Pfizer Global Clinical Lead Rare Disease in Collegeville, Pennsylvania
This role is a senior leadership position within Global Product Development Rare Diseases accountable for driving the strategic and technical aspects of global asset clinical development and lead the clinical development efforts for hemophilia.
This position requires strategic and innovative thinking, leadership, and exceptional communication skills. Both internal and external leadership is expected, for example, in Pfizer governance committee meetings, key opinion leader advisory board meetings, and health regulatory authority interactions.
Strategic and Innovative Thinking:
• Accountable for developing and delivering the clinical development strategy for assets consistent with the overarching strategy and vision for Pfizer Global Product Development and Pfizer Rare Disease
including creating and maintaining the clinical development plan.
• Responsible for identifying opportunities in the current treatment landscapes for future indications for which Assets may be developed, through current knowledge of and insight into the competitive environment and the standard of care in to create a highly differentiated strategy.
• Represents the Asset clinical team during health regulatory authority meetings.
• 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 Asset.
• Promotes a culture of innovation and applies drug development knowledge and experience to ensure that the design and conduct of Asset studies are done 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 Global Medicine Team, leading the design and execution of the clinical strategy for Assets leading to primary and supplemental regulatory approvals and/or support of approved indications.
• Contributes to designing the Asset publication strategy.
• Leads the Asset Clinical Sub-team, working closely with MD and non-MD Clinicians and Clinical Operational Group Leaders in Clinical Development and Operations to oversee the clinical development plan, protocol development, global study activation, execution, analysis, and reporting with high quality and compliance in timely fashion.
• Acts decisively, making effective decisions by applying scientific and development acumen, also acting with urgency and removing barriers that hinder productivity.
• Partners with the Asset Safety Risk Lead 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 (e.g., T2V, IB, AR/DSUR, core data sheet/product label). Ensures 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 programs.
• Creates a motivated, committed, and engaged Asset clinical team, modeling leadership behavior and expecting effective Asset clinical team behavior to achieve project goals.
• Effectively informs, negotiates with, and influences key internal stakeholders (including all levels of management as appropriate).
• Routinely engages with regional colleagues (e.g., Regional Presidents, Commercial Development, Medical Affairs, etc.) on clinical development strategy and regional execution.
• Takes lead roles in health regulatory authority interactions, preparation of briefing documents, and addressing questions from health regulatory authorities.
• Able to represent Asset and serve as lead presenter/moderator at regulatory defense proceedings (e.g., ODAC)
• 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.
• PhD degree required in a relevant scientific field and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice, or industry setting.
10+ years of drug development experience including pivotal study experience.
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.
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.
• Drug development experience in congenital or acquired bleeding disorders
• Prior experience in rare disease drug development (academia or industry) and track record of regulatory interactions
• Prior experience managing an external collaboration
This role can be done US Remote, or based at any Pfizer US (GPD) location.
Posting will expire on: April 26, 2019
N (Other) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.