Associate Principal Scientist, Clinical Research

MSD•Boston, PA

2d•Hybrid

About The Position

Translational Medicine drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate discoveries into human proof-of-concept and advance promising candidates. The Associate Principal Scientist, serving as an 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 execution of Immunology programs, including multiple Phase 1 and Phase 1b trials across programs and development stages. The position manages cross-functional team performance, ensures trial execution in accordance with GCP, ICH, and regulatory requirements, and provides safety assessment, risk management, and real-time oversight to identify and mitigate issues affecting participants, study design, data, or conduct. It reviews clinical trial data and may participate in site monitoring, training, and supervision of complex endpoint and biomarker collection. The role represents Early-Stage Development Clinical Operations on development teams, leads or contributes to clinical procedures and job aids, shares best practices, and coaches junior team members. It may also represent the company at professional events and present clinical initiatives or results. The role authors clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, health authority updates and responses, and audit or inspection materials. It develops operational documents such as monitoring plans, study operations and laboratory manuals, risk language, and informed consents, and authors or coordinates WMA/CTD subsections. It also supports Clinical Directors with investigator initiatives, publications, presentations, and due diligence. The Associate Principal Scientist leads, directs, or supports 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, collaborative workspaces and document management, and develops risk assessments and contingency plans, including under accelerated timelines.

Requirements

Life sciences degree and one of the following: bachelor's degree with at least 11 years of related experience; master's degree with at least 8 years; or PhD/doctorate with at least 3 years.
At least 3 years of Phase 1 clinical trial experience.
Experience developing, implementing, and managing clinical programs and trials in immunology involving healthy participants and/or patients, with responsibility for timely execution against milestones under accelerated timelines.
Ability to think creatively, explore new ways of working, and navigate ambiguity to deliver results.
Ability to solve complex problems and exercise independent judgment regarding regulations, guidelines, and investigator interactions.
Ability to quickly build working scientific knowledge across therapeutic areas.
Demonstrated excellence in complex project management and managing multiple projects and priorities.
Ability to work across organizational boundaries and account for cultural differences in communication and collaboration.
Demonstrated excellence in scientific, medical/safety writing, and reporting.
Ability to work independently across functions, make data-driven decisions, identify and 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

Lead operational design, planning, and execution of early-phase clinical trials in collaboration with Clinical Directors and cross-functional teams.
Manage execution of Immunology programs, including multiple Phase 1 and Phase 1b trials.
Manage cross-functional team performance to achieve trial objectives and address issues.
Ensure compliance with GCP, ICH, and regulatory requirements and deliver high-quality study data.
Ensure appropriate clinical safety assessment and compound risk management, and provide real-time trial oversight to identify and mitigate risks.
Review clinical trial data and, as needed, participate in on-site monitoring, site training, and supervision of complex endpoint and biomarker collection.
Represent Early-Stage Development Clinical Operations on early and product development teams.
Lead or participate in developing departmental job aids, SOPs, and global clinical development procedures; communicate best practices and promote adoption.
Coach, mentor, and develop junior team members.
Represent the company at professional events and present clinical initiatives, projects, or trial results as needed.
Author clinical protocols, investigator brochures, clinical study reports, health authority update reports, regulatory responses, and other clinical or regulatory documents.
Develop study operational documents, including monitoring plans, operations and laboratory manuals, risk language, and informed consents.
Author and coordinate WMA/CTD subsections and support publications, presentations, investigator initiatives, and due diligence.
Lead, direct, or support study planning, development, and execution activities, including program overviews, issue escalation and mitigation, management presentations, governance meetings, and advisory meeting preparation.
Manage trial and program projects, team meetings, collaborative workspaces, and document management.
Provide risk assessments and contingency planning, including under accelerated timelines.