Opportunities • Frink-Hamlett

Opportunities

Clinical Medical Director – Oncology (MA)

Job Title
Clinical Medical Director – Oncology (MA)
Duration
Location
Boston,  MA
Other Location
Description

Clinical Medical Director -  Oncology (MA)

Global pharmaceutical company located in Boston, MA seeks a Clinical Medical Director - Oncology.  Must have advanced knowledge of Oncology and Hematology. The salary is competitive.  

Primary Duties

  • Leads and demonstrates ownership of the design and implementation of a clinical development program based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, business operations, and emerging issues
  • 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. Oversees project-related education of investigators, study site personnel, and the study staff
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions  
  • Participate in the development of clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the head of clinical operations
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule
  • Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, accrual, and safety data review
  • Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned

Requirements

  • MD (MD/PhD preferred) with board qualification or experience in medical oncology
  • A minimum of three (3) years related clinical oncology experience in a pharmaceutical company, biotech firm is required
  • Technical, operational, and managerial experience in planning, executing, reporting and publishing clinical studies. Successful clinical research publication history
  • Proven ability to work independently and to lead a multidisciplinary trial team in a complex matrix environment. Experience in developing effective relationships with key investigators
  • Thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and global clinical development process. Advanced knowledge of Oncology and Hematology is necessary

 

IND1

Openings
1

Option 1: Create a New Profile