Senior Director, Vaccine Clinical Research & Development (MD required)

Senior Director, Vaccine Clinical Research & Development (MD required) ROLE SUMMARY The Senior Director of Vaccine Clinical Research & Development should be able to function independently and have direct experience with all the steps in designing and delivering results of clinical trials by applying extensive expertise and in-depth knowledge of clinical research to lead global clinical research programs and registration activities across one or more clinical projects. The Senior Director ensures successful global program implementation through oversight and review of the global program design including the clinical development plan or lifecycle strategy. The Senior Director partners with Franchise Lead in identifying and advancing new concepts and processes to provide innovative strategies to solve clinical issues. By directing and obtaining consensus from senior staff members, the Senior Director solves highly complex and specialized problems related to clinical research programs. The Senior Director applies technical/scientific expertise to resolve problems regarding the clinical components of documents (e.g., Investigational New Drugs, New Drug Applications/Common Technical Documents, global registration dossiers, lifecycle strategy documents, internal documents). The Senior Director provides procedural and scientific subject matter expertise to steer clinician medical monitors, clinician clinical scientists, clinical scientist leads, and other clinical staff members. The Senior Director 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. In addition to study level activities, the Senior Director will participate in standing committees, review opportunities for potential in-licensing, including performance of due diligence reviews, and aid new business development on market opportunities and the target product profile. The Senior Director may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a vaccine or group of vaccines. Mentor and/or manage more junior medical monitor colleagues. ROLE RESPONSIBILITIES Accountable for participant safety 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. Accountable for the development of and adherence to the Safety Surveillance Review Plan (SSRP) for a vaccine development program Has oversight of the subject safety data for all studies within a program, and the review of cumulative safety data with the safety risk lead. Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Steers discussion on benefit-risk analysis across functions 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 Responsible for development of the Clinical Development Plan. Designs clinical studies to meet the stated objectives of a program. Assures that clinical trial objectives of each study fit with the clinical program strategy. 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. Support study team Has oversight of 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) 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. Ensures the 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 are conducted appropriately. Ensures the 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) Provides protocol specific training to study team, investigators, clinical research associate, and others. Interacts with healthcare professionals at sites (leveraging Site Care Partners when assigned) 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. Is responsible for ensuring all materials are provided to DMC. Coordinates medical opinions with other colleagues globally to ensure consistency at program level. Ensures that appropriate study team colleagues are notified to inform investigators of any changes in research activity and any significant new adverse events. Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc. Support program team Ensures that the clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report) are completed timely. May co-author abstracts, posters, presentations and publications Acts as clinical representative in in-licensing activities such as due diligence reviews and reports. May be a key member of the Program team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Global Product Development 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. Leads 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. 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. Propose new concepts and innovative ideas in drug development. Excellent written and oral communication Understands the design, development, and execution of clinical programs and studies. Capacity to adapt to a fast-paced and changing environment. 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. PREFERRED QUALIFICATIONS Training and experience in infectious diseases and/or infection control in the hospital setting is preferred. Documented work experience/knowledge of statistics Experience with investigational clinical trials is preferred. Documented experience in the pharmaceutical industry related to clinical research programs and registration activities. Work Location Assignment: On Premise (Marlow, UK) #J-18808-Ljbffr