•The Senior Clinical Director 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 Clinical Director ensures successful global program implementation through oversight and review of the global program design including the clinical development plan or lifecycle strategy.
•The incumbent will have responsibility for preparing to evaluate new compounds in the clinic partnering with the research, drug safety, nonclinical pharmacology, clinical pharmacology and operations leads to advance the program
•The Senior Clinical Director will identify and advance new concepts and processes to provide innovative strategies to solve clinical issues. By leading and obtaining consensus from senior staff members, the senior clinical dirctor solves highly complex and specialized problems related to clinical research programs. The clinician medical monitor applies technical/scientific expertise to resolve problems regarding the clinical components of documents (i.e., Investigational New Drug applications, Common Technical Documents, Investigator Brochures, global registration dossiers, lifecycle strategy documents, Clinical Development Plans, internal documents).
•The Senior Clinical Director provides procedural and scientific subject matter expertise to lead clinician medical monitors, clinical scientists, clinical scientist leads, and other clinical staff members.
•The Senior Clinical Director is accountable for providing medical and scientific expertise and oversight for clinical trials and serves as a single point of accountability for design, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety.
•In addition to study level activities, the Senior Clinical Director will participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and providing assistance to new business development opportunities and input into the target product profile.
•The Senior Clinical Director will be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds.
•Mentor and/or manage more junior clinical director and/or scientific director colleagues.ROLE RESPONSIBILITIES
- Accountable for safety monitoring 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.
- Accountable for the development of and adherence to the Safety Surveillance Review Plan (SSRP) for development programs.
- 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. Leads 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.
- Responsible for preparing the required safety text utilized in Informed Consent Documents.
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
- Provides clinical input to protocol/study team for monitoring guidelines, statistical 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 reports in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness for analysis and reporting
- 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 the 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. 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.
- Provides medical oversight regarding protocol exemptions, protocol violations, subject eligibility issues, allowed/disallowed medications, and general medical-related study issue
Supports program team
- Prepares the clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report)
- 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.
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.
- Obtained a Medical degree (M.D./D.O. or equivalent) from a recognized medical school and have always been in good standing with their licensing Health Authority
- 15+ years of related experience with 5+ years in a drug/vaccine development setting
- 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.
- Documented experience in the pharmaceutical industry related to clinical research programs and registration activities.
- Possesses the ability to critically evaluate medical/scientific information. Propose new concepts and innovative ideas in drug development.
- Excellent written an oral communication.
- Understands the design, development, and execution of clinical programs and studies.
- Capacity to adapt to a fast pace and changing environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- 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.
Pfizer is a global organization and there will be a requirement to travel and work outside of their local business hours
Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.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.