Pfizer Executive Director, Xtandi Medicine Team Leader MD in New York, New York
This role is a senior leadership position within Global Product Development Oncology accountable for driving the strategy, implementation and successful delivery of the Medicine Plan for Xtandi (enzalutamide). Xtandi is one of our most important medicines and will require someone with exceptional strength in strategic thinking, leadership and communication.
Specific Duties of the Xtandi Medicine Team Lead (MTL) role :
Strategic Thinking and Innovation:
Accountable for delivering an integrated Xtandi Medicine Plan that is consistent with the overarching Strategy and Vision of Pfizer Oncology. The Medicine Plan for Xtandi will focus on expansion of regulatory approvals in prostate cancer and will be coordinated with our partner for this medicine, Astellas.
Able to develop unique insights and opportunities to improve upon the standard of care and position the asset for long-term success in an increasingly competitive environment.
Applies oncology drug development, commercial, and disease-area knowledge to assure that Xtandi is managed in an efficient and rigorous manner as reflected in the design, conduct, and prioritization of lifecycle opportunities with high likelihood of technical, regulatory, and commercial success
Promotes a culture of innovation within the Xtandi Global Medicine Team in order to bring forward differentiated lifecycle plan that maximize the medical and commercial potential of this medicine
Applies robust and evidence-based decision making principles in the development of new lifecycle concepts, programs, and strategies
Represents Pfizer on the Pfizer-Astellas Joint Lifecycle Management Team, the Joint Development Committee, and other joint governance committees as the need requires
Displays foresight and mental agility to rapidly adapt strategy based on compelling events in the scientific, clinical , regulatory, or competitive market landscape
Works with Oncology Enterprise leadership across Pfizer - including Pfizer Oncology, Global Product Development Oncology, and Oncology Research & Development - to ensure alignment of appropriate technologies, capabilities, talent and resource to support the Xtandi
Able to engage with Business Development and contribute to efforts to optimize Xtandi strategy through partnerships, co-development, and other collaborative efforts Leadership:
Possesses a deep understanding of and vision for Xtandi in prostate cancer
Inspires team to achieve goals with quality, speed, insight, and creativity
Leads execution of the Xtandi Medicine Plan for the lifecycle management of the medicine leading to the expansion of regulatory approvals and identification of new potential uses and indications
Leads and is responsible for coordinating a cross functional Xtandi Medicine Team comprised of colleagues from Clinical Development, Medical Affairs, Translational Oncology, Statistics, Clinical Pharmacology, Regulatory, Safety, Project Management, Clinical Operations, Pharmaceutical Sciences, Portfolio Strategy, Commercial Development, and Finance and other functions as determined by the needs of the team
Ensures thoughtful integration of these disciplines into the lifecycle management strategy for Xtandi
Leads regulatory submission oversight efforts and is responsible for asset team delivery of high quality, efficient submissions
Represents Pfizer Oncology and Global Product Development in our partnership with Astellas as appropriate or as required to advance Pfizer Oncology's position
Acts decisively making effective decisions by applying scientific, development, regulatory, commercial, and financial acumen. Acts with urgency and removes barriers that hinder productivity
Ensures that the team navigates the program 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 takes appropriate actions to de-risk decisions
Accountable for ensuring that projects are appropriately prioritized and receive the necessary resources and line support to position them for success
Assures the quality of materials provided to external health authorities
Creates a motivated, committed and engaged Medicine Team
Models leadership behavior and sets clear expectations for team behavior to achieve goals
Aligns on the integration of new findings/learnings (e.g. preclinical, clinical or safety) into Xtandi lifecycle strategy
Effectively informs, negotiates with and influences key internal stakeholders (including all levels of management as appropriate)
Actively and frequently engages with external prostate cancer experts and thought leaders on lifecycle plans and strategies
Routinely engages with Regional colleagues (e.g. regional presidents, commercial & medical, etc.) on lifecycle strategy, planning, and patient access strategies Communication:
Outstanding communicator who is able to adapt and deliver an effective presentation in a wide variety of settings to a wide variety of audiences
Able to inform, negotiate with and influence key internal stakeholders
Responsible for informing and ensuring alignment of key partners across the Pfizer Oncology Enterprise including but not limited to Pfizer Oncology, Global Product Development, Worldwide Commercial Development (WWCD), Worldwide Research and Development (WWRD), and Business Development (BD) Groups
Able to represent the Xtandi 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 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 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.
Education and Experience
Proven track record of success in an Oncology and Drug Development Team environment
Knowledge, experience, expertise, and established network in prostate cancer is highly desirable
Significant drug development leadership experience, both within a functional line and a matrix 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 late stage clinical development studies, programs and clinical operations with strong understanding of the elements of drug development programs and experience in their design and execution
Education: MD required. Clinical and clinical research experience in prostate cancer and/or oncology drug development is highly desirable.
At least 15 years of relevant experience in the pharmaceutical, academic and/or medical research environments
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 a functional or matrix leader (preferred). Applicants with outstanding individual contributions to one or more regulatory submissions will also be considered.
Direct experience of working in an alliance or partnership with an external company (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 clinical, commercial, regulatory, competitive and environmental issues that impact patient access to medicines
Demonstrates clinical and business acumen of regional market needs.
Articulate, inspiring, and decisive leader who can apply cost effective, time efficient and high quality approaches to drug development Desired Experience
Significant experience in late phase clinical research, preferably in oncology
Prior prostate cancer drug development and lifecycle management experience
Prior matrix team leadership
Track record of Health Authority advisory committee presentation (e.g. ODAC)
Competency - Detail / Comments (Specific skills-expanded definition)
Presentation, Analytical Skills and Communication : demonstrates ability to present clinical data, study plans, scenarios, strategy and tactics clearly, succinctly and accurately to relevant audiences in order to obtain decision, input and feedback when required
Influencing : Must be able to lead multi-disciplinary group in complex matrix environments
Courage with Decisiveness to Act : Bias towards action to achieving goals
Team Building : Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team
Conflict Management : Good at focused listening; can find common ground and get cooperation with minimum noise
Anticipates Issues : proactively anticipates emerging issues; knows how to take action to mitigate or resolve issues
Uses Benchmarks: Adept at benchmarking previous submissions, regulatory precedents, recent publications, or competitive events to inform and evolve strategies
EEO & Employment Eligibility
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Additional Offer Details:
Additional Location Information : Preferred Location is New York, NY. Consideration given to: LaJolla, CA; San Francisco, CA; Groton, CT; Cambridge, MA and Collegeville, PA
Eligible for Relocation Assistance
Eligible for Employee Referral Bonus
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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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
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