Director, Clinical Research

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.
• Ensure inspection readiness for audits and/or Health Authority inspections.

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.
• Able to anticipate and timely escalate issues and to define appropriate action plans.
• Decision-making and problem-solving skills.
• Prominent 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.
• 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

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
• Employee Assistance Programs
• Discretionary Bonus Programs and Long-term Incentive Plan
• Retail 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

Application Information

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.