Position Overview:
A growing life sciences company is seeking an experienced Program Director, Clinical Operations to lead strategic and operational aspects of clinical development programs. This role involves overseeing multiple studies, ensuring efficient execution within timelines and budget while upholding regulatory compliance. The ideal candidate thrives in a dynamic, cross-functional environment and is adept at managing teams, vendors, and clinical trial operations from early to late-stage development.

Key Responsibilities:

• Provide leadership and operational expertise for one or more clinical programs, ensuring timely study initiation, execution, and completion in compliance with industry regulations.
• Oversee and collaborate with study teams, vendors, and contract research organizations (CROs), serving as an escalation point and governance representative.
• Identify and mitigate program risks, ensuring smooth study execution, enrollment, and quality oversight.
• Communicate program status, risks, and key updates to leadership and stakeholders, maintaining alignment with corporate objectives.
• Work closely with cross-functional teams to address executional challenges and streamline study operations.
• Contribute to the development of clinical strategies, including site selection, patient enrollment, and data monitoring approaches.
• Manage program budgets, vendor contracts, and financial planning, including leading RFP processes and budget negotiations.
• Implement and monitor quality control measures, tracking key performance indicators and trial progress.
• Provide technical input on clinical documents such as protocols, informed consent forms, and safety assessments.
• Lead and support the development of operational processes, SOPs, and functional initiatives.
• Recruit, mentor, and develop clinical operations staff while fostering a high-performance team culture.
• Willingness to travel domestically and internationally as needed.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, or Pharmacy (advanced degree preferred).
• At least 12 years of clinical operations experience, including 8+ years in leadership roles within drug development.
• Minimum of 4 years of direct line management experience.
• Strong background in overseeing early to late-stage clinical trials, with a preference for oncology experience.
• Experience in a fast-paced biotech or pharmaceutical setting is desirable.
• Proven ability to develop and manage high-performing clinical operations teams.
• Strategic mindset with the ability to anticipate challenges and drive solutions.
• Strong organizational awareness and ability to manage multiple projects and shifting priorities effectively.
• In-depth knowledge of clinical regulatory requirements, including ICH GCP guidelines.
• Track record of success in clinical trial planning, execution, data management, and regulatory inspections.
• Excellent problem-solving, communication, and collaboration skills.
• High adaptability in a dynamic and evolving work environment.

This role offers an exciting opportunity to make a meaningful impact on the advancement of innovative therapies while working in a collaborative and fast-paced setting.