Job Description

The Director, Medical Review will manage and oversee the medical review of individual case safety reports (ICSRs) for marketed and investigational products, providing medical safety assessment and pharmacovigilance comment. You will also manage audits and peer retrospective medical review quality control (MRQC) activities.

JOB RESPONSIBILITIES:

• Establishes recognition as an expert on medical safety assessment of individual cases.

• Performs peer retrospective quality control (QC) of adverse event reports from a medical review perspective.

• Participates in both internal and external educational initiatives.

• Initiates, leads, or contributes to a functional or cross-functional project.

• Participates in process improvement initiatives by identifying areas for improvement and presents solutions.

• Collaborates with Kite Safety & Pharmacovigilance colleagues on select cases with suspected unexpected serious adverse reactions (SUSARs) from clinical trials.

• May contribute to develop and maintain procedural document and provide training.

• Supports internal and external audit and inspection.

• Provides medical consultation to Patient Safety (PS) Strategic Operations group including Literature Management, Coding Strategy, and Autolabeling Management on an ad hoc basis.

• Provides mentorship and trains junior staff, new hires, and contractors to independently review adverse event reports for investigational and marketed products.

• Responds to medical review-related questions from other functions in a timely manner.

• Makes contributions to process improvement within PS, particularly with adverse event processing and operational aspects of medical review.

• Participates in the Medical Review team meetings.

• Provides medical input to Strategic Operations on case queries.

• Ensures meticulous adherence to deadlines. Anticipates events which might impact deadlines and mitigates accordingly.

• May participate as Medical Review representative in audits/inspections.

• When needed, prioritizes work and delegates to other MR colleagues.

• Ensures appropriate and timely collaboration between MR and other groups for medical review activities.

• Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables.

• Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

BASIC QUALIFICATIONS:

• PharmD/PhD in life sciences or related field and with 8+years’ drug safety or related experience in the biopharma industry, at a regulatory agency, clinical research or related medical / healthcare environment, including significant experience in medical review - OR -

• MA/MS/MBA in life sciences or related field and with 10+years’ drug safety or related experience in the biopharma industry, at a regulatory agency, clinical research or related medical / healthcare environment, including significant experience in medical review – OR -

• BA/BS in life sciences or related field and with 12+years’ drug safety or related experience in the biopharma industry, at a regulatory agency, clinical research or related medical / healthcare environment, including significant experience in medical review.

PREFERED QUALIFICATIONS:

• MD/DO.

• Completion of an accredited medical or surgical residency program. Board certification is preferred.

• Minimum of 8 years’ experience in medical review and experience reviewing chimeric antigen receptor (CAR) T-cell therapy cases.

• Excellent scientific/clinical and analytical knowledge base, with ability to assess individual case safety reports and understand the safety/medical implications.

• Ability to communicate to high level stakeholders under tight deadlines and to manage multiple major projects simultaneously.

• Ability to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.

• Able to work independently.

• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.

• Ability to handle increasing and/or changing responsibilities (e.g., team growth, integration efforts across other functions or the organization)

• Strong interpersonal skills and understanding of team dynamics.

• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees.

• Strong negotiation and conflict resolution skills.

• Strong coaching capabilities to mentor/develop staff.