Medical Director, Oncology Location: Remote,

Full Time

The Medical Director, Oncology is the head of MedicalAffairs for client's burgeoning oncology business, and is a critical leadershiprole that dictates clients success with introducing ctDNA-based diagnosticsinto routine medical practice.

PRIMARY RESPONSIBILITIES

• Convince NCCN, ASCO, ESMO, and other leading medical societies worldwide to incorporate ctDNA analysis into practice guidelines. Drive relationships and evidence development strategy to achieve this goal.
• Lead and demonstrate ownership in design and implementation of Phase III clinical studies to demonstrate the utility and efficacy of ctDNA products for changing treatment decisions and improving clinical outcomes through earlier detection of minimally residual disease, relapse and treatment response. Studies should be regulatory compliant.
• Recruit industry-leading PIs and clinical sites to participate in clinical studies, meeting budget and timeline requirements in collaboration with Clinical Trial Operations dept.
• Engage with pharmaceutical companies to secure prospective and retrospective research collaborations using Client diagnostics
• Advise on product development for our testing portfolio: identify clinical unmet needs, new product opportunities, critical product features, product intended use, design and content of test reports, minimum validation studies
• Clinical operations post-launch: clinical interpretation of test results, customer support for physicians, advise on pre-and post-test counseling for patients
• Drive medical education efforts to support successful launch and commercialization of our oncology product portfolio by teaching the community how to use the tests
• Recruit key opinion leaders (KOLs) for medical advisory board, participate as a leader in advisory meetings
• Support the publication strategy by crafting papers in collaboration with Scientific Communications dept.
• Provide medical input into regulatory submissions
• Build and manage a top-class Medical Affairs department to achieve team objectives
• Represent clients medical voice in any public relations related to oncology
• This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on client training requirements.
• Employee must pass post offer criminal background check.

QUALIFICATIONS:

• M.D. required, Ph.D. preferred
• Minimum of 2 years of practice experience in medical oncology, hematology/oncology, or surgical oncology, seeing and treating patients. Strong knowledge and facility with practice guidelines across different solid tumor types
• Minimum of 2 years of clinical trial experience in academia, biotech industry, or equivalent
• Minimum of 1 year of experience in industry, Medical Affairs, or Clinical Development, with record of success in commercializing oncology products (therapeutics or diagnostics)

PREFERRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong knowledge of clinical trial methodology, protocol development, regulatory and compliance requirements, statistics and epidemiology
• Ability to quickly learn clients technology and that of our competitors, understand the strengths and limitations of each, and articulate strong customer value propositions
• Skill and experience in building and managing a team
• Effective in both written and oral communications, with strong persuasive skills in debate, thinking fast on your feet
• Project management skills, with ability to balance and execute across multiple projects simultaneously
• Proven team player, with ability to participate as a member of a cross-disciplinary team
• Ability to manage conflict with poise