Global Clinical Lead

The Global Clinical Lead is a leadership role that represents clinical development on the Medicine Team as the single point of accountability for clinical development strategy, program oversight and execution of multiple early-stage assets for heart failure and other cardiovascular indications.
Leads the Global Clinical Team towards the common goal of approvable worldwide regulatory submissions that meet customer (patient, payer, prescriber) needs, ensuring alignment of regional clinical development strategies with global strategies May provide indication-specific input for efficient clinical trial development and response to regulatory authorities May identify and maximize synergies across indications for efficient and cost-effective execution of clinical programs Works closely with therapeutic area Clinical Development & Operations to meet clinical development program deliverables May partner with Therapeutic Area (TA) Clinician Leads to optimize clinician resource utilization across indications In conjunction with the Safety Risk Lead, ensures patient safety during clinical trial conduct plus consistent, and focused medical review and reporting of adverse events, including serious adverse events, and other safety RESPONSIBILITIES Provides clinical expertise and technical excellence for asset development, clinical strategy, ensuring compliance with internal and external standards (regulatory authority requirements, stakeholder requirements and quality standards). Leads design, implementation and interpretation of the global clinical program for a drug candidate to deliver a successful regulatory submission worldwide through regulatory submission and approval (i.e., Phase 2, 3, pediatric and interventional Phase 4 studies) Works closely with early development to ensure alignment between early and late stage development strategy. May contribute to the design of innovative early development studies (Phases 1, 1b and 2a) in collaboration with the Research Unit (RU), with the aim of making strategic go/no go decisions efficiently and at low cost Provides innovative options to design and execute late stage clinical programs Ensures alignment of regional clinical development strategy with global strategies and oversees medical execution of regional studies for a development drug candidate Will contribute on transitioning projects or projects already transitioned Grows/maintains state of the art knowledge in the TA Representative on the Medicine Team; chairs the clinical sub-team of the Medicine Team; provides clear vision, strategies and goals to clinicians and clinical scientists to gather input in the development of clinical strategies and programs Negotiates milestones with Medicine Team Leader (MTL) and ensures delivery of clinical programs in line with agreed timelines; identifies needs and proposes solutions to keep the development programs on time and within budget Identifies and assesses program risks and, in conjunction with the Transition or Medicine Team and Clinical Development & Operations (CD&O), develops effective mitigation plans In conjunction with the Safety Risk Lead, ensures patient safety during clinical trial conduct plus consistent, timely and focused medical review and reporting of adverse events, including serious adverse events, and other safety data Accountable for operational excellence and timely production and approval of quality clinical deliverables, including clinical plans, protocols, clinical study reports and regulatory submission documents (e.g., NDA, MAA, AR, briefing documents, investigator's brochures) and, working wih Medical Affairs, international meeting abstracts or manuscripts intended for external publication that are based on Pfizer-sponsored clinical trials Interprets clinical data in support of asset strategy, working with the clinical pharmacology, statistics Leads cross-functional Clinical Development Team including clinical Triad in the design and execution of studies to support worldwide regulatory submissions Act as a senior company representative interacting with external scientific leaders and/or regulatory authorities Organizes expert panel, consultant or advisory board meetings (including the patients' voice) to provide input into clinical plans, study designs or data analysis; may also maximize opportunities for cross-indication consultancies or advisory boards by working closely with partner lines May serve as key scientific member of the Therapeutic Area Scientific Outreach Team (TASOT) and leader of Disease Area Working Groups (DAWG) or sub-teams May serve as the clinical development representative on the clinical research team May conduct technical review of licensing opportunities and/or due diligence activities May participate in the review of Investigator Initiated Trial Proposals relevant to medicine development QUALIFICATIONS MD or DO with post-graduate training/certification/fellowship in cardiology with drug development experience preferred; relevant drug development experience may be considered. Cardiologist preferred. Medical and scientific expertise in cardiovascular diseases preferred Demonstrated scientific productivity (e.g., publications, research reports, etc.); excellent independent writing and verbal communication skills a must Thorough understanding of local and international regulations applicable to clinical development • Track record of excellence in designing, defending, and executing clinical development plans and clinical studies Demonstrated expertise in managing clinical programs, either pre- or post-approval; expertise in managing large clinical programs (or adaptive clinical trials seeking conditional approval) preferred. Previous leadership/management training, documented experience and proficiency in managing direct reports and/or matrix teams and elevating the enthusiasm of all team members Comfortable discussing scientific/mechanistic aspects of drug development as well as strategic, regulatory or commercial aspects, and conversant of the interplay between the categories Demonstrated ability to lead the translation of patient, marketing and product positioning needs into scientific hypotheses to be tested and ability to translate these into clinical plans Demonstrated ability to anticipate issues related to the delivery of clinical project goals and manage risks Demonstrated ability to establish clear directions, set objectives, distribute the workload appropriately, and bring out the best in people Demonstrated ability to work across many interfaces within a complex matrix organization, and to help others to do so Demonstrated ability to work with (understand needs and concerns of) commercial, regulatory and operational colleagues, senior management, regulatory agencies and other stakeholders to balance conflicting priorities among these diverse parts of the organization, and line them up behind the most appropriate development and/or lifecycle plan for a medicine Demonstrated ability to coach and/or mentor clinical colleagues for success in technical and behavioral domains in a multidisciplinary matrix environment Demonstrated ability to present complex, technical ideas and concepts, both verbally and in writing, in such a way that they are understood by colleagues and stakeholders at all levels and/or from other disciplines Demonstrated ability in collaborative problem solving (handles conflict constructively) Demonstrated ability to embody Pfizer leader behaviors
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The annual base salary for this position ranges from $253,800.00 to $423,000.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0% 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 $203,600.00 to $339,300.00.
Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act
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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. This position requires permanent work authorization in the United States.
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