Instructor - Medicine jobs in Somerset, NJ

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Senior Medical Director?

Position Summary:

The Senior Medical Director serves as the project physician and provides medical and/or scientific expertise to oncology project teams. Advice and support provided by the Senior Medical Director encompasses all tasks from project concept and development through the final study report and/or submission.  The primary focus of the job is to ensure the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety. 

Essential functions of the job include but are not limited to:

Clinical Project Physician / Medical Monitor Activities 

• Provides high-quality comprehensive and strategic medical support to the high-profile domestic and international clinical research programs of Precision for Medicine clients
• Serves as the key project physician and provides medical and scientific expertise in support of early and late phase programs in oncology
• Supports business development activities for existing and potential Precision for Medicine clients
• Serve as project physician; 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 results, adverse events, coding dictionaries and data tables, listings and figures as needed
• 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; interact with other team members and clients as needed
• Participate in feasibility discussions relating to specific project proposals
• Develop training modules and provides training in disease states across company

Business Development Support

• Work closely with senior leaders in Medical, Operational Strategy and Business Development to support client engagement
• Support Business Development and Proposals teams by supporting the RFP process: • Prepares medical considerations sections for proposals
• Supports or participates in bid defense meetings
• Meets with clients as needed
• Write or edit scientific content of deliverables within budget timelines
• Collaborates with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy

Medical Department Support

• Participate in training opportunities to advance knowledge of drug development and Good Clinical Practice Guidelines
• Support company’s visibility and position with the CRO industry through publications and presentations
• Develop new and enhances existing client/investigator relationships whenever possible
• Participate in process improvement activities for company

Qualifications:

Minimum Required:

• MD, DO, MBBS, or equivalent medical qualifications

Other Required:

• Completed an accredited medical residency program
• At least 10 years of experience in clinical research
• Availability for domestic and international travel including overnight stays (potential 30% travel requirement)

Preferred:

• Oncology and/or Hematology Fellowship or equivalent
• Board Certification or equivalent in Oncology and/or Hematology
• Prior CRO experience
• Phase I and Phase II oncology clinical trial experience
• Maintains current scientific and medical knowledge base

Competencies:

• Ability to deliver on commitments, an understanding of the service culture
• Demonstrates a high degree of professionalism, as evidenced by punctuality, positive interactions with customers and teammates, including good interpersonal skills
• Identify training needs for direct reports and develop training plans to address those needs
• Communicate both verbally and in written form in an acceptable manner
• Conduct formal presentations to a wide variety of audiences including colleagues