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Employvision Inc. · 10 hours ago

Associate Director - Clinical Scientist

United States

Contract

Remote

Lead/Staff, Director/Executive

8+ years exp

Employvision Inc. is seeking an Associate Director, Clinical Scientist to take a key leadership role in shaping clinical strategy and driving high-quality documentation. This role involves leading critical clinical activities and collaborating closely with physicians and subject matter experts to ensure effective clinical development processes.

ConsultingDeliveryHuman ResourcesInformation TechnologyLegal

H1B Sponsor Likely

Responsibilities

Driving the clinical synopsis development process, partnering with SMEs and internal stakeholders

Leading review and input into Target Product Profiles (TPP) and clinical parameters

Contributing to the Clinical Development Plan (CDP) in collaboration with physicians and functional experts

Managing timelines, stakeholder alignment, and review cycles for clinical synopsis and related deliverables

Identifying and synthesizing relevant literature and prior studies to inform study design

Leading the creation of study designs, schematics, and decision documentation

Securing sponsor alignment on study concepts prior to drafting

Drafting and coordinating reviews of clinical synopsis documents, resolving comments, and facilitating sponsor discussions

Supporting handoff to medical writing/regulatory teams and ensuring documentation accuracy

Preparing background materials and slide decks for internal and external discussions

Leading clinical contributions to eCTD modules (2.7.3, 2.7.4, 2.5) and improving submission consistency

Drafting and reviewing clinical sections of regulatory briefing books, agency responses, and advisory board materials

Qualification

Clinical study designClinical synopsis developmentRegulatory document draftingStakeholder managementLiterature reviewCollaboration with SMEsWritten communicationVerbal communicationCross-functional coordinationIndependent work

Required

PhD or MD in a Life Science discipline (or local equivalent)

8+ years of clinical research or related industry experience

4+ years drafting clinical study synopses and clinical sections of regulatory documents

Exceptional written and verbal communication

Strong cross‑functional coordination and stakeholder management

Deep expertise in clinical study design and synopsis development

Proven ability to manage timelines and complex processes

Analytical strength in literature review and data extraction

Ability to work independently and navigate complex scientific challenges

Experience collaborating with physicians and SMEs

Preferred

Experience in drug development or pharmaceutical environments

Familiarity with regulatory interactions and sponsor engagement

Knowledge of CDP, TPP, and clinical synopsis processes

Demonstrated ability to design and implement 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.

Founded in 2005

Somerset, New Jersey, USA

51-200 employees

http://www.employvision.com

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 Stage

Leadership Team

Monali Geria

Co-Founder and Business Partner

Arav Geria

Strategic Alliances and Partnerships Associate

Company data provided by crunchbase