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Immuno-Oncology, Asset/Team Leader
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Cambridge, Massachusetts |
About this job
Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Role Description
Reporting to the Immuno Oncology Asset Team Leader (IO ATL), this leadership position is accountable for driving the strategy, implementation and successful delivery of the Integrated Asset Plan for one or more of the immuno-oncology products or indication in the Pfizer Oncology portfolio. The Team Leader (TL) leads the global cross functional Asset team/s and is the single point of accountability for the seamless execution of project deliverables and decisions across an immuno oncology asset or assets in a timely, cost-effective and quality manner. The Asset Team includes colleagues from Clinical Development, Medical Affairs, Commercial Development, Global Health and Value, Regulatory, Finance, Statistics, Clinical Pharmacology, Translational Oncology, Pharmaceutical Sciences, Project Management and Development Operations. The IO TL will be responsible for informing and ensuring alignment of the asset strategy with key partners across the Pfizer Oncology Enterprise including but not limited to Pfizer Oncology, Worldwide Commercial Development (WWCD), Pfizer's Worldwide Research & Development (WWRD including Rinat) and Business Development (BD) Groups.
For products within the Pfizer Oncology immuno-oncology portfolio, the TL is responsible for overseeing programs/studies spanning from first-in-human (FIH, Phase I) studies to exploratory Phase IIa studies, to randomized Phase IIb studies to registration-enabling studies and post-approval life-cycle management through loss of exclusivity.
The TL is accountable for budget development and critical oversight and for recommending individual asset investment opportunities that will support investment prioritization in the context of the overall WWRD and Pfizer immuno oncology portfolio.
The TL will be responsible for continuous optimization and refinement of the Asset strategy. The A/TL will also be responsible for approval of program and/or project plans as well as changes to the programs that impact the approved budget.
The TL applies oncology drug development knowledge and experience to assure that the asset is managed in an efficient and rigorous manner as reflected in the design and conduct of studies with high likelihood of technical, regulatory and commercial success. The A/TL will be an experienced people leader and will be responsible for optimizing team alignment, governance and overall team health.
The TL will be a decisive leader who can apply cost effective, time efficient and high quality approaches to drug development.
Responsibilities
This position will be within the new integrated EDTO and IO Team, and report to the IO ATL
Current IO strategic priorities include:
* Creating and executing a clear, integrated development strategy for immunotherapy at Pfizer Oncology that will ultimately lead to regulatory approvals
* Working closely with leaders from Pfizer Oncology Development, WWCD, WRD (including Rinat) and BD to ensure delivery of a robust pipeline that builds Pfizer's competitive position as a leader in immuno-oncology
* Identifying, developing and implementing immuno-oncology asset and immuno-oncology combination regimens that have a strong mechanistic rationale, the potential to substantially improve upon the current standard of care, and support an aggressive clinical development plan
* Leading collaborations with world experts (including other companies where appropriate) in the field of immuno-oncology to ensure optimization of the Pfizer immunotherapy strategy and pipeline
* Working with Oncology Enterprise leadership across Pfizer to ensure alignment of appropriate technologies, capabilities, talent and resources to support the immuno-oncology portfolio
* Ensuring teams navigate programs toward rapid decisions
Specific Duties of the TL role:
* Leads and is responsible for directing a cross functional Asset Team(s)
* Accountable for developing and delivering the Integrated Asset Plan, and ensuring that the Integrated Asset Plan is consistent with Pfizer Oncology, WWRD (including Rinat) strategy and Immuno-oncology Strategy
* Coordinate with the Translational Oncology Lead on the Asset Team in the thoughtful integration of biomarker and companion diagnostic studies into the clinical development strategy for each asset
* Accountable for assuring that projects are managed cost-effectively per budget, and looks to de-risk the candidate and investments as early as practical
* Accountable for ensuring that the necessary resources are applied to the project team to support its success
* Assures for the quality of asset deliverables to external authorities
* Promotes a culture of innovation and collaboration within the cross-functional team(s) in order to bring forward creative, defensible development plans that maximize the potential of each asset
* Acts as point of contact and project representative to governance and other decision-making bodies, including information dissemination and the resolution of critical project issues
* Leverages line expertise to achieve the team goals
* Has an appropriate role representing and leading Pfizer Oncology in asset-based development partnerships and alliances
* Able to engage with Business Development and contribute to efforts to optimize pre and post-PoC immuno oncology portfolio though in-licensing, out-licensing, co-sponsorship, and other collaborative efforts
* Negotiates and influences key internal stakeholders
* Creates a motivated, committed and engaged project team
* Models and expects effective team behavior to achieve the project goals
Manages key interdivisional interfaces on project issues with line functions.
