Development Head, RSV, RSV Combination, and Early Vaccine Programs

The primary purpose of the job is to oversee and ensure that vaccine clinical research and development program(s) are planned and implemented to meet company objectives. The Development Head: Applies extensive expertise and in-depth knowledge of clinical research to lead global clinical research programs and registration activities across one or more clinical projects; Ensures successful program implementation through oversight and review of the program design including the clinical development plan or lifecycle strategy; Serves as the major driver for identifying and advancing new concepts and processes to provide innovative strategies to solve clinical issues; By leading and obtaining consensus from senior staff members, solves highly complex and specialized problems related to clinical research programs in a highly matrixed environment; Applies technical/scientific expertise to resolve issues regarding clinical components of documents (e.g., Investigational New Drugs, New Drug Applications/Common Technical Documents, global registration dossiers, lifecycle strategy documents, internal documents); Provides procedural and scientific subject matter expertise to guide global trial leaders, clinical scientists and other clinical staff members. In addition to program level activities the Development Head may review compounds for potential in-licensing, including performance of due diligence reviews and provide assistance to new business development on market opportunity and target product profile. The Development Head may also be required to design a development strategy with multiple protocols to obtain worldwide approval for a compound or group of compounds or a vaccine.

Responsibilities

Lead the global clinical research program(s): provide high level oversight of the direction and planning of global clinical programs including preparation of Clinical Development Plans; Oversee one or more Clinical Project Teams; Identify program issues and develop sound strategic solutions with clinical teams; Form ad hoc teams to resolve clinical/medical issues; Provide updates to Senior Vaccines Research and Development Management; Oversee global clinical research program(s): establish program priorities and drive key programs; Collaborate with clinical lead to determine scientific content of Investigator meeting; Oversee and participate in writing/review of key documents; Assure quality of program through oversight of initial program activities, implementation and monitoring, and final documents; Administer/Oversee global clinical research program(s): oversee clinical lead and clinician medical monitor activities; Hire, train, and monitor personnel performance; Coach, train, and/or mentor clinician medical monitors and clinician clinical scientists; Provide input into staffing and budgetary planning; Define medical research resource requirements; Develop or oversee budget with Finance; Provide input into insource/outsource approach; Represent medical research and Vaccines R&D point of view to other line functions; Provide input into publications strategy and review publications; Provide input into regulatory strategy and interact with Regulatory Affairs; Provide strategic scientific input to global asset team; Interface with auditing groups; Function as global medical monitor: review serious adverse events and determine follow-up; Interact with Data Monitoring Committee and other committees; Answer safety questions and review literature; Review Informed Consent Documents; Provide safety communications to sites; Provide program teams with medical expertise during issue resolution, audit response, study closeout/inspection readiness; Interact with regulatory groups and internal auditing groups on project level; Contribute to, review, and edit Clinical Study Reports; Approve patient narratives; Conduct decision point preparation for senior management; Participate in and/or chair the Vaccines Clinical Review Committee.

Requirements

Medical degree (M.D./D.O. or equivalent); 10+ years of experience in the pharmaceutical industry related to clinical research programs and registration activities; End to end vaccine clinical development experience required; Possesses the ability to critically evaluate scientific/medical information; propose new concepts and innovative ideas in drug development; Understands the design, development, and execution of clinical programs and studies; Ability to critically evaluate scientific/medical information and to propose new concepts and ideas in drug development; Understanding of the design, development and execution of clinical programs and studies; Ability to develop and apply extensive therapeutic area expertise to create an effective development strategy for a variety of small molecules and biologics; Knowledge of global regulatory/industry rules and guidance; Ability to synthesize medical and scientific information; 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; Live within commuting distance and work on-site an average of 2.5 days per week or more as needed; Candidates must be authorized to be employed in the U.S. by any employer; U.S. work visa sponsorship is not available for this role; This position requires permanent work authorization in the United States.

Benefits

Eligibility for Pfizer's Global Performance Plan with bonus target of 30.0% of base salary; Eligibility to participate in share based long term incentive program; 401(k) plan with Pfizer Matching Contributions and additional Pfizer Retirement Savings Contribution; Paid vacation, holiday and personal days; Paid caregiver/parental and medical leave; Health benefits including medical, prescription drug, dental and vision coverage; Relocation assistance may be available based on business needs and/or eligibility.