A major focus of the role will be leading the cross-functional development activities for Anti-infective assets, serving as the single point of accountability within Pfizer Essential Health (PEH) R&D. A key focus is translating strategic objectives into operational plans and discrete deliverables that result in the submission and approval of the assets. The incumbent will drive cross-functional and cross-geographical alignment of clinical, medical, regulatory and pharmaceutical sciences lines within Pfizer Essential Health R&D. The development projects will have regional and global scope, making significant contributions to the business. The incumbent will work closely with External Scientific Affairs in the management of Anti-Infective Clinical Programs partnered with the US Government agency BARDA (Biomedical Advanced Research and Development Authority) to operationalize strategy through resource negotiation, project planning and execution, budget management, and risk identification and mitigation. The Asset Development Lead will consolidate and evaluate information in order to lead and participate in project reviews, ensuring that projects are prioritized and aligned to business and partnership priorities and goals.
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Development Leader
Maintain the Integrated Asset Development Plan, ensuring periodic review and incorporation of inputs and changes from stakeholders. Effectively manage the asset development team to ensure input from all team members, regions, lines and management are heard, validated and considered throughout the lifecycle. Manage interactions with internal stakeholders and governance bodies; participate actively with external stakeholders and governance bodies; ensures transparent information flow internally and externally. Continuously drive quality, cost and speed improvements, and make necessary tradeoff development decisions to maximize asset value. Proactively manage medicine-related events, risks and opportunities. Ensure effective operation of the Asset team to ensure flawless execution:
• Create and/or lead a motivated, committed and engaged Asset Team that models effective team behavior
• Encourage participation and involvement by all team members by building trust and team spirit
• Define success for the whole team, and hold team members accountable for their work
• Effectively leverage the expertise of team members in challenging the status quo, resolving conflict, and making recommendations.
• Be accountable for making operational and budget decisions within the team
• Develop an effective and collaborative work environment across the Business Units, R&D, and partner lines.
• Manage internal and external relationships either directly or through appropriate team members to build a network to key opinion leaders to support program development and commercialization.
• Work with project leaders and managers in R&D and/or licensing partners to ensure a seamless transition of acquired or in-licensed assets
Strategy and Execution
Drive the creation of the Integrated Asset Development Plan, setting global strategies built on customer insights. Ensure that aligned operational plans that are built to maximize the value of the assets to patients and stakeholders. Oversee and manage asset development related activities. Serve as the point of contact and development program representative to executive leadership, governance, and other decision-making bodies. Hold an manage the overall asset budget within authorized limits, making investment decisions win partnership with commercial counterpart and trade-offs across the program. Drive execution of strategies and programs to maximize asset performance including:
• Program delivery –delivering program milestones in a timely, cost-effective, and high quality fashion, including de-risking assets and investments as early as practical
• Ensure that the development program will allow asset registration as planned
• Develop and execute appropriate post-marketing plans
• Proactively and continuously identify and communicate development program risks; develop and implement risk mitigation strategies and resolve critical program issues.
• Ensure that projects have appropriate resources and technical expertise to achieve strategic objectives by working with leaders across functions.
• Ensure that the program is managed appropriately within budget and that resource forecasts for all activities across all functions are accurate and up to date.
• Drive the technical review for the program and overall due diligence related to the program
• Maintain scientific and regulatory awareness to ensure that project plans reflect the latest scientific/medical developments and regulatory environment
• Create, lead, and deliver continuous improvement strategies to improve productivity and increase asset value
• Ensure articulation of appropriate standards and specifications for input to contracts with vendors, suppliers and industry partners to deliver the project.
Reporting to the Vice President, Anti-Infectives Development, s/he will be an individual contributor managing a cross functional team and will interact regularly with the Medical and Clinical Therapy Area Leads, Heads of Clinical and Medical Affairs, and the Co-Chairs of the Anti-Infectives Portfolio Segment Team.
10% travel.
This position could either be located at Pfizer’s NY headquarters, or Groton, CT; Collegeville, PA; north suburban Chicago/Lake Forest, IL; Walton Oaks, Surrey, UK; Hurley (Near Maidenhead) UK; relocation provided.
Qualifications
Training & Education Preferred:
• Advanced degree required (Master’s, PhD, PharmD, MD). Degree should be in a relevant scientific, medical, business, or drug development discipline.
Prior Experience:
• Experience in Anti-infectives drug development required.
• Ten or more years’ experience in drug development experience or expertise with an in-depth knowledge of the drug development and commercialization process.
• Demonstrated success managing complex, high-visibility drug or commercial development or other strategic, cross-functional projects to achieve milestone goals and budget. Experience managing across all phases of development preferred.
• Experience with budget and resource management. Experience overseeing development of the annual Operating Plan.
• Experience partnering with government agencies (i.e. BARDA) preferred.
Core Skills:
• Proven leadership skills in a matrix environment.
• Influencing and negotiation skills.
• Managing team culture and conflict resolution.
• Knowledge of regulatory review and response processes.
• Ability to assemble technical data into a comprehensive picture
• Enthusiasm, energy, confidence and outstanding communication skills.
• Ability to drive, anticipate, influence and manage change.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
Occasional Business travel required
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