Director, Translational Medicine

Job Summary

Responsible for the management and execution of various aspects of translational and early‑stage clinical studies (implementation, site selection, patient recruitment, vendor selection and oversight, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH and regulatory requirements.

• Develop and deliver program level translational and early‑stage clinical drug development strategy.
• Design, plan and execute biomarker strategies to inform indication priorities, commercial differentiation, regulatory strategies, biomarker qualification plan, and achieve biomarker‑driven milestones, such as target engagement, measurement assay development and validation, pharmacodynamic activity, and other biomarker contexts of use in clinical‑stage programs.
• Integrate with colleagues in discovery research and research‑stage project teams to identify translational biomarkers and demonstrate preclinical target engagement, methodology of detection and measurement, proof‑of‑mechanism, pharmacodynamic activity, PK/PD relationships.
• Plan, implement, manage and report for regional or global clinical studies.
• Manage and lead the selection process of CROs for regional or global clinical studies.
• Direct, oversee 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.
• Manage activities for clinical site selection, investigator meetings and study initiation.
• Oversaw patient recruitment and development of recruitment strategies and plans.
• Responsible for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.).
• Track 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.
• Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to ensure studies are carried out in accordance with 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 output delivery in accordance with Statistical Analysis Plan.
• Coordinate with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites.
• Implement project‑specific training program and training materials.
• Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes.
• As needed and required perform other tasks and functions.

• Provide advice, professional development, and conduct performance management with cross‑functional groups if applicable.

• Must be able to work effectively in a multi‑cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma Japan (HQ), external partners and vendors.
• Experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets.
• Good cross‑functional team leader who fosters team spirit and team motivation (teamwork).
• Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies.
• Ability to anticipate and timely elevate issues and to define appropriate action plans.
• Decision‑making and problem‑solving skills.
• Ability to handle multiple tasks and prioritize.
• Strong organizational, communication and presentation skills.
• Team player, flexible, ability to adapt to change.

• PhD and/or MD with 8+ years of experience in pharmaceutical or biotech R&D. MS or BS with 12+ years of R&D experience with progressive levels of team leadership also considered.
• Preference for those with 5+ years’ experience as a Translational lead for clinical programs. Experience with Phase 2/3 or registrational programs desired.
• Excellent understanding of drug development, regulatory processes and…