Director, Vaccine Clinical Research and Development (MD)

Director, Vaccine Clinical Research and Development (MD)
ROLE SUMMARY
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). 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:

• Provide medical input during development and updates to the clinical development plan.
• Ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.
• Provides medical input into country feasibility.
• The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds.

Support 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.
• Monitor 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.

Support study team:

• 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 (ultimately oversees work of protocol/study team).
• Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites (in collaboration with regional medical monitors when assigned to a study).
• Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions (ClinicalTrials.gov, EudraCT, or Pfizer.com).
• Coordinates medical opinions with other physicians globally to ensure consistency.
• Monitor investigator compliance with protocol and regulatory requirements.
• Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.

Supports the program team:

• Authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report).
• Gains and maintains familiarity with the literature and research in the project area to input into program team discussions.
• Acts as clinical representative in in-licensing activities such as due diligence reviews and reports.
• As a key member of the Program team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Development Operations and other members of the extended project team(s).
• Responsible for the on-time and within-budget execution of protocols.
• Interact with regulatory authorities, key opinion leaders, and principal investigators:
• Support 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.

In addition to study level activities, the clinician medical monitor will participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews and provide assistance to new business development on market opportunities and the target product profile.
BASIC 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 one year.
• Possesses the ability to critically evaluate medical/scientific information.
• Excellent written an 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.
• Experience with investigational clinical trials.

DIRECTOR LEVEL REQUIREMENTS IN ADDITION TO THE ABOVE INCLUDE:

• Medical degree (M.D./D.O. or equivalent) with valid license for at least 2 years after graduation.
• Proven experience in the pharmaceutical industry (biopharmaceutical industry or Clinical Research Organization) related to clinical research programs and registration activities, preferably for vaccines, or;
• An investigator with significant experience in vaccine clinical studies in academic, NGO or public health institutions may be considered.
• Training in Infectious Disease, Internal Medicine or Paediatrics preferred.
• 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.

Work Location Assignment: Hybrid (some office presence is required)
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
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