Director of Clinical Operations

Cook Pharmica   •  

West Lafayette, IN

Industry: Biotech/Pharma


Not Specified years

Posted 361 days ago


The Director of Clinical Operations position at Cook Research Inc. is responsible for providing operational leadership in the management, conduct, and execution of global clinical studies. The position will also provide leadership, mentoring, and professional development to the Clinical Operations Team.


• Work closely with management of the global clinical process in setting expectations and developing policies for clinical study management, conduct, and execution
• Provide oversight of clinical monitoring within the Americas, and global support as needed
• Encourage and foster employee development through mentorship and training
• Provide leadership in accordance with company policies, procedures, applicable laws and regulations that apply to your business activities
• Participate in project and strategic meetings, as required
• Assist clinical project management manager(s), and team leads with the development of process goals for their teams
• Work with HR to recruit, interview, select, hire and orient new employees
• Plan and allocate resources to effectively staff and accomplish work to meet functional and company expectations for productivity and quality goals
• Foster an environment where the giving and receiving of feedback is encouraged
• Facilitate the annual employee performance review process coordinated by HR.  Encourage employee contributions through goal setting, feedback and performance development planning
• Consult HR to document, administer and resolve employee disciplinary action if required
• Maintain ongoing communication with employees through team meetings, one-on-one meetings, email, and other appropriate forms of communication
• Review and approve employee requests through appropriate pathways and according to company policies (e.g. expense reports, purchase orders, PTO approval, education and tuition assistance, and hardware/software workflows)
• Establish trusted relationships with Cook colleagues, management, and external stakeholders by providing respectful, mindful and purposeful communication and maintaining a commitment to exceeding expectations
• Understand, practice and model the principles of honesty and integrity as outlined in the Cook Global Code of Conduct


• Masters degree or PhD in scientific, medical, or engineering discipline, M.D., preferred, or substantial experience in the design and management of clinical studies, preferably in the medical device industry
• Working knowledge of FDA and other regulatory requirements that may impact global clinical studies

Physical Requirements:

• Able to travel 10-15% of the time

Requisition ID 2017-3050