Pfizer Global Clinical Lead, Rare Disease in New York City, New York
This role can be based in New York, NY, Collegeville, PA or Groton, CT.
This role is a leadership position within Global Product Development Rare Disease accountable for driving/contributing to the strategic and technical aspects of global tafamidis clinical development across therapeutic areas.
This position requires strategic and innovative thinking, leadership, and exceptional communication skills. Both internal and external leadership is expected, for example, within Pfizer committees, key opinion leader advisory board meetings, and health regulatory authority interactions.
Strategic and Innovative Thinking:
• Accountable for maintaining the clinical development plan, developing and delivering the clinical development strategy for tafamidis that is consistent with the overarching strategy and vision for Pfizer Global Product Development Rare Disease
• Able to develop unique insights and opportunities in the current ATTR amyloidoses landscape as well as any other future indications for which tafamidis may be developed, the competitive environment, and the standard of care in these disease areas to create a highly differentiated strategy.
• Actively and continuously engages with external thought leaders, both formally and informally, to bring in new ideas and insights into the clinical development strategy for tafamidis.
• Promotes a culture of innovation and applies Rare Disease drug development knowledge and experience to ensure that the design and conduct of tafamidis studies are performed with high likelihood of technical, regulatory, and commercial success.
• Applies robust and evidence-based decision making principles in the development of new clinical concepts, programs, and strategies.
• Sits on the Tafamidis Global Medicine Team, leading the design and execution of the clinical strategy for tafamidis leading to supplemental regulatory approvals and/or support of approved indications.
• Sits on the Tafamidis Publication Subcommittee and contributes to designing the Tafamidis publication strategy.
• sits on the Tafamidis Clinical Subteam, working closely with MD and non-MD Clinicians and Clinical Operational Group Leaders in Clinical Development and Operations to oversee protocol development, global study activation, execution, analysis, and reporting with high quality and compliance in timely fashion.
• contributes to a motivated, committed, and engaged Tafamidis Clinical Subteam, modeling leadership behavior and expecting effective Tafamidis Clinical Subteam behavior to achieve project goals.
• Acts decisively, making effective decisions by applying scientific and development acumen, also acting with urgency and removing barriers that hinder productivity.
• Partners with the tafamidis Safety Risk Lead and medical monitor in the maintenance of the safety risk management plan and ensuring its adherence.
• Leads or assists in the preparations of the clinical content of regulatory submissions/documents, ensuring that these documents convey a clear and accurate portrayal of the clinical data and place it into appropriate clinical context.
• Aligns on the integration of new findings/learnings (e.g., preclinical, clinical, or safety findings) into planned and ongoing clinical development programs.
• Effectively informs, negotiates with, and influences key internal stakeholders (including all levels of management as appropriate).
• Routinely engages with regional colleagues (e.g., Medical Affairs, etc.) on clinical development strategy and regional execution.
• Actively prepares for health regulatory authority interactions, contributing to briefing documents and addressing questions from health regulatory authorities
• Able to clearly and accurately articulate clinical strategy and clinical data, scenarios, and tactics in a way that is appropriate for the audience.
• Encourages transparency and fosters open dialogue with all stakeholders.
• Interacts closely with colleagues across Research and Development, including but not limited to Statistics, Clinical Pharmacology, Regulatory Affairs, Safety Risk Management, as well as Medical Affairs, Outcomes Research, and Commercial Development.
• MD or equivalent medical degree and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice, or industry setting.
• A minimum of five years of industry experience.
• Prior specialized training in Neurology or Cardiology is desired including board certification.
• Prior experience in drug development (academia or industry) and track record of regulatory interactions.
• Proven scientific writing skills and exceptional communication skills.
• Proven leadership skills with ability to defend the clinical development plan in front of strategic and technical governance committees.
• Proven ability to function effectively across a complex matrix organization with multiple stakeholders and constituents, with the expertise and the gravitas to align clinical team work towards a singular goal.
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