Associate Principal Scientist, Clinical Research

Job Description

Translational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients. We 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 for the design, planning, and execution of early-phase clinical trials and programs in collaboration with the Clinical Director and cross-functional teams.
• Oversee, direct, and execute immunology programs, including multiple Phase‑1 and 1b trials across programs and developmental stages.
• Manage cross‑functional team performance to achieve trial objectives and address issues promptly.
• Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements, supporting study objectives and delivery of high‑quality data.
• Maintain appropriate clinical safety assessment and risk management of compounds; provide real‑time oversight of ongoing trials to identify and mitigate participant, study design, data, or conduct issues.
• Review and interpret clinical trial data; may participate in on‑site study monitoring, including site training and 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 coaching, mentoring, and development opportunities.
• Represent the company at professional events, present clinical initiatives, projects, and/or clinical trial results.
• Author clinical protocols, investigator brochures, clinical study reports, health authority update reports, responses to regulatory agencies, and other clinical and regulatory documents.
• Coordinate the development of WMA/CTD subsections; assist Clinical Directors with scientific leadership and investigator initiatives, including publications, meeting presentations, and due diligence activities.
• Develop study operational documents with input from team members, including site monitoring plans, study operations/laboratory manuals, risk language, and informed consents.
• Lead and direct teams through key study planning, development, and execution activities, including program overviews, issue escalation and mitigation, senior management presentations, cross‑functional governance meetings, and advisory meeting preparation.
• Manage trial and program projects, including team meetings and collaborative workspace/document management, while providing risk assessments and contingency planning under accelerated timelines.

• 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

* e.g., clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing

• 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 (e.g., Phase 1b in rheumatology, dermatology, and/or gastroenterology) under accelerated timelines.
• 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.
• Ability to quickly develop a working scientific knowledge of…