Director, Clinical Research

NS Pharma Inc • Paramus, NJ

1d • $210,000 - $240,000

About The Position

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.

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.

Requirements

• 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
• Bachelor’s Degree in sciences or related field with 10 + years of pharmaceuticals/biotech experience.
• 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.)

Nice To Haves

• Certified Project Management Professional (PMP) preferred.
• Program and project management experience preferred.
• PMP certification preferred.
• Oncology and rare disease clinical trial experience preferred.

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director