Clinical Scientist (Senior Manager)
The Clinician, Clinical Scientist (CS) will provide medical and scientific study and project support for multiple, global, Phase 1-4 vaccine clinical studies in a clinical program. They are responsible for working collaboratively with the Clinical Lead Physician and Lead Study Clinician Physicians and will develop study strategies in support of the clinical plans. The CS support includes multiple tasks within the categories of: 1) protocol and study design, strategy, and training, 2) data review and interpretation, 3) study and/or program scientific and integrity oversight, 4) safety review and communication, 5) regulatory document, study report and publication preparation and review, and 6) clinical study implementation oversight, with a critical focus on consistency, quality, data integrity, safety, and alignment with company values. The CS may be assigned to lead implementation of program level activities identified by the Lead Clinical Scientist and Clinical Lead Physician as needed.
The Clinical Scientist is responsible for bringing together clinical, scientific and technical disciplines to ensure high quality protocol development, study execution and data interpretation. They will be responsible for clinical sciences deliverables on one or more interventional clinical trials, with the opportunity to work across multiple Therapeutic Areas within Global Product Development (GPD).
The Clinical Scientist is a key member of the study team and partners closely with the TA clinician and clinical operations team members, applying technical and scientific excellence to support the development and execution of clinical trials to meet the needs of internal and external customers.
Specific clinical scientist responsibilities impact key elements of the study lifecycle including protocol and ICD development, safety and quality data review, patient narratives and Clinical Study Report (CSR) development. ROLE RESPONSIBILITIES
- Provides scientific expertise to produce clinical study protocol
- Drives and obtains protocol content and quality review
- Independently writes/designs protocol outlines, protocols, and amendments of moderate complexity in collaboration with the TA Clinician, Global Clinical Lead, Clinical Operations, and other relevant groups
- Ensures study registration forms are complete and protocol amendment forms are updated
- Ensures appropriate CRF design, creates ICDs, and is responsible for the selection and implementation of PROs
- Partners with data management to develop data review plan for review of data.
- Responsible for establishing and management of Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes
- Reviews patient level and cumulative data per the data review plan across a study and coordinates with TA Clinician for study level review.
- Reviews protocol deviations.
- Reviews safety data, SAE reports, TME's, DME's and ensures clinical documents (eg ICD) are updated as required.
- Tracks and reconciles serious adverse events (SAEs) across a study and reports SAEs during Safety Review Team meetings.
- Collaborates with TA Clinician to provide medical/scientific guidance during the execution of the study.
- Ensures TMF compliance for clinical sciences study level TMF documents.
- Answers specific site protocol questions as needed and may provide medical issue resolution if medically qualified.
- Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, and for Pfizer site facing roles and vendor / CRO staff.
- Identifies scientific quality issues to discuss with clinicians and operations study team members so that corrective actions may be instituted.
- Escalates protocol-related issues requiring complex medical expertise to the TA Clinician.
- Escalates operational issues to the appropriate operations study team member.
- Provides scientific input to and review of CSRs including writing of narratives.
- At the asset level, assists the Global Clinical Lead and TA Clinician in the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR, medical narratives).
- May support and contribute to various sections of regulatory documents (Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses).
- Required: BA/BS or equivalent qualification.
- Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications. Postgraduatetraining/certification/ fellowship in a clinical / scientific discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).
- Knowledge and experience in Good Clinical Practices
- Experience in execution of clinical trials, including data review and investigative site relations
- Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval)
- Practical experience in clinical trial strategies, methods and processes
- Track record of design, oversight and interpretation of clinical studies
- Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data
- Proven ability to get results in a matrixed management environment
- Extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field
- Demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents
- Independently author clinical protocols and other clinical study documents
- Applies knowledge of internal/external business challenges to facilitate process improvements
- Ability to work independently with minimal supervision
- Working knowledge of statistics, data analysis, and data interpretation
- Able to place innovative approaches into action that focus on trial execution and site performance
- Collaborative problem solving (handles conflict constructively)
- Able to coach and/or mentor other clinical scientists
All applicants must have the relevant authorisation to live and work in the UK / USA as applicable.
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.Relocation support availableSunshine 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.