Director, Regulatory Program Management & Submission Strategy (Oncology)

The Director, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology's regulatory strategic and operational deliverables. The Director, RPMSS serves as the regulatory program operational leader, ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule and with quality that meets or exceeds business needs. The Director, RPMSS is viewed as a key leader on the GRST (Global Regulatory Strategy Team). The Director, RPMSS' responsibilities encompass regulatory strategic and scenario planning, execution of regulatory and submission deliverables, team effectiveness, resource management, risk management, and information and communication management. The Director, RPMSS needs to have a comprehensive understanding of strategic and tactical planning and the foundational tools that support planning, communication, and continuous improvements in operational delivery.
JOB RESPONSIBILITIES
Strategy and Planning

• Working with Global Regulatory Lead, leads development of integrated regulatory plan and ensures alignment with the overall strategic and operational plan for the asset, as well as Partner Line plans for the program. Spans from Pre-Clinical to Loss of Exclusivity.
• Offers leadership in regulatory strategy and planning, including development and assessment of scenarios and options, robust decision criteria, risk management, and internal/external communication and stakeholder management strategies.
• Designs, recommends, and implements new processes, approaches, or tools to manage the program/team.
• Leads development of the regulatory/submission critical path, decision criteria, and milestones/stage gates.
• Ensures alignment of regulatory/submission strategy with overarching asset strategy.
• Ensures all lines understand regulatory/submission strategy, key milestones, and interdependencies.

Project Execution and Delivery

• Provides cross-functional operational leadership to the Global Regulatory Strategy Team.
• Leads the development and coordination of regulatory goals in partnership with the Global Regulatory Lead and closely monitors progress against these goals for operational efficiency ensuring the program delivers on time and within scope.
• Monitors activities across all regulatory team members and associated lines to ensure achievement of key decision points and milestones according to time, cost, and quality parameters of the endorsed plan.
• Influences leadership across functional lines to ensure efficient delivery of regulatory projects.
• Negotiates the allocation of Partner Line resources to support the endorsed regulatory/submission strategy.

Risk Analysis and Management

• Leads the regulatory team in the preparation, implementation, maintenance, communication, and management of integrated risk management plans, including risk assessment and risk mitigation strategies.
• Proactively identifies operational issues, facilitates development of team recommendations and action options, and ensures appropriate escalation to senior leadership and Partner Lines.
• Partners with team and department leadership to identify options to de-risk project plans and capitalize on opportunities.

Information and Communication Management

• Ensures effective, accurate, and timely communication of regulatory information to meet the needs of the product team and stakeholders.
• Provides complete, accurate, and timely timeline and resource information in appropriate Pfizer systems to enable effective portfolio management and decision making.

Team Effectiveness

• Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional team performance.
• Ensures all appropriate team member views have been raised and incorporated into team decisions as appropriate.
• Identifies team performance issues and partners with team leadership to recommend and develop appropriate actions.
• Leads team chartering process.
• Clarifies project deliverables/workload to enable Partner Lines to assess resource needs, raise gaps, and partner with team leadership to resolve.
• Seen as key leader on the GRST with ability to influence.

Submissions

• Provides comprehensive project management for regulatory submission activities for initial and supplemental market authorizations.
• Provides operational excellence, planning, and execution leading to successful regulatory submissions and approvals.
• Provides support to the team up to 18 months in advance of a potential submission to map out submission contents and conduct scenario analyses of cost, schedule, and resource demands to identify the most efficient plan.
• Applies specialized knowledge of and expertise around endgame to contribute to the identification, evaluation, and optimization alternatives for the submission plan.
• May be responsible for the development of the submission integrated MS project plans and resourcing plans for endgame activities (partnership with Project Planner)

QUALIFICATIONS/SKILLS
Training & Education:

• Bachelor's degree in one of the disciplines related to drug development or business required. Advanced degree (PhD, PharmD, MBA) desirable.
• Mastery of program management skills and significant expertise in drug development (Oncology preferred).
• Directors are strongly preferred to have 10 or more years of relevant experience.
• Professional PM Certification (Project Management Professional [PMP] or equivalent) desirable.

Prior Experience/Skills:

• Experience leading the planning and execution of major regulatory submissions (e.g. NDA/BLA/MAA) is required.
• Strong track record of performance, delivery and team effectiveness in a complex matrix team environment.
• Proven ability to drive results.
• Extensive knowledge and experience in drug development, medical, and/or commercial disciplines with proven ability to think strategically and operationally.
• Demonstrated ability to translate strategy into effective operational goals and tactical plans.
• Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills.
• Knowledge of and experience with clinical operations/clinical trial execution is desirable.
• Knowledge of end-to-end drug development (pre-clinical through LOE) is desirable.
• Experience with Microsoft Project, Planisware, and/or OnePager is preferred.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% 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.
Relocation assistance may be available based on business needs and/or eligibility.
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EEO & Employment Eligibility
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