Benefits include: Medical, Dental, and Vision Insurance, 401(k), Stock Options

NOTE: You must have 5+ years experience in medical device, clinical research, data
analysis, and medical writing with a strong preference for experience in the spine and/or
implantable device industry to be considered for this position.

Providence Medical Technology, Inc. is a privately-held medical device company focused on innovation solutions for cervical spine conditions. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market.

Our purpose is to improve clinical outcomes for high-risk patients and prevent surgical failures of the cervical spine.

LOCATION

This is a remote position.

SUMMARY

As an integral team member of Clinical/Regulatory, the Clinical Affairs Scientist will serve a
hybrid function spanning Medical Writing, Data Science, and Clinical Data Management.
This role is designed for a small, agile clinical organization where cross-functional expertise
is essential to maximizing the value of our clinical, bench, and real-world evidence datasets.
The ideal candidate will help PMT deepen its understanding of our investigational and
commercial product performance, identify pathways for future regulatory or marketing
claims, support ongoing and new clinical studies, and lead the development of manuscripts,
abstracts, and clinical documents that communicate our evidence to internal and external
stakeholders.

This position will play a critical strategic role in shaping PMT’s clinical evidence generation,
data exploration, and scientific communications throughout the lifecycle of our cervical and
lumber interventional spine technologies.

MAIN RESPONSIBILITIES:

• Data Science & Evidence Exploration (~40%): Lead strategic analysis and
  exploration of PMT's clinical datasets to identify insights, claims opportunities,
  and research pathways.
• Conduct exploratory analyses on data from the IDE study, legacy clinical studies,
  real-world evidence programs, and materials/bench testing datasets.
• Integrate multiple datasets (IDE, post-market, legacy trials, bench data) to
  explore novel clinical or regulatory claims, identify signals, or highlight areas for
  further investigation.
• Develop analytical plans for exploratory work and hypothesis-generative
  analyses, independently and with consultation/guidance from team and PMT.
• Identify patterns or early signals that may support future studies, line extensions,
  product differentiation, or claims expansion.
• Support cross-functional partners (Regulatory, R&D, Marketing) by translating
  complex data into actionable narratives or claims opportunities; utilize knowledge
• Subject Matter Expert: Generate strategic reports and dashboards summarizing
  insights, trends, and opportunities discovered through advanced data
  exploration, and stay abreast of the competition and the clinical evidence factors
  that provide differentiation in the market. Remain current with regulatory
  requirements for medical device products.
• Clinical Data Management (~30%): Oversee data integrity, structure, and flow
  across all PMT studies, with hands-on responsibilities within our bespoke Clinical
  Trial Management System (CTMS).
• Ensure alignment with study protocols and data collection needs
• Manage data integrity, in tandem with study management, including eCRF
  builds, edit checks, user workflows, and quality control steps
• Conduct periodic data reviews, resolving inconsistencies and ensuring GCP-
  compliant data management practices
• Develop and deliver interim data summaries and reports to support study
  conduct, safety monitoring, and internal decision-making
• Collaborate with clinical team and contractors, as appropriate, to overseeing
  quality, timelines, and alignment with PMT study priorities
• Contribute to data lock, freeze, transfer, and final reporting activities for PMT's
  new and ongoing clinical studies
• Build signal-detection and forecasting tools to help Clinical Affairs anticipate
  emerging trends or areas of attention as data accrue.
• Medical Writing & Scientific Communications (~30%): Serve as a key driver of
  PMT's clinical storytelling through high-quality scientific and regulatory writing
• Draft, revise, or update key clinical documents, including Clinical Investigation
  Plans (CIPs) / Study Protocols, ICFs, IBs, protocol amendments and updates,
  Clinical Study Reports
• Develop high-quality scientific content, including abstracts and posters for
  scientific congresses, peer-reviewed manuscripts for journal submissions, and
  generate white papers, clinical summaries and value narratives
• Support surgeon-authors and key opinion leaders with writing assistance,
  literature searches, and data interpretation.
• Ensure consistency, accuracy, and high scientific standards across all written
  materials.
• Collaborate cross-functionally to support submissions and evidence packages,
  as needed
• Contribute to publication planning, scientific messaging and dissemination
  strategy across the organization.

QUALIFICATIONS:

• Advanced degree (Masters or PhD) in a relevant field
• Minimum five (5)+ years experience in medical device, clinical research, data
  analysis and medical writing. Medical device experience in spine and/or
  implantable device industry strongly preferred
• Ability/willingness to travel up to 10%
• Prior experience with clinical trial protocol development, abstract and manuscript
  generation
• Experience with proprietary or custom data platforms
• Experience working in small or mid-sized medical device companies where
  versatility is essential

REQUIRED SKILLS AND ABILITIES:

• Proficient with clinical trial management software
• Proficiency with statistical software (R, SAS, Python), even if supported by
  external partners.
• Expected subject matter expertise, centering on US Medical Device testing and
  clinical trials, and their respective regulations, guidance, and policy (i.e.,
  experience with IDE clinical trial and international regulatory process required
  including FDA (e.g., 21 CFR); ICH and ISO:14155)
• Self-motivated, team player, with excellent time management skills to impact a
  full range of customer, operational, and clinical service activities within the team
  and cross-functionally