Director, Clinical Development Scientist (Non-MD)

Pfizer • San Diego, CA

1d • $176,600 - $294,300 • Hybrid

About The Position

The Clinical Development Scientist (Director) provides scientific oversight of clinical trials in Internal Medicine, ensuring data integrity and quality while directly owning clinical deliverables for one or more studies. The role may include program-level accountability and management, supervision, and mentoring of clinical colleagues or contingent workers.

The position leads clinical study execution and supports protocol development, data collection and review, safety oversight, risk management, committee operations, site selection and training, investigator communications, protocol deviation management, clinical study reporting, data disclosure, and audit and inspection support. It also partners with development and cross-functional teams on study strategy, emerging data, regulatory interactions, and process improvements. The role may contribute to regulatory filings and publications.

This is a hybrid position requiring the employee to live within commuting distance and work onsite an average of 2.5 days per week. Global travel may be required. The annual U.S. base salary range is $176,600 to $294,300. The role is eligible for a 20% target bonus under Pfizer’s Global Performance Plan and participation in a share-based long-term incentive program. Relocation assistance may be available depending on business needs and eligibility. Candidates must have permanent U.S. work authorization; visa sponsorship is unavailable.

Requirements

• A science degree (PhD, PharmD, or equivalent) with at least 5 years of clinical research experience in a similar biopharmaceutical industry role; or an MA/MS with at least 7 years; or a BA/BS with at least 8 years.
• Permanent work authorization in the United States; U.S. work visa sponsorship is not available.

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 through publications, posters, abstracts, and/or presentations.
• Extensive knowledge of clinical development, global and regional regulations, and ICH/GCP.
• Clinical, administrative, and project management capabilities, with effective verbal and written communication skills.
• Experience launching, managing, and training clinical development teams.
• A record of achievement in pharmaceutical development and the ability to coordinate and execute clinical development through design, start-up, conduct, close-out, and reporting.
• Understanding of complexities and recent developments in principal disease areas, and competence discussing scientific and regulatory aspects of drug development.
• Ability to set priorities, manage cross-functional teams and complex projects, deliver milestones according to budgets and priorities, and define and manage resource requirements.
• Effective leadership, including mentoring and coaching, delegation and oversight, and developing others toward autonomy.
• Ability to resolve conflicts equitably, foster open dialogue, assess situations quickly, negotiate agreements, escalate issues appropriately, and take responsibility for decisions.
• Ability to share successes, define success in terms of the whole team, build morale and team spirit, and create a sense of belonging.
• 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 technologies 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.
• Breadth of leadership experience, including influencing and collaborating with peers, developing and coaching others, and guiding colleagues to achieve meaningful outcomes and business impact.

Responsibilities

• Independently lead the clinical execution of one or more studies and potentially own program-level clinical deliverables.
• Contribute to protocol design and lead development of protocols, amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Represent the study team in internal protocol review governance submissions and interactions; partner with or support the Global Development Lead on study and disease-area strategy; and potentially participate in protocol-related KOL and Health Authority interactions.
• Oversee development of Study Informed Consent Documents and responses to requests from external stakeholders, including Health Authorities and Independent Ethics Committees.
• Provide clinical guidance for the Statistical Analysis Plan and Tables, Listings, and Figures.
• Guide clinical data collection strategy, instruments, and review plans; establish the clinical data review strategy; lead review of emerging clinical data and trends; review and query data; present data; support site-facing colleagues in resolving data issues; and ensure clinical queries are addressed for database lock.
• Guide development of the Safety Review Plan and Safety Narrative Plan; review safety data; update clinical documents in response to emerging safety information; track and reconcile Serious Adverse Events; lead clinical safety discussions at Safety Review Team meetings with medically qualified colleagues; and review safety narratives.
• Guide development of the Risk Management Plan, ensure clinical activities align with the approved plan, and work with stakeholders to develop and implement risk mitigations.
• Establish and manage External Data Monitoring Committees and Adjudication Committees, including chartering, contracting, providing and presenting data, and documenting and disseminating recommendations.
• Develop site selection criteria, provide clinical input on site selection, and ensure protocol training is delivered to site-facing colleagues.
• Participate in investigator meeting planning and develop and deliver protocol training, including ongoing training in response to amendments, emerging data issues, and quality events.
• Serve as the primary clinical contact for investigators and the study team on protocol-related clinical questions; manage development, delivery, documentation, and curation of clinical responses, such as FAQs.
• Establish protocol deviation sub-categories; ensure deviations identified during clinical data review are reported and appropriately managed and reconciled; and lead protocol deviation trend reviews.
• Ensure clinical documents comply with Trial Master File requirements.
• Provide clinical input to and review the Clinical Study Report.
• Ensure disclosure of safety and efficacy data and trial conclusions, and potentially contribute to publications.
• Support audits and inspections, including responding to and addressing findings.
• Potentially contribute to clinical sections of regulatory filings, such as 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 improve clinical trial execution.
• Potentially manage, supervise, mentor, or develop clinical colleagues or contingent workers.

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 for a 20% target bonus through the Global Performance Plan.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

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