Clinical Development Scientist, Director (Secondment - 12 Months)

Pfizer • Bothell, MA

1d • Hybrid

About The Position

Oncology Late-Stage Development (OLSD) is seeking a highly motivated Clinical Development Scientist for a 12-month, full-time secondment. The colleague will contribute to the design, execution, oversight, and interpretation of global oncology clinical studies while gaining broad exposure to late-stage drug development and cross-functional decision-making. This opportunity is well suited to a colleague who wants to deepen clinical development expertise, broaden oncology experience, and contribute to high-priority study and portfolio deliverables in a matrix global environment.

Requirements

• Applicant must have a bachelor's degree with at least 8+ years of experience.
• 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.
• 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.
• 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.
• 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.
• 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.
• This position requires permanent work authorization in the United States.

Nice To Haves

• Master's degree with at least 7+ years of experience; OR a PhD with 5+ years of experience, OR a MD with 4+ years of experience.
• 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.
• Proven analytical skills with the ability to work on large data sets.
• 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

• Scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio.
• 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; may lead or actively participate in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures.

Benefits

• Salary, benefits, and compensation costs will be covered by the secondee's home organization.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Director