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Executive Director, Xtandi Medicine Team Leader MD


New York, NY
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Job Details

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.

Basic Qualifications

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

+ Business acumen

+ 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 Statement**

**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.

**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.

**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

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 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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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