Director, Vaccine Clinical Research and Development

Pfizer, S.A. de C.V; Marlow; Hybrid; GBP 80,000 - 110,000; Full time

Job summary

A leading pharmaceutical company is seeking a Director for Vaccine Clinical Research and Development in Marlow, UK. The successful candidate will oversee clinical studies, ensuring adherence to safety protocols and regulatory standards. Ideal applicants will possess a medical degree, at least two years of licensure, and experience in vaccine trials. Join a hybrid working environment dedicated to breakthroughs that enhance patient outcomes.

Benefits

Competitive compensation

Diverse workforce

Disability confidence support

Qualifications

• Proven experience in clinical research programs and registration activities.
• Training in Infectious Disease, Internal Medicine or Paediatrics preferred.
• Broad leadership experience required.

Responsibilities

• Lead clinical studies within a global vaccine program.
• Monitor study safety issues and provide medical context.
• Contribute to regulatory documents with senior medical monitor supervision.

Skills

Critical evaluation of medical/scientific information

Understanding of clinical program design

Adaptability to a fast-paced environment

Documented experience in statistics

Experience in infectious diseases

Education

Medical degree (M.D./D.O. or equivalent)

Licensed by a health authority

Job description

Director, Vaccine Clinical Research and Development (MD)

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals. Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

ROLE SUMMARY

As a Clinician within a Pfizer vaccine development program, you will serve as a primary clinical lead for one or more studies within a global program. Working closely with the global clinical program lead, you will provide medical and scientific expertise, oversee study design, execution, monitoring, and reporting, and ensure patient safety. Your role will be embedded in a matrix team, performing medical monitoring, regulatory interaction, and leadership of study teams to deliver high‑quality clinical data.

RESPONSIBILITIES

• Provide medical advice during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
• Develop, review, and adhere to the Safety Surveillance Review Plan (SSRP); conduct regular safety data reviews and collaborate with the safety risk lead.
• Monitor study safety issues; contribute to serious adverse events (SAE) reports and provide medical context.
• Participate in the Safety Review Team to evaluate medical benefits/risk for targeted clinical indications.
• Review literature to respond to safety questions posed by the Safety Review Team, Data Monitoring Committee (DMC), or other stakeholders.
• Communicate safety information to sites and address safety queries.
• Provide medical input during development and updates of the clinical development plan.
• Ensure that protocol, Informed Consent Document (ICD) and other documents meet regulatory requirements, company policy and have been reviewed by IRB/IECs.
• Offer medical input into country feasibility studies.
• Design development strategies for multiple protocols to obtain worldwide approval.
• With supervision of a medical monitor, provide clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.
• Contribute to contract research organization/vendor selection to ensure studies are conducted in alignment with protocol requirements and clinical plan expectations.
• Ensure high quality of data, including appropriate patient population and adequacy of clinical assessments.
• Interpret efficacy and safety data; collaborate with statistician and medical writer to deliver top‑line and clinical study reports.
• Provide protocol‑specific training to study team, investigators, and clinical research associates.
• Interact with healthcare professionals at sites to ensure quality, compliance and patient safety.
• Interact with DMCs and steering committees as required.
• Notify study team of changes in research activity and significant new adverse events.
• Monitor investigator compliance with protocol and regulatory requirements.
• Support study team in issue resolution, study close‑out, audit responses, and inspection readiness.
• Author clinical sections of regulatory documents (Investigator Brochure, Annual Reports, IND sections, clinical study report) under supervision of a senior medical monitor.
• Co‑author abstracts, posters, presentations, and publications as appropriate.
• Contribute to budget execution of protocols.
• Support Clinical Regulatory Authority interactions and provide requisite responses.
• Build and maintain a Key Opinion Leader (KOL)/Principal Investigator network for new trials.
• Coordinate global medical opinions to ensure consistency.

QUALIFICATIONS

BASIC QUALIFICATIONS

• Medical degree (M.D./D.O. or equivalent).
• Licensed by a health authority to prescribe medicines independently for at least one year in a patient‑care setting.
• Critical evaluation of medical/scientific information.
• Understanding of clinical program design, development, and execution.
• Adaptability to a fast‑paced, changing environment.

PREFERRED QUALIFICATIONS

• Documented experience/knowledge of statistics.
• Training and experience in infectious diseases and/or infection control in a hospital setting.
• Experience with investigational clinical trials.

DIRECTOR LEVEL REQUIREMENTS IN ADDITION TO THE ABOVE INCLUDE

• Medical degree with a valid license for at least 2 years after graduation.
• Proven experience in the pharmaceutical 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.
• Training in Infectious Disease, Internal Medicine or Paediatrics preferred.
• Broad leadership experience: influencing, collaborating, coaching, overseeing colleagues to achieve meaningful outcomes and create business impact.

Work Location Assignment: Hybrid (some office presence is required)

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 all forms of diversity, allowing 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 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.