Director, Non-MD Oncology Clinician at Pfizer

Role Description

• Applies clinical development knowledge to transform clinical research ideas into high quality clinical answers.
• Contributes to the development of clinical strategies and the creation of the Clinical Development Plan
• Designs efficient/innovative clinical studies in close collaboration with statistics, translational oncology, and clinical pharmacology colleagues
• Delivers high quality clinical documents (e.g. protocols, clinical reports, clinical components of IB’s and regulatory submissions) in compliance with regulatory standards
• Serves as a single point of accountability for the design and execution of clinical studies  by closely collaborating with the Study Team
• Ensures appropriate data review, interpretation and reporting in collaboration with other functional groups.
• Reviews and tracks emerging efficacy and safety data and keeps Clinical Lead informed of changes in the efficacy/safety as they occur and take action as appropriate
• Presents clinical trial results internally and to the scientific community and prepare manuscripts
• May manage other clinicians as direct reports.   

Responsibilities

General

Program-related:

• Clinical Leads contribute to the creation and maintenance of the Safety Risk Plan (SRP) for the program In close collaboration with the Medical Monitor for the study
• Clinical Leads in Early Development are responsible for the Safety Surveillance and Risk Management (SSRM) component of the compound development plan until achievement of POC, in agreement with SAF09 and with support from WSS in a consultation model, and if the CL is not a physician a Medical Monitor is appointed to support this effort The CL works in close collaboration with the Medical Monitor for the study
• May sit on the Publication Sub-Committee and contributes to designing the publication strategy for the compound
• Assists in the preparation of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert)
• May participate in discussions with regulators and with the resolution of clinical queries from drug regulatory agencies; leads or contributes to writing and reviewing responses to regulatory queries
• Provides input in the preparation and execution of meetings with HAs
• Works with (Global) Clinical Lead and (Asset) Team Lead to assure that the assigned study(ies) fulfills its role(s) in the overall development plan
• Provides clinical input to other departments (e.g. WRD, Safety Sciences, Commercial) to support development efforts as needed
• May organize expert panel, consultant or advisory board meetings to provide input to clinical plans
• May be an active member of an alliance partnership team
• Represents the clinical line on project-related teams and cross-divisional committees (e.g. TRC, PRC, IOBU-SDMC)
• Reviews IIR proposals
• Interfaces with other Pfizer sites, other TAs and other functions to share best practices, as appropriate

People-related:

• Motivates and engages colleagues to understand a disease, and communicates commitment and excitement about an indication and/or mechanism of action
• May coach and mentor less experienced Clinicians and clinical study sub-team members
• May manage direct reports, including performance management and career development (recruiting, retaining and developing top talent)

Study Planning and Facilitation

• Drives study protocol creation from outline to final protocol
• Authors study outlines and contributes clinical expertise to development of clinical protocols
• Champions novel approaches in study designs and through application of enhanced trial design, ensures the most efficient clinical protocols are developed
• Is responsible for review and approval of the Informed Consent Document (ICD)
• Provides clinical input to the CRF design, statistical analysis plan, monitoring guidelines, and drug supply planning
• Supports other lines  (e.g., Development Operations ) to ensure that they provide adequate support for the study and the overall development plan
• Works  with Development Operations and AP to identify, evaluate and select clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a time and cost effective manner
• Liaises with IOBU-SDMC, eDMC and Steering Committee as required by the protocol
• May lead compassionate use programs

Study Analysis and Reporting

• Works with bio-metrics and other clinical staff (e.g., clinical PK/PD) in the review and interpretation of data
• Authors/Co-authors abstracts, posters, presentations and publications   

Qualifications

• Bachelors or higher degree (RN, or equivalent) in field of Health Sciences or MD.  Advanced degree preferred.
• 3+ years of experience in Oncology including efforts on Clinical Study Reports, Clinical trial authorship, Investigator Brochure authorship/updates, and Annual Reports.
• Pharmaceutical industry experience in Oncology preferred.
• Extensive knowledge of the clinical development process, understand concepts of Phase I-IV and principles of study design.
• Experience in all phases of the clinical trial including study start, conduct and reporting, and full understanding of the principles of GCP
• Ability to work proactively and independently, organize tasks, time and priorities of self and others; ability to multi-task
• Fluency in written and spoken English
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Expertise in risk management and contingency planning is required.
• International clinical trial experience desirable.