Director, Vaccine Clinical Research and Development (MD required)
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.
Primary purpose is to serve as a Clinician for the Pneumococcal Vaccine Franchise to assist in the global clinical development of Pneumococcal Conjugate vaccines. The team is responsible for global clinical development and licensure of pneumococcal vaccines, including post-licensure regulatory commitments. This role will serve as a clinical lead for one or more studies, working closely with the clinical program lead responsible for overall execution. Importantly, this role will lead a matrix team in executing studies, medical monitoring, and study team leadership for many clinical deliverables.
ROLE RESPONSIBILITIES
The clinician is accountable for providing medical and scientific expertise and oversight for Clinical Trials, serving as the single point of accountability for design, execution, monitoring, delivery, and reporting of clinical studies to ensure patient safety.
Protocol design and strategy:
* Provide medical input during development and updates to the clinical development plan.
* Ensure documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy, and are reviewed by IRB/IECs.
* Provide medical input into country feasibility.
* Design development strategies for multiple protocols to obtain worldwide approval for a compound or group of compounds, if required.
Accountable for safety across the study:
* Provide medical advice for all medical issues during risk assessment and mitigation planning to ensure quality, compliance, and patient safety.
* Develop and adhere to the Safety Review Plan (SRP). Conduct regular reviews of safety data and collaborate with safety risk lead.
* Monitor safety issues, contribute to SAE reports, and inform investigators of significant new adverse events.
* Participate in the Safety Review Team to evaluate benefits/risks for targeted indications.
* Review literature as needed for safety questions.
* Communicate safety information to sites and respond to safety queries.
Support study team:
* Provide clinical input for monitoring guidelines, analysis plans, ICDs, review forms, data quality planning, and oversee related work.
* Build relationships with healthcare professionals at trial sites.
* Contribute to CRO/vendor selection to ensure study quality and data integrity.
* Ensure high-quality data collection and clinical assessments.
* Review efficacy and safety data, deliver reports, and ensure quality and timeliness.
* Ensure scientific validity of study reports and appropriate data disclosure.
* Train study team and investigators.
* Interact with healthcare professionals, DMCs, and steering committees.
* Coordinate medical opinions globally and monitor investigator compliance.
* Assist in issues resolution, study closeout, audits, and inspections.
Support program team:
* Author clinical sections of regulatory documents.
* Maintain familiarity with literature and research for program input.
* Participate in in-licensing activities and due diligence.
* Collaborate with various departments within the project team.
* Ensure timely and within-budget protocol execution.
* Engage with regulatory authorities, KOLs, and PIs to support interactions and build networks.
The clinician medical monitor will also participate in standing committees, review compounds for in-licensing, and support business development activities.
QUALIFICATIONS
* Medical degree (M.D./D.O. or equivalent) with a valid license for at least 2 years post-graduation.
* Experience in the pharmaceutical industry related to clinical research and registration, preferably for vaccines, or significant experience in vaccine clinical studies in academic or public health institutions.
* Training in Infectious Disease, Internal Medicine, or Pediatrics is preferred.
* Ability to critically evaluate scientific information and propose innovative ideas.
* Understanding of clinical program design, development, and execution.
Candidate should demonstrate leadership, collaboration, coaching, and influence skills.
The closing deadline for applications is May 23rd. All applicants must have the right to work in the UK.
Purpose
Breakthroughs that change patients' lives... At Pfizer, we are patient-centric, guided by values: courage, joy, equity, and excellence. Our culture supports transforming lives through innovation.
Our digital transformation strategy aims to accelerate drug discovery and development, enhancing health outcomes and patient experiences.
Flexibility
We foster a flexible, trusting workplace culture that promotes work-life balance, attracts talent, and supports employees’ best selves. Let’s start the conversation!
We value diversity and inclusion, celebrating all forms to mirror the communities we serve. We are committed to creating an empowering environment for all employees.
Disability Confident
We are proud to be a Disability Confident Employer, supporting applications with reasonable adjustments. Your journey with Pfizer begins here!
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