JOB SUMMARY:
Seeking a highly skilled and experienced Oncology Medical Director to join our dynamic team. The successful candidate will have a strong background in oncology, extensive experience in Phase III clinical studies, and a proven track record in managing global clinical trials. This role is pivotal in driving the clinical development of our oncology pipeline and ensuring the successful execution of our clinical programs.
PRINCIPAL DUTIES:
1. Clinical Development Leadership:
· Provide medical and scientific leadership in the design, execution, and interpretation of Phase III clinical studies.
· Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and biostatistics, to ensure alignment on clinical strategy and study design.
· Ensure clinical trials are conducted in compliance with applicable regulations, guidelines, and company policies.
2. Global Clinical Trial Management:
· Oversee and manage global clinical studies, ensuring consistency and quality across all regions.
· Lead interactions with global regulatory agencies and key opinion leaders to facilitate clinical trial approvals and align on clinical development plans.
· Monitor study progress and address any issues that arise to ensure timely completion and high-quality data.
3. Medical Monitoring and Safety Oversight:
· Serve as the medical monitor for assigned clinical trials, providing ongoing medical oversight and guidance.
· Assess and interpret clinical trial data, ensuring accuracy and completeness of safety and efficacy information.
· Collaborate with pharmacovigilance teams to monitor and manage adverse events and other safety concerns.
4. Data Analysis and Reporting:
· Participate in data analysis, interpretation, and presentation of clinical study results to internal and external stakeholders.
· Contribute to the preparation of clinical study reports, regulatory submissions, and scientific publications.
· Present clinical data at scientific conferences and advisory boards.
5. Stakeholder Engagement:
· Develop and maintain strong relationships with key opinion leaders, investigators, and clinical trial sites.
· Act as a key point of contact for external partners, including regulatory authorities, academic institutions, and industry collaborators.
· Represent company at scientific meetings, conferences, and industry events.
REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):
Education:
· Medical Doctor (MD) degree is required.
Experience:
· Minimum of 3-5 years of experience in oncology clinical development, with a focus on Phase III clinical studies.
· Demonstrated experience in managing global clinical trials and navigating international regulatory environments.
Skills:
· Strong clinical and scientific acumen in oncology.
· Excellent leadership, communication, and interpersonal skills.
· Proven ability to work effectively in a cross-functional, global team environment.
· Strong analytical and problem-solving skills with a keen attention to detail.
Preferred Qualifications:
· Experience working within a biotechnology or pharmaceutical company.
· Demonstrated ability to drive clinical development strategies and make data-driven decisions.
· Prior experience interacting with global regulatory agencies and key opinion leaders.
Posted On: Monday, November 11, 2024