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. Responsibilities 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. Education 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 *e.g., clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing Required Experience and Skills 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 different therapeutic areas (ECSs have opportunities to support other therapeutic areas based on portfolio needs). 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. Ability to independently work across functional areas to make data‑driven decisions, as well as proactively identify, appropriately escape, and plan for mitigations to potential issues within a study, program or initiative. Proven ability to partner effectively with external teams to achieve results. Effective communication (written and oral), problem solving and analytical skills. Working knowledge of GCP, ICH guidelines and regulatory requirements. Ability to mentor junior staff. Demonstrated leadership or participation in a cross‑functional initiative to address a business gap or process improvement. Must act with courage and candor. Preferred Experience and Skills An advanced degree is desirable. Global Phase 1 patient trials, safety reporting, and regulatory NDA/WMA submission experience a plus. Required Skills Biomarker Assay Development, Biomarker Assay Development, Clinical Development, Clinical Reporting, Clinical Research, Clinical Risk Management, Clinical Site Management, Clinical Study Design, Clinical Trials, Clinical Trials Operations, Detail‑Oriented, Due Diligence, Early Clinical Development, Ethical Compliance, Ethical Standards, Good Clinical Practice (GCP), Immunogenicity Assays, Immunology, Job Aids, Medical Writing, Multiple Therapeutic Areas, Patient Recruitment, Regulatory Requirements, Regulatory Responses, Scientific Leadership. Preferred Skills Current Employees apply here. Current Contingent Workers apply here. Location and Employment Conditions US and Puerto Rico Residents Only. The company is committed to inclusion and will provide accommodation during the application or hiring process if needed. Equal Employment Opportunity Statement We provide equal opportunities for all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. Salary and Benefits The salary range for this role is $142,400.00 – $224,100.00. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, and other insurance benefits (for employee and family), retirement benefits (including 401(k)), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at Job Details Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 07/15/2026 Requisition ID R403573 #J-18808-Ljbffr