Clinical Development Scientist, Senior Manager

Pfizer • San Diego, CA

1d • $139,100 - $231,900 • Hybrid

About The Position

The Clinical Development Scientist (Senior Manager) provides scientific oversight, data integrity, and quality oversight for clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies. The role may also supervise and mentor colleagues. It provides clinical input across study design and execution, including protocols, analysis plans, data collection and review, safety oversight, risk management, committees, site activities, regulatory documentation, and study reporting.

The position works with study teams, Global Development Leads, medically qualified colleagues, investigators, sites, and external stakeholders. It supports clinical trial governance and strategy, data and safety review, protocol training, deviation management, Trial Master File compliance, audits and inspections, and disclosure of study results. The role may contribute to publications and regulatory filings and participate in process improvement activities.

This is a hybrid role requiring residence within commuting distance and an average of 2.5 days per week on-site. Global travel may be required. Relocation support or assistance may be available based on business needs and eligibility. Candidates must be authorized to work in the United States; U.S. work visa sponsorship is not available.

Requirements

• A science degree (PhD, PharmD, or equivalent) and at least 1 year of Clinical Research experience in a similar biopharmaceutical-industry role; or an MA/MS and at least 5 years; or a BA/BS and at least 6 years.
• Demonstrated leadership capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing and guiding colleagues’ work to achieve meaningful outcomes and business impact.
• Candidates must be authorized to be employed in the United States by any employer; permanent U.S. work authorization is required, and U.S. work visa sponsorship is unavailable.

Nice To Haves

• Cardiometabolic disease experience, such as obesity, diabetes, or endocrinology.
• Biopharmaceutical clinical research experience in study design, start-up, conduct, and close-out, including regulatory submissions and inspections.
• Scientific productivity demonstrated through publications, posters, abstracts, or presentations.
• Knowledge of clinical development, global and regional regulation, and ICH/GCP.
• Clinical and administrative capabilities, including effective verbal and written communication.
• A track record of achievement in pharmaceutical development and the ability to execute clinical development through design, start-up, conduct, close-out, and reporting.
• Understanding of complexities and recent developments in principal disease areas, with competence discussing scientific and regulatory aspects of drug development.
• Ability to set priorities and deliver milestones according to budgets and priorities.
• Ability to mentor and coach, delegate to, and oversee others, develop their skills, and help them progress toward autonomy.
• Ability to resolve conflicts equitably, foster open dialogue, negotiate agreements, escalate issues appropriately, and take responsibility for decisions.
• Ability to build team morale and belonging, share success, and define success in terms of the whole team.
• Personal accountability for delivering results and the ability to maintain perspective and poise amid uncertainty and organizational change.
• Experience using common AI tools, including generative tools such as ChatGPT or Microsoft Copilot, to support problem-solving and productivity.
• Curiosity about how AI tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Provide clinical support for one or more studies and potentially take accountability for program-level clinical deliverables.
• Contribute to protocol design and development, including amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Support internal protocol review governance submissions and interactions, and support the Global Development Lead in study and disease-area strategy.
• Participate in protocol-related key opinion leader and Health Authority interactions as needed.
• Develop Study Informed Consent Documents and responses to external stakeholder requests, such as requests from Health Authorities and Independent Ethics Committees.
• Provide clinical input to the Statistical Analysis Plan and Tables, Listings, and Figures.
• Help develop clinical data collection strategies, instruments, and data review plans; conduct clinical data review; present data when needed; support resolution of data issues; and ensure clinical queries are addressed for database lock.
• Contribute to Safety Review Plans and Safety Narrative Plans; review safety data; update clinical documents in response to emerging safety information; track and reconcile Serious Adverse Events; participate in Safety Review Team discussions with medically qualified individuals; and review safety narratives.
• Contribute to Risk Management Plans, conduct clinical activities consistent with approved plans, and work with stakeholders to develop and implement risk mitigations.
• Support the establishment and management of External Data Monitoring Committees and Adjudication Committees, including charters, contracting, data provision and presentation, and documentation and dissemination of recommendations.
• Contribute to site-selection criteria and site selection, and provide protocol training to site-facing colleagues as needed.
• Participate in investigator meeting planning and develop and deliver protocol training, including ongoing training in response to amendments, emerging data issues, or quality events.
• Serve as a clinical point of contact for investigators and study teams on protocol-related clinical questions as needed, and contribute to the development, delivery, documentation, and curation of clinical responses such as FAQs.
• Develop protocol deviation sub-categories as needed; ensure deviations identified during clinical data review are reported, managed, and reconciled; and potentially lead deviation trend reviews.
• Ensure Trial Master File compliance for clinical documents.
• Provide clinical input to and review the Clinical Study Report.
• Support disclosure of safety and efficacy data and trial conclusions, and potentially contribute to publications.
• Provide clinical support for audits and inspections, including responding to and addressing findings.
• Potentially contribute to clinical sections of regulatory filings, including briefing documents, Pediatric Investigational Plans, Investigator Brochures, IND/NDA Annual Reports, Periodic Safety Update Reports, and responses to Health Authority requests.
• Contribute to continuous improvement, process enhancement, and innovative approaches to clinical trial execution.
• Potentially supervise, mentor, or develop others.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility to participate in Pfizer’s Global Performance Plan, with a bonus target of 17.5% of base salary.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation support or assistance may be available, subject to business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior