Are you inspired by a fast-paced, innovative environment that will challenge you to find creative solutions? At Balt, we foster a culture of collaboration that drives constant innovation. Our goal is to enhance the care of patients with neurovascular disease through physician-inspired innovative solutions. Balt’s 40 year legacy of bringing first-to-market products is now in the US. We are looking for dedicated, creative and collaborative individuals to join us in building the next great neurovascular device company. If this sounds like you, please select from our open positions below.

Senior Program Manager-Clinical Affairs

Are you a global leader driving large scale clinical programs and successfully impacting patients? We are looking for a Senior Program Manager to lead, build and maintain strong relationships with leaders inside the organization and industry, as well as with Key Opinion Leaders to support our growing and expanding commercial product portfolio. As the Senior Program Manager, you will have a direct impact on the continued evolution of Balt: from its history as a niche R&D company in Europe to a global neurovascular device company.

You are responsible for (but not limited to):

  • Providing input into the development of global clinical strategies for assigned therapeutic area(s) working in collaboration with Medical Science
  • Responsible for planning and managing all aspects of clinical trial including budgets, clinical site selection and contracting, vendor contracting and oversight, safety and strategy to support the expanding product portfolio for the business
  • Reviewing and approving project deliverables such as protocols, final study report, annual report(s), study manuals, study tools, etc.
  • Responsible for input to the Clinical Risk Benefit Analyses / FMEA / DFU, etc.; investigator and coordinator meetings, and managing the DMC activities including approval of the Manual of Operations, meeting coordination, and addressing DMC recommendations
  • Responsible for data review and dissemination of clinical data to Clinical Science and Medical Affairs. Providing input to the Safety organization for the Clinical Events Committee(s) and definitions used by the CEC
  • Demonstrates thorough knowledge of and coaches’ others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BALT SOPs and policies

The Senior Program Manager reports to the Head of Clinical Affairs for the US, sitting in the Boston Corporate office amongst the senior leadership team you will collaborate with the local, remote, and global clinical team to balance business objectives with available resources meeting goals and ensure success.

To succeed in this role, you should have the following skills and qualifications:

  • Ability to independently manage and provide significant tactical and leadership guidance to clinical team.
  • Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies.
  • Demonstrated previous success managing multiple, complex, and international projects; understanding the strategic goals and match the business needs of the company.
  • Ability to develop good interpersonal relationships with medical professionals, and internal teams globally.
  • Bachelor’s-level degree required, Masters-level degree (or equivalent) preferred. Studies focused in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences), or qualification in medicine.
  • 9+ years ’experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 5+ years’ experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. 3+ year experience managing complex, global trials including people management.

BALT is a world leader in the design and manufacture of interventional neuroradiology devices to treat neurovascular pathologies (strokes, aneurysms, AVMs). By placing innovation at the center of its model, the company maintains its leading position in the neuroradiology field worldwide. We are growing our company worldwide with a focus on the commercialization of Balt products in the United States as well as continuing a tradition of physician inspired innovation through novel research and development.

Diverse workforces create the best culture, company, and products! We at Balt are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Balt does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Senior Clinical Project Manager (CPM)

Are you a proactive project manager with great ability to interact with clinical professionals, vendors, CRO’s and internal team members to help drive clinical projects to completion? We are looking for a motivated individual that is passionate about making an impact in patient lives through their strong organizational skills.

You are responsible for (but not limited to):

  • Management and coordination of clinical trial(s), ensuring the trial is “audit ready”.
  • Ability to manage project(s) within the approved budgets and timelines, with knowledge across multiple projects to ensure attainment of project deliverables, effectively communicating within the Clinical Project Team and with functional management.
  • The selection, contracting, coordination and management of the CROs contracted for a given project. Preparing investigational site lists and participating in the reviews and approval of investigational sites.
  • Directing the forecasting of devices necessary for project in collaboration with supply-chain.
  • Representing the clinical project team at investigator and coordinator meetings.
  • Providing oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
  • Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits.
  • Must be able to demonstrate thorough knowledge in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BALT SOPs and policies.

The Clinical Project Manager reports to the Head of Clinical Affairs for the US, sitting in the Boston Corporate office amongst the senior leadership team. In this role you have the opportunity to support the growing and expanding commercial product portfolio for BALT through collaborations with data management, biostatistics, clinical research associates, trial coordinators, and field clinical monitors.

To succeed in this role, you should have the following skills and qualifications:

  • Analytical – Ability to analyze complex or diverse information; collects and researches data; uses results, intuition and experience to synthesize product specific direction.
  • Design – Generates creative solutions; demonstrates attention to detail.
  • Problem Solving – Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations.
  • Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions. Ability to develop good interpersonal relationships with medical professionals. Good presentation skills.
  • Written Communication – Writes clearly and informatively; presents numerical data effectively; able to read and interpret medical, scientific and engineering literature.
  • Innovation – Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
  • Demonstrated ability to manage multiple global complex clinical projects.
  • Bachelor’s-level degree required, studies focused in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences), or qualification in medicine.
  • 5+ years ’experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials

BALT is a world leader in the design and manufacture of interventional neuroradiology devices to treat neurovascular pathologies (strokes, aneurysms, AVMs). By placing innovation at the center of its model, the company maintains its leading position in the neuroradiology field worldwide. We are growing our company worldwide with a focus on the commercialization of Balt products in the United States as well as continuing a tradition of physician inspired innovation through novel research and development.

Diverse workforces create the best culture, company, and products! We at Balt are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Balt does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.