Medical Director

Position Summary:

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 autoimmune disease, 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 Vice President, Medical Science and other members of the Medical Science Department to support growth and development activities globally

Qualifications:

Minimum Required:

• MD, DO, MBBS, or equivalent medical qualifications 
• 5+ years of clinical experience

Other Required: 

• Completed an accredited medical residency program and a fellowship or equivalent in a subspecialty relevant to the care of patients with autoimmune diseases (e.g., rheumatology, allergy & immunology)
• 5+ years of experience in autoimmune disease clinical research 
• Demonstrated expertise around the lifecycle of autoimmune disease drug development with ability to strategically analyze autoimmune disease clinical trial protocols 
•  Availability for domestic and international travel including overnight stays (approximate 30% travel requirement)

Preferred:

• Drug development experience in autoimmune diseases
• Board Certification in relevant medical subspecialty or equivalent
• Phase I and Phase II autoimmune disease clinical trial experience
• Prior CRO experience
• Maintains current scientific and medical knowledge base

Skills/Competencies:

• 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

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