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Pulivarthi Group LLC is a Global Staffing & IT Technology Solutions company, with our prime focus of providing world class solutions to our customers with the right talent. We combine the expertise of our team and the culture of your company to help you with the solution that is affordable and innovative using high quality standards and technologies.
We’ve served some of the largest healthcare, financial services, and government entities in the U.S.
Job Title: Senior Clinical Research Director
Company Overview
Pulivarthi Group is a premier global provider of staffing and IT technology solutions, renowned for delivering exceptional services tailored to each client's unique needs. With a steadfast commitment to excellence, we merge expertise with innovation, ensuring cost-effective solutions of the highest quality. Our diverse client base spans healthcare, finance, government, and beyond, reflecting our adaptability and proficiency across industries. Operating in the United States, Canada, and Mexico, we pride ourselves on aligning with clients' cultures, deploying top-tier talent, and utilizing cutting-edge technologies. Pulivarthi Group stands as a beacon of reliability, efficiency, and innovation in the realm of staffing solutions.
Job Overview/Summary
We are seeking a highly experienced
Senior Clinical Research Director to provide medical expertise, strategic oversight, and regulatory leadership for clinical studies and registries. The role involves supporting end-to-end clinical development, contributing to submission dossiers, and representing projects in key regulatory meetings. This is an opportunity to lead high-impact programs across multiple geographies, including the U.S., EU, Japan, and China.
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.
Primary Skills
- Strong expertise in clinical development strategy and execution.
- Proven ability to represent programs at high-level regulatory meetings.
- Advanced knowledge of regulatory submission requirements and documentation.
Secondary Skills (Good To Have)
- Experience in in-licensing evaluations.
- Familiarity with immunology and inflammation therapeutic areas.
- Strong presentation and internal governance communication skills.
Qualifications
- 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.
Benefits/Perks
- Lead high-profile, global clinical research programs.
- Collaborate with international cross-functional teams.
- Competitive compensation and benefits.
Equal Opportunity Statement
Pulivarthi Group is proud to be an equal opportunity employer. We are committed to building a diverse and inclusive culture and celebrate authenticity. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, or any other legally protected characteristics.
