Director, Study Clinician - ECD Oncology
The overall role of the Early Clinical Development (ECD) Oncology Clinician is to lead and coordinate the development of multiple studies for novel biological and small molecule therapies for first in man (FIH), proof of mechanism (POM), early signals of efficacy (ESOE) and proof of concept (POC) studies in a given therapeutic areas: for this position the primary area will be early oncology studies.
The ECD Oncology Clinician 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
The ECD Oncology Clinician will lead the development of the clinical protocol and participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines. The ECD Oncology Clinician will work with other functional disciples to ensure the full scope and remit of ECD is represented as need within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).
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 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, IND, AR, CSR, 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.
Conducts data review, analysis and interpretation of clinical trials data together with the GCL, Clinical Safety, and Biostatistics.
Develop effective collaborations with key partners within Pfizer and external partners (KOLs, Business Partners, etc).
Develop effective collaborations with project leaders and projects team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine and development operations.
Partner with Translational Oncology and Biomarker 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.
Performs other duties as assigned related to clinical programs.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PhD/PharmD and 5+ years; MA/MBA/MS and 7+ years; BA/BS/BSN and 10+ years of experience in clinical development. 3-5 of these years should be in a clinician type role with a proven track record executing oncology development programs to completion or targeted milestone. Deep understanding of the biopharmaceutical environment and the drug development
Demonstrated experience in (and understanding of) oncology drug development especially in Early Development; familiarity with related disciplines (biostatistics, regulatory, pre-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
Data listing review experience a must
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
- Ability to perform mathematical calculations and ability to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Occasional Travel 5-10%
Other Job Details:
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
- Relocation support available