Vice President Clinical Research
Company: Portal Instruments
Posted on: November 23, 2022
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
- 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
- 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
- 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
- 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
In the role you will need:
- This role requires 15+ years of experience in the
pharmaceutical/medical device industry in a clinical/medical
- 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
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
Which all sounds great--- right? But what about the other
- 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%
- Did we mention employees are eligible for a variety of flexible
spending accounts (FSA)?
- 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
- 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: firstname.lastname@example.org. 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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