Pfizer Clinical Scientist (Director) in San Diego, California

This role can be remote based or at one of our Pfizer R&D locations:

Groton CT, NYC, Collegeville PA, La Jolla CA.

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.

• Provides scientific expertise to produce clinical study protocol

o Drives and obtains protocol content and quality review

o 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

o 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.

• May perform and coordinate clinical sciences deliverables across studies at the program level.

• 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.

o Escalates protocol-related issues requiring complex medical expertise to the TA Clinician.

o 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).

• Acts as a mentor to colleagues in core clinical sciences activities.

• Identifies, significantly contributes to, or leads continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.

Education

• Required: BA/BS or equivalent qualification.

• Preferred: Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications. Postgraduate

training/certification/ fellowship in a clinical / scientific discipline or in drug development.

Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).

Experience

• 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

Capabilities/Skills

• 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 scientistsA career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.