Director, Medical Sciences
Venatorx Pharmaceuticals, Inc
Mgr & Dir - R&D/Ops
Malvern, PA, US
The Director, Medical Sciences will serve as the primary scientific and medical advisor to the clinical study team(s), providing medical input to all aspects of product development and to drug discovery teams. The Director, Medical Sciences is directly involved in the planning, implementation, analysis and interpretation of clinical studies, and provides medical expertise necessary to advance development programs to the filing of INDs and NDAs.
- Provides clinical perspective and guidance to Venatorx Development initiatives and programs.
- Develops creative and realistic clinical drug development protocols for Venatorx programs.
- Provides medical input and responsibility to Clinical Research efforts, including CRO and site selection, clinical monitoring, adverse event review and other clinical trial duties as required.
- Collaborates closely with Preclinical, Regulatory, Clinical Operations, Biometrics, outside contractors and CRO's to ensure timely development and execution of clinical trials.
- Contributes medical input to all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials relevant to Clinical R&D on assigned programs, working with staff and contract Medical Writers as needed.
- Contributes to the authoring, review and sign off with respect to all required clinical documents including protocols, IBs, informed consent forms, safety reports, briefing books, advisory committee presentations.
- Contributes to clinical trial safety by performing safety review and analysis of pre-market and/or post-market trials and tracking emerging efficacy and safety profile of drugs consistent with Safety Review Plan; responsible for identifying emerging safety trends and escalating them for further discussion with the Clinical Development organization.
- Works with study team to ensure high quality data, e.g., appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
- Conducts medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety.
- Influences internal and external audiences in a high impact, highly visible fashion through written and verbal communication and presentations.
- Provides strategic clinical perspective and guidance to Licensing and Business Development opportunities, as needed.
- MD or MD, PhD with anti-infective clinical and drug development experience; Infectious Diseases physician preferred
- 5+ years industry experience in the design, conduct and analysis of multinational Phase 2 and/or 3 efficacy and safety studies for anti-infective (bacterial, fungal, or viral) drugs.
- Prior experience in a small/medium size company is highly desired.
- Early stage development and regulatory experience desirable.
- Ability to work well with peers and external audiences such as opinion leaders and regulatory bodies.
Equal Employment Opportunity/M/F/disability/protected veteran status