Director, Vaccine Clinical Research and Development (MD) in Marlow

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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 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.
• 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 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.

Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.

Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!