Director, Translational Medicine

NS Pharma, Inc.; Paramus (NJ); Hybrid; USD 175,000 - 220,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

Retirement Savings 401k with company 


Discretionary Bonus Programs

Flexibly scheduled work arrangement

Job summary

NS Pharma, Inc. is seeking a senior leader to manage translational and early-stage clinical studies across global programs. You will implement biomarker strategies, coordinate cross-functional teams including NS Pharma Japan HQ, and oversee trial execution from planning to data delivery.

You will lead CRO selection, site initiation, and investigator meetings, while ensuring FDA/ICH compliance and robust TMF/SOP processes. A hybrid role with Paramus office visits is expected.

Qualifications

• Experience working in multi-cultural global teams including NS Pharma Japan (HQ).
• Experience negotiating Master Service Agreements, project contracts and budgets.
• Strong leadership and ability to lead in a matrix organization while working independently.
• Thorough understanding of clinical operations from planning to closeout of studies.
• Ability to anticipate issues and define action plans; strong problem-solving skills.

Responsibilities

• Develop and deliver translational and early-stage clinical drug development strategy.
• Design and execute biomarker strategies to inform priorities and regulatory plans.
• Coordinate with discovery, clinical and CROs to meet biomarker and trial milestones.
• Plan, implement, and manage regional or global clinical studies and site initiation.
• Lead CRO selection and oversight; manage vendors and data management partners.
• Provide guidance with Clinical Lead to achieve project objectives and resolve issues.
• Coordinate training programs and develop TMF and SOPs within global QMS.
• Ensure regulatory compliance with FDA, ICH and SOPs across sites.

Education

PhD/MD with 8+ years in pharma/biotech R&D

MS/BS with 12+ years R&D leadership

Job description

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.

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.

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

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, 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.

Supervisory Responsibility

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

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 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

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
• Must have oncology and 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.

NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job.

The annualized target salary range for this role is $175,000 to $220, 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, and Employee Assistance Programs
• Discretionary Bonus Programs and Long-term Incentive Plan
• Retirement Savings 401k with company match
• Generous Paid Time Off, Sick Time & Paid Holidays
• Career Development, Progression and Training
• Flexible Work Arrangement Programs
• Year-End Paid Holiday Shutdown