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Responsibilities:

• 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.


• Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.


• Collaborates with senior colleagues 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 companys vision.

Qualifications:

• Medical degree (or equivalent).


• Board certification/eligibility and clinical experience in I/I through phase 3 highly preferred.


• 8+ years of clinical development experience within the pharmaceutical or biotechnology industry with a focus and strong track record of experience leading clinical trials.


• 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.