Director, Oncology Early Stage Clinical Scientist

ROLE SUMMARY:

The overall role of the Oncology Early Stage Clinical Scientist (ESCS) 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 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.

ROLE RESPONSIBILITIES:

• 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 POD 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.

• The Early Stage Clinical Scientist 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 Early Stage Clinical Scientist 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 Early Stage Clinical Scientist will work with other functional disciples to ensure the full scope and remit of OESD is represented as need within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).

• Performs other duties as assigned related to clinical programs.​

QUALIFICATIONS:

• 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 collaborativel