Director, Clinical Development HIV Prevention (MD)

Description de l'emploi

POSITION OVERVIEW:

You will typically lead multiple components of clinical trial programs in HIV clinical development. You will help design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide expertise in clinical HIV medicine. You will primarily be involved in developing long-acting drugs for HIV prevention and may also support programs for HIV treatment and for HIV cure research. Working in collaboration with the HIV Prevention Global Development Team Lead, you will be responsible for various aspects of ongoing clinical trial program-related activities within the HIV therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start up/execution/close out, specifically including, medical monitoring, data analysis/reporting and support of Regulatory filings, and clinical development input into regulatory documentation, publications, and scientific presentations.

EXAMPLE RESPONSIBILITIES:

• Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products
• Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines
• Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries
• Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
• Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans
• Coordinates the collection and assimilation of ongoing data for internal analysis and review
• Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations
• Presents scientific information at scientific conferences as well as clinical study investigator meetings
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs

REQUIREMENTS:

We are all different, yet we all use our unique contributions to do the work. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• MD or equivalent with 4+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment
• Board certification in Internal Medicine and Infectious Diseases is preferred, including familiarity with HIV treatment and prevention care
• Direct experience in the strategic, and tactical implementation of drug development is preferred
• Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting, or academia
• Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations
• Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership
• Experience with engaging internal and external expert physicians, scientists, and other key stakeholders, including community and civil society leaders, in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results

• Successful leadership and program management experience
• Experience in business development and assessment of opportunities is desired

Knowledge & Other Requirements

• Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
• Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
• Well-developed sense of integrity, strong work ethic, strong ttention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
• Excellent scientific written and oral communication and interpersonal skills are required.
• Must be capable of working with attention to detail in a time sensitive environment.
• Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is required.
• Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job related programs such as Spotfire and RDMS
• Ability to partner, influence and inspire others.
• Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~up to 20% travel expected).
• Proven analytical abilities as demonstrated through past experience and/or academic research.
• Has core expertise in HIV prevention and/or treatment and infectious diseases, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
• Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.