Pulivarthi Group (PG) Healthcare Staffing · 4 months ago
Senior Clinical Research Director
Albany, NY
Full-time
Onsite
Mid, Senior Level
4+ years expPulivarthi Group LLC is a premier global provider of staffing and IT technology solutions, renowned for delivering exceptional services tailored to each client's unique needs. They are seeking a highly experienced Senior Clinical Research Director to provide medical expertise, strategic oversight, and regulatory leadership for clinical studies and registries, with opportunities to lead high-impact programs across multiple geographies.
Artificial Intelligence (AI)Data ManagementInformation TechnologyRobotic Process Automation (RPA)Robotics
Responsibilities
Provide medical expertise for clinical studies and registries, including protocol development, key results, and clinical study reports
Support clinical development activities such as feasibility assessments, medical data review, validation, and study risk assessment
Contribute to the clinical sections of global submission dossiers (FDA, EMA, Japan, China) and address health authority queries
Deliver medical training, feasibility reviews, and clinical information to study teams, medical advisors, clinical project leaders, and investigators
Prepare documentation and presentations for internal governance meetings
Collaborate on defining the product value proposition (TVP), target product profile (TPP), and market access strategies
Represent projects in regulatory agency meetings as the medical spokesperson
Lead strategy and preparation of clinical sections for BLAs/CTDs, briefing packages, PSPs/PIPs, and label submissions/modifications
Contribute to core regulatory documents including Investigator’s Brochure, CTA, IND, DSUR, INDAR, DRMP, and RMP
Evaluate in-licensing candidates and provide clinical advice to research teams in the I&I therapeutic area
Qualification
Required
Medical Doctor (MD) preferred; GP or specialist
Fluent in English (spoken and written)
Minimum 4 years of experience in the pharmaceutical industry or CRO
Prior experience in clinical development required
Preferred
Experience in in-licensing evaluations
Familiarity with immunology and inflammation therapeutic areas
Strong presentation and internal governance communication skills
Benefits
Lead high-profile, global clinical research programs.
Collaborate with international cross-functional teams.
Competitive compensation and benefits.
Company
Pulivarthi Group (PG) Healthcare Staffing
Pulivarthi Group | Experts in Permanent & Specialized Staffing for Healthcare Welcome to Pulivarthi Group, your strategic staffing and recruiting partner across the United States and Canada.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase