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Senior-Level Medical Director

Cambridge, MA 02138

Posted: 05/14/2024 Employment Type: Direct Hire Job Category: Operations and Development Job Number: 3667

Job Description

The Associate Medical Director is a medical doctor who provides medical and scientific leadership and oversees assigned clinical development programs and associated clinical trials.

Responsibilities:
  • Serves as a cross-functional medical lead on clinical trials to achieve efficient, high-quality study execution.
  • Utilizes novel and creative methods to independently structure study designs and resolve clinical development problems. Supports clinical trial design and execution to prevent risk and promote safety of patients enrolled in investigational trials.
  • As a medical expert, accountable for achieving efficient, high-quality outcomes during the planning and execution phases of the clinical trials.
  • Responsible for the scientific and clinical inputs and review of study-related documents and analysis plans, including protocols, investigative brochures, informed consent forms (ICF), case report forms (CRF), associated data management documents, statistical analysis plans (SAP), independent Data Monitoring Committee (IDMC) and/or Study Review Committee (SRC) charters, and clinical study reports (CSR).
  • Understands the unmet needs of patients in the community and provides strategic inputs to the business management team to successfully run ongoing projects and propose new projects.
  • Works closely with cross-functional leads to support the clinical trial design and execution.
  • Serves as the primary or backup Medical Monitor responsible for monitoring the safety of enrolled study participants. Supports the Pharmacovigilance Lead in performing safety reviews of clinical trial data and develops proactive strategies to prevent risk and promote the safety of clinical trial participants.
  • Supports the Regulatory team and participates in the preparation of regulatory documents for regulatory submissions.
  • Utilizes novel and creative methods to independently structure study designs and resolve clinical development problems.
  • Conducts literature reviews, creates research questions and hypothesis-driven scientific approaches to problems, and understands the current landscape of the assigned therapeutic indications.
  • Facilitates continuous learning and knowledge transfer throughout the duration of the project, as well as upon its completion.
  • Provides scientific leadership and mentorship to cross-functional leads. Responsible for effectively communicating the science to the clinical and non-clinical team members.
  • Collaborates with internal stakeholders including Clinical Scientists, Clinical Operations, Pharmacovigilance, Biostatisticians, Data Management, Regulatory, and Pharmacology teams.
  • Serves as a representative of the organization to outside medical personnel in the development of clinical protocols and study conduct. Communicates with key opinion leaders, principal investigators and other subject matter experts in therapeutic areas of interest to better understand the unmet needs in the community.
  • Addresses questions from clinical sites and ethics committees/IRBs.

Requirements / Qualifications:
  • A Medical Degree (M.D.) or international equivalent is required. Board certification/eligibility in relevant medical field is highly desired.
  • A minimum of 3-5 years of clinical research experience in an academic, pharmaceutical, or biotechnology industry setting designing and executing clinical trials and working with cross-functional teams with experience in analysis of research data and scientific publications.
  • Experience in clinical development in Hematology and Oncology.
  • Knowledge of ICH Good Clinical Practice Guidelines, FDA regulations, biostatistics, data management, clinical operations, and clinical pharmacokinetics to support trial design and execution.
  • Demonstrate ability to conduct literature reviews independently and experience in scientific publications.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • Willingness to learn specialized software tools used in clinical trial conduct.
  • Strong analytical skills and problem-solving capabilities.
  • Highly organized with strong attention to detail, clarity, accuracy, and conciseness.
  • Demonstrate ability to effectively interact with internal and external teams who may not possess the knowledge and background to readily understand the medical aspects of the therapeutic indications being studied and drug development.
  • Excellent communication and presentation skills.

Physical Demands
  • Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting/moving up to 15 pounds (e.g. in order to shred documents, to maintain a neat and organized work environment, and to lift paper supplies, and large boxes and files).

Work Environment
  • The noise level in the work environment is usually quiet.
  • As a global company, the candidate may be required to attend and participate in weekly or monthly business meetings in person or via conference call, which will be scheduled in the evenings or early mornings.

Business Travel
  • This role requires the incumbent to travel up to 30% of the time.
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