Global Oncology Medical Director, Clinical Development

Meet Life Sciences Ltd.; Cambridge (MA); Vor Ort; USD 260.000 - 400.000; Vollzeit

Zusammenfassung

Meet Life Sciences Ltd. in Cambridge, MA, seeks a Senior Medical Director, Clinical Development to lead global oncology trials with a focus on medical monitoring and patient safety.

The role requires an MD with board eligibility in oncology and 5+ years of clinical development experience, preferably in solid tumors. You will lead cross-functional teams and interact with regulators during trial submissions.

Qualifikationen

• MD or equivalent medical degree required.
• Board certification or board eligibility in Medical Oncology, Hematology/Oncology, or a related specialty strongly preferred.
• Approximately five or more years of clinical development experience within a biotechnology, pharmaceutical, or related research organization.
• Demonstrated experience serving as a study physician or medical monitor for interventional oncology clinical trials.
• Strong knowledge of solid-tumor drug development and contemporary oncology clinical practice.

Aufgaben

• Serve as the medical lead and study physician for global oncology clinical trials.
• Provide hands-on medical monitoring, including review of eligibility, safety events, lab findings, dose modifications, protocol deviations, and patient-level data.
• Lead ongoing assessment of safety, efficacy, pharmacokinetic, and pharmacodynamic data.
• Collaborate with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Translational Medicine, and Medical Writing.
• Contribute to development plans, study concepts, protocols, informed consent documents, investigator brochures, clinical study reports, and regulatory submissions.
• Support study design, dose-escalation and expansion strategies, and benefit-risk assessments.
• Provide medical guidance to investigators, study sites, CROs, and internal teams.
• Lead or participate in safety review committees, data review meetings, investigator meetings, and governance discussions.
• Develop relationships with investigators and key opinion leaders; support interactions with health authorities including the FDA.
• Evaluate clinical data to identify trends, risks, and optimization opportunities.
• Contribute to publications, abstracts, and presentations.

Kenntnisse

Study physician

Oncology clinical trials

Safety monitoring

Data review

Regulatory interactions

Cross-functional collaboration

Global teams

Medical leadership

Ausbildung

MD or equivalent medical degree

Board certification in Medical Oncology or Hematology/Oncology

Jobbeschreibung

Meet Life Sciences Ltd. in Cambridge, MA, seeks a Senior Medical Director, Clinical Development to lead global oncology trials with a focus on medical monitoring and patient safety.

The role requires an MD with board eligibility in oncology and 5+ years of clinical development experience, preferably in solid tumors. You will lead cross-functional teams and interact with regulators during trial submissions.