Associate Principal Scientist, Clinical Research

Job Description

Position Title (Short Title): Associate Principal Scientist

Department: Translational Medicine, Clinical Operations

Brief Description of Position:

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.

The Early Clinical Scientist (ECS) provides clinical operational leadership for the design, planning, and execution of early-phase clinical trials and programs in collaboration with the Clinical Director and cross-functional teams. Accountable for the execution of Immunology programs including multiple Phase 1 and 1b trials across programs and developmental stages. Manages cross-functional team performance to achieve trial objectives and addresses issues if they arise. Ensures execution excellence and compliance with GCP, ICH, and regulatory requirements, supporting study objectives and the delivery of high-quality data.

Ensures appropriate clinical safety assessment and risk management of compounds and provides real-time oversight of ongoing trials to identify and mitigate participant, study design, data, or study conduct issues. Reviews clinical trial data and may participate in on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes.

Represents Early-Stage Development Clinical Operations on early development and product development teams. Leads the development of departmental job aids/SOPs and participates in, or leads, cross-functional teams developing global clinical development procedures. Identifies and communicates best practices across the organization. Promotes departmental adoptation of new procedures and builds 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.

Technical Writing & Communications:

• Responsible for authoring clinical protocols, investigator brochures, clinical study reports, health authority update reports, responses to regulatory agencies and audits/inspections, and other clinical and regulatory documents.
• Develops study operational documents with input from team members, including site monitoring plans, study operations/laboratory manuals, risk language, and informed consents.
• Authors and coordinates the development of WMA/CTD subsections.
• Assist Clinical Directors with scientific leadership and investigator initiatives, including publications, meeting presentations, and due diligence activities.
• Ensures documents are completed in accordance with applicable standards.

Project Management:

• Leads, directs, or supports 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.
• Manages trial and program projects, including team meetings and collaborative workspace/document management, while providing risk assessments and contingency planning under accelerated timelines.

Reports to

Director/Senior Principal Scientist/Distinguished Scientist

Location

WP/RY/BOS/SSF

Extent of Travel

~10%

Qualifications, Skills & Experience

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 3 years Phase 1 clinical trial experience.

• Experience developing, implementing, and managing immunology clinical programs and trials in healthy participants and/or patients to ensure efficient, timely execution against milestones under accelerated timelines; experience with immunology early patient trials (eg, Phase 1b patient trials in rheumatology, dermatology, and/or gastroenterology) preferred.

• 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).

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