Senior Director Clinical Development

Senior Director, Clinical Development

Remote - United States

Seeking highly experienced, motivated, and confident physician within Clinical Development to join a small start-up biotech company focused on Vaccines and Infectious Diseases. This new hire will lead targeted antiviral programs. This is a remote opportunity with small, fast-paced biotech. This role will report to the Chief Medical Officer.

Responsibilities:

• Drive the execution of the clinical program on a tumor agnostic biomarker-driven basket trial in solid tumors.
• Assist clinical development and lead the design plans and target product profiles.
• Lead engagement and interactions of Key Opinion Leaders and with study sites and investigators.
• Lead clinical review of data (including adverse events, efficacy, medical and correlative science data), and for data query generation and resolution.
• Responsible for data analysis and interpretation.
• Lead author of clinical content of documents for interactions with regulatory authorities (i.e.: FDA, Health Canada) and relevant sections of IND, Investigator Brochures, Protocols, and periodic safety reports.
• Work closely with all cross-disciplinary functions (including preclinical and clinical teams, manufacture, bio-analytics, correlative science, regulatory, quality, and business development) to ensure integration of all disciplinary components for effective decision making.
• Work closely with CROs and key strategic alliance partners.
• Provide therapeutic area medical and scientific expertise to senior management and key stakeholders.
• Lead execution of external and internal stakeholder meetings (i.e.: IM, KOL, patient advocacy groups, etc.)
• Work with cross-functional team members to prepare manuscripts and external presentations.
• Anticipate trends in medicine and industry that may have an impact on the clinical/commercial viability of products and factor into planning.
• Medical Monitoring responsibilities and site visits.
• Ensure compliance with corporate policies and procedures, and all related healthcare laws and regulations.
• Responsible for writing and designing the clinical studies, clinical study protocols, clinical sections of IBs, and safety reports and summaries, etc.

Requirements:

• A Medical Doctorate degree is required with at least 5 years of industry experience.
• Vaccine development or anti-infectives working knowledge and experience.
• Expertise writing CSRs, Clinical Protocols, ICFs, CRFs, and other related documents for execution of studies.
• US FDA and global regulatory authorities' interactions.
• Board-certified or board-eligible is preferred.
• 5+ years of industry experience in drug development in Phase I-III studies within vaccine development.
• Demonstrated skills in scientific analysis and reasoning. Excellent ability to communicate, specifically on clinical and scientific topics. Ability to distill complex issues into actionable solutions.
• Demonstrated ability to build effective working relationships, influence, negotiate and drive cross-functional alignment and organizational engagement. Ability to be flexible, incorporate insights from multiple stakeholders and adapt quickly to changing needs of the organization.
• Demonstrated ability in leading high-performing teams and delivering results in a matrix and collaborative environment and operating across multiple geographies.

If you meet the qualifications & interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com for more information.