Location
Waltham, MA | United States
Job description
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 company’s 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.
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