Late-Stage Oncology Clinical Scientist (Director, Non MD) Two (2) Positions

POSITION SUMMARY

You will be 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. You may have managerial responsibility for one or more direct reports and/or contingent worker(s).

POSITION RESPONSIBILITIES

• Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.

• Effectively partner 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).

• Represent the study team in governance meetings and submissions, partner with/support the Development lead/Medical Director regarding study and disease area strategy.

• Author 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.

• Set the clinical data review strategy and lead the team in the collection of quality data and review of emerging clinical data and trends; review and query data; present and discuss relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.

• In close partnership with medically qualified colleague/s, analyze 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).

• Follow 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.

MINIMUM QUALIFICATIONS/SKILLS

• Relevant PhD or PharmD and a minimum of 7 years of experience in a similar role in industry/CRO, OR  

• MS and a minimum of 9 years of experience in a similar role in industry/CRO, OR 

• BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO

• Clinical Research experience in the Phase 3/pivotal space in Oncology, on the side of the sponsor leading studies

• Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations.

• Strong scientific writing skills and communication skills (written and verbal) 

• Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations.

• Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance.

• Experience building consensus and driving change across all levels of the organization including senior management.

• Data listing review experience

• Experience working collaboratively in a fast-paced, team-based matrix environment as well as independently

• Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform 

PREFERRED QUALIFICATION

• Experience leading a team

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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel 10% or less; mostly national, rarely international.

Work Location Assignment: Hybrid

The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this positio