NewAmsterdam Pharma Corporation

NewAmsterdam Pharma Corporation

2 open positions available

1 location
1 employment type
Actively hiring
Full-time

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NewAmsterdam Pharma Corporation

Clinical Project Manager, Phase I Studies

NewAmsterdam Pharma CorporationAnywhereFull-time
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Compensation$90K - 130K a year

Oversee operational management of Phase 1 clinical studies ensuring compliance and quality execution. | Requires 5+ years clinical trial management experience including Phase 1, with strong knowledge of early-phase study operations and regulatory requirements. | 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 world’s 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 Alzheimer’s disease. The Phase 1 Clinical Project Manager (CPM) oversees end‑to‑end operational management of first‑in‑human, 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, dose‑escalation logistics, and cross‑functional 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: • Bachelor’s 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 early‑phase 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 10–20% 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.

clinical trial management
vendor management
regulatory compliance
Verified Source
Posted 4 days ago
NewAmsterdam Pharma Corporation

Senior Corporate Counsel, Securities & Governance

NewAmsterdam Pharma CorporationAnywhereFull-time
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Compensation$200K - 250K a year

Support SEC filings, board governance, and strategic transactions for a publicly traded company. | Minimum 8-10+ years of securities and governance legal experience, JD, and bar admission. | Job Description: We are seeking a dynamic and hands-on Senior Corporate Counsel to join our Legal team. This role will be primarily responsible for ensuring compliance with SEC reporting and securities laws, as well as Board of Directors and corporate governance matters. We are looking for someone with strong technical securities expertise who enjoys working in a fast-paced and nimble organization; where you like to roll up your sleeves and have an impact across the organization. This is a remote position. Key Responsibilities: Securities Law & SEC Reporting • Support the preparation, review and submission of SEC filings, including Forms 10-K, 10-Q, 8-K, proxy statements and registration statements • Support the preparation and review of earnings releases, earnings call scripts, investor presentations and other investor and public disclosures • Manage Section 16 compliance (including Forms 3, 4, 5) • Assist with maintaining disclosure controls and procedures and Reg FD compliance • Administer insider trading compliance program, including 10b5-1 trading plans • Ensure corporate compliance with SEC, stock exchange and other legal requirements applicable to a publicly traded company Board of Directors & Corporate Governance • Support the preparation of Board and Committee meeting materials, resolutions and minutes • Monitor and ensure compliance with Board and Committee responsibilities • Develop, implement and ensure compliance with corporate governance policies • Legal partner responsible with coordinating the Annual Meeting of Shareholders, including coordinating activities of third-party vendors to ensure timely distribution of proxy materials to shareholders Capital Markets & Strategic Transactions • Support equity and debt financings, including public offerings, ATM and private placements • Support M&A, partnerships, joint ventures and other strategic transactions including due diligence, structuring and contracting matters General Legal • Provide contracting and other legal support to business departments to advance corporate objectives • Develop legal forms, policies and procedures that scale with the organization • Handle such other legal matters as determined by business needs Qualifications: • Juris Doctor (JD) from an accredited law school and admitted to and in good standing with the bar of at least one state in the US • Minimum of 8-10+ years of legal experience with public-company securities and governance • Experience as an attorney in a top law firm or in-house legal environment in the biotechnology or pharmaceuticals industry • Deep understanding of securities laws and SEC reporting, as well as Board and corporate governance matters • Excellent interpersonal skills, communication skills and a positive, team-oriented attitude • Listens to internal client needs to advance and enable business objectives • High integrity, ability to assess risk, make decisions and think strategically while applying knowledge of applicable legal issues • Must be detail-oriented and have strong organizational and time management skills • Ability to handle multiple, competing workloads with changing priorities to meet necessary deadlines • Ability to effectively work with all levels of the organization • Proactive self-starter with ability to work independently, spot issues and develop business-oriented resolutions • Curious to learn new areas of law and apply to evolving business needs • Has strong computer skills (e.g. Microsoft suite) • Remote position, east coast residence preferred Salary and Benefits: We offer a competitive base salary, annual bonus, and long-term incentives. In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans. 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.

Securities Law
SEC Reporting
Corporate Governance
Verified Source
Posted 10 days ago

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