Global Clinical Lead - Benign Hematology nonMD (Executive Director)

This role is a senior leadership position within Global Product Development Benign Hematology accountable for driving the strategic and technical aspects of global asset clinical development and lead the clinical development efforts for multiple late-stage programs in Sickle Cell Disease and contributing clinical expertise to earlier Sickle Cell Disease programs and business development opportunities.

ROLE RESPONSIBILITIES
This position requires strategic and innovative thinking, individual and team leadership, and exceptional communication skills. Both internal and external leadership is expected, for example, leading cross-functional teams, preparing for and participating 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 Benign Hematology, within the Pizer Oncology and Rare Disease group. This includes including creating and executing 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.
• Leads business development and staged diligence activities on a range of hematology opportunities
• Leads Clinical colleagues from the Global Medicine Team during health regulatory authority meetings and their preparation.
• Leads engagement with external thought leaders, both formally and informally, to bring in new ideas and insights into the clinical development strategy for programs.
• Provides medical insights to the Medicine Plan and clinical studies across multiple programs
• Promotes a culture of innovation and applies drug development knowledge and experience to ensure that the design and conduct of studies results in a 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.
• Applies clinical decision-making expertise to relevant aspects of the program design and execution

Leadership:
• Leads the design and execution of the clinical strategy for multiple programs as Clinical Team leader for programs seeking primary and supplemental regulatory approvals and/or support of approved indications.
• Key driver of clinical regulatory strategy and submission preparation for initial and follow-on indications across multiple programs.
• 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 motivated, committed, and engaged clinical teams, modeling leadership behavior and expecting effective Asset clinical team behavior to achieve project goals across multiple programs

Communication:
• 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 andaccurately 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.

QUALIFICATIONS
BASIC QUALIFICATIONS
Advanced scientific degree 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 or equivalent 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.

PREFERRED QUALIFICATIONS
• Prior experience in rare disease drug development (academia or industry) and track record of regulatory interactions
• Prior experience managing an external collaboration

PHYSICAL/MENTAL REQUIREMENTS
• Presentation, Analytical Skills and Communication: demonstrates ability to present clinical data, study plans, scenarios, and tactics clearly, succinctly, and accurately to relevant audiences to obtain decision, input, and feedback when required.
• Influencing: Must be able to lead a multidisciplinary group in complex matrix environments.
• Courage with Decisiveness to Act: Bias towards action to achieving goals.
• Team Building: Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team.
• Conflict Management: Expert at focused listening; can find common ground and get cooperation with minimum noise.
• Anticipates Issues: proactively anticipates emerging issues; knows how to take action to mitigate or resolve issues.
• Uses Benchmarks: Adept at benchmarking previous regulatory submissions, regulatory precedents, recent publications, or competitive landscape events to inform and evolve strategies.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel to internal/external conferences and health regulatory authority meetings required as appropriate or according to business need. Areas covered include Asia and ROW.

Work Location Assignment: Flexible

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Medical

EEO & Employment Eligibility:

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.

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