Job Title: Director Clinical Science/Oncology
Job Number: 32280
The role of Director, Clinical Science, Oncology, will work collaboratively with the study physician and the cross functional team to manage clinical activities that will bring novel cancer therapeutics to patients in need. The role will be accountable for the clinical science aspects of clinical development programs. The ideal candidate is self-motivated, curious, detail oriented, works collaboratively and has highly relevant experience and expertise. This is a fast-paced biotech company of passionate employees, and there is ample opportunity for the ideal candidate to grow and develop with the organization.
- Acts as a key member of the clinical study team with relevant expertise in clinical science and clinical trial conduct, execution, and data interpretation.
- Works closely and collaboratively with clinical operations and CRO/vendors in planning and execution of clinical study deliverables from initiation to closeout.
- With oversight from study physician, responsible for: raising and tracking investigator/CRF queries to resolution, first-line medical monitoring, clinical data review, data trend review, protocol deviation review, data cleaning, interpretation of results, review of safety narratives, and safety reporting.
- With clinical operations lead, assures appropriate oversight of study conduct.
- Develops and manages tools to track clinical data
- Builds key relationships with external partners, sites, and investigators and, with clinical operations lead, organizes study committees and boards as needed.
- Authors and/or reviews, with support from the clinical study team, clinical study plans and documents (e.g. CRF pages, CRF completion guidelines, medical monitoring plan, data management plan, ICFs, patient eligibility forms, or other clinical or regulatory documents as needed).
- Develops relevant site facing clinical study training materials.
- With support from clinical leadership and study physician, plays a key role in the development and authorship of clinical protocol(s) and any amendments., as well as any related documents.
- With support from clinical leadership and study physician, provides clinical input and authorship for CSRs, clinical memorandums, and other key documents (e.g. IB, PSUR, DSUR, responses to regulatory authorities, etc.).
- Works closely and collaboratively with CRO clinical staff (and sites as needed) to support clinical aspects of the study including: study start up, training, subject screening and enrollment, study conduct, data and sample collection, and close out activities.
- With oversight from study physician, advises sites on accurate interpretation of protocol to ensure protocol adherence.
- With clinical study team, manages and monitors clinical sites and their performance from a clinical perspective.
- Responsible for timely delivery of relevant and accurate clinical data and data interpretation as needed for investigator calls, dose-escalation calls, and all other study, regulatory, or company milestones.
- Works closely with data management partners to design clinical databases and assure complete and accurate collection of study data.
- Escalates any important issues that involve patient safety or data integrity to study physician.
- Bachelor’s degree required, advanced degree or degree in clinically related field a plus.
- 10 years experience, with at least 5 in clinical development and at least 3 in an oncology clinical science role.
- Deep understanding and experience in conduct of clinical trials including first-in-human oncology studies.
- Experience contributing to clinical protocols and key study documents.
- Strong knowledge of medical monitoring, clinical data cleaning and interpretation, database management, good clinical practice, and relevant regulatory requirements.
- Proven track record of collaborative work to achieve program objectives.
- Commitment to patient safety, data integrity, teamwork, and successful conduct of clinical programs.
- Excellent written and verbal communication skills.
- Excellent organizational and time management skills
- Preferred Skills, not required
- Data Management and/or database build skills
- Experience in Safety and Pharmacovigilance operations
- Experience interacting with regulatory agencies
- Experience in sample management
- Strong understanding of basic science
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