Employvision Inc. ยท 10 hours ago
Clinical Scientist - Associate Director
United States
Contract
Remote
Lead/Staff, Director/Executive
8+ years expEmployvision Inc. is a company in the Clinical Research and Drug Development industry, seeking an experienced Associate Director, Clinical Scientist. This role involves leading and coordinating complex clinical activities, collaborating with various stakeholders to ensure high-quality clinical deliverables and effective study design.
ConsultingDeliveryHuman ResourcesInformation TechnologyLegal
Hiring Manager
Mritunjay Kumar
Responsibilities
Lead the clinical synopsis drafting process, collaborating with physicians and SMEs while coordinating cross-functional stakeholder input
Drive review and contribution to Target Product Profile (TPP) clinical parameters and Clinical Development Plans (CDP)
Manage end-to-end study design development, including literature review, schematics, design decisions, and internal/sponsor alignment
Identify and analyze relevant completed or ongoing clinical studies to inform current program strategy
Own timeline management for clinical synopsis and study design activities, ensuring internal and sponsor alignment
Lead drafting, review, and resolution of comments for clinical synopses in accordance with contractual requirements
Support regulatory deliverables including eCTD clinical sections (2.5, 2.7.3, 2.7.4) and consultation briefing materials
Contribute to and review clinical content for regulatory meetings, advisory boards, and agency interactions
Partner with Medical Writing and Regulatory teams to ensure accurate and complete handovers
Prepare background materials and slides to support program leadership and decision-making
Lead stakeholder discussions, summarize findings, and develop risk/gap assessments as needed
Qualification
Required
PhD or MD in Life Sciences (or local equivalent)
8+ years of relevant clinical research or industry experience
4+ years of experience drafting clinical study synopses and clinical sections of regulatory documents
Strong scientific writing and verbal communication skills
Deep expertise in clinical study design and synopsis drafting
Proven ability to manage complex timelines and cross-functional processes
Strong analytical skills and attention to detail
Ability to work independently on complex problems with minimal supervision
Experience collaborating with physicians and senior subject matter experts
Preferred
Experience in pharmaceutical or drug development environments
Familiarity with sponsor and regulatory agency interactions
Working knowledge of CDP, TPP, and regulatory submission processes
Demonstrated ability to design and execute complex clinical protocols
Company
Employvision Inc.
Employvision is a talent acquisition and management solutions company delivering services that enable its clients to win in the changing work environment.
51-200 employees
H1B Sponsorship
Employvision Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (2)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Monali Geria
Co-Founder and Business Partner
Arav Geria
Strategic Alliances and Partnerships Associate
Company data provided by crunchbase