VP of Clinical Affairs (Location: United States or Galway, Ireland)
A strategic visionary who is motivated by forging new ground, you’ll create WhiteSwell’s clinical trial roadmap and build a stellar clinical team. You’re experienced collaborating with world class clinicians on the successful execution of clinical trials and the effective publication and presentation of results. You’ve preferably led cardiovascular device trials.
Join WhiteSwell, a dynamic, rapidly growing organisation, as we seek to fundamentally shift treatment of acute decompensated heart failure by harnessing the vital role of the lymphatic system in restoring fluid balance.
What you’ll do:
- Act as a strategic partner and advisor to the CEO on all Clinical Affairs matters and serve as a key member of the senior management team.
- Develop the clinical roadmap, clinical trial protocol, biostatistical modelling and endpoint selection in alignment with the CEO, senior management team and key physician advisors.
- Build the clinical organisation, ensuring that trials are conducted to a very high standard and in compliance with all applicable regulations and are executed in a cost-efficient manner.
- Develop and manage relationships with KOL’s, participating physicians and study sites, CRO’s, and publishing channels.
- Lead all aspects of the Company’s clinical trials conduct from study concept through to report writing in support of regulatory approval and reimbursement applications.
- Define clinical strategic objectives that align with the business strategy and execute on approved objectives.
What you bring:
- Bachelor’s Degree (B.A. or B.S.) in scientific, engineering, or medical field. Master’s Degree or Doctorate is highly desirable.
10+ years of medical device clinical research management experience, with a track record in bringing products through feasibility, pivotal and post-market studies.
- Thorough knowledge of Heart Failure Clinical trials with a deep understanding of clinical endpoints in terms of biostatistical modelling, clinical study execution, regulatory approval and reimbursement.
- Strong leadership profile with strategic, technical, problem-solving and negotiation skills. Highly collaborative with team orientation.
- Outstanding presentation, written and oral communication skills.