Associate Director, Clinical Operations

About us:

Ventus is a clinical-stage biopharmaceutical company with two novel small-molecule programs entering Phase 2 clinical trials for immunology, inflammation, and neurology therapeutic areas. The two wholly owned programs include VENT-03 a first-in-class, oral cGAS inhibitor expected to be evaluated for lupus and VENT-02 a brain-penetrant, oral NLRP3 inhibitor in development for Parkinson’s disease and osteoarthritis.

Our pipeline is powered by ReSOLVE® - a platform combining the latest advances in AI/ML (machine learning), protein science, structural biology, and biophysics to substantially increase the speed and accuracy of small-molecule drug discovery.

The Associate Director, Clinical Operations, is the operational leader of the Clinical 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 GCP and ICH guidelines. Trials may be international and/or domestic, First in Human/Phase I – IV, and across multiple indications. This is a hybrid role, and the ability to commute to one of our sites (Waltham, MA or Montreal, QC) on an ad-hoc basis is required (#LI-Hybrid).

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
• Works efficiently as an individual contributor, actively engaging in day-to-day clinical trial management activities
• Contributes to the development and presentation of clinical trial operational strategy and updates to senior/executive leadership
• Oversees, manages and ensures clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
• Contributes to global regulatory submissions (FDA, EMA, Health Canada and other governing regulatory bodies)
• Develops, review and approve Quality Documents
• Oversees the development of site clinical trial agreements and other relevant documents
• Reviews, contribute and/or author the creation and finalization of key trial documents: Protocols, Informed consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc.
• Liaises with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships
• Collaborates with CROs to develop and ensure execution of activities outlined in various study plans s(e.g. data management, risk management, safety management, and study communication plans)
• Partners with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
• Leads, plans, and executes 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 using innovative ideas and technologies.
• Travel: up to 25% domestic and international

Qualifications:

• Bachelor’s degree in a relevant scientific or healthcare discipline or equivalent experience preferred
• 8-10 years of clinical operations experience, including 5+ years as a leading cross-functional teams and accountable for planning and executing global clinical trials
• Experience working at a small biotechnology company a plus

Required & Desired Knowledge

• 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
• Strong oral and written communication skills required
• Ability to organize and manage multiple priorities required
• Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
• Proactive and positive management approach
• Flexibility to adapt to changing program needs
• Develop positive and effective relationships with colleagues and key stakeholders, of diverse backgrounds and expertise, that support and advance trial team goals and objectives