The TA Clinician MD 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. The TA Clinician will also be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol.
In addition to study specific activities, the TA Clinician MD 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 UpdateReports, Periodic Benefit-Risk EvaluationReports).
The Therapeutic Area (TA) Clinician, MD is accountable for the medical & scientific integrity of the study and the well-being of the patients enrolled for a particular TA. 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.
S/he is responsible for effective medical/scientific oversight of studies (in partnership with TA Clinicians, Clinical Scientists and Clinical Operations team members) and supports appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). The TA Clinician MD safeguards compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues.
Provides medical input to develop study outline and/or key protocol elements and proactively ensures efficient protocols that minimize the likelihood of amendments in a Therapeutic Area.
- Serves as the primary contact with external investigators and internal study team for questions relating to clinical / medical aspects of protocol
- At the asset level, provides medical input to assist the Global Clinical Lead in the Clinical Development strategy and supports 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, and is accountable for the selection and implementation of PROs
- Provides input for the design of the Statistical Analysis Plan (SAP) and the Clinical Data output
- Reviews and approves IQMP and Risk Management, Safety Review and Data Review Plans.
- Reviews and approves country selection, develops site selection criteria and ensures protocol specific training
- Approves investigator meeting plans.
- Ensures the integrity of medical & scientific aspects during clinical study execution, analysis and reporting.
- Consistent with Safety Review Plan, performs and documents regular medical review of individual subject safety data and cumulative safety data with the safety risk lead
- Identify quality issues and discuss 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 (Clinical Project Manager, Study Manager)
- Responsible for clinical and scientific validity of study report, 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 (e.g. site visits if specific medical expertise is required to further investigate or remediate findings)
- Reviews and manages protocol deviation and approves protocol amendments
- Ensures that clinical documents are updated and current in accordance with protocol changes or issues arising in the study
- Attending and representing Clinical Development & Operations at governance meetings (including co-development studies)
- Supports and contributes to various sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, and Periodic Safety UpdateReports and Regulatory authority responses)
- Assist responsible colleagues with the development of the IB, key safety documents, responses to regulatory queries and audit/inspection findings, CTAs, and submission documents by providing relevant clinical support.
Required: M.D. or equivalent medical qualification.
Preferred: Postgraduate training/certification /fellowship in a medical discipline or in drug development. Oncology or Hematology experience strongly preferred.
Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).
- 5 or more years experience providing medical advice in a clinical research setting, including in academia, as an investigator, at a pharmaceutical company or CRO
- 1 year of post internshipexperience in medical care of patients
- Proven track record of being a successful medical monitor at the study level or program level
- Has demonstrated knowledge of designing and delivering clinical program(s), to produce both timely and good quality data, including knowledge (and appropriate use) of innovative clinical trial principles and methodologies (e.g. Enhanced Clinical Trial Design (ECTD)/ Enhanced Quantitative Drug Development (EQDD), etc.)
- Regulatory awareness – proven track record of proactive management of regulatory issues related to protocols and programs, including comprehensiveexperienceof interactions with regulatory authorities
- Proven ability to get results in a matrixed management environment
- Demonstrated potential or 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