About this opportunity
SK Life Science, Inc. lists this Vice President, Quantitative Sciences & Development opportunity in paramus, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
First-in-human (FIH) study design
Adaptive design methodologies
IWRS (Interactive Web Response System)/IRT (Interactive Response Technology) design
Database design
Wearable device integration
The Vice President, Quantitative Sciences & Development provides strategic, scientific, and operational leadership for the company's Clinical Pharmacology, Pharmacometrics, Toxicology, DMPK, Biostatistics, Statistical Programming, and Clinical Data Management functions across all phases of drug development.
This executive is responsible for developing and overseeing execution of integrated quantitative strategies that support efficient translation from non-clinical development, clinical development, regulatory submissions, and evidence generation while ensuring delivery of high-quality, inspection-ready clinical data and statistical analyses. The VP serves as a key member of the Clinical Leadership Team and partners closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Quality Assurance, and external CROs to advance the company's portfolio.
Responsibilities
Develop and implement the company's Clinical Pharmacology, Biometrics and Data Sciences strategy aligned with corporate development objectives.
Serve as a key member of the Clinical Leadership Team.
Build organizational capabilities to support a growing clinical pipeline.
Lead organizational planning, budgeting, resource allocation, and vendor strategy.
Represent Clinical Pharmacology, Data Management, and Biometrics in governance committees and executive reviews.
Clinical Pharmacology & Toxicology
First-in-human (FIH) study design
SAD/MAD studies
Food-effect and drug-drug interaction (DDI) studies
QT/QTc and organ impairment studies
Population PK, PBPK modeling, exposure-response analyses, dose optimization, and model-informed drug development (MIDD)
Nonclinical toxicology strategy, including general, reproductive, developmental, genotoxicity, and carcinogenicity studies, as applicable
Guide clinical pharmacology and toxicology strategy across all phases of development.
Review and approve PK/PD and toxicology protocols, analysis plans, study reports, and regulatory submissions.
Interpret nonclinical safety data to support first-in-human studies, dose selection, and benefit-risk assessments.
Ensure compliance with FDA, EMA, PMDA, and ICH guidance and represent the function in regulatory interactions and cross-functional governance.
Biostatistics
Provide strategic oversight for all biostatistical activities supporting clinical development.
Responsibilities include
Develop statistical strategy across the clinical development portfolio.
Oversee study design and statistical methodology.
Review and approve: Statistical Analysis Plans (SAPs)
Protocol statistical sections
Interim analyses
Adaptive design methodologies
Integrated summaries
TLFs (Tables, Listings, and Figures)
Guide sample size estimation, endpoint selection, multiplicity strategies, estimands, and innovative trial designs.
Support Data Monitoring Committees (DMCs), Independent Review Committees (IRCs), and interim decision-making.
Provide statistical leadership for: NDA/BLA submissions
FDA Type B/C meetings
EMA Scientific Advice
PMDA interactions
Ensure statistical integrity and regulatory compliance across all studies.
Statistical Programming
Provide executive oversight of statistical programming activities including:
SDTM and ADaM dataset development
TLF (Tables, Listings, and Figures) generation
CDISC implementation
SAS and R programming standards
Submission-ready datasets
Define.xml preparation
Regulatory submission programming
Automation and programming innovation
Validation and quality control processes
Establish efficient programming standards that ensure timely database analyses and global submission readiness.
Clinical Data Management
Provide executive oversight of all Clinical Data Management activities.
Ensure high-quality, inspection-ready clinical databases.
Oversee: IWRS (Interactive Web Response System)/IRT (Interactive Response Technology) design
Database design
CRF/eCRF development
Data review plans
Data cleaning
Medical coding
Database lock
Data quality metrics
Establish enterprise data standards including: CDISC SDTM
CDASH
Controlled Terminology
Ensure timely delivery of clean data for interim analyses and regulatory submissions.
Lead implementation of innovative technologies including: Risk-based data review
Centralized monitoring
AI-assisted data review
Electronic Clinical Outcome Assessments (eCOA)
Wearable device integration
Decentralized clinical trial data capture
Cross-Functional Collaboration
Clinical Development
Clinical Operations
Regulatory Affairs
Medical Affairs
Safety/Pharmacovigilance
Medical Writing
Clinical Supply
Quality Assurance
Commercial
Health Economics & Outcomes Research (HEOR)
Regulatory Leadership
Provide clinical pharmacology leadership for regulatory interactions.
Lead preparation of: Clinical Pharmacology Summary
Module 2.7 documents
Module 5 components
NDA/BLA/MAA submissions
Support FDA Type A/B/C meetings, End-of-Phase meetings, and Advisory Committees.
Respond to global regulatory information requests.
Vendor Management
Select, oversee, and evaluate CROs and specialty vendors.
Establish KPIs and performance metrics.
Manage budgets and contracts.
Ensure vendor compliance with GCP and company quality standards.
Quality & Compliance
Ensure compliance with: ICH GCP
FDA regulations
EMA guidance
21 CFR Part 11
GCDMP
Company SOPs
Maintain inspection readiness.
Support regulatory inspections and audits.
People Leadership
Build, mentor, and lead high-performing Clinical Pharmacology, Biometrics and Data Management teams.
Recruit and retain top scientific and operational talent.
Foster a culture of innovation, collaboration, accountability, and continuous improvement.
Develop succession plans and leadership capabilities.
Qualifications
PhD, PharmD, MD, or equivalent advanced degree in:
Clinical Pharmacology
Pharmaceutical Sciences
Pharmacokinetics
Biomedical Sciences
Biostatistics
Medicine
Related scientific discipline
Work Experience
15+ years of progressive pharmaceutical or biotechnology industry experience.
Significant experience in both Clinical Pharmacology and Clinical Data Management/Biometrics leadership.
Experience leading programs from early clinical development through regulatory approval.
Demonstrated success supporting NDA/BLA submissions.
Executive leadership experience preferred.
Experience managing global CROs and strategic partnerships.
Experience in neuroscience, CNS, rare disease, oncology, or specialty pharmaceuticals.
Experience supporting global development programs.
Familiarity with AI-enabled clinical development platforms and advanced analytics.
Experience implementing modern data strategies, including real-world data integration and decentralized clinical trial technologies.
Compensation & Benefits
The anticipated salary range for this position is $325,000 to $375,000. Actual compensation may vary based on factors including experience, qualifications, skills, and business needs.
In addition to base salary, SK Life Science offers a competitive benefits package, including a 401(k) plan with company match and medical, dental, and vision coverage. Benefits are subject to eligibility requirements and may be modified at the Company's discretion.
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Worksite address
paramus, NJ, 07653, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.