Clinical Development Manager

ViiV Healthcare

Clinical Development Manager at ViiV Healthcare leading HIV research protocols and collaborating with cross-functional teams. Ensuring quality and timely clinical study outputs in a hybrid work setup.

Posted 5/28/2026full-timeDurham • North Carolina • 🇺🇸 United StatesMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Contributes to ViiV Healthcare early- and/or late-stage clinical development programs
Leads the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfils strategic objective of clinical development
Liaises with Operations, Clinical Pharmacology, Medical, Regulatory and Commercial Leads to help ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possible
Provides scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with the protocols, thereby allowing for intended scientific interpretation of study data and results
Partners with study team to ensure that all regulatory reporting requirements are met
Collaborates with physicians and other study team members and stakeholders to enable appropriate review of safety data
May assist in identification of safety review committee members and preparation of interim safety review charter document
Works closely with study physician(s) to help monitor safety and benefit/risk for studies
Works within the study team to help to create evidence generation and scientific outputs including content of investigator meeting, clinical study report, preparation of study results for scientific meetings, congresses, and external journal publications, preparation of regulatory documents, and other relevant study documents
Partners with clinical operations colleagues to help ensure optimal delivery of study while maintaining close collaborations with other functions supporting the study
Contributes to quality assurance and inspection readiness activities

Requirements

What you’ll need

B.S., Masters, Ph.D., Pharm.D., or MD with 3 plus years of recent clinical drug development experience in a pharmaceutical industry or CRO environment
Prior drug development experience in HIV, infectious diseases or other relevant therapy area
Experience in working with or writing study protocols, informed consent forms and clinical study reports
Experience with reviewing and interpreting of clinical and scientific data
3 plus years contributing to a cross-functional team, including internal and external partners (e.g. 3rd parties, academic partners, and subcontracted organizations)

Benefits

Comp & perks

Health insurance
401(k)
Paid time off
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical developmentstudy protocolsdata collectionstudy analysis plansregulatory reportingsafety data reviewevidence generationclinical study reportregulatory documentsclinical drug development

Soft Skills

collaborationscientific oversightcommunicationleadershipcross-functional teamworkstakeholder engagementquality assuranceproblem-solvingorganizational skillsinterpersonal skills

Certifications

B.S.MastersPh.D.Pharm.D.MD