The MD Clinician is accountable for the medical & scientific integrity of the study or studies and the well-being of the patients.
This role serves as the protocol owner and applies technical and clinical / medical excellence to ensure the design of cost-
efficient clinical trials to meet the needs of internal and external customers.
Responsible for effective medical / scientific oversight of studies (in partnership with Global Clinical Leads (GCL), non-
MD Clinicians and Clinical Operations team members, as applicable) and supports appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities.
Safeguards compliance with internal and external standards and proactively mitigates risk and manages emerging clinical issues.
Reports to the VP, Biosimilars Clinical Development Lead, the Functional Head of the Clinical Line (FHCL) for Biosimilars and may be assigned to work with Global Clinical Leads or the Clinical Team lead(s) responsible for Study Conduct (who have accountability for study, program and portfolio deliverables).
May support the GCL in the Clinical Development strategy and may act as the FCLH’s delegate or as that of the GCL.
Supports the organization of expert panels and advisory board meetings to provide input into clinical plans, study design or data analysis;
primary contact with external investigators and the internal study team for questions relating to clinical / medical aspects of the protocol;
approves investigator meeting plans.
In addition to study specific activities, s / he may provide product / program specific medical input for target product profile(s), due diligence activities on potential in-
licensing opportunities and regulatory documents as appropriate (e.g., product labels, core data sheets, Investigator’s Brochures, Development Safety Update Reports, Periodic Benefit-
Risk Evaluation Reports).
Provides medical input to develop study outline and / or key protocol elements and proactively ensures efficient protocols that minimize the likelihood of amendments.
At the asset level, provides medical input to assist the GCL in the Clinical development strategy and supports Business Development of the technical review of licensing opportunities.
Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
Provides medical input, reviews and approves CRFs and ICDs; provides input for the design of the Statistical Analysis Plan (SAP) and the Clinical Data output.
Reviews and approves Risk Management, Safety Review and Data Review Plans.
Reviews and approves country selection, develops site selection criteria and ensures protocol specific training.
Ensures the integrity of medical and scientific aspects during clinical study execution, analysis and reporting; consistent with the Safety Review Plan, performs and documents regular medical review of individual subject safety data and cumulative safety data with the safety risk lead.
Identifies quality issues and discusses with Pfizer clinical / operations study team members so that corrective actions may be instituted;
reviews protocol-related issues requiring medical expertise; escalates operational issues to the appropriate operations study team member.
Responsible for clinical and scientific validity of study report and regulatory submission documents, especially conclusions regarding medical components of efficacy and safety
Responsible for disclosure of appropriate safety and efficacy data and conclusions and contributes to primary publication of clinical trial results.
Provides medical advice and oversight to the study team or clinical program in response to audits or inspections, including providing medical advice and support as needed to audit / inspection responses (eg, site visits if specific medical expertise is required to further investigate or remediate findings)
Attends and represents Clinical Development and Operations at governance meetings
Supports and contributes to various sections of regulatory filings (eg, Investigator Brochure, IND / NDA Annual reports, and Regulatory authority responses)
Assists responsible colleagues with the development of the IB, key safety documents, responses to regulatory queries (is a member of the rapid response team), and audit / inspection findings, CRAs, and submission documents by providing relevant clinical support.
Participates in driving execution of the Global Clinical Development Plan throughout the lifecycle of one or multiple assets of the Biosimilars portfolio.
Maintains a high degree of awareness of the external environment; applies creativity and / or ability to put innovative approaches into practice in clinical development;
takes appropriate risks to challenge the status quo, resulting in enhanced processes
Volunteers to actively participate in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures.
Physician (MD, MBBS, etc) and minimum of 5 year Clinical Research and Clinical Development experience in industry / CRO.
Clinical Development experience in the phase 3 clinical trials, ideally on the side of the sponsor and with a track record of participation in successful regulatory submission(s), inspections and, preferably regulatory approval.
Background in Oncology preferred and experience preferred in Clinical Development of Biosimilars and monoclonal antibodies;
experience in medical care of patients in Oncology.
Proven teaching / training ability, preferably in Oncology
Proven track record of being a successful Medical Monitor at the study or program level; ability to review and understand the emerging safety and efficacy profile of the drug candidate;
putting the profile in perspective with the innovator / comparator agent(s).
Understanding of related disciplines (development operations, safety, biostatistics, regulatory, pre-clinical, pharmacology, pharmaceutical sciences)
Regulatory awareness proven track record of proactive management of regulatory issues related to protocols and programs
Demonstrated scientific productivity and scientific writing / verbal skills via publications, posters, abstracts and / or presentations;
ability to evaluate, interpret and present complex data.
Demonstrated strong inter-personal, excellent communication skills (written and verbal) in English; strong collaborative problem solving skills (handles conflict constructively)
Able to work on the computer, communicate efficiently via phone and / or webex.
Proven ability to collaborate and get results in a matrixed management environment.
Act independently on self-initiated or delegated projects
Leverages knowledge from others related to overall objectives, strategy, critical issues and policy matters; has foresight and judgment in complex decisions
Promotes team health
Able to embody leadership behaviors and competencies
Is able to travel occasionally (
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.