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Vice President Clinical Research

Company: Portal Instruments
Location: Cambridge
Posted on: November 23, 2022

Job Description:

About PortalPortal aims to transform medicine by enabling patients to self-inject their biological drugs with a revolutionary needle-free device. This innovative drug delivery system is designed to replace auto-injectors and our early studies show it is overwhelmingly patient preferred. Issued from MIT Research and connected to the cloud, the Portal device allows biopharmaceutical companies to differentiate their therapies with a patient-centric drug-delivery solution. Join us on this exciting journey of making patient care and comfort a priority.
At Portal we believe in workplace inclusion - all employees belong, contribute, and thrive in our fast-paced environment. All people need to be represented for all patients to be represented. We encourage you to apply no matter your background - because we understand a diverse culture formulates diverse solutions.
Vice President Clinical ResearchReports to: CEOThis role is based in our Cambridge, MA office, and we are looking for someone to be onsite in the office every week, though not every day.
OverviewWe're looking for a VP of Clinical Research who is passionate about making a difference in the lives of patients and how medicines are delivered today.
The VP Clinical Research will report to the CEO and will provide medical and clinical (including pre-clinical) leadership and guidance to the organization with a patient-centric focus on drug delivery, patient education and training at Portal Instruments. This role will plan and execute successful pre-clinical and clinical studies in support of corporate objectives, demonstrating proficiency in all areas of clinical study development and execution with an ability to build and direct effective multi-disciplinary project teams.
The VP Clinical Research will be responsible for strategic planning and roadmap development for the pre-clinical and clinical programs. These studies span from ex-vivo and in vivo animal testing to human clinical trials. This role is also responsible for hands-on protocol development, clinical study report creation, manuscript preparation, and conference abstracts and presentations.
In this role you will:

  • Provide in-house medical guidance to the cross-functional teams with respect to drug delivery practices across therapeutic areas
  • Lead pre-clinical and clinical research planning and oversee the data analysis presentation/communication of data both internally and externally
  • Lead study design and protocol development for all pre-clinical and clinical studies
  • Lead the evaluation, selection, and oversight of CROs and other external vendors to ensure successful clinical trial implementation and execution
  • Develop and manage overall study budgets, negotiation of budgets with clinical sites, vendors, and consultants
  • Facilitate strong relationship building with medical, R&D and clinical staff at pharma partner organizations
  • Lead and participate in clinical discussions including clinical data interpretation, strategic guidance on evidence generation, clinical communications and developing changes in medical practice
  • Coordinate the development, drafting, and submission of regulatory documents for approval including but not limited to clinical reports, clinical study data, Clinical Evaluation Reports and Summary of Safety and Effectiveness Data
  • Develop, support, and provide data reviews of abstracts, manuscripts, presentations, Instructions for Use, and other materials that include study data
  • Drive the publication and presentation strategy including publishing of research papers in peer-reviewed journals, and conference abstracts and presentations
  • Conduct on-site clinical monitoring/quality activities as needed
  • Develop an in-depth understanding of the Portal products and the potential clinical applications and develop a working knowledge of the therapeutic areas of these clinical applications
  • Serve as the Portal clinical lead for animal and human clinical research activities of the Portal products with external pharmaceutical partners

    In the role you will need:
    • This role requires 15+ years of experience in the pharmaceutical/medical device industry in a clinical/medical sciences role
    • Drug/device combination product experience a huge plus; experience in biological drug development a plus too
    • Minimum of MS in biological/medical sciences
    • Advanced degrees a plus: MD / DO / PhD / PharmD

