Medical Director

hace 3 semanas

Madrid, Madrid, España Precision Medicine Group, Llc. A tiempo completo
Job Title: Medical Director - Clinical Trial Services

Job Summary:
Precision Medicine Group, Llc. is seeking a Medical Director to provide medical and scientific expertise to project teams. The successful candidate will serve as the project physician and ensure the accuracy and integrity of the data resulting from the trial, with a focus on patient safety.

Key Responsibilities:
• Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement.
• Support Business Development and Proposals teams by participating in the RFP process, preparing medical considerations sections for proposals, and supporting or participating in bid defense meetings.
• Write or edit scientific content of deliverables within budget and timelines.
• Collaborate with Regulatory Affairs on regulatory product landscape and strategies as part of the overall drug development strategy.
• Provide scientific insight and create content for specified company releases, such as white papers and publication manuscripts.
• Review and revise protocols, case report forms, training materials, project-specific tools, analysis plans, study designs, clinical trial reports, and new drug applications.
• Review laboratory values, adverse events, coded adverse events, and medication data, as well as data tables, listings, and figures as needed.
• Serve as a medical resource for study sites, the project team, and clients.
• Assist in the preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions.
• Assume responsibility for medical and safety monitoring on assigned projects.
• Participate in feasibility discussions relating to specific project proposals.
• Develop training modules and provide training, focusing on disease states.
• Participate in process improvement activities.
• Collaborate with Senior Vice President, Global Medical, and other members of the Medical Science Department to support growth and development activities globally.

Requirements:
• MD, DO, MBBS, or equivalent medical qualifications.
• 5+ years of clinical experience.
• 5+ years of experience in oncology clinical research.
• Demonstrated expertise around the lifecycle of oncology drug development, with the ability to strategically analyze oncology clinical trial protocols.
• Availability for domestic and international travel, including overnight stays (approximately 30% travel requirement).

Preferred Qualifications:
• Drug development experience in Oncology.
• Oncology Fellowship or equivalent.
• Board Certification in Oncology or equivalent.
• Phase I and Phase II oncology clinical trial experience.
• Prior CRO experience.
• Maintains current scientific and medical knowledge base.
• Ability to deliver on commitments, understands the service culture.
• Strategic thinker who can build strategic drug development solutions associated with novel development programs, study designs, and patient populations.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, positive interactions with customers and teammates, including good interpersonal skills.
• Communicate both verbally and in written form in an acceptable manner.
• Conduct formal presentations to a wide variety of audiences, including colleagues.
• Strong visual and presentation skills.
• Ability to work effectively in a fast-paced team setting, with minimal supervision.

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