Director, Translational Medicine

Essential Duties And Responsibilities

• 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 that 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 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
• Oversight of 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 assure 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 output delivery in accordance with Statistical Analysis Plan
• Responsible for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites
• Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes

Qualifications

• 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 escalate 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

Education And/or Experience

• 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 Ph2/3 or registrational programs desired
• Excellent understanding of drug development, regulatory processes and clinical development
• Strong leadership abilities and proven abilities to lead a team within a matrix organization as well as able to work independently and be proactive