Director, Clinical Development Scientist (Non-MD)

Pfizer • San Diego, PA

1d • Hybrid

About The Position

The Clinical Development Scientist (Director) provides scientific oversight for clinical trials in Internal Medicine, ensuring data integrity and quality, and holds direct responsibility for clinical deliverables for one or more studies. The role may also manage, supervise, and mentor other colleagues. It partners with study teams, development leaders, investigators, sites, committees, and internal and external stakeholders across the clinical development lifecycle, from protocol design and study start-up through conduct, close-out, reporting, and regulatory activities.

This is a hybrid role requiring the employee to live within commuting distance and work on-site an average of 2.5 days per week. Global travel may be required. The annual base salary range is $176,600–$294,300 in the United States, excluding Tampa, Florida and locations outside the United States. The role is eligible for Pfizer’s Global Performance Plan, with a 20% bonus target, and a share-based long-term incentive program. Relocation assistance may be available based on business needs and eligibility. Candidates must have permanent U.S. work authorization; U.S. work visa sponsorship is not available.

Requirements

• A science degree (PhD, PharmD, or equivalent) and at least 5 years of Clinical Research experience in a similar biopharmaceutical industry role; or an MA/MS and at least 7 years; or a BA/BS and at least 8 years.
• Clinical, administrative, and project management capabilities, with effective verbal and written communication skills.
• Ability to set priorities and manage cross-functional teams and complex projects to deliver milestones according to budgets and priorities, and to define and manage resource requirements.
• Ability to lead, mentor or coach, delegate to, and oversee others, develop their skills, and support their progression toward autonomy.
• Ability to influence and collaborate with peers and guide colleagues’ work to achieve outcomes and business impact.
• Ability to resolve conflicts equitably, foster open dialogue, negotiate agreements, escalate issues when appropriate, and take responsibility for decisions.
• Ability to take personal responsibility for delivery of results and maintain perspective and poise amid uncertainty and organizational change.
• Permanent work authorization in the United States; 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 demonstrated through publications, posters, abstracts, or presentations.
• Extensive knowledge of clinical development, global and regional regulations, and ICH/GCP.
• Experience launching, managing, and training clinical development teams.
• A track record of achievement in pharmaceutical development and ability to coordinate and execute clinical development across 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.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and productivity; curiosity about their potential and understanding of responsible AI practices, including risk management and ethical use.
• A breadth of diverse leadership experience and capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing and guiding colleagues’ work.

Responsibilities

• Independently lead clinical execution of one or more studies and potentially be accountable for program-level clinical deliverables.
• Provide input 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 participate in protocol-related KOL and Health Authority interactions as appropriate.
• Ensure development of Study Informed Consent Documents and responses to requests from external stakeholders, including Health Authorities and Independent Ethics Committees.
• Provide clinical guidance on the Statistical Analysis Plan and Tables, Listings, and Figures.
• Guide development of clinical data collection strategy, instruments, and data review plans; set the clinical data review strategy; lead review of emerging data and trends; review and query data; present data to stakeholders; support site-facing colleagues with data issue resolution; and ensure clinical queries are addressed for database lock.
• Guide development of the Safety Review Plan and Safety Narrative Plan; review safety data; ensure clinical documents reflect 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 follow 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, data provision and presentation, and documentation and dissemination of recommendations.
• Develop site selection criteria, provide clinical input into 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 clinical protocol questions; manage development, delivery, documentation, and curation of clinical responses.
• Establish protocol deviation sub-categories; ensure deviations found during clinical data review are reported and appropriately managed and reconciled; and lead review of deviation trends.
• Ensure TMF compliance for clinical documents.
• Provide clinical input to and review the Clinical Study Report.
• Ensure disclosure of safety and efficacy data and trial conclusions; potentially contribute to publications.
• Support 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 improve clinical trial execution.
• Potentially manage clinical colleagues or contingent workers and 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 20% bonus target.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs and eligibility.

What This Job Offers

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