Associate Director Clinical Operations

Dompé is an Italian bio-pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand-in-hand with a commitment to research and development to meet unsatisfied therapeutic needs.  

Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L’Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).  

Job Summary:

The Associate Director (AD), Clinical Operations will provide operational leadership for the planning, execution, and oversight of clinical trials across assigned therapeutic areas. AD will be accountable for ensuring that studies are delivered on time, within budget, and in compliance with global regulatory and quality standards. The role will also provide mentorship and leadership to Clinical Operations Project Managers (COPMs) while collaborating cross-functionally to advance the company’s clinical development programs and in alignment with the Head of Clinical Operations. The AD supports the COPM in executing on the clinical trials and in collaborating with CROs and/or other partners qualified by Dompé to execute their tasks in compliance with the GCP, GxPs, the Legal and the Regulatory requirements; he/she must ensure compliance with the Dompé Group quality standards and policies. 

Essential Funtions:

●    Lead the planning, execution, and oversight of global clinical trials (Phase I–IV) in accordance with regulatory requirements, timelines, and budgets.
●    Provide strategic leadership and operational expertise in the development and execution of clinical study protocols and operational plans.
●    Manage, lead, and mentor Clinical Operations team members, including Clinical Operations Project Managers (COPMs), and Clinical Trial Assistants (CTAs).
●    Manage CROs, vendors, and external partners to ensure high-quality delivery of clinical trial activities and compliance with GCP/ICH guidelines and applicable laws and regulations.
●    Contribute to vendor selection, contract negotiation, and ongoing vendor performance management.

●    Drive risk management and proactive issue resolution throughout the lifecycle of studies.
●    Oversee clinical trial project timelines, budgets, resources, and risk mitigation strategies across one or more programs.
●    Ensure timely and accurate reporting of study progress, metrics, and issues to senior leadership and stakeholders.
●    Partner cross-functionally with Regulatory Affairs, Clinical Development, Data Management, Biostatistics, Pharmacovigilance, Clinical Supply, Quality Assurance, Legal, and Procurement.
●    Represent Clinical Operations in governance committees and project team meetings.
●    Contribute to the development and continuous improvement of departmental processes, systems, and SOPs.
●    Provide leadership in audits, inspections, and due diligence activities.
●    Support inspection readiness and regulatory submissions by ensuring clinical trial documentation is complete, accurate, and audit ready.
●    Participate in the development and review of SOPs, operational best practices, and quality improvement initiatives.
●    Drive continuous improvement by implementing innovative approaches, tools, and technologies to enhance trial efficiency and quality.
●    Must be fully familiar with all the SOPs relevant to the clinical operating model in force at Dompé and ensure that study documentation is properly archived in the Clinical Trial Master File (CTMF), in compliance with the GCP requirements.

Experience and Education:

• Bachelor’s/Master’s Degree in Pharmacology, Biotechnology or related scientific discipline preferred.
• 7-12 years of experience in similar roles, preferably in the Pharmaceutical/Life-science sector preferred; strong experienced PM with at least 3 years in a leadership role would be considered.
• Languages: English (fluent); Italian (a plus)
• Knowledge of the main productivity and collaboration tools (Google Workspace, MS Office);
• Knowledge of GCP/ICH phase I-IV clinical trials and observational studies;
• Knowledge of research and clinical trial methodologies;
• Knowledge of CRO industry;
• Knowledge of Project Management;
• Knowledge of Pharmaceutical sector.
• Proven track record of successfully leading global clinical trials across multiple phases and therapeutic areas.
• Experience in vendor/CRO selection and management.
• Excellent leadership, communication, and organizational skills.
• Ability to influence and collaborate effectively in a cross-functional, matrixed environment.
• Strong problem-solving skills and the ability to manage competing priorities in a fast-paced setting.
• Project Management Certification is preferred. 

BENEFITS OF JOINING OUR TEAM

• Comprehensive medical benefits: we value access to healthcare for our patients as well as our employees •    Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle
• Competitive 401(K) matching 
• Bay Area office with great views, located in vibrant downtown San Mateo and within walking distance to restaurants, coffee shops, and the Cal Train 
• A super cool team who’s excited to transform lives through innovative therapies 

$220,000 - $245,000 a year 

At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 

We believe that the unique contributions of all employees create our success. To ensure that our products and culture continue to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status. All your information will be kept confidential according to EEO guidelines.