Associate Principal Scientist, Clinical Research

About the role

The Early Clinical Scientist (ECS) provides operational and scientific leadership, along with therapeutic expertise, for the design, planning, and execution of early-phase clinical trials and programs in collaboration with the Clinical Director and cross-functional teams. The ECS manages cross-functional team performance to achieve trial objectives and addresses issues if they arise. They ensure execution excellence and compliance with GCP, ICH, and regulatory requirements, supporting study objectives and the delivery of high-quality data.

Responsibilities

• Design and execute clinical pharmacology strategies spanning first-in-human studies through proof-of-biology/proof-of-concept and into late-stage development, supporting worldwide marketing applications and lifecycle management.
• Provide operational and scientific leadership, along with therapeutic expertise, for the design, planning, and execution of early-phase clinical trials and programs in collaboration with the Clinical Director and cross-functional teams.
• Manage cross-functional team performance to achieve trial objectives and address issues if they arise.
• Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements, supporting study objectives and the delivery of high-quality data.
• Ensure appropriate clinical safety assessment and risk management of compounds, and provide real-time oversight of ongoing trials to identify and mitigate participant, study design, data, or study conduct issues.
• Review and interpret clinical trial data and may participate in on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes.
• Represent Early Stage Development on early development and product development teams.
• Lead the development of departmental job aids/SOPs and participate in, or lead, cross-functional teams developing global clinical development procedures.
• Identify and communicate best practices across the organization.
• Promote departmental adaptation of new procedures and build junior team members’ capabilities through proactive coaching, mentoring, and development opportunities.
• May represent the company at professional events. Present clinical initiatives, projects, and/or clinical trial results.

Qualifications

• Minimum Requirement: Degree in Life Sciences (Bachelor’s degree and ≥11 years related experience, OR Master’s degree and ≥8 years related experience, OR PhD or doctorate degree and ≥3 years related experience).
• Required Experience: At least 6 years early phase/translational medicine clinical research experience. Experience developing, implementing, and managing immunology clinical programs and trials to ensure efficient, timely execution against milestones, including experience with immunology early patient trials (eg, Phase 1b in rheumatology, dermatology, and/or gastroenterology) under accelerated timelines.
• Skills: Ability to think creatively, explore novel ways of working, and comfortably navigate ambiguity to drive results. Ability to solve complex problems and use independent judgment relating to regulations, guidelines, investigator interactions. Demonstrated excellence in complex project management and effectively managing multiple projects/priorities; work effectively across boundaries, applying an understanding of cultural differences to communication and collaboration practices. Demonstrated excellence in scientific, medical/safety writing, and reporting. Proven ability to partner effectively with external teams to achieve results. Effective communication (written and oral), problem solving and analytical skills.

Preferred Skills

• Biomarker Assay Development
• Current Phase 1 patient trials, safety reporting, and regulatory NDA/WMA submission experience