Senior Manager, Global Therapy Advancement
The Senior Manager, Global Therapy Advancement possesses a unique combination of therapy advancement, project management, and clinical proficiencies in the cardiac medical device industry: trains implanting and supporting physicians on the use of the Parachute device; proctors live procedures; and educates physicians and allied health professionals on the trial protocol, IFU, data, safety and efficacy of Parachute Therapy (a novel Structural Heart therapy). Plan, develop, and implement policies, procedures, practices, and strategy for achieving comprehensive Sales Training programs for both internal employees and external customers. Establish clinical proficiency goals that will facilitate positive clinical outcomes with CardioKinetix Parachute procedure. This position will be primarily responsible for creating and implementing Training Department programs, as well as, mentoring all new hires until they have completed all required training.
This position is responsible for assisting with content development, management and execution of professional education / clinical marketing activities to support clinical trial and product commercialization objectives. Target audience includes global internal “employee” and external “customer” stakeholders. Position responsibilities, accountability and scope include:
- Demonstrate clinical proficiency on all CardioKinetix products.
- Assist in the design/formatting of materials, implementation and management of world class education programs.
- Train employees to drive utilization and study enrollment through cultivating relationships with key investigators: Heart Failure physicians, Electrophysiologists, Echocardiologists, and Interventionalists.
- Help ensure compliance with quality system and standard operating procedure specific to the approval of non-promotional, clinical marketing and scientific materials.
- Identify continuous improvement opportunities to enhance training material approval process efficiency, effectiveness and increase compliance within the quality system and SOP.
- Complete training reports as requested by management, and complete all additional documentation requested by management in a timely basis.
- Evaluate customer (both internal/external) needs and recommend appropriate product training modifications.
- Format/assemble, maintain, and update educational tools and curriculum materials.
- Provides direction and input to all in-house groups such as Clinical Affairs, Regulatory Affairs, Quality Assurance, Operations, IT, Finance, R&D that affect the successful achievement of business objectives.
- Maintain documented case tracking log listing proctor prioritization toward certification with each proctor skills status and projected window of certification completion with parallel development path.
- Collaborate with Clinical/Regulatory Affairs to develop clinically-focused communication tools and guides to increase employee understanding of clinical activity and to aid in effective discussions with physicians.
- Remains aware of all changes that may impact training requirements by seeking out information that may change the clinical process and implementing changes/improvements to training protocols and materials accordingly.
- Manage training process and formal certification process to ensure consistency and quality: training completion verification, track and store training documentation forms, manage continuing education requirements, displayed with reflected records.
- Support internal and external audits.
- Responsible for compliance with applicable Corporate Policies and Procedures.
- Performs other related duties and responsibilities, as assigned.
- Support, execute and collaborate with internal clinical parties to include V.P. of Global Therapy Advancement and Director of Clinical Operations.
- Must be able to effectively negotiate internally with other internal groups, and work across functions to support various business initiatives.
- Must help to ensure training materials meet business needs and comply with all regulatory and company requirements.
- Must help influence cultural change to improve compliance within the organization, through continuous education and by working with Quality, Regulatory, Clinical, Engineering, and R&D colleagues in the development of materials and activities to support training.
- Must constantly seek to improve the efficiency and effectiveness of the quality system and standard operating procedure supporting the review and approval process.
- Must be willing/able to travel > 60% of the time.
SKILLS & EXPERIENCE
Minimum of a Bachelor of Science or Arts degree, or equivalent job experience. Advanced degree preferred.
- Minimum of 5-6 years of sales/clinical training in the medical device industry.
- Minimum of 2 years of supervisory experience.
- Experience with sales training methods and programs.
- Strong written and verbal presentation skills.
- Strong communication and interpersonal skills.
- Knowledge of vascular anatomy & physiology and the Cath lab environment.
- Knowledge with the interventional (coronary, endovascular and structural heart) market place.
- Awareness of trends and changes in the market, customers and technologies.
- Knowledge and experience in training.
- Ability to assess and identify individual training needs and design and implement corrective actions.
- 5+ years’ experience in clinical field support role on devices requiring assembly or calibration in the field (pacemaker, TAVI, mitral repair etc.).
- Clinical trial implementation experience and knowledge of Good Clinical Practice guidelines.
- Comfortable with sterile field practice.
- Good physician relationships.
- Experience with CT reconstruction.
- Capable of reading echo, fluoro and CT.
- Mentoring, coaching, or leadership experience.
- Well-developed computer skills.