      Preferred Qualifications & Experience
      • Industry knowledge: Understands medical device/pharmaceutical industry regulations governing clinical trials and the regulatory process; thorough knowledge of FDA and ICH GCP Guidelines, and knowledge of IRB procedures through all phases of development
      • Understanding of the patient challenges associated with self-administration of medicines for chronic diseases
      • Clinical Operations: multi-dimensional clinical operations background, specifically in early-stage clinical studies from animal PK through human clinical trials
      • Leadership: Excellent track record of effective leadership in the pharmaceutical or medical device industry; expected to demonstrate confidence and willingness to make decisions to achieve functional goals; ability to provide mentorship, ongoing feedback and coaching to employees, and to provide clinical guidance to fellow leaders in the organization
      • Communication: outstanding ability to clearly communicate ideas and data both orally and in writing
      • Analytical Skills: ability to understand and analyze a wide range of scientific and clinical data using a variety of research and statistical tools
      • Business Acumen: the ability to understand the business context and how clinical data is there to establish value of the Portal technology; ability to implement business solutions to meet the needs of the organization, including managing tasks on budget and on time; ability to maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy
      • Interpersonal Proficiencies: strong skills in motivating, negotiating, listening, conflict resolution
      • Advanced Computer Skills: Word, Excel, PowerPoint, SharePoint, and software tools such as Endnote or Reference Manager, as well as tools for literature searches such as PubMed or Embase
      • Ability to work in a fast-paced, cross-functional, startup environment

        Working at PortalPortal Instruments offers employees the opportunity to work in a fast-paced start-up that values innovation, creativity, accountability, teamwork, and openness while providing excellent leadership and development opportunities.
        Which all sounds great--- right? But what about the other stuff??
        Pay
        • We believe in transparency so if your resume meets the job requirements, we will discuss salary range with you right from the start, so feel free to ask us!
        • Portal offers a competitive salary, a comprehensive benefits package, including stock options, both Roth and traditional 401(k) retirement plans, thoughtful health and dental plans and a chance to make a difference in the lives of thousands of patients.
          Healthcare for FTE:
          • Portal works very hard to select healthcare plans that keep costs low for employees while still maintaining the level of care you deserve and expect from leading healthcare companies. We even pay the first half of your deductible so that we can keep the premium costs low for you!
          • We offer both PPO and HMO healthcare plans, dental, orthodontic, vision and accident insurance plans too!
          • Paid family medical leave is covered by Portal both short- and long-term disability as well as AD&D insurance and all are 100% company sponsored
          • Did we mention employees are eligible for a variety of flexible spending accounts (FSA)?
            Vacation
            • 20 days of vacation for everyone, because everyone deserves to take a break and our team is encouraged to take all their time off each year to recharge!
            • 13 company-wide state and federal holidays and often a company-wide holiday shutdown - sometimes the best reward for hard work and results is no work and all rest!
            • If you're sick.. you're sick! And being sick is certainly no picnic (or vacation!), so all employees get sick days to use when they are under the weather. We want you to take care of yourself, plus staying home helps protect everyone! At Portal we want to make sure you know that our strong team has your back to support you through all of life's obstacles.
              Flexibility - We put flex in flexibility!
              • Life shouldn't just revolve around work - if you want to go exercise at 2 PM or grab lunch with an old friend, be our guest!
              • We are a results driven team - so we don't have to see a green dot on Slack to trust that you're doing your job!
              • Portal offers employee's an assistance program which includes confidential counseling, financial information and resources, work-life solutions, free online will preparation and more!
              • We also offer a commuter reimbursement account, dependent care accounts, on-site parking (subject to availability), a bike room and locker room with a shower!
                Growth at Work
                • We invest in your career - our company's growing quickly, and we'll give you the opportunity to do the same. You'll have access to several professional development opportunities so that you can keep up with the company's evolving needs and grow your career along the way.
                • Portal offers its employees access to the Southern New Hampshire University discount program on part time tuition - a 10% employee discount for both undergraduate and graduate students.
                  More Benefits--- seriously!
                  • Daily free lunch
                  • Casual dress code
                  • Pop-up wellness benefits
                  • Happy hour
                  • Annual company sponsored events
                  • Volunteer opportunities
                  • Annual donation match program though Brightfunds
                    To Apply: Please apply via LinkedIn or submit a resume and cover letter to: careers@portalinstruments.com. You will be contacted if your background meets Portal's needs.

Keywords: Portal Instruments, Cambridge , Vice President Clinical Research, Executive , Cambridge, Massachusetts

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