Manager, Clinician, Early Clinical Development
The overall role of the Early Clinical Development (ECD) Clinician is to support the execution of one or more studies for small molecule and novel biological therapies from first in human (FIH) through proof of concept (PoC) studies, including proof of mechanism (PoM) and early signals of efficacy (ESoE) studies in a given therapeutic area. The primary therapeutic areas for this position are Internal Medicine, Inflammation and Immunology, and Rare Diseases.
The ECD Clinician will participate as an individual contributor on clinical study teams to meet enrollment and study delivery timelines. The ECD Clinician will work with other functional disciples as needed (e.g. Research Unit clinicians, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).
The individual will be involved with clinical drug development activities from FIH through PoC and will be a key member of clinical sub team(s) to ensure collaboration and seamless connectivity.
- Responsibility to assist/lead execution of simple to moderately complex clinical studies; on more complex studies may support a lead clinician by taking responsibility for a portion of the overall clinical team’s deliverables.
- Supports execution for post-FIH programs through PoM and PoC and able to operate independently on project teams, although, may need instruction on more complex or unusual study challenges and/or tasks.
- Serve as technical support for clinical issues raised by internal and external collaborators, investigators, consultants and contractors.
- Attend select clinical sub team(s) meetings from FIH/PoM/ESoE through PoC trial completion to support development implementation and contribution to development milestones, e.g., start-up and delivery of ESoE and PoC trials.
- Support or lead preparation or review of study-related documents, including but not limited to clinical protocol, study training documents, and regulatory documents.
- Lead clinician data review efforts; on more complex studies may work with lead clinician to collect and collate safety data for safety review meetings.
- Collaborate with the study team to maintain open communications and ensure successful study completion.
- Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and therapeutics areas.
- Accountable to multiple project/core study teams and clinical sub-teams and manages his/her own time to support the start-up, conduct, and close-out of individual clinical trial plans and processes.
- 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 and apply knowledge gained within the Clinical Sciences group by way of process improvement and learning and serve as SOP subject matter experts.
- Develop expertise navigating Pfizer compliance systems, registries (e.g. GDMS, pTMF, Clinical Trial Registries, etc.) and other study systems related to study start-up activities (e.g., IQMP, etc., and apply lessons learned within the Clinical Sciences group.
- Support and assist in the development of publications, abstracts, and presentations, as needed,
- While generally not serve in an official manager role, may review the work of others within the group or serve in a mentoring role.
- Requires a minimum of a bachelor’s degree in science or related science with at least 3-5 years’ clinical study experience OR MS degree and 2 years’ clinical study experience; clinician-type role or clinical operations-type role with a proven track record executing clinical studies preferred.
- Comprehensive knowledge of GCP and ICH guidelines.
- Good understanding of the pharmaceutical/biopharmaceutical environment and drug development.
- Strong interpersonal skills and team player with demonstrated ability to achieve work within ECD Clinical Sciences.
- Project management skills preferred.
- Strong organizational skills and ability to prioritize work a must.
- Proficiency in MS Office: Word, PowerPoint, and Excel.
Other Job Details:
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus