Senior Director/Team Head--Oncology Late Stage Data Review

Pfizer • La Jolla, MA

2d • Hybrid

About The Position

You will be responsible for setting the data oversight, integrity, analysis, quality, and consistent adoption of AI and best practices in support of the data strategy for the Late-Stage Oncology portfolio. You will manage and/or mentor colleagues and/or contingent workers across several indications in Oncology, providing clarity of purpose and priorities. You will also develop talent within the team.

Requirements

• Science related PhD or PharmD and minimum of 7 years of Clinical Research experience in a similar role in industry, OR MS degree and a minimum of 10 years of Clinical Research experience in industry, OR BA/BS and minimum of 12-year Clinical Research experience in a similar role in industry.
• Clinical Research and data experience in the phase 3/pivotal space in Oncology on the side of the sponsor with a track record of successful regulatory submission, inspection, and regulatory approval.
• Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations.
• Experience in application of AI in streamlining and accelerating data review activities, reporting, and visualization.
• Experience working with large data sets.
• Strong experience working with cross functional internal and externals stakeholders
• Strong communication skills (verbal, presentation as well as experience leveraging a variety of communication tools and techniques to communicate results
• Minimum of 10 years of supervisory experience with groups of 10 to 20 team members.

Nice To Haves

• Embraces evolving technologies including but not limited to AI and adopts best practices aimed at improving the efficiency and quality of clinical data review
• Has the flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned.
• Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities.
• 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.

Responsibilities

• Clinical development data and AI expert for assigned late stage (Phase 2-3) studies maintaining clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Effectively partners with other clinical and medical colleagues, clinical operations, data management, digital, and other functional lines for the successful implementation and execution of the clinical data deliverables within the Oncology Late Stage Portfolio.
• Holds colleagues/reports accountable, manages conflicting priorities with stakeholders and exhibits strong clinical judgement to ensure scientific oversight, data integrity and quality of clinical data.
• Sets the clinical data review strategy and leads the team in the review, reporting, and optimization of the data analysis; presents to stakeholders as needed.
• Follows relevant SOPs and regulations, complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical data procedures
• Leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing data procedures.
• Potential subject matter expert or business process owner for a relevant SOP or procedure as needed
• Manages line reports and/or contingent workers, providing clarity of purpose and priorities.
• Develops talent within the team.

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree