Associate Principal Scientist, Clinical Research

Early Clinical Scientist (ECS)
Responsibilities

• Provide operational and scientific leadership for early-phase clinical trial design, planning, and execution in collaboration with Clinical Director and cross-functional teams.
• Oversee and execute Immunology programs (multiple Phase 1 and 1b trials), manage cross‑functional performance to meet objectives, and ensure GCP/ICH/regulatory compliance.
• Conduct clinical safety assessment and real‑time oversight of ongoing trials; review and interpret trial data and support site monitoring and training for novel endpoint/biomarker collection.
• Represent Early Stage Development on product and early development teams; lead departmental job aids/SOPs; develop and promote global clinical procedures; coach and mentor junior staff.
• Author and coordinate clinical/regulatory documents (protocols, investigator brochures, study reports, health authority updates, regulatory/audit responses; WMA/CTD subsections); develop study operational documents.
• Lead study and program project management (planning, issue escalation and mitigation, governance/advisory preparation) with risk assessments and contingency planning.

• Degree in Life Sciences.
• Bachelor’s + ≥11 years related experience, OR Master’s + ≥8 years, OR PhD/doctorate + ≥3 years (e.g., trial management/execution, clinical site training/monitoring, medical/regulatory writing).

• ≥6 years early‑phase/translational medicine clinical research; immunology clinical program/trial experience (including early patient trials such as Phase 1b in rheumatology, dermatology, gastroenterology) under accelerated timelines.
• Strong clinical research execution, scientific/medical/safety writing, data‑driven decision‑making, and independent judgment on regulations and investigator interactions.
• Working knowledge of GCP/ICH/regulatory requirements; effective communication; ability to mentor.

• Advanced degree.
• Global Phase 1 patient trials and safety reporting.
• NDA/WMA submission experience.

Salary range: $–$; bonus and long‑term incentive eligibility (if applicable); comprehensive medical, dental, and vision coverage, retirement (401(k)), and paid time off.

Apply via  (or Workday Jobs Hub for current employees). Apply by the deadline stated on the posting.