Clinical Development Medical, Associate Director

Role Summary

The primary purpose is to serve as a Clinician within a Pfizer vaccine development program. This role may serve as a clinical lead for one or more studies within a clinical program and works closely with the global clinical program lead who is ultimately responsible for execution of the overall program. Importantly, this role will be set within a matrix team in executing studies, performing medical monitoring, supporting regulatory interaction, and taking on a leadership role in study teams for many of the clinical deliverables. The clinician is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety.

Responsibilities

• Accountable for safety across the study
• Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
• Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Performs and documents regular review of individual subject safety data, and review of cumulative safety data with the safety risk lead; may delegate to the study clinician scientist as identified in the SSRP.
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports; provide medical context for risk factors, medical history and other factors.
• Participates in the Safety Review Team to evaluate medical benefits/risks for targeted indications; reviews literature as needed to respond to safety questions.
• Communicates safety information to sites and responds to safety questions.

Protocol design and strategy

• Contributes to medical input during protocol development and updates to the clinical development plan.
• Works with other medical monitors to ensure documents meet regulatory requirements and company policy and are reviewed by IRB/IECs.
• Provides medical input into country feasibility.

Support study team

• With supervision of medical monitor provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning.
• Contributes to CRO/vendor selection to ensure study is conducted per protocol and timelines; ensures medical/technical data integrity requirements.
• Ensures high quality data and adequate clinical assessments; contributes to medical review and interpretation of efficacy and safety data; delivers top-line reports with statistician and clinical study report with medical writer; responsible for quality and timeliness of analysis and reporting.
• Provides protocol-specific training to study team, investigators, and staff.
• Interacts with healthcare professionals at sites to enable quality, compliance and patient safety; interacts with DMCs and steering committees as required.
• Notifies study team of changes in research activity and significant new adverse events; monitors investigator compliance with protocol and regulatory requirements.
• Supports study team in issue resolution, study closeout, audit responses, and inspection readiness.

Supports the program team

• Under supervision authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, IND sections, clinical study report).
• May co-author abstracts, posters, presentations and publications.
• May contribute to budget execution of protocols.

Interact with regulatory authorities, key opinion leaders, and principal investigators

• May support Clinical Regulatory Authority interactions and provide responses.
• Liaise with Key Opinion Leaders and Principal Investigators to build a network for new trials.

Qualifications

• Required:
  • Medical degree (M.D./D.O. or equivalent).
  • Licensed by a health authority to prescribe medicines (independently) for at least one year and have used the license in patient care for at least one year.
  • 0–4 years of work experience.
  • Ability to critically evaluate medical/scientific information.
  • Excellent written and oral communication.
  • Understanding of the design, development, and execution of clinical programs and studies.
  • Capacity to adapt to a fast pace and changing environment.
• Preferred:
  • Documented work experience/knowledge of statistics.
  • Training and experience in infectious diseases and/or infection control in hospital settings.
  • Experience with investigational clinical trials.
  • No pharmaceutical industry experience required.
  • Leadership experience including ability to influence, collaborate, develop and coach others, and create business impact.