Director, Vaccine Clinical Research and Development (MD required)
Primary purpose is to serve as a Clinician for the Pneumococcal Vaccine Franchise to assist in the global clinical development of a Pneumococcal Conjugate vaccines. The team has responsibility 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, within a clinical program, and work closely with the clinical program lead who is ultimately responsible for execution of the overall program. Importantly, this role will lead a matrix team in executing studies and medical monitoring and take a lead 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.
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.
- Provides medical input into country feasibility.
- The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds.
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 Review Plan (SRP). 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, as well as ensure study team personnel inform investigators of any changes in research activity and any significant new adverse events.
- 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.
Support study team:
- 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 (ultimately oversees work of protocol/study team).
- Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites (in collaboration with regional medical monitors when assigned to a study).
- 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 (e.g. lab specifications).
- Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
- Conducts 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; accountable for overall quality and timeliness of analysis and reporting.
- 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).
- Provides protocol specific training to study team, investigators, clinical research associate, and others.
- Interact with healthcare professionals at sites (leveraging the Regional Medical Monitors - RMMs - 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.
- Coordinates medical opinions with other physicians globally to ensure consistency.
- 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:
- Authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report).
- Gains and maintains familiarity with the literature and research in the project area to input into program team discussions.
- 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.
- Interact with regulatory authorities, key opinion leaders, and principal investigators:
- Support 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.
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.
Candidate 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.
- Medical degree (M.D./D.O. or equivalent) with valid license for at least 2 years after graduation.
- At least 2 years of 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 Pediatrics preferred.
- Possesses the ability to critically evaluate medical/scientific information; propose new concepts and innovative ideas in drug development.
- Understands the design, development, and execution of clinical programs and studies
Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Additional Location Information: Pearl River, NYSunshine ActPfizer 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 EligibilityPfizer 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.Medical