Job Summary

Asset Specific

• The Obesity Development Lead will be the single point of accountability for Obesity-related programs within PRD Clinical Development
• Oversees and directs Medicine Team Leads, Global Clinical Leads, and Category Clinicians on obesity-related programs
• Build end-to-end development plans for obesity assets in phase 3 and post-marketing
• Designs, develops, and delivers seamless execution and decision-making for obesity-related business development efforts in Internal Medicine
  - Single point of accountability for all obesity-related diligence efforts
  - Responsible to bring GPD development expertise to diligence efforts
• Coordinates business development integration efforts for Internal Medicine
• The role brings broad therapeutic expertise and is responsible for maximizing the long-term value of the assets through innovative development approaches
• Shortens the overall development time by building fast to approval plans for early medicine candidate
• Leads cross functional teams comprised of colleagues from Clinical Development & Operations, Medical Affairs, Commercial Development, Global Health and Value, Regulatory, Finance, Statistics, Clinical Pharmacology, Pharmaceutical Sciences, Project Management, and any other functional lines as needed
• Highly visible and critical position which requires strategic thinking, leadership and exceptional communication skills
• The role will have responsibility for all business development deals’ assessments on a global basis

Portfolio Specific

• Senior leadership role within Global Product Development Internal Medicine & Infectious Diseases accountable for driving the strategy, implementation and successful delivery of obesity-related clinical development plans, obesity-related business development assessments and the provide expertise / leadership for late-development plans for early assets with the Internal Medicine Research Unit (IMRU)
• This role requires strategic and innovative thinking, leadership and exceptional communication skills; both internal and external leadership is expected, i.e., governance committee meetings, KOL advisory boards and health authority interactions

Managerial

• Reporting to the Chief Development Officer of Internal Medicine & Infectious Diseases the, this position will lead and manage Medicine Team Lead(s), Global Clinical Lead(s) and Category Clinicians

Job Responsibilities

• Accountable for designing, developing and delivering the integrated development strategy for obesity-related assets that is consistent with the intended label and overarching strategy and vision for Pfizer
• Serves as the Chief Development Officer’s delegate, when needed, for key activites
• Develop unique insights and opportunities to improve upon the standard of care and position the assets for long-term success
• Promote 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
• Apply drug development knowledge and experience to assure that the asset is managed in an efficient and rigorous manner as reflected in programs with high value to all stakeholders, balancing costs with likelihood of technical, regulatory, and commercial success 
• Display foresight and mental agility into changes or compelling events in the scientific, clinical, regulatory, or market landscape
• Effectively informs, negotiates with and influences key internal stakeholders (including all levels of management as appropriate) and works with TA leadership across Pfizer to ensure alignment of appropriate technologies, capabilities, talent and resource to support the asset
• Single point of contact and program representation to internal and external stakeholders, including leadership teams and governance bodies; ensuring transparent information flow internally/externally
• Builds End-to-End development plans, setting global strategies and an aligned operational plan, which are built on customer insights to maximize the value of our medicines to customers
• Proactively manages risks and opportunities of the asset and continuously drives quality, cost and speed improvements, and makes necessary tradeoff decisions to maximize asset value
• Engages executive leadership regarding strategic issues, project plans, options and recommendations to support uninterrupted project execution
• Create, lead and deliver continuous improvement strategies to improve productivity and increase asset value
• Ensure the articulation of appropriate standards and specifications for input to contracts with vendors, suppliers and industry partners to deliver the project
• Travel to external meetings and symposia required as appropriate or per business need
• Recruit, train, develop, mentor staff, and retain skilled colleagues to provide effective and qualified resources to maximize Internal Medicine portfolio deliverables in support of Internal Medicine objectives

Stakeholder Management

• Develop an effective and collaborative work environment across the Business Units (BUs), PRD and partner lines. 
• Ensure that inputs from all members, regions, lines and management are heard, validated and considered throughout the program lifecycle
• Manage key interdivisional interfaces on program issues including Research, Manufacturing and other BUs
• Manage internal relationships (e.g., platform lines, other BUs) and external relationships (e.g., customers, regulatory agencies, key opinion leaders) either directly or through appropriate Medicine Team members 
• Work with project leaders and managers in Research & Development and/or with licensing partners to ensure a seamless transition of potential assets into development, registration and/or commercialization
• Work in concert with appropriate Medicine Team members to build a network to key opinion leaders to support program development (strategies and plans) and commercialization

Communication

• Able to represent the asset and serve as lead at regulatory advisory committees, health regulatory authority interactions, preparation of briefing documents and addressing questions from health regulatory authorities (FDA, EMA, etc.)
• Routinely engages with Regional colleagues (e.g. regional presidents, commercial & medical, etc.) on development strategy, planning, and patient access strategies
• Able to clearly and accurately articulate clinical strategy, clinical data, scenarios, and tactics in a way that is appropriate for the audience
• Create and maintain relationships with patient advocacy groups to ensure all protocols are patient friendly and address the needs of such groups
• 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

Qualifications

Education and Experience

• MD or MD/PhD
• 5+ years of obesity-related clinical development activities with GLP-1 agents and a minimum of 15+ years of relevant drug development experience in the pharmaceutical/biotechnology industry, academic and/or medical research environments, including significant experience leading early and late phase clinical development studies, programs and clinical operations with strong understanding of the elements of drug development programs and experience in their design and execution
• Proven track record of success in Drug Development Team environment
• Significant drug development leadership experience with a history of effective management of cross functional teams in complex environments, running them effectively, efficiently and on target 
• Proven ability to manage effectively across a complex matrix organization with multiple stakeholders and constituents, with ability and gravitas to align team work towards a singular goal
• Capable of recognizing when team interventions are required to enhance team effectiveness
• 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
• Experience with successful health authority interactions (i.e., FDA, EMA)
• 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 of 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 with Internal Medicine drugs including successful NDA submission(s) and approval(s)
• Direct experience of working in an alliance or partnership with an external company as an individual contributor or leader
• Direct experience of working in an alliance or partnership with an Academic (or Government) Research Organization as an individual contributor or leader
• Prior asset or program matrix team leadership
• Formal business education and/or business leadership courses
• Track record of Health Authority advisory committee presentation
• Experience with precision medicine development

Key Technical Competencies

• Understands the value of and demonstrates strong leadership skills
• Business focused, decisive
• Self-awareness
• Adapts to change, responds positively with a sense of urgency
• Highly effective, motivational leader
• Strong interpersonal skills
• Excellent communication skills
• Proven ability to mentor and improve performance of direct reports
• Acts decisively
• People management experience
• Active medical license
• Expert in Internal Medicine and related fields
• Deep understanding of clinical study design

The annual base salary for this position ranges from $299,600.00 to $499,400.00.* In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

* The annual base salary for this position in Tampa, FL ranges from $235,900.00 to $393,100.00.

Relocation assistance may be available based on business needs and/or eligibility.

Medical