Director, Clinical Research
16 days ago
Paramus
Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Summary: Accountable for the oversight, management, and execution clinical studies (feasibility, country and site selection, engagement in site start-up activities, patient recruitment and study initiation, conduct, and close-down, vendor oversight and timeline management, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH GCP, and global regulatory requirements. This is a hybrid position that requires to travel to the Paramus, NJ office at least twice a week. Essential Duties and Responsibilities: • Plan, implement, manage, and report for regional or global clinical studies., • Oversee, manage, and lead selection process of CROs for regional or global clinical studies., • Direct and manage the performance of study vendors (e.g., CROs and central labs)., • Provide direction and guidance with the Clinical Lead to achieve project objectives., • Manage and resolve project performance issues (issue management) if they arise., • Lead, oversee, and manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans., • Accountable for the creation of study related documentation (protocol, ICF, CRF, operations manuals etc.)., • Oversee the tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans., • Ensure compliance of investigational sites with SOPs, FDA regulations and ICH GCP guidelines to ensure that the studies are carried out fulfilling the requirements of the study protocols., • Manage negotiation of clinical trial contracts between investigational sites and CROs., • Oversight of data management vendors and statistical analysis vendors to ensure timely analysis and output of deliverables in accordance with Statistical Analysis Plan., • Accountable for oversight of clinical team members responsible for managing clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies and investigational product to global clinical trial sites., • Implement project specific training program and training materials., • Create and maintain clinical SOPs and oversee the TMF for assigned projects as part of global QMS and TMF processes., • As needed and required perform other tasks and functions., • Ensure inspection readiness for audits and/or Health Authority inspections Supervisory Responsibilities: • Supervise two (2) or three (3) Senior Clinical Study Managers and one Associate Director; including expatriates from Japan Qualifications: • Extensive experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets, oversight of CROs/vendors and management of timeline, • Proven ability to lead and motivate the cross-functional team to achieve project goals and deliverables on time, with high quality, and within budget., • Demonstrated leadership and accomplishment in operational/project management roles., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include extensive drug development collaboration with global project teams including project managers, Nippon Shinyaku (JapanHQ), external and internal stakeholders, partners, and vendors., • Builds strong, open, and collaborative working relationships characterized by mutual respect with superiors, peers and subordinates within and outside the company., • Thorough understanding of clinical operations as related to the planning, initiating, conducting, and closing clinical studies., • Ability to anticipate and timely escalate issues and to define appropriate action plans., • Decision-making and problem-solving skills, • Proven ability to handle multiple tasks and projects, including excellent time management and prioritization skills., • Strong organization, communication, and presentation skills, • Team player, flexible, ability to adapt to change., • Experience actively managing resources, staff, integrated timelines, and budgets for one or multiple assets in development Education and Experience: • Bachelor’s Degree in sciences or related field with 10 + years of pharmaceuticals/biotech experience. Certified Project Management Professional (PMP) preferred., • Minimum of 10 + years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials., • Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, Advisory Board Meeting, etc.), • Program and project management experience preferred., • PMP certification preferred., • Oncology and rare disease clinical trial experience preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $210,000to $245,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until September 9, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.
