Director/Senior Director, Clinical Science

About the company

IDRx is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. IDRx is an exciting early stage company that aims to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong response to therapy. IDRx’s lead program is IDRX-42, designed to inhibit key genetic drivers and drug-resistant mutations of KIT in gastrointestinal stromal tumor (GIST). IDRx's pipeline also includes a second KIT inhibitor, IDRX-73.

About the role

Our growing clinical development team is looking to fill a key newly created position of Director/Senior Director, Clinical Science. IDRx is an early-stage oncology company with an exciting, potentially best-in-class asset in the clinic, and we are looking for an individual to take on an integral role in building out the Clinical Science function at IDRx. This role reports directly to the Chief Medical Officer (CMO). The dynamics of a small team will allow for high visibility and an opportunity to contribute significantly to the clinical development strategy and execution of our lead program, IDRX-42.

Role and Responsibilities

• In collaboration with medical leadership, drive clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.
• In collaboration with internal/external experts on biostatistics, clinical pharmacology, translational medicine, pharmacovigilance, clinical operations and data management, contributes to the development of the plan to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization.
• Collaborate within the clinical development organization on the review, analysis, and interpretation of study results and assure appropriate data review and accurate data reporting.
• Identify study issues and program issues by review and monitoring of emerging clinical study data.
• Develop sound, strategic solutions to issues and collaborate with the clinical study team to ensure issue resolution.
• Work closely with the Sponsor and/or CRO medical monitor to assure they are informed of pertinent study information, including but not limited to safety and efficacy data.
• Support the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
• In conjunction with the CMO and other clinical development team members, develop presentations and communicate study data results to colleagues internally, and to external audiences including investigators at sponsor meetings or audiences at scientific conferences.
• Present clinical data to KOLs and other clinicians at investigator meetings, advisory boards and other interactions.
• Serve as clinical science representative on cross-function teams as assigned.

Requirements:

• Minimum of MA 5 years of experience in a clinical science or related role in a biotech or pharmaceutical setting; advanced clinical or scientific degree, such as RN, PharmD, PhD 3 years of experience preferred
• Experience in clinical development of oncology therapeutics
• Technical/operational experience in planning, executing, reporting and publishing clinical studies within the pharmaceutical industry
• Demonstrated ability to review and summarize clinical study data, including experience in preparing and presenting data
• Thorough understanding of the drug development process from pre-IND through registration and post-registration required
• Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization)
• Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy
• Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols
• Successful track record of interpreting, analyzing, and presenting clinical data, including aggregate data analyses, in order to inform decision-making and set clinical strategy
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
• Strong organization, documentation and communication skills with an ability to multitask
• Excellent interpersonal skills: ability to collaborate across disciplines
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations