Director, Clinical Research

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.

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…