Associate Director, Study Clinician (Non-MD), Early Clinical Development - Oncology
The overall role of the Associate Director, Early Clinical Development (ECD) Oncology Clinician (non-MD position) is to work collaboratively with the Global Clinical Lead (and members of the development team) to establish, lead, coordinate, and execute the early oncology clinical development plan(s) for one or more novel biological or small molecule therapies, spanning first in human (FIH), proof of mechanism (POM), early signals of efficacy (ESOE) and proof of concept (POC) studies.
The Associate Director will also be mentored/obtain guidance from a more senior study clinician. Depending on experience, 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 timelines.
The ECD Oncology Clinician will work with other functional disciplines (e.g. Clinical Operations, Biostatistics/Data Management, Clinical Pharmacology, Translational Oncology, and Biomarkers) to ensure the full scope and remit of EODCR is represented as needed within clinical study teams.
Primary responsibilities in supporting the GCL in the execution of the clinical development strategy and plan for the assigned molecule(s)/indications(s).
Depending on experience, may lead the preparation of clinical protocol and may lead or support other critical documents, e.g., protocol amendments, investigator brochure, and regulatory documents.
Together with Clinical Operations, is responsible for timely execution of all FIH programs through proof-of concept and delivering on innovative clinical study designs, high quality trial execution with Oncology Research Development (ORD), safety assessment and interpretation of clinical study results.
Conducts data review, analysis, and interpretation of clinical trials data together with the GCL, Clinical Safety, and Biostatistics.
In accordance with the Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the Safety Risk Lead (or their delegate) and the GCL.
May support the transition of early development clinical programs into late stage development, as appropriate.
In conjunction with members of the development team, may prepare presentations regarding strategy and/or data, and may assist with authoring clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
Supports and assists in the development of publications, abstracts, and presentations.
May interface with safety sciences, statistics, PK/PD, regulatory, outcomes research, development operations, other members of the extended project team(s), internal governance, external experts and regulators in such a way as to foster a transparent environment that encourages strong partnerships and mutual trust.
Supports the GCL and senior study clinician in developing effective collaborations with project leaders and project team members.
Partners with Translational Oncology and Biomarkers as needed to ensure that biomarker plans to help determine early signs of efficacy and proof of concept, patient stratification, etc. are enabled.
In conjunction with the GCL and senior study clinician, may 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.
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.
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.
Demonstrated experience with GCP and (the ability to apply Pfizer policies and SOPs).
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.
PhD/PharmD and 4+ years; MA/MBA/MS and 7+ years; or BA/BS/BSN and 9+ years of experience in clinical development. Three of these years should be in a clinician type role with a proven track record executing oncology development programs to completion or targeted milestone.
Data listing review experience.
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
Ability to perform complex data analysis
NON-STANDARD WORK SCHEDULE OR TRAVEL REQUIREMENTS
OTHER JOB DETAIL
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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