Late Stage Clinical Scientist TA Head (Sr. Director)

ROLE SUMMARY

• The Late-Stage Clinical Scientist TA Head (Senior Director) is accountable for scientific oversight, data integrity, quality, and consistent adoption of best practices in support of the clinical development strategy for several studies or programs within the Late-Stage Oncology portfolio.
• The TA Head’s responsibilities are focused on managing an organization that includes individual contributor direct reports, may include TA Leads with direct reports and/or contingent workers across several indications in one therapeutic area of Oncology, providing clarity of purpose, priorities and cost efficiencies.
• The TA Head will represent the Clinical Sciences line and exhibit strong scientific leadership for their TA in clinical sub-team meetings (i.e., GDT, GPT), cross functional/limited duration teams, governance meetings, and leadership discussions. Is familiar and up to date with the therapeutic treatment landscape.
• The TA Head will maintain training and may assume tasks as Late-Stage Clinical Scientist, according to program needs.
• The TA Head will build and maintain effective relationships with key partners in the Clinical Development line (i.e. GDL, Med Directors, GRA and Biostats).
• The TA Head will collaborate with other TA Heads in the Clinical Development function to ensure appropriate resourcing of clinical studies and other cross functional leaders for other enterprise level projects.
• The TA Head will ensure that Clinical Scientists within their group are trained and compliant with requirements and regulations by defining the training curriculum and confirming appropriate assignment and completion.
• The TA Head will develop the existing clinical staff and build clinical expertise in their group as well as recruit additional clinical staff where needed.

ROLE RESPONSIBILITIES

• Manages line reports and/or contingent workers, providing clarity of purpose and priorities. Develops talent within the team.
• The number of reports (up to 20 FTEs total), clinical studies and clinical programs overseen by the TA Head will vary depending on size and complexity of the TA.
• Holds Clinical Sciences TA organization accountable, manages conflicting priorities with stakeholders, and exhibits strong clinical judgement to ensure scientific oversight, data integrity and quality of clinical program(s).
• Effectively partners with other clinical and medical colleagues, clinical operations, and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program/s.
• Ensures technical excellence and functional competency of Clinical Scientists within the TA through oversight, coaching, mentoring, performance management, and training.
• Represents the Clinical Sciences line and exhibits strong scientific leadership for their TA on Clinical sub-team meetings (i.e., GDT, GPT) cross functional/limited duration teams, governance meetings, and leadership discussions.
• May serve as a subject matter expert (SME) or business process owner (BPO) for relevant standard operating procedures (SOPs) or procedures.
• Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing Pfizer clinical development procedures.
• Clinical development expert for assigned programs.  Maintains current scientific and clinical knowledge in the specific therapeutic area(s) of assignment.
• May assume the role or perform tasks of Late-Stage Clinical Scientist on the Clinical Study Team, depending on program needs and other responsibilities.

QUALIFICATIONS

• MD with minimum of 5-years, or PhD with minimum of 10-years or MS with minimum of 13-years or BA/BS with minimum of 15-years of Clinical Research experience in industry.
• Minimum of 5 years' previous management experience of direct reports.
• Clinical Research experience in the pivotal trial space in Oncology, on the side of the sponsor, preferably with a track record of successful regulatory submission, inspection, and regulatory approval.
• Excellent knowledge of clinical procedures, ICH guidelines, and GCP and familiarity with FDA, EMA, and global regulations.
• Demonstrates clinical/medical, administrative, and project management capabilities.
• Proven analytical skills with the ability to understand and guide data review strategy for large datasets.
• Effective communication, presentation, and organizational skills with multiple senior stakeholders to ensure coordinated and timely delivery.
• Extensive understanding of related disciplines, e.g., clinical operations,