Provides clinical leadership and strategic medical input for all clinical deliverables in critical projects.
Collaborates with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff, and others as necessary to develop and execute clinical trials from beginning to end.
Drives clinical strategy and leads efforts to generate clinical development plans and target product profiles.
Designs and develops clinical study protocols and associated clinical study documents and contributes to program level documents such as Investigator Brochures.
Drives clinical trial execution to achieve timely completion of studies in collaboration with clinical teams.
Assumes medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and safety data review.
Conducts safety monitoring in collaboration with CRO pharmacovigilance group of active clinical studies.
Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.
Collaborates with colleagues in Regulatory Affairs, CMC, Toxicology, Research, and Pharmacology to respond to health authority and ethics committee queries.
Collaborates with Principal Investigators in the evaluation and assessment and presentation of publications (abstracts, posters, manuscripts) associated with clinical data.
Participates in clinical study report writing and review, using medical expertise to identify ways to best analyze and present data.
Performs functions in compliance with GCP, and good medical practice.
Networks extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of the company’s vision.
Medical degree (or equivalent).
Board certification/eligibility and clinical experience in I/I highly preferred.
8+ years of clinical development experience within the pharmaceutical or biotechnology industry with a focus and strong track record of experience leading I/I clinical trials.
Academicians with clinical and research experience relative to the I/I platform will be considered.
Strong working knowledge of the clinical drug development process required.
Must have a solid understanding of the relevant clinical landscape and health care practitioners in the field.
Requires a track record in the conduct of/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
Requires strong credibility within the US medical community including the ability to reach out to key thought leaders in academia.
The demonstrated ability to work in a matrix environment with cross-functional teams is required.