Senior Director, Clinical Development – Solid Tumor

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

📋 Description

• Develop strategies for clinical programs and create clinical development plans that align with global regulatory and commercial access requirements for partnership assets.

• Provide recommendations for clinical development and ensure that regulatory submissions yield high-quality, compliant outcomes.

• Collaborate with core team members and Execution Units to design and implement clinical studies.

• Offer scientific expertise in the selection of investigators and vendors.

• Deliver scientific and medical guidance throughout the duration of clinical trials.

• Review, query, analyze, interpret, and present clinical trial data to internal and external stakeholders.

• Establish and maintain networks with opinion leaders and investigators.

• Organize and present at advisory boards and meetings with key opinion leaders and investigators.

• Generate, draft, update, and review various clinical development and regulatory documents, including protocols, informed consent forms, Investigator Brochures, clinical study reports, publications, and regulatory submissions.

• Address inquiries regarding study design, analysis, and interpretation from monitors, regulators, investigators, and CROs.

• Consult with Advisory Committees and integrate relevant feedback into strategy and execution.

• Provide training and guidance to Execution Unit, CRO, and study-site personnel.

• Coach and mentor team members as necessary for performance enhancement and team development.

• Conduct regular review meetings to support ongoing studies and ensure adherence to quality and timelines.

• Report on study status, objectives, operational KPIs, and quality KPIs.

• Promote global collaboration and ensure consistency across Global Development efforts.

• Escalate asset-related concerns to the core team of the partnership program.

• Contribute to research in the therapeutic area and conduct competitor analysis.

• Take part in discussions on company-wide standards, including finalization and implementation.

• Manage direct reports who support assigned partnership programs.

⛳️ Requirements

• MD, DO degree, or an equivalent qualification in a related field is required.

• A minimum of 6+ years of experience in clinical development is necessary.

• At least 5 years of experience in the oncology therapeutic area is essential.

• A total of 10+ years of experience is preferred.

• Professional expertise and skills in oncology therapeutics are required.

• Proven success in building, managing, and developing teams.

• Familiarity with applicable international compliance guidelines and regulations is essential.

• Experience in a global work environment is preferred.

• A deep understanding of immuno-oncology is highly desired.

• Proficiency in written and verbal English is required.

• Competency in Microsoft Office Suite is necessary.

• Willingness to travel domestically and internationally, up to 20% of the time.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial positions.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.