Clinical Affairs Lead

Beta Bionics Clinical Affairs Lead

Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing better access to better solutions and a better life for those living with diabetes with the world's first bionic pancreas called the iLet. The iLet Bionic Pancreas is the first and only insulin delivery system that does not require carb counting*, bolusing, correction factors, or pre-set basal rates. The only number needed to get started with the iLet Bionic Pancreas is a user's weight the iLet does the rest. The iLet lets users "Go Bionic" with their diabetes management. *User must be carb aware.

Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields. We have a mission-driven, passionate and collaborative culture where you will have a high degree of empowerment and opportunity to make a significant impact.

The Clinical Affairs Lead will work within established company objectives and finances to support both the commercial and investigational use of company products. The Clinical Affairs Lead will work closely with the clinical operations and regulatory teams in the set up and execution of clinical research protocols. The Clinical Affairs Lead will also engage with the sales and quality teams as healthcare providers and patients use the device commercially.

Support clinical research operations:

• Collaborate with clinical operations team to support the overall coordination and execution of multiple clinical research studies, including both investigator-initiated and sponsor-initiated studies using investigational drugs, investigational devices, or both
• Review reported adverse events and provide a clinical assessment of the event based on available device data and event descriptions, including following up with study staff and participants as needed to ensure complete and accurate documentation
• Determine relatedness to investigational product, expectedness, seriousness, and severity for all reported adverse events reported in accordance with the clinical study protocol, investigational product labeling, and study-specific safety management plans
• Write clinical study protocols, consent/assent forms, and other study required documents as needed for regulatory submissions
• Assist in the preparation of protocol-specific comprehensive manuals of operations for use by study sites describing all aspects of procedures required to execute the protocol from start to finish
• Support the management of clinical site budgets in collaboration with the finance and regulatory departments to ensure study operations are efficient and cost effective and that milestone payments are submitted on time
• Assess all potential clinical sites before their participation in research to determine if they have the appropriate facilities and experience to adequately conduct the trial
• Assist with the creation and maintenance of a comprehensive data collection system including protocol-specific case report forms, source documents and study visit checklists to ensure patient safety, data integrity, and compliance with the study protocol and all regulations
• Create and tailor clinical study staff and participant training materials, translating complex manuals/instructions for use and research procedures into plain language for all levels of health literacy
• Create study-specific safety management plans that comply with the study protocol, and all regulatory and institutional requirements and update plans as the protocol changes
• Train study sites on use of the investigational product as well as all research related operations
• Perform site initiation visits to train study staff on the protocol and all study procedures
• Manage day-to-day operations with the study sites throughout the execution of the study
• Support clinical sites during audits and develop corrective action plans as needed to ensure timely resolution of audit findings
• Assist with preparing the final study report and study-related abstracts, posters, presentations, and manuscripts

Support medical affairs and commercial clinical operations:

• Provide clinical guidance and advice to all departments within the company to ensure that new products or modifications to existing products meet medical needs and safety requirements of users and healthcare providers
• Serve as a resource for questions related to off-label or non-traditional use of commercial products, including answering inquiries from the field clinical team or healthcare providers, representing Beta Bionics at conferences and events, and presenting to healthcare providers as needed
• Support the review and processing of device-related complaints and adverse events by providing a clinical assessment of the event based on available device data and event descriptions, including providing coordination with external parties as needed

Other duties and responsibilities:

• Participate in third party and internal quality audits involving areas of responsibility. Assist with related corrective/preventive action planning and implementation
• Establish and maintain Standard Operating Procedures and Forms related to areas of responsibility to comply with US and International (as applicable) Good Clinical Practice regulations and pertinent standards, including US 21CFR50, 54, 56 and 812 and ISO 14155
• Other duties as assigned by Supervisor
• Comply with privacy expectations/HIPAA and other regulatory, legal, and safety requirements.

Required education and experience:

• Bachelor of Science degree
• Clinical licensure (RN, NP, RD, PA, RPh)
• 5+ years of clinical experience in the diabetes space
• 5+ years of experience in clinical research
• Competence in drafting clinical documents including but not limited to abstracts, presentations, and posters for submission to conferences, clinical research protocols, study manuals of procedures, etc.
• Knowledge of medical device industry clinical requirements, relevant US regulations, and guidance including ICH GCP guidelines
• Experience with ethics committee/IRB submissions, US IDE submissions, and related requirements
• Excellent attention to detail, organizational skills, and flexibility to handle multiple tasks and the pressure of competing deadlines
• Ability to interpret and utilize scientific/technical information to collect information needed to complete assessments of events and determine potential relatedness to investigational product
• Self-motivated, takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary
• Proficient in pertinent software and tools including Microsoft Office suite, Adobe Acrobat, and Salesforce
• Ability to communicate professionally in verbal and written format with physicians, researchers, and patients
• Strong collaborative and team-building skills

Preferred experience and qualifications:

• Master's Degree
• Certified in diabetes care and education (CDCES or BC-ADM)
• Certified in clinical research (CRN-BC, CCRP, etc.)
• Experience in both inpatient and outpatient diabetes management

Location/Work Environment:

• This job can be based in either Massachusetts (currently Concord, subject to change) or California (Irvine or San Diego). California offices require in-person work 5 days a week. The Massachusetts office requires in-person work 2-3 days a week.
• Required travel will include attendance at the annual American Diabetes Association Scientific Sessions (typically June), Friends for Life Children with Diabetes conference (typically July), and Association of Diabetes Care and Education Specialists annual meeting (typically August) to support the commercial team by staffing the Beta Bionics booth in the exhibit hall as required. Other occasional travel, including regular visits to the other offices, will be required.

Physical Demands:

• While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers. This position requires travel up to 20% depending upon business needs.

Salary Range:

$120,000+ based on experience

Benefits:

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options, including an annual company contribution to the HSA
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule

Equal Employment Opportunity Statement:

It is the policy of Beta Bionics to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.