SetPoint Medical is currently seeking a Medical Science Liaison (MSL). The qualified candidate for this role will demonstrate a high level of proficiency in effectively developing, engaging and maintaining professional relationships - primarily with investigators, top tier KOLs, healthcare providers and scientific experts focused on our rheumatoid arthritis clinical trials. Successful candidates are adept at preparing and delivering bi-directional scientific information and effectively entering into strategic discussions as they relate to our clinical trials. Additionally, the candidate must be able to engage healthcare professionals, including physicians, researchers, and others regarding medical/clinical, health economics, and outcomes research data on our products.

Experienced candidates are expected to demonstrate leadership competencies and support team members via collaboration, sharing of best practices and influencing others. This may include but is not limited to the teaching, coaching, and mentoring new hires and/or less experienced clinical team members and by assuming responsibility for special projects as they arise. Demonstrated leadership, strategic thinking, learning agility, adaptability, and depth of scientific knowledge are key competencies that must be readily demonstrated by a qualified candidate.

 

Essential Functions

• Develop on-going professional relationships with Key Opinion Leaders (KOLs), healthcare practitioners, clinical investigators and healthcare decision makers to provide medical and scientific support for company’s product(s) and clinical development programs/pipeline
• Provide medical and scientific information when responding to unsolicited requests regarding company’s products and related therapeutic areas
• Deliver presentations to KOLs and other key decision makers
• Facilitates the education of healthcare providers and colleagues regarding approved product(s) and new therapies developed by company
• Identifies and communicates medical/scientific insights and trends
• Identifies appropriate clinical investigators and supports interactions of Clinical Operations team with investigators and potential investigators in conjunction with ongoing and planned clinical trials as well as Investigator Initiated Studies
• Supports internal initiatives through collaboration with internal stakeholders as a clinical and scientific subject matter expert to deliver training and support other internal activities
• Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations
• Collect intelligence through scientific and medical exchange with clinical investigators and medical experts and provide relevant information to SetPoint to improve clinical strategies
• Attend scientific meetings, provide scientific support and report relevant findings of strategic interest to internal customers

Education, Experience and Skills Requirements

• PharmD, PhD or MD with focus in Rheumatoid Arthritis or other Inflammatory Diseases
• Minimum 10 years plus of relevant experience in the pharma industry
• Strong knowledge base of regulatory, compliance, commercial, and clinical issues affecting the medical device industry
• Must be an excellent communicator and skilled diplomat in all venues, including the ability to effectively combine scientific knowledge and communication skills
• Successful experience in fast-paced entrepreneurial environment
• Fit with the company’s culture and values

Other Requirements

• The position will require travel both within the US and abroad, at times up to 50%

Relocation

Negotiable

Location

Company Headquarters in Valencia, CA

Company Description

SetPoint Medical is an early-stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.

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As the acting Production Planner the ideal candidate will operate cross-functionally working with Manufacturing, Quality Assurance, Program Management, Clinical, and Purchasing departments to ensure effective management of production builds in a timely and cost-effective way. The right candidate will be highly organized and well versed in ClassIII medical device manufacturing processes and controls.

 

The Production Planner must be self-motivated, independent and able to work efficiently in a small team environment. A successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project and organization priorities. As SetPoint works exculusively through contract manufacturers it is essential that the Production Planner have excellent communication skills.