Qualifications
* Graduate with post-graduate training in biomedical sciences or one of the disciplines related to drug development
* Proven ability to function effectively across a complex matrix organization with multiple
stakeholders and constituents, with the ability and gravitas to align a team to work towards a singular goal
* Minimum of 8 years of relevant experience in the pharmaceutical, academic and/or medical research environments having successfully executed a major component of a development program. Significant Phase 1-3 clinical research experience with strong understanding of the elements of drug development programs and experience in their design and execution.
* An organized, independent, self-motivated individual with exceptional presentation, written, and oral communication skills
* Able to tailor presentations to the knowledge level of the audience to suit their needs and maximize understanding of the topic
* At least five years experience in Oncology Drug Development
* Proven track record of success in an Oncology and Drug Development Team environment
Prior Experience Preferred:
* Experience in clinical development of immune-therapeutics for oncology
* Demonstrated experience in successfully leading teams, running them effectively, efficiently and on target. Capable of recognizing when team interventions and escalations are required to enhance team effectiveness
* Significant experience leading early and late stage clinical development studies, programs and clinical operations
* Direct experience in preparation of regulatory submissions, presentation to regulatory advisory panels in support of registration of a new drug
* Knowledgeable of the commercial and environmental issues that drive drug development projects
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
Travel up to 10% of time to congresses and business meetings
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.
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Role Description
Reporting to the Immuno Oncology Asset Team Leader (IO ATL), this leadership position is accountable for driving the strategy, implementation and successful delivery of the Integrated Asset Plan for one or more of the immuno-oncology products or indication in the Pfizer Oncology portfolio. The Team Leader (TL) leads the global cross functional Asset team/s and is the single point of accountability for the seamless execution of project deliverables and decisions across an immuno oncology asset or assets in a timely, cost-effective and quality manner. The Asset Team includes colleagues from Clinical Development, Medical Affairs, Commercial Development, Global Health and Value, Regulatory, Finance, Statistics, Clinical Pharmacology, Translational Oncology, Pharmaceutical Sciences, Project Management and Development Operations. The IO TL will be responsible for informing and ensuring alignment of the asset strategy with key partners across the Pfizer Oncology Enterprise including but not limited to Pfizer Oncology, Worldwide Commercial Development (WWCD), Pfizer's Worldwide Research & Development (WWRD including Rinat) and Business Development (BD) Groups.
For products within the Pfizer Oncology immuno-oncology portfolio, the TL is responsible for overseeing programs/studies spanning from first-in-human (FIH, Phase I) studies to exploratory Phase IIa studies, to randomized Phase IIb studies to registration-enabling studies and post-approval life-cycle management through loss of exclusivity.
The TL is accountable for budget development and critical oversight and for recommending individual asset investment opportunities that will support investment prioritization in the context of the overall WWRD and Pfizer immuno oncology portfolio.
The TL will be responsible for continuous optimization and refinement of the Asset strategy. The A/TL will also be responsible for approval of program and/or project plans as well as changes to the programs that impact the approved budget.
The TL applies oncology drug development knowledge and experience to assure that the asset is managed in an efficient and rigorous manner as reflected in the design and conduct of studies with high likelihood of technical, regulatory and commercial success. The A/TL will be an experienced people leader and will be responsible for optimizing team alignment, governance and overall team health.
