Director Clinical Operations

Essential Functions

• Aid in the development and execution of clinical trials supporting strategic product development programs, both short and long range, to meet financial and business development objectives of the organization.
• Oversee the execution and management of clinical trials under Curium sponsorship, ensuring compliance with protocols, regulations, and best practices.
• Cook up and ensure data collection and integrity.
• Plan, develop, organize, implement, direct, and evaluate execution of Curium’s clinical product development activities.
• Partner with members of the management team to ensure communications are coordinated, support corporate objectives, and meet organizational expenditure requirements.
• Assist in identifying new vendors/CROs and negotiate contract terms and conditions for major services.
• Oversee and manage clinical trial budgets.
• Partner with members of the management team to ensure communications are coordinated, support corporate objectives, and meet organizational expenditure requirements.
• Partner with Regulatory as needed to liaise with regulatory agencies regarding clinical trials; support submissions and contribute to/attend authority meetings.
• Evaluate clinical product development against target product and medical plan and adjust clinical strategy to meet changing market and competitive conditions.
• Establish and maintain relationships with industry influencers and key community and strategic partners.
• Coordinate and assist in the ongoing training and development of clinical development team members.
• Provide direction to product development teams by establishing clear goals and objectives for performance.
• Represent the organization at scientific meetings as required.
• Present progress reports and strategies to management.

Requirements

• Technical degree in a science-related field required.
• Ten to fifteen years of broad clinical product development experience in the pharmaceutical, biotech industries, or working directly for a CRO.
• Experience in the review and selection of CROs.
• FDA/EMA regulatory experience is encouraged as is interaction with key opinion leaders (KOL’s).
• Budgetary management experience required.
• Proven analytical and strategic thinking skills, planning and implementation experience, track record of successful negotiations.
• Excellent written and verbal communication and presentation skills.
• Team player with high integrity and an open, interactive style with strong interpersonal skills.