Associate Director, Clinical Operations

About us:

Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.

Our proprietary drug discovery platform, ReSOLVETM, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.

Position overview:

The Associate Director, Clinical Operations is the operational leader of the Trial Team and will closely partner and proactively manage internal stakeholders, CROs, and vendors, and collaborate cross-functionally to deliver trials according to plan and while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines. Trials may be international and/or domestic, First in Human/Phase I – IV, and across multiple indications.

Responsibilities:

• Leads the team in the evaluation, selection and management of Global Contract Research Organizations (CROs) and other external vendors.
• Conducts on-going trial risk identification and analysis, and develops risk-based mitigation strategies for a variety of complex problems, in order to maintain study deliverables.
• Contributes to the development and presentation of clinical trial operational strategy and updates to senior/executive leadership.
• May be a member of the development team responsible for clinical trial operational strategy for development of a program.
• Oversees, manages and ensures clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs]).
• Contribute to global regulatory submissions (FDA, EMA, Health Canada and other governing regulatory bodies).
• Develop, review and approve Quality Documents.
• Oversee the development of site clinical trial agreements and other relevant documents.
• Reviews, contributes and/or authors the creation and finalization of key trial documentation: Protocols, Informed consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc.
• Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships.
• Collaborate with CROs to develop and ensure execution of activities outlined in various study plans (e.g. data management, risk management, safety management, and study communication plans).
• Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials.
• Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.
• Contributes to support company values and focus on making clinical trials patient and site centric through the use of innovative ideas and technologies.
• Travel: up to 25% domestic and international

Requirements:

• Bachelor’s degree preferred in a relevant scientific or healthcare discipline or equivalent experience.
• 8-10 years of clinical operations experience, with at least 5 years as a clinical trial manager accountable for planning and executing global clinical trials.
• Excellent team management abilities with a comfort level working with senior management, and ability to influence without authority.
• Management of FIH - Phase 3 Programs from start-up to registration as well as understanding of drug development from pre-IND through NDA.
• Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
• Knowledge of GCP’s governing clinical trials and working knowledge of FDA, EMA and ICH registrations and guidelines
• FDA and other Regulatory Agencies inspection experience a plus
• Experience managing clinical trials, CROs, budgets, and timelines.
• Solid oral and written communication skills required
• Ability to organize and manage multiple priorities required.
• Ability to thrive in a fast-paced, entrepreneurial environment.
• Proactive and positive management approach.
• Flexibility to adapt to changing program needs.
• Establish and nurture highly effective relationships with colleagues and key stakeholders, of diverse backgrounds and expertise, that support and advance trial team goals and objectives.