Sr. Manager, Scientific Affairs at BIOTRONIK, Inc. in Lake Oswego, Oregon

Job Description:

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

Manage the scientific and technical aspects of pre-market, post-market, and after-market clinical investigations of medical devices in various therapeutic areas (e.g. Cardiac Rhythm Management, Vascular Intervention, and Spinal Cord Stimulation) through the leadership and direction within the Clinical Studies Department. Liaise and assist Clinical Study Management with operational and strategic clinical studies responsibilities. This includes responsibility for the strategic planning phase through conducting and reporting of the trial results. This will include supporting the design and implementation of complex protocols, training of site and internal staff and monitors in protocol specific procedures, implementation of clinical systems to capture and manage data, and development of reports to support both study management and clinical reporting requirements. Provides supervision and direction of the Clinical Study Engineer, Clinical Statistical Programmer, and Clinical Data Analyst groups within the Clinical Studies Department.

Your Responsibilities

• Provide significant input for strategic, scientific, and operational aspects of IDE submissions, clinical reports, and PMA/510K submissions to FDA or other Regulatory bodies for medical devices that are undergoing testing for FDA approval, required post-approval surveillance and/or for products undergoing a clinical study for potential labeling claims. Additionally, actively participating in FDA telephone conferences or meetings discussing BIOTRONIK sponsored studies.
• Develop and execute strategic and operational objectives for the Clinical Study Engineer, Clinical Statistical Programmer, and Clinical Data Analyst groups through the creation and maintenance of GCP Standard Operating Procedures and Work Instructions
• Key responsibility for day to day management of Clinical Study Engineer, Clinical Statistical Programmer, and Clinical Data Analyst groups in close collaboration with Clinical Study Management
• Responsible for recruiting, training, mentoring and evaluation of the Clinical Study Engineers, Clinical Statistical Programmers, and Clinical Data Analysts on staff
• Responsible for activities related to implementation of sponsored clinical studies and supported clinical projects:
  
  
  • Developing clinical strategy and protocols for medical devices that are undergoing testing for FDA approval, required post-approval surveillance and/or for products undergoing a clinical study for potential labeling claims.
  • Develop real world evidence methodologies to supplement or enhance data collected through conventional clinical trials
  • Training of Clinical Studies personnel on the scientific and technical aspects of new studies
  • Oversee development and maintenance of validated study databases on electronic data capture (EDC) platform
  • Ensure accuracy of database design, error checks, work flow, user access rights, testing procedures, software validation, and FDA required documentation
  • Oversee biostatistics deliverables, including clinical programming, validation, documentation, statistical analysis, regulatory reporting, manuscript support, and sample size estimation
  • Monitor effectiveness of data management systems and procedures used by the department
  • Interface with Regulatory, Marketing, Advanced Product Support, Sales, Materials Management, Contracts, Sales Operations, and administrative staff as necessary to accomplish the above responsibilities
  • Provide guidance and assistance with all product launches which may include brochures, training, and marketing launch meetings as requested
  • Responsible for critical review of marketing materials with regards to accuracy and integrity of study design, scientific outcomes, and interpretation of results
• Represent BIOTRONIK, Inc. at scientific and business meetings/conferences
• Cultivate and maintain excellent working relationships with domestic and global KOL's and Principal Investigators
• Provides regular project reports and updates to BIOTRONIK Executive Management as requested
• Interfaces and collaborates with BIOTRONIK Clinical and R&D global partners (e.g. BIOTRONIK SE & Co. KG, BIOTRONIK AG, MicroSystems Engineering, Inc. and Clinical Research Center, etc.)
• Work with CIS (IT) department to provide technical leadership and ensure the appropriate implementation of infrastructure, tools, and systems to enable the department's strategy

Your Profile

• BS/BA in one of the life sciences and/or engineering fields and a minimum of 7 years direct clinical trial experience in a CRO, Pharma, or Medical Device company with at least 5 years of progressive experience in the medical device field including a minimum of 3 years direct management experience. Master's degree preferred.
• Thorough knowledge of clinical research process from Phase I through PMA submission
• Demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently
• Demonstrated ability to interface effectively with all levels of staff and management, both internally and externally
• Demonstrated ability to build and maintain productive alliances and partnerships with internal and external clients
• Strong leadership skills including meeting facilitation, cross-functional team integration, strategic thinking, negotiation, and coaching
• Quality driven, positive attitude and enthusiastic toward work
• Strong communication skills (verbal and written) to express complex ideas
• Excellent organizational and interpersonal skills
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Ability to manage multiple priorities within a variety of complex clinical trials
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings
• Understanding of data processing functions, including electronic data capture
• Working knowledge of current GCP/ICH guidelines
• Excellent leadership skills and the ability to motivate others to work together to a common goal
• Excellent communication skills and the ability to work with all levels of the Company
• Demonstrated aptitude and knowledge in relevant therapeutic areas and ability to learn and integrate new therapeutic areas knowledge
• Excellent computer skills and data management experience
• Excellent organizational skills and attention to detail
• Ability to work independently, prioritize, and interact within a matrix team environment is essential
• Working knowledge of industry clinical research data standards and best practices
• Demonstrated understanding of biostatistics
• Experience in electronic data capturing platforms
• Familiarity with databases, including queries, data merge considerations, file structure manipulation, and relational design
• Knowledge of Reporting Tools such as SAP Business Objects
• Ideal candidate will have Real World Evidence and/or Medicare claims data exposure

Travel Requirements

• This role may require occasional travel, up to 15%, with exact frequency dependent on if the candidate is local.

Physical Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to be independently mobile.

• The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers.
• Must be able to work a minimum of 40 hours / week.
• Must be able to travel to other office locations.

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Lake Oswego, OR

Apply now under: www.biotronik.com/careers

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.