Vice President/Senior Medical Director
Posted on 7/19/2023
INACTIVE
Locations
Belmont, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
CategoriesNew
Medical, Clinical & Veterinary
Biology & Biotech
Requirements
- Medical degree (or equivalent)
- Board certification/eligibility and clinical experience in oncology or hematology/oncology highly preferred
- 8+ years of clinical development experience within the pharmaceutical or biotechnology industry with a focus and strong track record of experience leading oncology clinical trials
- Academic oncologists with clinical and research experience relative to the oncology platform will be considered
- Strong working knowledge of the clinical drug development process required
- Must have a solid understanding of the clinical landscape relevant to oncology patients 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
Responsibilities
- Provides clinical leadership and strategic medical input for all clinical deliverables in critical projects and clinical programs
- 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 trial execution to achieve timely completion of clinical studies in collaboration with clinical teams
- Designs and develops clinical study protocols and associated clinical study documents and contributes to program level documents such as Investigator Brochures and Clinical Development Plans
- 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