Vice President, Medicine Team Lead, Non-MD Breast Cancer

ROLE SUMMARY

The Vice President, Medicine Team Lead, Non-MD for our Breast Cancer franchise is a senior leadership position accountable for driving the strategy, implementation, and successful delivery of the Global Medicine Plan for our breast cancer medicines. This is a highly visible, critical position which requires strategic thinking, leadership, and exceptional communication skills. You will have responsibility for medicines after the achievement of Proof of Concept for pivotal registration development, subsequent registrations, post-approval trials and life-cycle management. The appointee will also play a key role in business development, external partnerships and real-world evidence strategies, as it pertains to breast cancer.

ROLE RESPONSIBILITIES

Strategic and Innovative Thinking:

• Accountable for developing and delivering the integrated development strategy and Medicine Plan that is consistent with the overarching Strategy and Vision of Pfizer Oncology
• Develops unique insights and opportunities to improve upon the standard of care and position a medicine for long-term success
• Proven track record of innovative strategies to shorten development timelines and maximize a medicine's lifecycle
• Applies oncology drug development knowledge and experience to assure that a medicine 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
• Understands the Clinical Trial Budget and responsible for conducting studies within planned budget
• Lead and develop the pediatric strategy, where appropriate, for each medicine
• Coordinates with the Translational Oncology Lead on the Medicine Team to ensure thoughtful integration of biomarker and companion diagnostic studies into the clinical development strategy for the medicine
• Promotes a culture of innovation within the Global Medicine cross-functional team(s) in order to bring forward differentiated development plans that maximize the potential of each medicine
• Applies robust and evidence-based decision-making principles in the development of new clinical concepts, programs, and strategies
• Displays foresight and mental agility into changes or compelling events in the scientific, clinical, regulatory, or market landscape
• Works with Oncology Enterprise leadership, ensuring alignment of appropriate technologies, capabilities, talent and resource to support a medicine
• Engages with Business Development and contributes efforts to optimize a medicine's strategy through partnerships, co-development, and other collaborative efforts
• Monitors and applies the various regulatory landscapes to leverage new, innovative avenues for approvals (e.g., RTOR, RWE, ORBIS)

Leadership:

• Leads the Global Medicine Team
• Creates a motivated, committed and engaged Global Medicine Team
• Experience in cross functional matrix leadership required
• Ability to oversee/manage/monitor multiple products/studies/compounds, potentially overseeing additional GPD staff
• Leads and/or participates in additional cross-functional working groups/initiatives outside of the MTL's daily responsibilities, demonstrating the ability to effectively manage and/or partner with teams outside of their normal line of business, while representing the priorities of GPD
• Leads execution of the Integrated development strategy and Medicine Plan for the development of the medicine leading to regulatory approval, expansion of regulatory approvals, and/or support of approved indications
• Leads and is responsible for coordinating a cross functional Medicine Team or indication team (s) comprised of colleagues from Clinical Development, Medical Affairs, Translational Oncology, Statistics, Clinical Pharmacology, Regulatory, Safety, Project Management, Clinical Development Operations, Pharmaceutical Sciences, Portfolio Strategy, Global Marketing & Commercial Development, and Finance and other functions as determined by the needs of the team
• Ensures thoughtful integration of the functional disciplines into the clinical development strategy and medicine-based decision-making
• Leads Medicine regulatory submission oversight efforts and is responsible for medicine team delivery of high quality, efficient submissions
• Represents and leads Pfizer Oncology and Global Product Development in medicine-based development partnerships, collaborations and alliances, as appropriate (for instance, co-chairing a Joint Development Committee, JDC)
• Acts decisively, making effective decisions by applying scientific, development, and/or financial acumen. Acts with urgency and removes barriers that hinder productivity
• Ensures that the team(s) navigate a program or indication(s) toward rapid decisions
• Recognizes situations in which the MTL must provide guidance or a decision even when incomplete information is available
• Accountable for ensuring that projects are managed cost-effectively and per budget/timeline, can make trade-offs as necessary, and looks to de-risk the medicine and investments as early as practical
• Accountable for ensuring that the necessary resources are applied to the project team to support its success and negotiating with line leaders to obtain resources
• Assures the quality of medicine deliverables to external health authorities
• Models leadership behavior and expects effective team behavior to achieve project goals
• Aligns on the integration of new findings/learnings (e.g. preclinical, clinical or safety) into planned and ongoing clinical programs
• Effectively informs, negotiates with and influences key internal stakeholders (including all levels of management as appropriate)
• Actively engages with external thought leaders on development strategies and plans
• Routinely engages with regional colleagues (e.g. regional presidents, commercial & medical, etc.) on development strategy, planning, and patient access strategies

