The overall role of the Early Clinical Development (ECD) Clinician is to lead and coordinate the development of multiple studies for novel biological and small molecule therapies for first in human (FIH), proof of mechanism (POM), early signal of efficacy (ESOE) and proof of concept (POC) studies in a given therapeutic area: e.g., Internal Medicine, Immunology and Inflammation, and Rare Diseases.
The ECD Clinician will participate as an individual contributor on clinical teams with Pfizer development operations to meet enrollment and study delivery timelines. The ECD Clinician will work with other functional disciples as needed (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).
The individual will be involved with clinical drug development activities from FIH through POC. They will be a key member of clinical subteams to ensure collaboration and seamless connectivity between ECD, Research Units and Global Product Development.
Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
• Supports execution for all post-FIH programs through proof-of concept
• Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
• Support and assist in the development of publications, abstracts, and presentations
• Sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials.
• Lead preparation of clinical protocol and lead or support other critical documents, including clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
• Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and therapeutic areas.
• Coordinate with other clinical research activities in ECD and greater World-Wide Research and Development (WRD) organization.
• Develop effective collaborations with key partners in Pfizer Research Units (RU) and Operations.
• Develop effective collaborations with project leaders and projects team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, precision medicine and development operations.
• Partner with Precision Medicine as needed to ensure that biomarker plans are enabled in all relevant therapeutic area programs to help determine early signs of efficacy and proof of concept, patient stratification, etc.
• Establish and support relationships with external experts, consultants, key opinion leaders, regulators and disease specific investigator networks to ensure implementation of latest clinical thinking and guidelines into clinical development plans and study designs, as well as management and recruitment of study, analysis, interpretation and presentation of results.
• Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues
• Requires PhD, PharmD, MSc, BSc
• Deep understanding of the biopharmaceutical environment and the drug development
• 5-8 years of relevant experience in drug development; 3-5 years of relevant experience in a clinician type role with a proven track record executing development programs to completion or targeted milestone
• 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
Other Job Details:
Additional Location Information: Cambridge, MA, Groton CT, Collegeville PA
Relocation Package – Yes
Eligible for Employee Referral Bonus – Yes
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EEO & Employment Eligibility
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