At a Glance
- Tasks: Lead innovative clinical development programs for HIV treatments and ensure high-quality study designs.
- Company: ViiV Healthcare, a global leader in HIV research and medicine.
- Benefits: Comprehensive benefits package and equal opportunity employer.
- Other info: Collaborative environment with opportunities for mentorship and career growth.
- Why this job: Make a real difference in the lives of people living with HIV through impactful research.
- Qualifications: 5+ years in drug development, especially in HIV or infectious diseases.
The predicted salary is between 70000 - 90000 £ per year.
ViiV Healthcare is a global specialty HIV company dedicated to researching and delivering new medicines for people living with, and at risk of, HIV.
Core purpose: Provide scientific leadership, direction, and contribute to the strategy employed in ViiV Healthcare clinical development programs. This 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) and contributing to governance and regulatory reporting at the study level.
Responsibilities:
- Drive the strategy of ViiV Healthcare early- and/or late-stage development programs.
- Accountable for the development, finalization, and amendments of study protocols, ensuring they fulfill strategic objectives.
- Liaise with Operations, Clinical Pharmacology, Medical, Regulatory and Commercial Leads to ensure studies evaluate key aspects of the Asset Target Product Profile.
- May co-lead Clinical Matrix Teams with the accountable physician.
- Provide scientific oversight of clinical studies, ensuring data collection and analysis plans align with protocols.
- Partner with study team to ensure all regulatory reporting requirements are met.
- Collaborate with physicians and other team members to review safety data and assist or lead safety review committees.
- Help create evidence generation and scientific outputs including investigator meeting content, clinical study reports, and publications.
- Partner with clinical operations colleagues to ensure optimal study delivery while maintaining close collaboration.
- Contribute to quality assurance and inspection readiness activities.
- Coach and mentor team members.
- Partner across ViiV Healthcare and the broader GSK enterprise to provide clinical science insights on key business priorities.
Basic Qualifications:
- B.S., M.Sc., Ph.D., or Pharm.D. with 5+ years of recent drug development experience in a pharmaceutical or CRO environment.
- Prior drug development experience in HIV or infectious diseases.
- Experience writing study protocols, informed consent forms, and clinical study reports.
- Experience reviewing and interpreting clinical and scientific data.
- Experience contributing to end to end clinical development strategy, including study design, data interpretation, risk assessment, and milestone planning.
- Experience translating complex study level issues into program level recommendations.
- 5+ years leading cross functional teams including internal and external partners.
- Experience managing multiple programs concurrently.
Preferred Qualifications:
- Experience in HIV drug development across multiple phases and in regulatory interactions/submissions.
- Track record of influencing cross functional strategy and driving alignment without formal authority.
- Strong communication skills to convey complex scientific information to senior governance forums.
Benefits: ViiV offers a comprehensive benefits program equal to that of GSK employees. All employees receive the same benefits options and plans.
Equal Opportunity Employer: ViiV is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, parental status, national origin, age, disability, or any other protected characteristic.
ViiV Healthcare (GSK) Clinical Development Director employer: Job Search Place Limited
ViiV Healthcare is an exceptional employer, offering a dynamic work environment where innovation and collaboration thrive. With a strong commitment to employee growth, we provide comprehensive benefits and opportunities for professional development, all while being at the forefront of HIV research in a supportive and inclusive culture. Join us in our mission to make a meaningful impact on the lives of those affected by HIV, and be part of a team that values your contributions and fosters your career advancement.
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We think this is how you could land ViiV Healthcare (GSK) Clinical Development Director
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We think you need these skills to ace ViiV Healthcare (GSK) Clinical Development Director
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