The Therapeutic Area (TA) Clinician Lead will manage Study Clinicians to ensure high quality, cost efficient, and timely delivery of clinical programs.
They will work with the CD&;O Clinical Group Leader to ensure appropriate resourcing of studies and other clinical projects including submissions. They will work with the Clinical Group Leader and relevant members of the study team to develop direct reports objectives, track progress and receive feedback on a regular basis. Depending on the TA, the TA Clinician Lead will provide line management of 6-10 TA Clinicians,
They will ensure that Clinicians within their group are well trained and compliant with requirements and regulations. They will develop the existing clinical staff and recruit additional clinical staff where needed. The TA Clinician Lead will be responsible for ensuring appropriate study design, protocol development and protocol clinical and medical oversight of the studies within the assigned group according to the relevant SOPs for clinical development responsibilities.
In collaboration and under the direction of the CD&;O Clinical Group Leader, they will provide day to day oversight to ensure the progress of clinical studies in accordance with agreed clinical development plans and OpCo endorsed timelines. They will mentor and coach TA Clinicians on best practices and build the clinical expertise in their group.
The TA Clinician Lead is accountable for the medical &; scientific integrity of the studies within their assigned portfolio and the well-being of the patients enrolled.
They are responsible for effective medical/scientific oversight of studies (in partnership with TA MD Clinicians, Clinical Scientists and Clinical Operations team members) and supports appropriate interpretation, communication and editing of clinical trial data including high quality regulatory submissions and product defense activities. The TA Clinician Lead safeguards compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues.
Through their leadership of a group of clinicians, the TA Clinician Lead also supports the Global Clinical Lead in the Clinical Development strategy and supports the organization of expert panels and advisory board meetings to provide input into clinical plans, study design or data analysis.
• Manage Study Clinicians to ensure high quality, cost efficient, and timely delivery of clinical programs.
• Work with the CD&;O Clinical Group Leader to ensure appropriate resourcing of studies and other clinical projects including submissions.
• Mentor and coach TA Clinicians on best practices and build the clinical expertise in their group.
• Oversees and supports development of study outline and/or key protocol elements and proactively ensures efficient protocols that minimize the likelihood of amendments in a Therapeutic Area
• At the asset level, may assist the Global Clinical Lead in the Clinical Development strategy and support technical review of licensing opportunities
• Supports establishment of Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes
• Oversees review and approval of Case Report Forms (CRFs) and Informed Consent Documents (ICDs), and selection and implementation of Patient Reported Outcomes (PROs)
• Oversees review and approval of Integrated Quality Management Plan (IQMP) and Risk Management, Safety Review and Data Review Plans
• Oversees review and approval of country selection, site selection criteria, and protocol specific training
• Oversee the integrity of clinical &; scientific aspects during clinical study conduct, analysis and reporting.
• Consistent with the Safety Review Plan, oversees regular review of individual subject safety data and cumulative safety data with the Safety Lead
• For all studies, ensures clinical safety reviews are performed in consultation with the designated Medical Monitor
• Oversees identification of quality issues and review with Pfizer clinical/operations study team members so corrective actions may be instituted.
• Responsible to oversee clinical and scientific validity of study report, especially conclusions regarding efficacy and safety
• Responsible to oversee disclosure of appropriate safety and efficacy data and conclusions and contributions to primary publication of clinical trial results
• Oversees review and management of protocol deviations and approval of protocol amendments
• Ensures that clinical documents are updated and current in accordance with protocol changes or issues arising in the study
• Assist responsible colleagues with the development of the Investigator Brochure (IB), key safety documents, responses to regulatory queries and audit/inspection findings, Clinical Trial Applications (CTAs), and submission documents by providing relevant clinical support.
• Create career development plans with their report and finalize after discussion with Clinical Group Leader (CGL).
• Justify and recommend business-related travel for reports to the CGL for their approval
• Provide medical monitoring coverage when appropriate.
• M.D, or D.O. required. Postgraduate training/certification /fellowship in a medical specialty . Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.). Post-graduate training in biomedical sciences or one of the disciplines related to drug development
• At least 10 years of experience in conduct and execution of clinical trials, including recruitment, investigator performance, investigative site relations
• Previous leadership / management experience and training
• Knowledge and experience in Good Clinical Practices
• Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval)
• Practical experience in clinical trial strategies, methods and processes
• Proven track record of design, oversight and interpretation of clinical studies
• Proven track record of proactive management of regulatory issues related to protocols and programs, including comprehensive experience of interactions with regulatory authorities
• Proven ability to get results in a matrixed management environment.
• Demonstrated ability to design, initiate and conduct clinical studies in industry, academic, or research clinic setting
• Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data
• Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents
• Collaborative problem solving (handles conflict constructively)
• Creativity and/or ability to put innovative approaches into practice in clinical development
• Able to discuss investigator performance issues, coach and/or mentor clinical investigative site staff to achieve operational and recruitment goals and quality standards
• Able to place innovative approaches into action that focus on trial execution and site performance