Clinical Development Director

ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated.

The core purpose of the Clinical Development Director is to provide scientific leadership, direction, and contribute to the strategy employed in ViiV Healthcare clinical development programs. This role also includes scientific leadership of the asset study team in the design and development of high quality, timely studies (‘end to end’ from Commit to Study to reporting, submission and publication). This role contributes to governance and regulatory reporting at the study level by collaborating across functional lines to ensure accuracy, quality, and timeliness of study results.

Key Responsibilities

• Helps drive the strategy of ViiV Healthcare early- and/or late-stage development programs.
• Accountable for the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfills strategic objective of clinical development/integrated evidence plan.
• Liaises with Operations, Clinical Pharmacology, Medical, Regulatory and Commercial Leads to ensure study/program evaluates key aspects of the Asset Target Product Profile critical to product differentiation/reimbursement where possible.
• May co-lead Clinical Matrix Teams with the accountable physician.
• Provides scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with 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.
• Works with the study team to help create evidence generation and scientific outputs including content of investigator meeting, clinical study report, and preparation of study results for scientific meetings.
• Contributes to quality assurance and inspection readiness activities.
• Coaches and mentors team members.

Basic Qualifications

• B.S. OR Masters OR Ph.D. OR Pharm.D., with 5 plus years of recent drug development experience in a pharmaceutical industry or CRO environment leading the scientific aspects of clinical program(s) and regulatory submission(s).
• Prior drug development experience in HIV/infectious diseases.
• Experience in working with or writing study protocols, informed consent forms and clinical study reports.
• Experience with reviewing and interpreting clinical and scientific data.
• Experience in contributing to end-to-end clinical development strategy, including study design, data interpretation, risk assessment, and milestone planning.
• 5 plus years leading cross-functional teams, including internal and external partners.

Preferred Qualifications

• HIV drug development experience, including experience across multiple phases of development and contribution to regulatory interactions/submissions.
• Strong track record of influencing cross-functional strategy and driving alignment across internal and external stakeholders without formal authority.
• Ability to communicate complex scientific and clinical information effectively to senior governance forums.

ViiV is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.