Associate Principal Scientist, Clinical Research

Merck•Boston, MA

6d•$142,400 - $224,100•Hybrid

About The Position

The Associate Principal Scientist, serving as an Early Clinical Scientist in Translational Medicine, Clinical Operations, 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 Phase 1b trials across programs and development stages. It manages cross-functional team performance, resolves issues, and ensures execution excellence and compliance with GCP, ICH, and regulatory requirements to deliver high-quality data and meet study objectives. The position oversees clinical safety assessment and compound risk management, providing real-time oversight of trials to identify and mitigate participant, study-design, data, or conduct issues. It reviews clinical trial data and may participate in on-site monitoring, including site training and supervision for complex or novel endpoint and biomarker collection. The role represents Early-Stage Development Clinical Operations on early-development and product-development teams; develops departmental job aids and SOPs; contributes to global clinical development procedures; shares best practices; and supports junior team members through coaching and mentoring. 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, regulatory responses, and other clinical and regulatory documents. It develops operational documents with team input, including site monitoring plans, study operations and laboratory manuals, risk language, and informed consents; authors and coordinates WMA/CTD subsections; and assists Clinical Directors with investigator initiatives, publications, presentations, and due diligence. It ensures documents meet applicable standards. The Associate Principal Scientist leads, directs, or supports teams through study planning, development, and execution, 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 and document management, and provides risk assessments and contingency planning under accelerated timelines. The position reports to a Director, Senior Principal Scientist, or Distinguished Scientist and is hybrid, with 10% travel.

Requirements

Degree in Life Sciences.
Bachelor’s degree with at least 11 years of related experience, or a master’s degree with at least 8 years of related experience, or a PhD/doctorate with 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, ensuring 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 exercise 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 managing multiple projects and priorities; ability to work across boundaries and account for cultural differences in communication and collaboration.
Demonstrated excellence in scientific, medical/safety writing, and reporting.
Ability to work independently across functional areas, make data-driven decisions, proactively identify and appropriately escalate issues, and plan mitigations for studies, programs, or initiatives.
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.
Required skills listed include biomarker assay development, clinical development and reporting, clinical research, clinical site management, clinical study design, clinical trial development and operations, contingency planning, early-phase clinical trials, enterprise leadership, ethical compliance and standards, GCP, independent thinking, life science, medical writing, meeting facilitation, multiple therapeutic areas, non-disclosure agreements, patient recruitment, presentation preparation, project management leadership, and regulatory compliance.

Nice To Haves

Advanced degree is desirable.
Experience with early immunology patient trials, such as Phase 1b trials in rheumatology, dermatology, and/or gastroenterology, is preferred.
Global Phase 1 patient-trial experience, safety reporting, and regulatory NDA/WMA submission experience are a plus.

Responsibilities

Provide clinical operational leadership for the design, planning, and execution of early-phase clinical trials and programs in partnership with Clinical Directors and cross-functional teams.
Execute Immunology programs, including multiple Phase 1 and Phase 1b trials across programs and developmental stages.
Manage cross-functional team performance, address issues, and ensure trial objectives, execution excellence, and compliance with GCP, ICH, and regulatory requirements.
Oversee clinical safety assessment and compound risk management, and provide real-time trial oversight to identify and mitigate participant, design, data, or study-conduct issues.
Review clinical trial data and, as needed, participate in on-site monitoring, site training, and supervision of complex or novel endpoint and biomarker collection.
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; coach, mentor, and develop junior team members.
As appropriate, 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, and other clinical and regulatory documents.
Develop study operational documents with team input, including site monitoring plans, study operations and laboratory manuals, risk language, and informed consents.
Author and coordinate development of WMA/CTD subsections, and assist Clinical Directors with publications, meeting presentations, investigator initiatives, and due diligence.
Ensure documents are completed in accordance with applicable standards.
Lead, direct, or support study planning, development, and execution activities, 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 workspace and document management; provide risk assessments and contingency planning under accelerated timelines.