ROLE SUMMARY
The Late-Stage Clinical Scientist (non-MD, Director) is responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio. The successful candidate may have managerial responsibility for one or more direct reports and/or contingent worker(s).
ROLE RESPONSIBILITIES
- Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
- 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.
- Responsible for scientific oversight, data integrity and quality of the clinical trial(s).
- Represents the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy.
- Authors protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.
- Sets the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
- In close partnership with medically qualified colleague/s, analyzes the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).
- 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 PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.
- May have managerial responsibility for other Clinical Scientists or contingent workers assigned to the project; may supervise, mentor, and/or develop others.
QUALIFICATIONS
- Science degree (PhD, PharmD, or equivalent) and minimum of 7-year Clinical Research experience in industry/CRO, OR BA/BS and minimum of 10-year Clinical Research experience in a similar role in industry/CRO.
- Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and 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.
- Demonstrates a passion for helping patients with cancer and for the science of oncology.
- Proven analytical skills with the ability to work on large data sets.
- Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery.
- Demonstrated scientific writing skills and excellent communication skills (written and spoken) in English; scientific productivity via publications, posters, abstracts and/or presentations.
- 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.
- Has extensive understanding of related disciplines, e.g., clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance.
- 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.
PHYSICAL/MENTAL REQUIREMENTS
- Has the flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned.
- Must have the relevant personality features and competencies supporting the responsibilities:
- Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities.
- Promotes team health and exemplifies Pfizer’s leadership behaviors and actionable attitudes.
- Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies.
- Has foresight and judgment in complex decisions.
- Leverages a variety of communication tools and techniques to communicate results.
- Effectively builds partnerships across the company to achieve the needs of the program.
- Solves problems collaboratively and handles conflict constructively.
- Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes.
- Ability to work proactively and independently, organize tasks, time and priorities of self and others.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Occasional travel 10% or less; mostly national, rarely international.
Work Location Assignment: Must be on-site an average of 2.5 days/week.
The annual base salary for this position ranges from $161,600.00 to $269,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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.
Relocation assistance may be available based on business needs and/or eligibility.
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.
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