At Claire Joster, we are collaborating with PharmaMar, a global leader in the research and development of innovative marine derived medicines for oncology. We are currently seeking a Medical Oncologist Manager, Early Clinical Development to join their team.
Mission of the Role:
Medical oversight and monitoring of early stage clinical development programs in oncology for PharmaMars emerging pipeline compounds.
Key Responsibilities:
Expertise & Strategic Contribution:
* Serve as an internal clinical expert in translational and clinical oncology, providing scientific and medical support for ongoing projects.
* Contribute strategically to clinical study decision making (from Phase I to Phase IIa ).
Study Phases:
1.Study Design & Initiation:
* Lead the design and implementation of clinical studies, ensuring regulatory compliance.
* Develop protocols, eligibility criteria, safety monitoring procedures, and risk mitigation strategies .
* Collaborate with internal teams and CROs for study planning.
* Train investigators and study personnel .
2.Study Execution:
* Act as Medical Monitor, resolving critical clinical issues.
* Oversee study integrity, including safety and efficacy data interpretation .
* Monitor patient enrollment and adherence to study timelines.
* Assess and report serious adverse events (SAEs) .
* Contribute to Development Safety Update Reports (DSURs) .
3.Study Closure:
* Analyze and interpret clinical data.
* Draft key sections of Clinical Study Reports (CSR) .
4.Ongoing Responsibilities:
* Supervise Clinical Scientists working on related programs.
* Engage with Key Opinion Leaders (KOLs) in the field.
* Ensure compliance with international regulatory requirements and participate in key regulatory discussions.
* Maintain adherence to Good Clinical Practices (GCP) and pharmacovigilance regulations .
Requirements:
1. Medical Degree (MD) with a scientific background in Oncology .
2. Experience in early phase clinical trials (FIH, Phase I/II ).
3. Advanced knowledge and experience in clinical trial design, safety, trial management, and clinical data management .
4. Strong understanding of clinical trial regulations and Good Clinical Practices (GCP) .
5. Knowledge of pharmacokinetics and pharmacodynamics and their