Scientist - Development

The Scientist for Clinical Trials - Late Stage (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. You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within our 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 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, partners with/supports 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; Set 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.
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; PhD/Pharm D OR MS in a relevant Science discipline and strong Clinical Research experience in industry/CRO, OR
BA/BS in a relevant Science discipline and extensive Clinical Research experience in a similar role in industry/CRO
Clinical Research experience in the phase 2 - 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
Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance
Experience working on large data sets
Proficiency with Microsoft Office and relevant scientific software
Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
Experience building partnerships across the company to achieve the needs of the program

Demonstrates passion for helping patients with cancer and for the science of oncology
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
Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies
Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes
Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development
Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. Work Location Assignment: Hybrid (some office presence is required)

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