Vivid Resourcing
Job Title:
Medical Director (Medical Monitor) – Vivid Resourcing
Location:
Boston, MA
We are seeking an experienced
Medical Director (Medical Monitor)
to provide strategic and hands‑on medical leadership to help drive the clinical development.
Responsibilities
Supervise clinical trials, ensuring SOPs, GCPs and following regulatory requirements.
Design, implement clinical trials in the oncology space based on ICH‑GCP and research guidelines.
Serve as Medical Monitor for oncology clinical trials, providing medical oversight and ensuring patient safety.
Review and assess SAEs, AESIs, and safety trends, partnering with Pharmacovigilance on signal detection and benefit–risk evaluation.
Provide medical input into protocol design, dose escalation decisions, and safety monitoring plans.
Contribute to clinical and regulatory documents (protocols, IBs, ICFs, CSRs) and support health authority interactions.
Collaborate cross‑functionally with Clinical Operations, Regulatory Affairs, Biometrics, and Translational Medicine.
Engage with investigators, KOLs, and study sites to ensure high‑quality trial execution and scientific alignment.
Requirements
MD or DO (or international equivalent) with board certification or eligibility.
4+ years of clinical trial experience in oncology/hematology, including medical monitoring responsibilities.
Strong understanding of oncology drug development, safety assessment, and global regulatory requirements.
Experience reviewing and managing SAEs, DLTs, and safety narratives.
Excellent communication skills with the ability to engage internal teams, investigators, and regulators.
Prior experience in biotech or emerging pharmaceutical companies.
Good communication with internal and external partners/stakeholders.
Offer
Competitive salary ($200-300k)
Professional development and potential for upward career growth.
Impact in shaping regulatory strategy.
Seniority level:
Director
Employment type:
Full‑time
Job function:
Health Care Provider
Industries:
Health and Human Services, Biotechnology Research
#J-18808-Ljbffr
Medical Director (Medical Monitor) – Vivid Resourcing
Location:
Boston, MA
We are seeking an experienced
Medical Director (Medical Monitor)
to provide strategic and hands‑on medical leadership to help drive the clinical development.
Responsibilities
Supervise clinical trials, ensuring SOPs, GCPs and following regulatory requirements.
Design, implement clinical trials in the oncology space based on ICH‑GCP and research guidelines.
Serve as Medical Monitor for oncology clinical trials, providing medical oversight and ensuring patient safety.
Review and assess SAEs, AESIs, and safety trends, partnering with Pharmacovigilance on signal detection and benefit–risk evaluation.
Provide medical input into protocol design, dose escalation decisions, and safety monitoring plans.
Contribute to clinical and regulatory documents (protocols, IBs, ICFs, CSRs) and support health authority interactions.
Collaborate cross‑functionally with Clinical Operations, Regulatory Affairs, Biometrics, and Translational Medicine.
Engage with investigators, KOLs, and study sites to ensure high‑quality trial execution and scientific alignment.
Requirements
MD or DO (or international equivalent) with board certification or eligibility.
4+ years of clinical trial experience in oncology/hematology, including medical monitoring responsibilities.
Strong understanding of oncology drug development, safety assessment, and global regulatory requirements.
Experience reviewing and managing SAEs, DLTs, and safety narratives.
Excellent communication skills with the ability to engage internal teams, investigators, and regulators.
Prior experience in biotech or emerging pharmaceutical companies.
Good communication with internal and external partners/stakeholders.
Offer
Competitive salary ($200-300k)
Professional development and potential for upward career growth.
Impact in shaping regulatory strategy.
Seniority level:
Director
Employment type:
Full‑time
Job function:
Health Care Provider
Industries:
Health and Human Services, Biotechnology Research
#J-18808-Ljbffr