Communication:

• Demonstrates the ability to effectively present and/or prepare presentations for senior management (PSI, ELT, Board of Directors)
• Informs, negotiates with and influences key internal stakeholders
• Responsible for informing and ensuring alignment of the medicine plan strategy with key partners across the Pfizer Oncology Enterprise including but not limited to Global Product Development (GPD), Biopharma (commercial and medical affairs), Worldwide Research and Development and Medical (WRDM), and Business Development (BD) Groups
• Able to represent the Medicine and serve as lead presenter/moderator at regulatory defense proceedings (e.g. ODAC)
• Leverages line expertise to achieve the team goals
• Able to clearly and accurately articulate medicine plans, clinical data, scenarios, and tactics in a way that is appropriate for the audience
• Encourages transparency and fosters and open dialogue with all stakeholders
• Surfaces and represents diverse points of view in interactions with the global medicine team and with stakeholders
• Manages key inter-divisional interfaces on project issues including but not limited to research, regulatory affairs, development, commercial, medical affairs, manufacturing, supply chain and operations.
• 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

Duties Specific to the MTL Role:

• Strategic leadership of upcoming global health authority interactions for in collaboration with the regulatory strategy lead and Medicine Team
• Serves as the steward for new medicine development plans at upcoming milestones/decision-points at internal governance proceedings and with Senior Pfizer Leaders
• Delivers on post-approval regulatory commitments/requirements according to agree upon milestones for the asset
• Delivers pediatric development plans
• Ensures timely and execution delivery of the new and ongoing clinical trial programs
• Actively engages with academic research networks and internal stakeholders to develop and deliver clinical research collaboration development programs
• Engages regional counterparts (regional presidents, regional commercial/medical) to align on and establish the global strategies and footprint for the go-forward clinical development program
• Provides support to the regional marketing/medical colleagues with current and steady data flow on key topics
• Enables effective communications, planning, and execution of public statements or presentations of clinical trial results and milestones
• Effectively leads or co-leads development alliances/partnerships
• Coordinates with Oncology Research Colleagues (ORD) to integrate emerging science into clinical development plans and implement acceleration towards pivotal studies
• Continuously monitors the external competitive environment and delivers timely communication of insights
• Prepare and dispatch global regulatory submissions with high quality and according to timelines
• Provide strategic guidance and input to ROW strategy to align with overall global strategy and program development

BASIC QUALIFICATIONS

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.

• PhD or PharmD with post-graduate training in biomedical sciences or one of the other disciplines related to drug development
• Minimum of 15+ years of relevant experience in the pharmaceutical, biotechnology, academic and/or medical research environments
• Proven track record of success in an Oncology and Drug Development Team environment
• Preference will be given to candidates with breast cancer drug development experience
• Significant drug development leadership experience, both line and team with a history of effective management of cross functional teams
• Proven ability to function effectively across a complex matrix organization with multiple stakeholders and constituents, with ability and gravitas to align team work towards a singular goal
• Demonstrated experience in successfully leading teams in complex environments, running them effectively, efficiently and on target. Capable of recognizing when team interventions are required to enhance team effectiveness
• Significant experience leading clinical development studies, programs and clinical operations with strong understanding of the elements of drug development programs and experience in their design and execution
• Direct experience in preparation of global regulatory submissions as an individual contributor, functional or matrix leader
• Direct experience of working in an alliance or partnership with an external stakeholder (co-development experience preferred) as an individual contributor or leader
• An organized, independent, self-motivated individual with exceptional presentation, written and oral communication skills
• Able to tailor presentations to knowledge level of the audience to suit their needs and maximize understanding on the topic
• Knowledgeable of the commercial, pharmsci/CMC and environmental issues that drive drug development projects
• Demonstrates business acumen and be able to interface seamlessly to ensure successful support of regional market needs
• Articulate, inspiring, and decisive leader who can apply cost effective, time efficient and high-quality approaches to drug development

PREFERRED QUALIFICATIONS

• Significant experience in Phase 1-3 clinical research and with a preference to breast cancer experience
• Prior medicine or program matrix team leadership
• Formal business education and/or business leadership courses
• Track record of Health Authority advisory committee presentation (e.g. ODAC)

Other Job Details:

Additional Location Information: New York, NY; Collegeville, PA; La Jolla, CA; Groton, CT; Cambridge, MA

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