The TL will be a decisive leader who can apply cost effective, time efficient and high quality approaches to drug development.
Responsibilities
This position will be within the new integrated EDTO and IO Team, and report to the IO ATL
Current IO strategic priorities include:
* Creating and executing a clear, integrated development strategy for immunotherapy at Pfizer Oncology that will ultimately lead to regulatory approvals
* Working closely with leaders from Pfizer Oncology Development, WWCD, WRD (including Rinat) and BD to ensure delivery of a robust pipeline that builds Pfizer's competitive position as a leader in immuno-oncology
* Identifying, developing and implementing immuno-oncology asset and immuno-oncology combination regimens that have a strong mechanistic rationale, the potential to substantially improve upon the current standard of care, and support an aggressive clinical development plan
* Leading collaborations with world experts (including other companies where appropriate) in the field of immuno-oncology to ensure optimization of the Pfizer immunotherapy strategy and pipeline
* Working with Oncology Enterprise leadership across Pfizer to ensure alignment of appropriate technologies, capabilities, talent and resources to support the immuno-oncology portfolio
* Ensuring teams navigate programs toward rapid decisions
Specific Duties of the TL role:
* Leads and is responsible for directing a cross functional Asset Team(s)
* Accountable for developing and delivering the Integrated Asset Plan, and ensuring that the Integrated Asset Plan is consistent with Pfizer Oncology, WWRD (including Rinat) strategy and Immuno-oncology Strategy
* Coordinate with the Translational Oncology Lead on the Asset Team in the thoughtful integration of biomarker and companion diagnostic studies into the clinical development strategy for each asset
* Accountable for assuring that projects are managed cost-effectively per budget, and looks to de-risk the candidate and investments as early as practical
* Accountable for ensuring that the necessary resources are applied to the project team to support its success
* Assures for the quality of asset deliverables to external authorities
* Promotes a culture of innovation and collaboration within the cross-functional team(s) in order to bring forward creative, defensible development plans that maximize the potential of each asset
* Acts as point of contact and project representative to governance and other decision-making bodies, including information dissemination and the resolution of critical project issues
* Leverages line expertise to achieve the team goals
* Has an appropriate role representing and leading Pfizer Oncology in asset-based development partnerships and alliances
* Able to engage with Business Development and contribute to efforts to optimize pre and post-PoC immuno oncology portfolio though in-licensing, out-licensing, co-sponsorship, and other collaborative efforts
* Negotiates and influences key internal stakeholders
* Creates a motivated, committed and engaged project team
* Models and expects effective team behavior to achieve the project goals
Manages key interdivisional interfaces on project issues with line functions.
Qualifications
* Graduate with post-graduate training in biomedical sciences or one of the disciplines related to drug development
* Proven ability to function effectively across a complex matrix organization with multiple
stakeholders and constituents, with the ability and gravitas to align a team to work towards a singular goal
* Minimum of 8 years of relevant experience in the pharmaceutical, academic and/or medical research environments having successfully executed a major component of a development program. Significant Phase 1-3 clinical research experience with strong understanding of the elements of drug development programs and experience in their design and execution.
* An organized, independent, self-motivated individual with exceptional presentation, written, and oral communication skills
* Able to tailor presentations to the knowledge level of the audience to suit their needs and maximize understanding of the topic
* At least five years experience in Oncology Drug Development
* Proven track record of success in an Oncology and Drug Development Team environment
Prior Experience Preferred:
* Experience in clinical development of immune-therapeutics for oncology
* Demonstrated experience in successfully leading teams, running them effectively, efficiently and on target. Capable of recognizing when team interventions and escalations are required to enhance team effectiveness
* Significant experience leading early and late stage clinical development studies, programs and clinical operations
* Direct experience in preparation of regulatory submissions, presentation to regulatory advisory panels in support of registration of a new drug
* Knowledgeable of the commercial and environmental issues that drive drug development projects
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
Travel up to 10% of time to congresses and business meetings
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.