapeutic area. Participate in all phases of the clinical trial process (mainly Phase 2–3), including study design, medical monitoring, medical/scientific interpretation of study analyses, regulatory reporting, and publication. Apply disease and drug pharmacology expertise to the infectious disease clinical development strategy and short- and long-term research objectives. Provide internal scientific leadership and external leadership with key scientific leaders. Role may be remote.

Responsibilities:
- Plan clinical trials (design, operational plans) for infectious disease drugs
- Monitor and manage ongoing or new clinical trials
- Analyze and summarize clinical findings to support safety/efficacy decisions and new drug applications, clinical study reports, or publications
- Participate in internal and joint internal/external research teams for investigational and marketed drugs
- Develop clinical development strategies
- Present study data and program strategic plans to governance committees
- Maintain scientific knowledge by tracking scientific developments, engaging investigators, and attending scientific meetings
- Author development documents/presentations and scientific publications; facilitate global collaborations
- Travel up to ~10% to manage clinical research projects

Qualifications:
- Education: M.D. or M.D./Ph.D. (preferably infectious diseases); medical licensure/board certification desirable; PharmD with clinical practice/research expertise may be considered
- Requirements: 5+ years industry experience in clinical research/drug development; success overseeing clinical studies/protocols; record of scientific scholarship; experience in clinical medicine; excellent verbal/written communication; strong interpersonal skills and leadership
- Preferred: infectious diseases clinical research/drug development; registrational trials and major health authority filings

Required/Preferred skills (as listed): Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research Management, Clinical Trial Compliance, Clinical Trial Development, Clinical Trials, Data Analysis, Decision Making, Drug Development, Ethical Standards, Infectious Disease/Research, Intellectual Curiosity, Interdisciplinary Problem Solving, Medical Research, Mentorship, Protocol Development, Regulatory Compliance/Reporting, Scientific Consulting/Publications, Strategic Planning, Vaccinology, Veterinary Medicine.