Clinical Sciences Director, Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Contribute to the late-stage clinical development within the field of oncology.

• Collaborate with teams to define, design, and deliver results for late-phase clinical studies.

• Support translational initiatives as part of the ongoing drug development strategy.

• Act as an internal clinical authority in translational and clinical oncology.

• Assist the medical monitor in clinical trials while helping to resolve any emerging issues.

• Present findings and information both internally and externally across various cross-functional teams.

• Identify and manage relationships with oncology collaborators, consultants, and/or Clinical Research Organizations (CROs).

• Convert clinical strategy into study concept documents, study protocols, and related materials.

• Ensure the integrity of protocols and facilitate the delivery of final protocols with governance approval.

• Provide clinical insights during the implementation and execution of clinical trials.

• Review and interpret data and results from clinical trials.

• Conduct assessments of data quality as part of a data monitoring plan.

• Ensure data accuracy, completeness, and compliance with protocols and regulatory standards.

⛳️ Requirements

• Doctorate degree with 4 years of experience in life sciences/healthcare, OR a Master’s degree with 7 years of experience, OR a Bachelor’s degree with 9 years of experience in life sciences/healthcare.

• Preferred: 5 years of experience in pharmaceutical clinical drug development.

• Strong preference for candidates with a demonstrated history of improving oncology clinical trial processes.

• Experience in either industry or academia related to late-phase oncology drug development is highly desirable.

• Excellent written and verbal communication skills, including presentation capabilities.

• Proven experience in designing, monitoring, and implementing oncology clinical trials.

• Familiarity with interpreting test results in accordance with Good Clinical Practice standards and regulatory mandates.

• Knowledge of study data readout processes, including data cleaning, database locking, data extraction, and generating data outputs.

• Experience in drafting comprehensive submission documents for regulatory purposes.

• Experience in preparing clinical regulatory responses for health authority interactions.

• Proven record of contributing to scientific publications and presenting data at scientific conferences.

• Experience with clinical data analysis tools such as Spotfire or similar analytical software.

• Please note that sponsorship for this position is not guaranteed.

🏝️ Benefits

• Comprehensive employee benefits package.

• Generous company contributions to retirement and savings plans.

• Group coverage for medical, dental, and vision.

• Life and disability insurance provided.

• Flexible spending accounts available.

• Participation in a discretionary annual bonus program.

• Stock-based long-term incentives offered.

• Award-winning time-off plans.

• Flexible work arrangements, including remote and hybrid options when feasible.

• Opportunities for career development.

• Support for work/life balance.

• Financial planning options to help save for retirement or other goals.