Oncology Late-Stage Clinical Scientist (non-MD, Director)

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 del