Director of Early-Stage Oncology Clinical Science

POSITION SUMMARY

Join our dynamic team as a leader in the development of groundbreaking clinical studies related to innovative biological therapies and small molecules in Oncology. In this role, you will be pivotal in coordinating and executing first-in-human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE), and proof of concept (POC) studies. Collaborating closely with the Global Development Lead (GDL) and various functional experts, you will guide the clinical development plans with precision, ensuring that project timelines are met while maintaining high standards for safety and data interpretation.

POSITION RESPONSIBILITIES

• Collaborate with the Global Development Lead to implement effective clinical development strategies for assigned molecules and indications.

• Provide scientific leadership in the execution of clinical studies, focusing on innovative designs and ensuring high-quality trial execution.

• Support the timely execution of FIH programs through to proof of concept.

• Develop and oversee clinical data review strategies, ensuring quality and correctness of emerging data, and present findings to stakeholders.

• Work with GDL and other departments to analyze and interpret clinical trial data.

• Serve as a technical resource for clinical queries from collaborators, investigators, and consultants.

• Contribute to the creation of scientific publications, abstracts, and presentations.

• Participate actively in project teams for the successful implementation of key milestones.

• Lead the preparation of clinical protocols and support documents like clinical development plans, INDs, and regulatory submissions.

• Encourage a transparent and collaborative work environment across various teams within the organization.

• Build strong collaborations with key partners across disciplines such as clinical operations, safety, and biostatistics.

• Engage with Translational Oncology and Biomarker teams to integrate biomarker plans into clinical development.

• Establish relationships with external experts and regulators to incorporate leading clinical insights into development plans.

• Stay current with scientific literature relevant to Oncology and clinical development.

• Perform additional duties as assigned to support clinical programs.

• Support departmental initiatives and priorities as directed.

MINIMUM QUALIFICATIONS / KEY SKILLS

• PhD or PharmD with a minimum of 5 years of related experience in the industry/CRO, or MS with 7 years, or BA/BS with 10 years.

• Demonstrated clinical research experience in Phase 1 Oncology as a sponsor.

• Strong understanding of Oncology Drug Development, particularly in early development phases.

• Expertise in clinical procedures, ICH guidelines, GCP, and familiarity with FDA and EMA regulations.

• Exceptional scientific writing and communication skills, both written and verbal.

• Experience in clinical document writing and complex data analysis.

• Proven track record of scientific publication, presentations, and professional contributions.

• Ability to work collaboratively in a fast-paced environment and drive consensus across organizational levels.

• Familiarity with complex data analysis platforms.

PREFERRED QUALIFICATIONS

• Experience in a leadership role.

Candidate should exhibit diverse leadership capabilities, including influencing peers, mentoring, and guiding team members towards achieving impactful outcomes.

PHYSICAL/MENTAL REQUIREMENTS

Ability to perform complex data analysis and interpret significant research findings.

TRAVEL REQUIREMENTS

5-10% travel may be required.

This position is eligible for hybrid work arrangements. The annual base salary ranges from $169,700.00 to $282,900.00, with a bonus target of 20% and participation in a long-term incentive program. Comprehensive benefits are provided to support work-life balance.

Relocation assistance may be available based on business needs.