Clinical Research Clinician, Associate Director

Pfizer • New Haven, CT

3d • $139,100 - $231,900 • Onsite

About The Position

The Clinical Research Clinician serves as an Investigator and/or Principal Investigator for clinical trials conducted in the Pfizer Clinical Research Unit (PCRU). The role is accountable for trial oversight across medical and clinical aspects of study conduct and operates independently to provide medical support, consulting with clinic physicians as needed. It provides continuous, 24/7 safety coverage for study participants and contributes to the medical and clinical oversight of PCRU operations.

As an Investigator, the clinician is accountable for the medico-legal and scientific integrity, participant safety, and medical governance of assigned studies. The role supports study planning, execution, data review, participant assessments and consent, and review of study data, adverse events, and concomitant medications.

As a Principal Investigator, the clinician is responsible for executing allocated trials and coordinating Phase I–IIa–IV studies, including early- and full-development clinical pharmacology studies. Responsibilities include contributing to protocol development and review, regulatory and IEC submissions, clinical and statistical reports, safety-data review, and ensuring project timelines and quality standards are met.

The role also develops expertise in study management, ICH-Good Clinical Practice, Pfizer procedures and guidance, and pharmaceutical medicine; supports and trains less-experienced staff; maintains productive relationships across the PCRU, hospitals, and Pfizer sites; and performs regular on-call duties. With relevant Phase 1 experience, the clinician may represent the PCRU and Pfizer in internal and external forums and contribute subject-matter expertise to global clinical research activities. The position is on premise and contributes to the on-call schedule for continuous unit coverage.

Requirements

• Advanced practitioner degree (APRN).
• Connecticut license to practice within the scope defined by the state, or clear ability to obtain a Connecticut license.
• BLS certification.
• At least 2 years of clinical experience.
• Excellent interpersonal skills.
• Detail-oriented, with the ability to work in a fast-paced environment.
• Ability to influence and collaborate with peers, develop and coach others, and oversee and guide colleagues’ work to achieve meaningful outcomes and business impact.
• Permanent work authorization in the United States; U.S. work visa sponsorship is not available.

Nice To Haves

• Knowledge of the FDA-regulated drug development process is an asset.
• Relevant experience in Phase 1 clinical research for additional responsibilities and expert representation.

Responsibilities

• Serve as Investigator and/or Principal Investigator for clinical trials conducted in the PCRU.
• Provide medical oversight and 24/7 safety coverage for study participants, including regular on-call/duty work.
• Maintain accountability for medico-legal and scientific integrity, participant safety, and medical governance of assigned studies.
• Liaise with Pfizer sites on the design, conduct, and progress of PCRU studies.
• Assist with medical and clinical oversight of PCRU functions and work.
• Participate in planning, execution, and data review for allocated studies.
• Review laboratory data, perform physical assessments, obtain medical histories, and evaluate participant inclusion and exclusion criteria.
• Review, correct, update, and approve study data, including coding adverse events and concomitant medications for accuracy and consistency.
• Support development of informed consent documents and assist with obtaining participant consent.
• Assume responsibility for execution of allocated clinical trials.
• Facilitate and coordinate Phase I–IIa–IV studies, including early- and full-development clinical pharmacology studies, protocol development and review, and regulatory and IEC submissions.
• Support preparation of clinical protocols, integrated clinical and statistical summary reports, and other requested documents.
• Review source data and safety-data listings, including adverse experiences, laboratory results, and vital signs; investigate abnormal trends with relevant clinical and project teams, sponsoring Pfizer sites, and regulatory agencies as appropriate.
• Review concomitant medications and individual adverse-event reports for accuracy and clinical importance, and characterize relationship to study drug, severity, and seriousness.
• Meet established timelines and required clinical-work quality standards.
• Develop knowledge of study management, ICH-Good Clinical Practice, and Pfizer SOPs, work instructions, and guidance.
• Share knowledge of clinical trial activities with less-experienced staff and assist or act as a preceptor in staff and contractor training.
• Liaise with university hospitals and develop productive working relationships with hospital, PCRU, and Pfizer-site colleagues.
• Attend appropriate training, meetings, and conferences and contribute positively to PCRU teamwork.
• Represent the PCRU in company-wide initiatives and Pfizer in external settings in areas of expertise, as appropriate after acquiring relevant experience.
• Develop, maintain, and share subject-matter expertise in Clinical Pharmacology and/or Biomarker Methodology.
• Act as a Phase 1 clinical research clinician expert for Pfizer research and development groups and contribute to global clinical research committees.
• Develop knowledge to support compliance with Pfizer standards, ethical standards, ICH, regulatory and legal requirements, and applicable health and safety legislation.

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.
• Participation 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 assistance may be available based on business needs and/or eligibility.

What This Job Offers

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