 

Job Responsibilities

• Plan and prioritize manufacturing processes to ensure component and device availability
• Maintain accurate detailed reporting to ensure agreed upon production schedules are being achived
• Maintain assembly and product level cost of goods (COGs)
• Prepare semi-annual supplier reports, including forecst, KPIs, and yield rates
• Support deployment and compliance of supplier agreements
• Coordinate supplier workflow for one or multiple products
• Work with Manufacturing to determine equipment and raw materials needed to cover production demand
• Monitor jobs to ensure they will finish on time and within budget
• Address issues when they arise aiming for minimum disruption
• Obtain output information (number of finished products, percentage of defectives etc.)
• Collaborate with Quality Assurance, Product Development and other internal departments
• Support supplier management and supplier quality initiatives
• Prepare quarterly supplier and manufacturing forecasts

Minimum Qualifications

• Proven experience as production planner
• Excellent knowledge of production planning and quality control principles
• Experience in MRP (Manufacturing Resource Planning)
• Working knowledge of MS Office and ERP systems
• Strong math and statistical skills
• Strong organizational and problem-solving skills
• Excellent communication abilities
• High school diploma; Further education or certification is preferred

Relocation

Not available

Location

Company Headquarters in Valencia, CA

Company Description

SetPoint Medical is an early-stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.

Apply Now

 

The SetPoint Medical’s Sr. CRA is primarily responsible for the hands-on management of CRAs and the monitoring of clinical study sites. The Sr. CRA will assist in the implementation and execution of study protocols and associated study documents for clinical trials, with primary emphasis on monitoring oversight, including the development of monitoring plans and review of all monitoring reports. The Sr. CRA will assist in the clinical monitoring of studies, including the coordination of site activities from site start-up to site closure as needed. The Sr. CRA will work closely with the Sr. Clinical Affairs Managers to ensure the study meets project deliverables. The Sr. CRA will contribute to the protocol design, informed consent development, CRF design, participate in EDC development and testing, preparation of site-specific logs/documentation and investigator study files. The Sr. CRA will conduct clinical site monitoring visits as needed. This position reports to the Sr. Manager of Clinical Affairs

Essential Functions

• Ensure sites comply with study protocol
• Ensure adherence to GCP, ICH, and FDA regulations and guidelines
• Liaise with CRO and study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
• Prepare, track, and manage required study documentation and supplies
• Develop training, assessment tools, job aids for both CRAs and Sites
• Oversee and track project progress at assigned sites (subject status, safety/adverse events, CRF completion, payments, clinical sample management, regulatory documents)
• Determine and oversee site investigational product requirements and accountability and other supply requirements
• Oversee field monitoring activities, including review of site visit reports and study documentation
• Participate in key site visits including site qualification, initiation, and close-out visits
• Lead and conduct visits to underperforming sites to clean data and resolve urgent issues
• Assist CRAs in identification of site issues/problems, and communicate those to Sr. Management
• Assist in project coordination, planning and logistics, including overview of budget and timelines
• Oversee implementation and maintenance of study-specific Electronic Trial Master File
• Verify that all research staff and facilities have adequate qualifications and resources and are maintained throughout the course of the clinical study
• Manage the review and approvals of Informed Consent Forms and other study related materials
• Manage continuing IRB review and approval of study sites
• Manage site payments
• Ensure adverse events are reported in accordance with the protocol on the CRF
• Communicate deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensure corrective action is implemented
• Participate in project team meetings
• Participate in departmental development initiatives (e.g. training, SOP development/updates, etc.)

Minimum Qualifications

• BA/BS or AA degree in science, pre-medicine, nursing, bioengineering, or a related field
• At least 3 years of industry experience in clinical trials for a pharmaceutical or Class III medical device company
• Experience as a lead or Sr. CRA for clinical trial along with management experience of a team of CRAs on project
• Thorough knowledge of GCP, ICH and FDA regulations
• Strong organizational skills, detailed oriented, and able to multi-task and work effectively in a fast-paced environment
• Experience with medical device and/or complex clinical trials desired but not required

Preferred Qualifications

• Ability to manage role/responsibility independently
• Able to recognize problems and react to resolve issue quickly and to bring effect resolution
• Proficient with Microsoft Office.
• Position will require travel within the US (travel expectations: up to 45% at times)

Relocation

Negotiable

Location

Company Headquarters in Valencia, CA

Company Description

SetPoint Medical is an early-stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.

Apply Now