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Medical Director

Cambridge, MA

Posted: 08/24/2020 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2589

Job Description

Our client is seeking a Medical Director to oversee the design and implementation of multiple clinical development programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, their customers, markets, business operations, and emerging issues. The person in this role will oversee project-related education of investigators, study site personnel, and study staff.

  • Monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy.
  • Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment of serious adverse events per corporate policy and regulations for those protocols on which assigned.
  • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
  • Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects.
  • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s).
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Represent client company at key external meetings.
  • Responsible for understanding the regulatory requirements related to the clinical studies and drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

  • Medical Doctor (M.D) degree. Completion of a subspecialty fellowship in hematology and/or oncology is strongly preferred.
  • Minimum 2-5 years of clinical trial experience in the pharmaceutical industry and/or academia.
  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in the design of study protocols.
  • Ability to exercise judgment and address complex problems and create solutions for one or more projects.
  • Proven ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
  • Must possess excellent oral and written English communication skills.
  • Approximately 10%-20% travel requirement (when COVID vaccine available)

Meet Your Recruiter

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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