Associate Principal Scientist, Clinical Research

MSD•Boston, MA

4d•$142,400 - $224,100•Hybrid

About The Position

The Associate Principal Scientist is an Early Clinical Scientist in Translational Medicine, Clinical Operations. Translational Medicine drives early clinical development by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof of concept and advance promising candidates. It designs and executes clinical pharmacology strategies from 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 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. The role is accountable for executing Immunology programs, including multiple Phase 1 and 1b trials across programs and developmental stages. It manages cross-functional team performance, addresses issues, and ensures execution excellence and compliance with GCP, ICH, and regulatory requirements. The position 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 conduct issues. It reviews clinical trial data and may participate in on-site study monitoring, including site training and supervision of complex, novel endpoint and biomarker collection processes. It represents Early-Stage Development Clinical Operations on early development and product development teams; leads or participates in development of departmental and global procedures; identifies and communicates best practices; promotes adoption of new procedures; and coaches and mentors junior team members. It may also represent the company at professional events and present clinical initiatives, projects, or trial results. The role authors clinical protocols, investigator brochures, clinical study reports, health authority update reports, responses to regulatory agencies and audits/inspections, and other clinical and regulatory documents. It develops study operational documents with team input, authors and coordinates WMA/CTD subsections, supports Clinical Directors with scientific leadership and investigator initiatives, and ensures documents meet applicable standards. The position leads, directs, or supports teams through study planning, development, and execution activities, including program overviews, issue escalation and mitigation, senior management presentations, governance meetings, and advisory meeting preparation. It manages trial and program projects, team meetings, and collaborative workspaces/document management, while providing risk assessments and contingency planning under accelerated timelines. The position is based at the primary location in West Point, Pennsylvania, with a hybrid work arrangement and approximately 10% travel.

Requirements

Degree in Life Sciences.
Bachelor’s degree and at least 11 years of related experience, or a Master’s degree and at least 8 years of related experience, or a PhD/doctorate and at least 3 years of related experience.
At least 3 years of Phase 1 clinical trial experience.
Experience developing, implementing, and managing immunology clinical programs and trials in healthy participants and/or patients, with efficient and timely execution against milestones under accelerated timelines.
Ability to think creatively, explore novel ways of working, and navigate ambiguity to drive results.
Ability to solve complex problems and use independent judgment concerning regulations, guidelines, and investigator interactions.
Ability to quickly develop working scientific knowledge of different therapeutic areas.
Demonstrated excellence in complex project management and management of multiple projects and priorities.
Ability to work effectively across boundaries and apply understanding of cultural differences to communication and collaboration.
Demonstrated excellence in scientific, medical/safety writing, and reporting.
Ability to work independently across functional areas, make data-driven decisions, identify and appropriately escalate potential issues, and plan mitigations.
Proven ability to partner effectively with external teams.
Effective written and oral communication, 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 addressing a business gap or process improvement.
Must act with courage and candor.

Nice To Haves

Experience with early immunology patient trials, such as Phase 1b trials in rheumatology, dermatology, and/or gastroenterology.
An advanced degree.
Experience with global Phase 1 patient trials, safety reporting, and regulatory NDA/WMA submissions.

Responsibilities

Provide clinical operational leadership for design, planning, and execution of early-phase clinical trials and programs in collaboration with the Clinical Director and cross-functional teams.
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.
Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements.
Ensure appropriate clinical safety assessment and compound risk management, and oversee ongoing trials in real time to identify and mitigate participant, design, data, and conduct issues.
Review clinical trial data and, when needed, participate in on-site study monitoring, site training, and supervision of complex endpoint and biomarker collection processes.
Represent Early-Stage Development Clinical Operations on early development and product development teams.
Lead development of departmental job aids and SOPs and participate in or lead cross-functional teams developing global clinical development procedures.
Identify and communicate organizational best practices, promote adoption of new procedures, and coach and mentor junior team members.
Potentially represent the company at professional events and present clinical initiatives, projects, or trial results.
Author clinical protocols, investigator brochures, clinical study reports, health authority update reports, regulatory responses, audit and inspection responses, and other clinical and regulatory documents.
Develop study operational documents, including site monitoring plans, study operations and laboratory manuals, risk language, and informed consents.
Author and coordinate development of WMA/CTD subsections.
Assist Clinical Directors with scientific leadership and investigator initiatives, including publications, meeting presentations, and due diligence activities.
Ensure documents are completed in accordance with applicable standards.
Lead, direct, or support study planning, development, and execution, including program overviews, issue escalation and mitigation, senior management presentations, governance meetings, and advisory meeting preparation.
Manage trial and program projects, team meetings, and collaborative workspaces and document management.
Provide risk assessments and contingency planning under accelerated timelines.