Senior Manager, Oncology Early Stage Clinical Scientist (NonMD)
ROLE SUMMARY:
The Senior Manager, Oncology Early Stage Clinical Scientist will work collaboratively with the Global Development 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.
You 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 Oncology Early Stage Development (OESD) is represented as needed within clinical study teams.
You will also be mentored/obtain guidance from a more senior study clinician. Depending on experience, you may lead the development of the clinical protocol and may participate as an individual contributor on clinical study teams and clinical sub teams to meet enrollment and study delivery timelines.
ROLE RESPONSIBILITIES:
Primary responsibilities in supporting the GDL 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 leads or supports 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 GDL, 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 his/her delegate) and the GDL.
May support the transition 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 GDL and senior clinical scientist, 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 GDL 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
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.
QUALIFICATIONS:
PhD/PharmD and 2+ years experience in a clinical scientist type role
MA/MBA/MS and 5+ years clinical development experience including 2 years of experience in a clinical scientist type role with a proven track record executing oncology development programs to completion or targeted milestone
BA/BS/BSN and 7+ years of experience in clinical development including 2 years of experience in a clinical scientist type role with a proven track record executing oncology development programs to completion or targeted milestone
Experience in Oncology drug development especially in Early Development
Familiarity with related disciplines (Biostatistics, Regulatory, Pre-Clinical Pharmacology, Pharmaceutical Sciences)
Proven scientific writing skills and strong communication skills
Demonstrated experience with GCP and (the ability to apply Pfizer policies and SOPs)
Experience building consensus and driving change across all levels of the organization including senior management.
Data listing review experience
Experience working collaboratively in a fast-paced, team-based matrix environment as well as independently
Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform
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.
PHYSICAL/MENTAL REQUIREMENTS
Ability to perform complex data analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
5-10% domestic travel
Work Location Assignment: Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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