Senior Director Global Clinical Lead - Dermatology ( MD required )

Pfizer   •  

Groton, CT

Industry: Biotech/Pharma

  •  

11 - 15 years

Posted 242 days ago

Job Summary

  • Represents I&I clinical development on the Medicine Team as the single point of accountability for clinical development strategy, program oversight and execution
  • 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

Job Requirements

  • Works closely with therapeutic area Clinical Development & Operations to meet clinical development program deliverables
  • 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).  Therapeutic area (TA) expertise desired but not necessary.
  • Leads design, implementation and interpretation of the global clinical program for a drug candidate to deliver successful regulatory submissions worldwide, which will initially include alopecia areata with >50% hair loss, including alopecia universalis and totalis and may include lifecycle extensions, such as vitiligo
  • Provides innovative options to design and execute clinical programs
  • Ensures alignment of regional clinical development strategy with global strategies and oversees medical execution of regional studies for a development drug candidate
  • Leads execution for overall clinical development program for the asset
  • 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 to clinicians and clinical scientists about the goals of the clinical program
  • Negotiates milestones with Asset Team Lead (ATL) and ensures delivery of clinical programs in line with agreed timelines
  • Identifies and assesses program risks and, in conjunction with the Medicine Team and Clinical Development & Operations, 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 the Clinical Development Plan, protocols, clinical study reports and regulatory submission documents (e.g., NDA, MAA, AR) 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 Triad (clinical pharmacology, statistician and clinician)
  • 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 serve as key scientific member of the Therapeutic Area Scientific Outreach Team (TASOT) and leader of Disease Area Working Groups or sub-teams
  • May contribute to the design of innovative early development studies (Phases 1, 1b and 2a) in collaboration with the RU, with the aim of making strategic go/no go decisions efficiently and at low cost
  • May conduct technical review of licensing opportunities and/or due diligence activities

QUALIFICATIONS / SKILLS

  • MD, DO or equivalent with post-graduate training/certification/fellowship in a medical discipline or in drug development preferred;
  • 12 or more years of medical, scientific or drug development expertise in Medical Dermatology 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
  • 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 an asset
  • Demonstrated ability to coach and/or mentor clinical colleagues for success in technical and behavioral domains
  • 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
  • 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 adaptive clinical trials and programs seeking conditional approval preferred
  • other disciplines
  • Demonstrated ability in collaborative problem solving (handles conflict constructively)
  • If a current Pfizer employee, demonstrated ability to embody Pfizer leader behaviors and the OWNIT culture

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