Director NA Clinical Operations

The Director NA Clinical Operations , reporting to the VP Clinical Operations will be responsible for managing Clinical Research Organizations (CROs), the clinical trial team and trial budgets, directing activities related to supporting clinical trial design and assuring clinical trials are efficiently and effectively executed against project timelines. This will include facilitating external medical experts as the clinical development program of new products is defined.

In addition, the position will define operating procedures bridging sponsor requirements to the CRO ensuring requirements are followed for respective responsibilities.

The position will evaluate clinical product development against target product and medical plan and adjust clinical strategy to meet changing market and competitive conditions.

This position requires strategic thinking, interaction with KOL's, FDA regulatory experience and the ability to work cross functionally to formulate and implement action plans to meet the vision, goals and timelines of the company.

Work Schedule: Mon - Fri 8am-5pm

• Assist in 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, ensure compliance with protocols, regulations and best practices.
• Coordinate 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 identification of 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.
• Ensure effective control of clinical product development activities and take corrective action to guarantee that achievement of objectives falls within designated budgets.
• 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.
• Help represent the organization at scientific meetings as required.
• Present progress reports and strategies to management.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA,EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
  
  

• Technical degree in a science related field required.
• Fifteen or more 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.

Working Conditions:

• Standard office environment
• Willingness to work in a team-based environment
• Close attention to detail required
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as businessneeds require
• May be required to sit or stand for long periods of time while performing duties