8+ years in pharmaceutical or biotech R&D (PhD/MD preferred; MS/BS with 12+ years acceptable)
5+ years as Translational lead for clinical programs, with Phase 2/3 or registrational experience desired
Experience in negotiating Master Service Agreements and project contracts
Strong knowledge of clinical operations and regulatory processes
Proven leadership and team management skills in a matrix organization
Ability to address issues proactively and execute decision-making strategies
Excellent organizational and communication skills
Responsibilities
Develop translational and early-stage clinical drug development strategies
Design and execute biomarker strategies for clinical-stage programs
Collaborate with discovery research teams to identify and validate biomarkers
Lead planning and execution of regional or global clinical studies
Select and manage CROs and study vendors for clinical projects
Guide project teams to meet clinical deliverables and objectives
Ensure compliance with regulatory standards and manage site selection processes
Benefits
Medical, Dental & Vision Insurance with various insurance options
Discretionary Bonus and Long-term Incentive Plan
Generous Paid Time Off and holidays including Year-End Shutdown
401k retirement savings plan with company match
Career development programs and training opportunities
Flexible work arrangement options
Full Job Description
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 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
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.
Compensation And Benefits:
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 including a paid Year-End Shutdown.
Career Development, Progression and Training
Flexible Work Arrangement Programs
Applications will be accepted until July 1, 2026 or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma.
