Clinical Research Clinician, Associate Director

Pfizer • New Haven, CT

20h • Onsite

About The Position

The Clinical Research Clinician acts as an Investigator and/or Principal Investigator for clinical trials conducted in the Pfizer Clinical Research Unit (PCRU). The role is accountable for oversight of the clinical and medical aspects of study conduct, including participant safety, medical governance, and the scientific integrity of assigned studies. The clinician works independently, consults with clinic physicians as needed, and contributes to continuous 24/7 medical coverage of study participants.

As an Investigator, the clinician oversees assigned studies, coordinates with relevant Pfizer sites, supports PCRU clinical operations, and contributes to study planning, execution, and data review. Work includes reviewing laboratory data, performing physical assessments, obtaining medical histories, evaluating participant eligibility, reviewing and correcting study data, and supporting informed consent activities.

As a Principal Investigator, the clinician is responsible for execution of allocated clinical trials and facilitates 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, study reports and other documents, and review of source data and safety information. The role also ensures project timelines and quality standards are met.

The clinician develops expertise in study management, ICH-Good Clinical Practice, Pfizer procedures, clinical pharmacology, and/or biomarker methodology. The position includes collaboration with PCRU staff, hospitals, and Pfizer colleagues; staff training and mentoring; regular on-call duties; and, after relevant Phase 1 experience, representation of the PCRU and Pfizer in internal initiatives and external scientific settings.

Requirements

• Advanced practitioner degree (APRN) required.
• Connecticut license to practice medicine within the state-defined scope of practice, or clear ability to obtain a Connecticut license.
• BLS certification required.
• At least 2 years of clinical experience.
• Excellent interpersonal skills.
• Detail-oriented, with the ability to work in a fast-paced environment.
• Demonstrated leadership capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing and guiding colleagues’ work to achieve 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.

Responsibilities

• Serve as an Investigator and/or Principal Investigator for clinical trials conducted in the PCRU.
• Maintain accountability for the medico-legal and scientific integrity, participant safety, and medical governance of assigned studies.
• Liaise with Pfizer sites regarding study design, conduct, and progression.
• Support medical and clinical oversight of PCRU functions and work.
• Participate in planning, execution, and data review for allocated studies.
• Work with clinical research personnel to review laboratory data, perform physical assessments, obtain medical histories, and evaluate participant inclusion and exclusion criteria.
• Review, correct, update, and approve study data, particularly adverse events and concomitant medications.
• Support development of informed consent documents and assist with obtaining participant consent.
• Assume responsibility for execution of allocated clinical trials as a Principal Investigator.
• Facilitate 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; follow up on abnormal trends as appropriate.
• Review concomitant medications and individual adverse event reports for accuracy and clinical importance, and assess their relationship to study drug, severity, and seriousness.
• Meet established timelines and clinical work quality standards.
• Develop knowledge of study management, ICH-Good Clinical Practice, Pfizer SOPs, work instructions, and guidance, and share clinical trial knowledge with less experienced staff.
• Liaise with university hospitals and develop productive relationships with hospital, PCRU, and Pfizer colleagues.
• Attend appropriate training, meetings, and conferences to develop familiarity with pharmaceutical medicine.
• Contribute to PCRU teamwork and perform regular on-call or duty tasks to maintain continuous clinical coverage.
• After gaining relevant Phase 1 clinical research experience, represent the PCRU in company-wide initiatives and Pfizer in external settings, and develop and share expertise in clinical pharmacology and/or biomarker methodology.
• Contribute as an expert clinician in Phase 1 clinical research and participate in or contribute to global clinical research committees.
• Participate in relevant clinical research, pharmaceutical medicine, and pharmacology training.
• Assist with or serve as a preceptor for less experienced PCRU staff and contractors.
• Develop knowledge to support compliance with Pfizer standards, ethical standards, ICH, regulatory and legal requirements, and applicable health and safety and other 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.
• 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 assistance may be available based on business needs and/or eligibility.

What This Job Offers

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