Medical Director

6 days ago

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pfm medical, inc.

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Medical Device Manufacturing

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Description

• Precision for Medicine is hiring a Medical Director to join our team, candidates can work remotely in any of the following locations: UK, Spain, Poland, Hungary, Romania, Serbia or Slovakia. • The Medical Director serves as the project physician and provides medical and scientific expertise to project teams. • The Medical Director’s primary focus of work will be to ensure the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety. • This position also participates in the strategic planning and execution of critical development programs for a variety of clients in haematology and oncology, contributes to the development of Precision’s Medical team, and supports Business Development activities. • Essential functions of the job include but are not limited to: • 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; prepare medical considerations section for proposals; and support or participate in bid defense meetings. • Write or edit scientific content of deliverables within budget and timelines. • Collaborates with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy. • Provide scientific insight and create content for specified company releases (e.g., 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 event and medication data, and 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 concentrating 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 ability to strategically analyze oncology clinical trial protocols. • Availability for domestic and international travel including overnight stays (approximate 30% travel requirement). • 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-pacing team setting, with minimal supervision. • Proven efficiency in working remotely