Search Jobs

Your NEXT GREAT OPPORTUNITY is within reach!

Medical Director, Oncology Therapeutics

Cambridge, MA

Posted: 08/19/2020 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2608

Job Description

Our client is seeking a highly motivated and enthusiastic physician with hands-on expertise in taking novel oncology compounds from first in human through to completion of phase 2 clinical trials. This will support our client’ s continued effort to identify unique anti-cancer compounds for the treatment of targeted patient populations. Reporting to the CMO, the successful candidate will function as a scientific and medical resource for the Clinical Development department as well as a liaison to development partners while managing the conduct of multiple clinical trials in hematologic malignancies. She/he will be responsible for preparation of study related materials, relationship management between study sites, leveraging internal and external (CRO) development resources, and the supervision of all other study related activities. Additionally, this individual will be responsible for the identification of project risks, contingency planning implementation, and operating within the project timelines and budget.

Principal Duties and Responsibilities:
  • Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, customers, markets, business operations, and emerging issues.
  • Oversees project-related education of investigators, study site personnel, and study staff.
  • 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.
  • May participate in or lead clinical development contributions to due diligence or other business development activity.
  • As required by program needs, contributes in partnership with Discovery colleagues to the design and implementation of translational strategies.
  • 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. 
  • Participates 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.
  • Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
  • Collaborate with clinical and discovery scientists, regulatory professionals, biostatisticians, clinical operations and other colleagues in the development and execution of a clinical program.
  • Assume 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.
  • Conduct safety monitoring in collaboration with pharmacovigilance groups of active clinical studies.
  • Lead the analysis, interpretation and reporting of clinical study data.
  • Working with other clinical and regulatory colleagues, address health authority and ethics committee queries.
  • Represent company at medical meetings, advisory boards and other KOL/investigator outreach meetings as needed.
  • Collaborate in the preparation of publications (abstracts, posters, manuscripts) of data from clinical programs.

Requirements / Qualifications:
  • MD, MD/PhD in life sciences or healthcare required plus clinical oncology experience with advanced knowledge in hematology. Board certification in oncology or hematology preferred. Solid tumor experience a plus.
  • A minimum of three (3) years’ related clinical oncology experience in a pharmaceutical company, biotech firm, or CRO is required. This includes technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies.
  • 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 the global clinical drug development process, GCP, clinical trial design, statistics, and regulatory processes.
  • A proven track record in the conduct/participation in company sponsored clinical trials
  • A successful clinical research publication history

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.