Design and optimize clinical trials, including development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts and clinical study reports in collaboration with the clinical development team
Serve as medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies in close collaboration with the clinical operations team
Serve as primary medical contact for ongoing large-scale trials providing appropriate clinical guidance to both internal (Clinical Operations) and external (CRO) stakeholders to ensure program objectives are met in accordance with the medical plan
Lead integrated, cross-functional team and provides vision and oversight of project execution; ensures appropriate integration and representation of all R&D functions in support of assigned priority assets
Responsible for preparing company responses to health authorities and ethics committees for ongoing clinical programs to ensure timely registration and initiation of trials globally
Establish and implement exploratory pharmacodynamic, predictive and prognostic biomarker plans in conjunction with staff, consultants and collaborators
Interact with study investigators, thought leaders, including advisory boards, academicians, and internal colleagues
Ensure adherence to Company’s Standard Operating Procedures
Maintain clinical and scientific awareness in area of expertise.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
An M.D. or combined M.D. / Ph.D.
5+ years of industry experience designing, leading and managing clinical studies. Experience in rare disease or gene therapy preferred. Level will be dependent upon experience.
Demonstrated understanding of the drug development process.
Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements.
Ability to effectively evaluate outside expert advice.
Ability to communicate and explain technical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background.
Ability to work independently.
Experience working effectively in a fast-paced, team-based environment.
Strong clinical/scientific/technical skills.
Strong interpersonal capabilities.
Ability to anticipate and resolve problems effectively.
Strong verbal communication and technical writing skills.
Ability to present clearly using scientific and clinical terminology
Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings.
Sound organizational skills.
Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
Motivates team members; fosters and nurtures teamwork.
Project management skills and focus on delivery of results.
Ability and willingness to travel at least 25% of the time (domestic & international medical meetings, functions etc)