What are the responsibilities and job description for the Senior Manager, Clinical Affairs position at BIOTRONIK Inc?

Senior Manager, Clinical Affairs

At BIOTRONIK Neuro, we're ready to redefine relief for patients experiencing chronic pain. Leveraging BIOTRONIK's advanced cardiovascular technologies, BIOTRONIK Neuro has created a new approach to SCS therapy management : one that's not just implanted, but truly connected to the needs of patients and providers.

The Senior Manager, Clinical Affairs role at BIOTRONIK Neuro will oversee clinical evidence generation programs for Neuromodulation products, focusing on Spinal Cord Stimulation (SCS) for chronic pain. This position will work closely with cross-functional clinical research teams.

Your Responsibilities

Lead clinical studies for SCS products, including the design and execution of pre-market, post-market, and real-world evidence (RWE) studies.
Execute clinical studies in compliance with FDA regulations, ICH guidelines, ISO standards and GCP requirements and in alignment with business goals and objectives.
Provide scientific input into trial design, protocol development, statistical analysis plans and publications.
Work closely with cross-functional teams-statisticians, clinical affairs support, regulatory, marketing and reimbursement -to ensure studies and evidence dissemination meet business needs.
Implement Real World Evidence strategies to support products from clinical development through licensing, market access, and lifecycle management with clinical studies and complex healthcare data (e.g. insurance claims, electronic health record (EHR), registry data).
Develop clinical strategy and documents to support regulatory submissions and respond to queries from regulatory authorities.
Collaborate with external stakeholders, such as physician investigators and key opinion leaders, representing BIOTRONIK as an SCS clinical research expert.
Analyze and interpret clinical data and lead publication efforts, including project management and coordination with investigator authors.
Build working relationships with National Principal Investigator(s) and steering committees to assure best practices are integrated into study design, implementation, and analysis of clinical results.
Coordinate and lead Steering Committee, Clinical Events Committee (CEC), Data Safety Monitoring Board (DSMB) and investigator / coordinator meetings.
Obtain approvals for planned study compensation and clinical consultants according to procedures.
Ensure consistency and compliance with department and company quality management system procedures.
Assess project-staffing needs, identify and communicate resource issues to management.
Assist in selection, qualification and management of third-party vendors, including Clinical Research Organizations, core labs, adjudication committees, statistician and electronic records services, and others as needed. Act as liaison with vendor project manager / primary contact.
Assist with budget negotiations and contracts with vendors and clinical study site contracting, upon request.
Support BIOTRONIK project-specific internal and site FDA inspection preparation, as needed.
Contribute to optimization of internal processes and procedures.
Represent BIOTRONIK at scientific and business meetings / conferences.

Your Profile

Bachelor's degree in a science, health professions or engineering field, with a strong technical and clinical background.

7 years of progressive experience in medical device clinical research on studies involving all phases of the medical device total product life-cycle, with prior experience in project / program management and leadership roles preferred.

3 years experience in SCS clinical research (or related neuromodulation devices).

Strong clinical study and technical experience in relevant BIOTRONIK Neuro product and / or relevant therapeutic areas.

Knowledge and / or experience conducting medical device clinical studies through all phases of total product lifecycle (e.g. First in Human, Investigational Device Exemption, post-approval and post-market studies).

Prior experience providing clinical evidence support for submissions to global regulatory authorities.

Understanding of current GCP / ICH guidelines and FDA regulations specifically, 21 CFR Parts 11, 50, 54, 56, 812, and 820, ISO requirements governing medical device clinical studies.

Excellent organizational and problem-solving skills, including demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently.

Excellent interpersonal skills, ability to interface effectively with all levels of staff and management, both internally and externally. Ability to interact constructively in communication of adherence to protocol and regulatory requirements.

Excellent leadership skills including meeting facilitation, cross-functional team integration, strategic thinking, negotiation, and coaching.

Excellent communication and presentation skills to express complex ideas including technical and / medical writing proficiency.

Significant prior experience with scientific abstract and manuscript writing, and related project management from conception through publication.

Significant prior experience with clinical data analysis and interpretation, including clinical study data and real-world data sources.

Basic understanding of biostatistics and trial design.

Graduate degree (e.g. MS, PhD) in a science, health professions or engineering field preferred, preferred.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

The physical demands described here 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.

Constantly operate a computer, mobile device and other office-productivity equipment.

Constantly required to communicate with peers, co-workers, healthcare providers via computer or mobile device.

Must be able to remain in a stationary position for up to 8 hours total per day, and up to 4 hours continuously.

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

Position Type / Expected Hours of Work

This is a full-time position. Standard days of work are Monday through Friday. Hours of work may vary depending on time zone supported. Occasional evening and weekend work will be required as job duties demand.

This is a fully remote position based in the United States, with the location determined by the candidate's location.

Travel

Approximately 20% travel may be required for site visits, investigator meetings, internal business meetings and conferences (domestic and international).

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 : 59938 | | BIOTRONIK NRO INC. | USA

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.

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