Clinical Development Medical, Associate Director

About the role

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.

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).
• Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead.
• As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP.
• The specific components of safety data review are detailed in the appropriate SOPs and the “Safety Data Review Guide – for Clinicians.”
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports.
• Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context.
• Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications.
• Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study.
• Communicates safety information to sites across the study and provides responses to questions on safety.
• Protocol design and strategy
• Contributes towards the medical input during protocol development and updates to the clinical development plan.
• Work closely with other medical monitors to ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and have been reviewed by IRB/IECs.
• Supports study team With supervision of medical monitor (Director/Sr Director) provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.
• Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.
• Works with study team to ensure high quality of data e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing.
• Contributes to medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting.
• Provides protocol specific training to study team, investigators, clinical research associate, and others.
• Interacts with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.
• Interacts with DMCs and steering committees as required.
• Notifies appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.
• Maintain investigator compliance with protocol and regulatory requirements.
• Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.
• Supports the program team Under supervision (Director/Sr. Director) authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report).
• May co-author abstracts, posters, presentations and publications.
• May contribute budget execution of protocols.
• Interact with regulatory authorities, key opinion leaders, and principal investigators
• May support Clinical Regulatory Authority interactions accountable for providing responses.
• Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials.

Qualifications

• Medical degree (M.D./D.O. or equivalent).
• Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year) and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least two years.
• 0-4 years' work experience
• Possesses the ability to critically evaluate medical/scientific information.
• Excellent written and oral communication.
• Understands the design, development, and execution of clinical programs and studies.
• Capacity to adapt to a fast pace and changing environment

PREFERRED QUALIFICATIONS

• Documented work experience/knowledge of statistics.
• Training and experience in infectious diseases and/or infection control in the hospital setting is preferred.
• Experience with investigational clinical trials is preferred.
• No pharmaceutical industry experience required.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.