Job Description
NewAmsterdam is an innovative biotech company with the 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 for 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.
The Senior Manager, Clinical Operations, supports the Director, Clinical Operations in oversight and management of clinical operational activities. We are looking for someone who is entrepreneurial, resourceful, thrives working in a fast-paced environment and tenacious. The Senior Manager works with cross-functional teams within NewAmsterdam in support of Sponsor relationships with vendors and CROs to ensure successful execution of clinical trials. This position reports to the Executive Director, Clinical Operations.
Key Responsibilities:
- Coordinates clinical trial and operational activities to ensure completion according to project timelines and budget
- Contributes to review of protocols and protocol amendments
- Support the writing of informed consents, amendments and case report forms (CRFs) with vendors and manages the internal review of these documents
- Contributes to the vendor selection process, including review of returned proposals, bid defense meetings, audits, and final vendor selection
- Develops clinical trial timelines, enrollment projections, and study budgets in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
- Contributes to the writing and review of key regulatory documents including Investigator Brochures (IB), Annual Reports (AR), INDs and NDAs
- Coordinates cross-functional teams that include representatives from multiple disciplines (e.g. Regulatory Affairs, CMC, etc.)
- Works with regulatory affairs to ensure key regulatory documents are maintained and filed in accordance with regulatory requirements
- Manages vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget
- Support the development and maintenance of cost estimates at the study and project level
- Ensures study execution compliance with NewAmsterdam Pharma SOPs, GCP/ICH and any other regulatory requirements and works cooperatively with Quality Assurance with respect to site audits
- Develops (or manages the development and review) of trial monitoring, safety, data management, and statistical analysis plans in coordination with vendors and tracks and reports compliance
- Oversees the construction and maintenance of the trial master file (TMF) with vendors and assures completeness and successful transfer from vendor to NewAmsterdam Pharma
- Stays current with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best practice standards
- Actively communicates project issues and identifies emerging risks, then works with internal team to resolve challenges
- Assists in the development of standard operating procedures
- Remote position US, Northeast based with travel required based on business need
Requirements:
- Bachelor’s degree in a scientific discipline, RN, or equivalent. PMP preferred
- 5+ years Phase 1-3 clinical research experience
- Demonstrated experience managing external vendors/CROs
- Experience in cardiovascular disease strongly preferred
- Demonstrated self-discipline, motivation, and entrepreneurial
- Advanced knowledge of GCP, ICH and FDA 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 (e.g. Outlook, Word, PowerPoint, Excel)
Salary and Benefits:
We offer a competitive base salary, commensurate with experience. In addition to the salary, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, retirement plans, and stock option awards.
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.
