Pfizer Asset Team Leader, Talazoparib (nMD) in San Diego, California

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.

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.

Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

This role is a senior leadership position within Global Product Development Oncology accountable for driving the strategy, implementation and successful delivery of the Integrated Asset Plan for an asset or assets in late phase oncology development.

This is a highly visible, critical position which requires strategic thinking, leadership and exceptional communication skills.

The leader will have responsibility for an asset after the achievement of Proof of Concept for pivotal registration development, subsequent registrations, post-approval trials &; life-cycle management.

Specific Duties of the Oncology Asset Team Lead (ATL) role:

Strategic and Innovative Thinking:

• Accountable for developing and delivering the integrated development strategy and Asset Plan that is consistent with the overarching Strategy and Vision of Pfizer Oncology. The Asset plan will lead to initial regulatory approval, expansion of regulatory approvals, and/or support of approved indications

• Able to develop unique insights and opportunities to improve upon the standard of care and position the asset for long-term success

• 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

• Coordinates with the Translational Oncology Lead on the Asset Team to ensure thoughtful integration of biomarker and companion diagnostic studies into the clinical development strategy for the asset

• Promotes a culture of innovation within the cross-functional team(s) in order to bring forward differentiated development plans that maximize the potential of each asset

• 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 across Pfizer to ensure alignment of appropriate technologies, capabilities, talent and resource to support the Asset

• Able to engage with Business Development and contribute to efforts to optimize the Asset strategy through partnerships, co-development, and other collaborative efforts

Leadership:

• Leads execution of the Integrated development strategy and Asset Plan for the late phase development of the asset leading to initial regulatory approval, expansion of regulatory approvals, and/or support of approved indications

• Leads the Asset Management Team comprising of the Global Commercial Development Lead, Global Medical Affairs Lead and Global Clinical Lead

• Leads and is responsible for coordinating a cross functional Asset Team or indication team (s) comprised of colleagues from Clinical Development, Medical Affairs, Translational Oncology, Statistics, Clinical Pharmacology, Regulatory, Safety, Project Management, Development Operations, Pharmaceutical Sciences Portfolio Strategy, Commercial Development, and Finance and other functions as determined by the needs of the team

• Leads Asset regulatory submission oversight efforts and is responsible for asset team delivery of high quality, efficient submissions

• Represents and leads Pfizer Oncology and Global Product Development in asset-based development partnerships, collaborations and alliances as appropriate or as required to substantially improve upon the standard of care and advance Pfizer Oncology's position

• Ensures that the team(s) navigate a program or indication(s) toward rapid decisions

• 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 asset 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 asset deliverables to external health authorities

• Creates a motivated, committed and engaged project/asset team

• 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 negotiates with and influences key internal stakeholders (including all levels of management as appropriate)

• Actively engages with 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:

• Negotiates with and influences key internal stakeholders

• 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, Global Product Development, Worldwide Commercial Development (WWCD), Worldwide Research and Development (WWRD), and Business Development (BD) Groups

• Able to represent the Asset 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 asset plans, clinical data, scenarios, and tactics

• Encourages transparency and fosters and open dialogue with all stakeholders

• Surfaces and represents diverse points of view in interactions with the asset 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

Duties Specific to the Talazoparib ATL Role:

• Strategic leadership of upcoming global health authority interactions in collaboration with the regulatory strategy lead and Asset team

• Serve as the steward for new Asset development plans at upcoming milestones/decision-points at internal governance proceedings

• Ensure timely start-up and execution delivery of the phase 3 clinical trial program

• Engage regional counterparts (regional presidents, regional commercial/medical) to align on and establish the global strategies and footprint for the go-forward clinical development program

• Develop and execute a patient access strategy upon enrollment completion of key trials

• Enable effective communications, planning, and execution of public statements or presentations of clinical trial results and milestones

• Prepare and dispatch asset global regulatory submissions with high quality according to timelines

Education and Experience

• Proven track record of success in an Oncology and Drug Development Team environment

• 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 early and 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

• Graduate with post-graduate training in biomedical sciences or one of the other disciplines related to drug development (PharmD, PhD)

• 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

• Minimum of 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

• At least ten years' experience in Oncology Drug Development in the pharmaceutical and/or biotechnology industry

• 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 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 commercial 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

Desired Experience

• Significant experience in Phase 1-3 clinical research

• Prior asset or program matrix team leadership

• Formal business education and/or business leadership courses

• Track record of Health Authority advisory committee presentation (e.g. ODAC)

• Experience with precision medicine development

PHYSICAL/MENTAL REQUIREMENTS

Competency - Detail / Comments (Specific skills-expanded definition)

• Presentation, Analytical Skills and Communication: demonstrates ability to present clinical data, study plans, scenarios, 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

RELOCATION - is offered for this position

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel to external meetings and symposia required as appropriate or per business needA 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.