Director, Translational Medicine

NS Pharma Inc•Paramus, NJ

17h•Hybrid

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. Japan. This is a hybrid position that requires to be in the Paramus office twice a week.

Requirements

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
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.
Excellent understanding of drug development, regulatory processes and clinical development
Must have rare disease experience
Strong leadership abilities and proven abilities to lead a team within a matrix organization as well as able to work independently and be proactive.

Nice To Haves

Preference for those with 5+ years’ experience as a Translational lead for clinical programs.
Experience with Ph2/3 or registrational programs desired.

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, oversight 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.).
Tracking 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.
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.