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, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance.
Demonstrates scientific writing skills and excellent communication skills (written and spoken) in English; scientific productivity via publications, posters, abstracts and/or presentations.
Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned.
Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets; sets priorities; able to define and manage appropriate resource requirements (budgets and FTEs) both in-house and vendors / contractors.
Good judge of talent; can articulate strengths and limitations of people; provides challenging tasks and assignments, holds frequent development discussions; is aware of each person's career goals and constructs compelling development plans; is a people builder.
Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development; proficient with basic IT; efficiently using a computer and telecommunications (voice and video).
Has a global perspective and mindset works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies, both as a leader and a key contributor; works effectively with internal and external partners and investigators/medical professionals.
Able to act as mentor / coach; helps others improve soft skills; holds development discussions; is aware of each person's career goals and constructs development plans.
Demonstrates a passion for helping patients with cancer and for the science of oncology.
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel 10% or less; mostly national, rarely international.
LI-PFE
Location: Hybrid
The annual base salary for this position ranges from $204,700.00 to $341,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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.
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. This position requires permanent work authorization in the United States.
Medical
