Clinician/Clinical Scientist, Associate Director

Role Summary

The overall role of the Early Clinical Research Clinician/Clinician Scientist Associate Director is to support the development and execution of multiple studies for small molecule and/or novel biological therapies, spanning from first in human (FIH), proof of mechanism (PoM), early signals of efficacy (ESoE) and proof of concept (PoC) studies in a given therapeutic area.

The Clinician/Clinical Scientist Associate Director may be mentored by a more senior Early Clinical Research Clinician. Depending on experience, the Clinician/Clinical Scientist Associate Director may lead the development of the clinical protocol and may participate as an individual contributor on clinical study teams and clinical subteams to meet enrollment and study delivery timelines. The Associate Director will work with other functional disciplines as needed (e.g. Clinical Operations, Global Clinical Leads/Medical Monitors, Biostatistics, Data Management, Clinical Pharmacology, and Digital Medicine).

The Clinician Associate Director may be a member of the clinical sub team(s) to ensure collaboration and seamless connectivity.

Responsibilities

• Scientific leadership and oversight of clinical studies, and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
• Lead preparation of study related documents, including but not limited to clinical protocol, informed consent document, and study training materials.
• May support preparation of other study related documents, including but not limited to clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
• Conducts data review, analysis and interpretation of clinical trials data together with the Global Clinical Lead, Clinical Safety, and Biostatistics/Data Management.
• Collaborate with the study team to maintain open transparent communications and ensure successful study completion.
• Develop expertise working with Pfizer clinical checklists and Standard Operating Procedures (SOPs) to ensure compliance with good clinical practice (GCP), regulatory agencies, Institutional Review Boards (IRBs), and Pfizer processes. Apply knowledge gained within the Internal Medicine Early Clinical Research group by way of process improvement.
• Develop expertise navigating Pfizer compliance systems, registries (e.g. GDMS, pTMF, Clinical Trial Registries, etc.) and other study systems related to the study (e.g., CORD, JReview, Signal Management etc.), and apply lessons learned within the Internal Medicine Early Clinical Research group.
• Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
• Sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of FIH/PoM/ESoE/PoC trials.
• Performs other duties as assigned related to clinical programs

Qualifications

• BA/BS/BSN with 4 years of clinical study experience OR MA/MBA/MS with 2 years of clinical study experience; two years of relevant experience in a clinician type role with a proven track record executing development programs to completion or targeted milestone preferred.
• Demonstrated experience in (and understanding of) drug development especially in Early Development; familiarity with related disciplines (biostatistics, regulatory, clinical pharmacology, pharmaceutical sciences)
• Must have proven scientific writing skills and good communication skills.
• Strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization including senior management
• Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.

Skills

• Leadership and collaborative skills across functional teams
• Clinical trial design, execution, and data interpretation
• Regulatory and GCP/compliance knowledge
• Scientific writing and communication

Education

• Not specified beyond degree requirements in Qualifications

Additional Requirements

• Travel may be required for investigator meetings US/EX; US for presenting protocol for research sites.
• Relocation support available
• Hybrid work location: live within commuting distance and on-site an average of 2.5 days per week.