Clinical Project Manager, Phase I Studies
Position Summary
NewAmsterdam is an innovative biotech company with experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related diseases. Our vision is that people at risk of heart disease can take control of their health and live longer, fuller lives. Our team is led by a world-class team of industry veterans and key opinion leaders, including some of the worldâs preeminent cardiometabolic experts and we foster a passionate, supportive culture that is backed by a high level of integrity and inclusivity.
NewAmsterdam Pharma is advancing therapies targeting Cardiovascular and Alzheimerâs disease. The Phase 1 Clinical Project Manager (CPM) oversees endâtoâend operational management of firstâinâhuman, SAD/MAD, food effect, drug-drug interactions, and early proof-of-concept studies ensuring compliance with SOPs, ICH-GCP, and applicable regulatory requirements while delivering high quality execution on time and within budget.
Key Responsibilities
⢠Lead operational planning and feasibility assessments for Phase 1 studies
⢠Contribute to protocol development, including dose escalation, PK/PD, biomarker sampling, and specialty assessment planning.
⢠Oversee vendor selection and management including contracting, performance, and budget management (Phase 1 units, bioanalytical labs, specialty testing providers, central labs).
⢠Manage study execution, budget, timelines, risk mitigation, doseâescalation logistics, and crossâfunctional communication.
⢠Oversee pharmacokinetic sampling, specialty assessments (ECGs, Holter monitoring), neurological endpoints, and biomarker collection.
⢠Lead CRO and vendor oversight, ensuring delivery quality and adherence to timelines.
⢠Coordinate safety review committees, data flow, AEs/SAEs, SUSAR management, and inspection readiness.
⢠Support study close out activities including data review, database lock, CSR development, TMF completeness and archiving.
Requirements:
⢠Bachelorâs degree in Life Sciences or related field.
⢠5+ years of clinical trial management experience, including 2+ years in Phase 1.
⢠Experience in cardiovascular and/or neuroscience clinical research.
⢠Strong understanding of operational complexities of earlyâphase studies and safety monitoring (intensive PK sampling, confinement studies, rapid safety reviews).
⢠Experience managing CROs, vendors, and Phase 1 units.
⢠Demonstrated self-discipline, motivation, and entrepreneurial
⢠Advanced knowledge of ICH-GCP, FDA, and global regulatory requirements
⢠Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision
⢠Ability to effectively collaborate with cross functional teams
⢠Excellent interpersonal, oral, written communication skills
⢠Proficient in MS Office applications (e.g. TEAMS, Outlook, Word, PowerPoint, Excel), CTMS systems and EDC systems
⢠Travel up to 10â20%
NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.
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NewAmsterdam is an innovative biotech company with experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related diseases. Our vision is that people at risk of heart disease can take control of their health and live longer, fuller lives. Our team is led by a world-class team of industry veterans and key opinion leaders, including some of the worldâs preeminent cardiometabolic experts and we foster a passionate, supportive culture that is backed by a high level of integrity and inclusivity.
NewAmsterdam Pharma is advancing therapies targeting Cardiovascular and Alzheimerâs disease. The Phase 1 Clinical Project Manager (CPM) oversees endâtoâend operational management of firstâinâhuman, SAD/MAD, food effect, drug-drug interactions, and early proof-of-concept studies ensuring compliance with SOPs, ICH-GCP, and applicable regulatory requirements while delivering high quality execution on time and within budget.
Key Responsibilities
⢠Lead operational planning and feasibility assessments for Phase 1 studies
⢠Contribute to protocol development, including dose escalation, PK/PD, biomarker sampling, and specialty assessment planning.
⢠Oversee vendor selection and management including contracting, performance, and budget management (Phase 1 units, bioanalytical labs, specialty testing providers, central labs).
⢠Manage study execution, budget, timelines, risk mitigation, doseâescalation logistics, and crossâfunctional communication.
⢠Oversee pharmacokinetic sampling, specialty assessments (ECGs, Holter monitoring), neurological endpoints, and biomarker collection.
⢠Lead CRO and vendor oversight, ensuring delivery quality and adherence to timelines.
⢠Coordinate safety review committees, data flow, AEs/SAEs, SUSAR management, and inspection readiness.
⢠Support study close out activities including data review, database lock, CSR development, TMF completeness and archiving.
Requirements:
⢠Bachelorâs degree in Life Sciences or related field.
⢠5+ years of clinical trial management experience, including 2+ years in Phase 1.
⢠Experience in cardiovascular and/or neuroscience clinical research.
⢠Strong understanding of operational complexities of earlyâphase studies and safety monitoring (intensive PK sampling, confinement studies, rapid safety reviews).
⢠Experience managing CROs, vendors, and Phase 1 units.
⢠Demonstrated self-discipline, motivation, and entrepreneurial
⢠Advanced knowledge of ICH-GCP, FDA, and global regulatory requirements
⢠Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision
⢠Ability to effectively collaborate with cross functional teams
⢠Excellent interpersonal, oral, written communication skills
⢠Proficient in MS Office applications (e.g. TEAMS, Outlook, Word, PowerPoint, Excel), CTMS systems and EDC systems
⢠Travel up to 10â20%
NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.
Apply tot his job
Apply To this Job