Director – Clinical Affairs

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

How you’ll make an impact：

• Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables.
• Manage and oversee the work of Clinical Affairs and have financial budget responsibilities.
• Develop a robust talent development plan and performance management in alignment with functional growth strategies of the department.
• Identify risk, develop and lead in the implementation of broad and more complex Clinical Affairs strategies which may include negotiations with internal and external parties.
• Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams.
• Manage Clinical Affairs vendors.

What you'll need (Required):

• Bachelor's Degree or Equivalent in in related field strong clinical background Required
• Master's Degree or equivalent in in related field Preferred

What else we look for (Preferred):

• Proven successful project management leadership skills
• Proficient in Microsoft Office Suite and related tools and systems
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expert understanding of Clinical Research procedures while identifying applications of functional knowledge and existing methodologies to complex problems
• Expert understanding of related aspects of Clinical Research processes and/or systems
• Expert knowledge of financial mechanism that relates to Clinical Research.
• Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of Clinical Affairs to the business
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Knowledge of Good Clinical Practice
• Frequently interacts with internal and external stakeholders concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
• Lead briefings and technical meetings for internal and external representatives
• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
• Dedicated to quality stakeholder service and pro-active and responsive to internal and external stakeholder needs.
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control