Director, Clinical Development Scientist (Non-MD)

About the role

The Clinical Development Scientist (Director) provides scientific oversight, ensures data integrity, and maintains quality for clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies. This role may also include managing, supervising, and mentoring others.

Responsibilities

• Independently leads clinical execution of one or more studies; may be accountable for program-level clinical deliverables.
• Provides input to protocol design; leads development of the protocol, including amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Represents the study team in internal protocol review governance submissions; partners with the Global Development Lead on study and disease area strategy; may participate in protocol-related KOL and Health Authority interactions.
• Ensures development of Study Informed Consent Documents and responses to external stakeholder requests (e.g., Health Authority and Independent Ethics Committee).
• Provides clinical guidance for the Statistical Analysis Plan and Tables, Listings, and Figures.
• Guides the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP; sets the clinical data review strategy and leads review of emerging clinical data and trends.
• Reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues to resolve data issues and ensures clinical queries are addressed for database lock.
• Provides clinical guidance for the Safety Review Plan and Safety Narrative Plan; reviews safety data and updates clinical documents in response to emerging safety profiles.
• Tracks and reconciles Serious Adverse Events; leads clinical safety discussions during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives.
• Provides clinical guidance for the Risk Management Plan; ensures clinical activities align with the approved Plan and partners with stakeholders to develop and implement risk mitigations.
• Establishes and manages External Data Monitoring Committees and Adjudication Committees, including chartering, contracting, data provision, and dissemination of Committee recommendations.
• Develops site selection criteria, provides clinical input for site selection, and ensures protocol training is delivered to site-facing colleagues.
• Participates in investigator meeting planning; develops and delivers protocol training and ongoing training in response to amendments, data issues, or quality events.
• Serves as the primary clinical point of contact for investigators and study teams regarding protocol-related questions; manages clinical response development, delivery, documentation, and curation (e.g., FAQs).
• Ensures protocol deviation sub-categories are established; manages and reconciles protocol deviations identified during clinical data review.
• Ensures TMF compliance for clinical documents.
• Provides clinical input and review of the Clinical Study Report.
• Ensures disclosure of safety and efficacy data and trial conclusions; may contribute to publications.
• Provides clinical support for audits and inspections, including responding to and addressing findings.
• May contribute to clinical sections of regulatory filings (e.g., Briefing Documents, Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, responses to Health Authority requests).
• Contributes to continuous improvement and process enhancement activities to maximize clinical trial execution effectiveness.
• May have managerial responsibility for clinical colleagues or contingent workers; may supervise, mentor, or develop others.

Qualifications

Basic Qualifications

• Science degree (PhD, PharmD, or equivalent) with at least 5 years, or MA/MS with at least 7 years, or BA/BS with at least 8 years of Clinical Research experience in a similar role in the biopharmaceutical industry.

Preferred Qualifications

• Cardiometabolic disease experience (e.g., obesity, diabetes, endocrinology).
• Clinical research experience in the biopharmaceutical industry in study design, start-up, conduct, and close-out, including regulatory submissions and inspections.
• Scientific productivity via publications, posters, abstracts, and/or presentations.
• Extensive knowledge of clinical development, global and regional regulations, and ICH/GCP.
• Strong clinical, administrative, and project management capabilities; effective verbal and written communication skills.
• Experience launching, managing, and training clinical development teams.
• Track record of achievement in pharmaceutical development; ability to coordinate and execute clinical development during design, start-up, conduct, close-out, and reporting.
• Understanding of complexities and recent developments in principal disease areas; competence in discussing scientific and regulatory aspects of drug development.
• Ability to set priorities, manage cross-functional teams, and deliver milestones according to budgets; defines and manages resource requirements.
• Effective leadership skills; ability to mentor, coach, delegate, and oversee others; develops others’ skills and fosters autonomy.
• Conflict resolution skills; fosters open dialogue, negotiates agreements, and escalates issues when appropriate.
• Builds strong team morale and spirit; shares success and defines success in terms of the whole team.
• Takes personal responsibility for delivery of results.
• Demonstrates perspective and poise in uncertainty and organizational change.
• Breadth of diverse leadership experiences, including influencing peers, developing and coaching others, and guiding colleagues to achieve meaningful outcomes and business impact.

Schedule

This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week. Global travel may be required.

Pay

The annual base salary for this position ranges from $176,600.00 to $294,300.00. This position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in the share-based long-term incentive program.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, prescription drug, dental, and vision coverage.
• Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to work in the U.S. by any employer. U.S. work visa sponsorship is not available for this role now or in the future.