Medical Director Oncology Hematology

Senior Principal Recruitment Consultant - Clinical Development. This is a hybrid on-site role in Boston, Massachusetts. Candidates must be local to the Boston area.

$200.00/hr - $280.00/hr

Senior Principal Recruitment Consultant - Clinical Development

• Provide clinical expertise in ALL (adult and pediatric) to support completion of ongoing studies (e.g., CSR)
• Provide strategic and clinical insights for data generation and potential new study designs
• Collaborate in cross-functional working groups to deliver a strategic plan for internal governance decision making prior to year end
• Support regulatory interaction preparations for new sponsored studies
• Clinical Development Strategy and Execution: provide medical and strategic leadership for all clinical initiatives including supporting regulatory interactions with regulatory affairs and cross-functional representatives
• Develop and lead presentations for internal governance meetings to support timely and efficient decision making
• Coordinate with DMPK teams to understand PK modelling applications for dosing/schedule recommendations
• Perform literature searches and support data generation and key publications
• Support Business Development evaluations of promising late-stage assets under consideration for in-licensing or acquisitions
• Medical Monitor: lead design and execution of clinical trials, ensuring alignment with regulatory requirements and company objectives
• Provide medical monitoring oversight for clinical studies in accordance with GCP
• Review data for critical clinical and/or safety endpoints and consult on medical literature for evidence-based decision-making
• Team collaboration: work with asset teams, clinical sub-teams, regulatory affairs, medical affairs, and commercial teams to ensure alignment and successful product development
• KOL engagement, investigational led studies, and publication support
• Support interactions with KOLs and development of advisory board content
• Other duties as required or directed by the Manager or Functional Management

• M.D. required with a strong preference for specialty training and board certification in Medical Hematology/Oncology
• Experience with Acute Lymphoblastic Leukemia is required
• 3+ years in industry with strong preference for regulatory interactions experience
• Demonstrated ability to lead clinical development efforts across phases of development within the Hematology/Oncology space
• Excellent public speaking, writing, and communication skills required. Ability to teach and mentor is also critical and work in a cross-functional collaborative way.
• Problem solving mindset with the ability to be creative and to execute a vision that seeks to drive innovation
• Ability to organise and prioritise work streams and guide teams through challenges
• Excellent operational execution and ability to meet critical timelines
• Team player with strong matrix working capability
• Proven track record practicing sound medical judgment as it relates to clinical acumen and risk assessment including leading cohort safety evaluation meetings in early phase studies, co-authoring investigator brochures, and providing clinical expertise on PV-related documents
• Core competencies:
  
  Leadership, Execution, Strategy, Collaboration

• Mid-Senior level

• Contract

• Health Care Provider

• Pharmaceutical Manufacturing