Director, Clinical Affairs NRO

Director, Clinical Affairs NRO

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

BIOTRONIK is looking to add a Director, Clinical Affairs to our new Neuromodulation Segment. The Director, Clinical Affairs NRO is responsible for leading and managing the strategy, planning, and execution of clinical research and investigational affairs while assuring full compliance with applicable GCP regulations as well as relevant worldwide standards and regulations. Provides global leadership for NRO Clinical Research Activities. Responsible to interface with data management, biostatistics, regulatory agents, clinical research associates, study coordinators, field clinical specialists, business stakeholders, medical/safety monitors, and functional management. Acts as the liaison with key opinion leaders, site investigators, and clinical site staff. Responsible for clinical study designs and required documentation and all data publications including scientific publications with site investigators, white paper publications, clinical data summaries, etc.

This role requires strong technical and client management skills, the ability to work with cross-functional teams: Sales, Sales Operations, Engineering, Product Management, Regulatory Affairs, and Marketing.

We are looking for a highly motivated, self-directed individual who will thrive in a fast start-up environment and possess strong interpersonal skills.

Your Responsibilities

• Develop global clinical affairs strategies, in collaboration with regulatory affairs, marketing, research & development, reimbursement, and outcomes planning, and obtain approvals by the most effective method possible
• Develop and execute a Clinical Affairs Strategy to generate data for both marketing and regulatory purposes
• Enroll and manage KOL / physician-clinician engagement and lead the management of all Clinical Affairs investments and required support
• Support regulatory/clinical strategies as NRO clinical affairs leader
• Prepare and manage NRO clinical affairs budget
• Develop and manage the Clinical Affairs NRO Team: assign, direct, and evaluate their work, and oversee the development and maintenance of staff competence
• Develop clinical study strategy and protocols for investigational devices and/or for new products being introduced to the marketplace
• Oversee the management, planning, and execution of respective clinical studies including:
  • Provide oversight of individual clinical trials to ensure full compliance with GCP and that safety concerns and/or adverse events are identified and appropriate responses to such concerns are executed
  • Travel to clinical sites for training and clinical trials monitoring purpose
  • Participate in investigator recruitment and selection activities and assist with clinical site contracting and budget negotiations
  • Serve as an interface to site coordinators, investigators and other field personnel regarding study devices and clinical protocols.
  • Develop training and other clinical study support materials for investigational or study devices and procedures
  • Train study centers, and field personnel on clinical protocol and investigational devices
  • Train site and field personnel on data collection methods to ensure collection of patient data that is accurate, complete and conforms to project data standards and protocol requirements
  • Interface with relevant internal and external stakeholders to ensure that clinical studies meet targeted enrollment and approval timelines
• Oversee the execution of clinical studies in compliance with FDA, IRB and other applicable regulations and requirements, ICH guidelines, ISO standards, GCP requirements and in alignment with internal procedures, business goals and objectives
• Responsible for market research, competitive analysis, and literature reviews in the field of neuromodulation clinical studies; remain current on market dynamics and competitive developments
• Create and maintain relationships with internal and external partners
• Responsible for data collection, analysis, and presentation to management
• Responsible for preparing data for publication, white papers, presentations, etc.
• Prepare and approves protocols for projects; reviews final study conduct documents such as study manuals, study plans, study tools, etc.
• Develop staffing plans according to needs
• Initiate investigator and coordinator meetings
• Provide advice to the customer complaint reportability team of adverse events and other clinical trial issues to regulatory agencies
• Determine membership criteria and identify potential members for clinical events committees and data monitoring committees
• Review and approve Clinical Risk-Benefit Analyses
• Review and approve study corrective action plans. Prepares for and participates in internal/external study-related audits
• Develop and maintain Clinical Investigation, conduct infrastructure – drafting and/or reviewing of SOPs, DOPs, and Work Instructions
• Demonstrate thorough knowledge of and coaches’ others in the appropriate application of clinical research conduct, laws, regulations, standards, and compliance with applicable SOPs and policies
• Other initiatives as required

Your Profile

• BS/MS in either (Biomedical) Engineering, Science, or a related field.
• 8-12 years’ experience in clinical/scientific medical devices/pharmaceutical clinical trials and research.
• 5 years’ experience managing projects and working with clinical professionals and cross-functional product development teams
• Well versed in EU and FDA regulations and standards and GCP, ICH guidelines
• Familiar with the laws, regulations, standards, and guidance governing the conduct of clinical studies
• Excellent leadership, management, collaboration, and effective decision-making skills
• Highly organized and detail-oriented, with solid analytical skills
• Ability to understand strategic goals and match the business needs of the company
• Ability to independently manage and provide significant tactical leadership and guidance
• Demonstrated ability to manage multiple, complex, and international projects
• Prior experience in all aspects of FDA investigational studies
• Excellent leadership skills and the ability to motivate others to work together to a common goal
• Excellent written and verbal communication skills and the ability to work with all levels of the Company
• Familiarity with considerations and terminology of health care and/or medical device industry
• Strategic thinking and analytical skills

Preferred Education and Experience:

• Work experience in clinical study planning and execution of implantable neuromodulation devices
• Work experience in other functional areas beyond clinical affairs (e.g. marketing, regulatory, quality, etc.)
• Strong team player, self-motivated, self-directed, action oriented, able to learn quickly
• German language skills

Travel Requirements:

• Must be able to travel international and domestically.

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

Location: Lake Oswego, OR | Working hours: Full-time | Type of contract: Undefined

Apply now under: www.biotronik.com/careers

Job ID: 37785 | Contact: Amanda Willott

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.