Pfizer
Oncology Early Stage Clinical Scientist Senior Manager)--Two (2) Positions
Pfizer, Collegeville, Pennsylvania, United States, 19426
Oncology Clinical Development Lead
You will work collaboratively with the Global Development Lead (GDL) (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 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 subteams to meet enrollment and study delivery timelines. 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. Key Position Responsibilities Support the GDL in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(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. Collaborate with Clinical Operations to ensure timely execution of First-in-Human (FIH) programs through proof-of-concept, delivering innovative clinical study designs and high-quality trial execution with Oncology Research Development (ORD). Participate in safety assessment and interpretation of clinical study results. 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). Support 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. Support the GDL and senior clinical scientist, in developing effective collaborations with project leaders and project team members. Partner 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 Lead Clinical Scientist, 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. While generally not serve in an official manager role, may review the work of others within the group or serve in a mentoring role. Perform other duties as assigned related to clinical programs Minimum Qualifications / Skills 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 Preferred Qualification Experience applying Pfizer policies and SOPs 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% Travel Work Location Assignment: Hybrid
You will work collaboratively with the Global Development Lead (GDL) (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 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 subteams to meet enrollment and study delivery timelines. 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. Key Position Responsibilities Support the GDL in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(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. Collaborate with Clinical Operations to ensure timely execution of First-in-Human (FIH) programs through proof-of-concept, delivering innovative clinical study designs and high-quality trial execution with Oncology Research Development (ORD). Participate in safety assessment and interpretation of clinical study results. 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). Support 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. Support the GDL and senior clinical scientist, in developing effective collaborations with project leaders and project team members. Partner 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 Lead Clinical Scientist, 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. While generally not serve in an official manager role, may review the work of others within the group or serve in a mentoring role. Perform other duties as assigned related to clinical programs Minimum Qualifications / Skills 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 Preferred Qualification Experience applying Pfizer policies and SOPs 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% Travel Work Location Assignment: Hybrid