Senior Director, Vaccine Clinical Research

ROLE SUMMARY
The clinician medical monitor 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 clinician medical monitor ensures successful global program implementation through oversight and review of the global program design including the clinical development plan or lifecycle strategy.
The clinician medical monitor 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 clinician medical monitor solves highly complex and specialised problems related to clinical research programs. The clinician medical monitor 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 clinician medical monitor provides procedural and scientific subject matter expertise to steer clinician medical monitors, clinician clinical scientists, clinical scientist leads, and other clinical staff members.
The clinician medical monitor 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 clinician medical monitor 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 clinician medical monitor 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 organisation / 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 utilised 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.
• 5 + years' work experience.

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.

The annual base salary for this position ranges from $226,200.00 to $377,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Medical