15 days old

Senior Director Science Communications

Avadel Management Corporation
Chesterfield, MO 63005
Apply Now
Apply on the Company Site
  • Job Code

About Avadel Pharmaceuticals plc

Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com. Our organization fosters our culture based on being relentless for patients, having confidence with humility, being courageous, taking insight to action and togetherness. Success for us is defined through how we improve the lives of patients and how we achieve our objectives as ONE Team.

Our approach to developing new medicines is based on applying proprietary, drug delivery technology that improves the way drugs are dosed and released. We are currently focused on the development and potential FDA approval of our lead candidate, FT218.

Avadels FT218 is an investigational, once at bedtime, extended-release formulation of sodium oxybate intended to treat excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. Sodium oxybate is currently the standard of care for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. However, currently approved sodium oxybate products are immediate release formulations requiring two nightly doses - one dose at bedtime and the second dose 2.5-4 hours later, in the middle of the night.

Once at bedtime FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that once at bedtime FT218 may be clinically superior to a formulation of sodium oxybate already approved by the FDA for the same indication. In particular, once at bedtime FT218 may be safer due to ramifications associated with the dosing regimen of the currently marketed twice-nightly product. Avadels market research suggests that FT218, if approved by the FDA, has the potential to command a meaningful share of the multi-billion-dollar narcolepsy treatment market. FT218 currently has patent protection until at least mid-2037 with additional patent applications pending that could extend that date beyond 2040.

On April 27, 2020, we announced positive topline results from our pivotal phase 3 REST-ON trial of once-nightly FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. On December 16, 2020, we announced the submission of our New Drug Application (NDA) in the United States for FT218. On March 1, 2021, we announced FDA acceptance of the FT218 NDA with a target action PDUFA date of October 15, 2021; FDA review of that NDA is still ongoing.

We are a small, agile, and patient-obsessed team that is growing, and we have a lot of work to do in building our best-in-class team to support the launch and commercialization of FT218, if approved, and the future expansion of our portfolio. We are seeking bright people who want to roll up their sleeves, build our company together and make an impact so we can help people suffering from narcolepsy.

Position Summary:

The Sr. Director/Executive Director will be the subject matter expert in all aspects of conveying messaging for FT218, a once-nightly sodium oxybate currently under review at the FDA (PDUFA October 15, 2021) for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. Working with the head of medical affairs and the senior medical director, this position will help to drive strategy to externalize a robust dataset, including ongoing generation of data via an open-label study, as well as other projects underway using real-world evidence (RWE), with the opportunity to identify additional projects. A critical need is to serve as the primary medical reviewer for all promotional messaging in preparation for a product launch.

Essential Functions:

  • Serves as the primary medical reviewer for all promotional materials in preparation for product launch
  • Actively contributes to the existing publication strategy and drives identification of new ideas to augment the current strategy.
  • Identify, coordinate, and execute activities for medical congresses, including medical information booth presence, development of medical booth content, symposia, alignment of competitive intelligence, pre- and post-meeting congress reporting.
  • Develops assets used by the field medical affairs team; listens to needs and works with head of medical to prioritize development, including completing internal review by legal and regulatory partners, with a solution-oriented mindset to adapt changes, as needed.
  • Develops assets for posting to the Avadel Medical Affairs website, including appropriate review and sign-off by legal and regulatory partners.
  • Identifies additional means to amplify existing external assets (e.g., publications, posters, etc).
  • Ensures timely publication and externalization of key data that comply with laws, regulations, and guidelines.
  • Directs, reviews, and approves manuscripts, abstracts, posters, and other documents to ensure appropriate evaluation and presentation of data, methodology, and interpretation.
  • Partners externally with 3rd party vendors to ensure the appropriate balance of internal and external execution of work, aligned to the budget.
  • Builds strong cross-functional collaborations and communicates updates to internal stakeholders.
  • Reinforces good publication practices and fosters a collaborative, collegial rapport with both internal stakeholder and external authors.

Experience and Qualifications:

  • Advanced Degree with minimum 10 years experience in similar role; Doctorate (PhD, PharmD, or MD/DO) preferred
  • Deep understanding of FDA standards necessary to meet substantial level of evidence for inclusion in promotional messaging
  • Experience with enterprise wide VeevaVault
  • Pharmaceutical company experience contributing to or leading congress abstract submissions, poster and oral presentations, and peer-reviewed publications
  • Proven ability to manage multiple priorities
  • Sense of urgency with excellent time management skills to allow sensitive deadlines to be met
  • Real-world evidence (RWE) and health economic outcomes research (HEOR) experience preferred
  • Understanding of FDA regulations for promotional review standards
  • Experience with positively contributing to promotional review; pro-actively offering solutions to ensure that messages are adequately and appropriately supported by science
  • Understanding of Good Publication Practice (GPP3) and International Committee of Medical Journal Editors (ICMJE) standards
  • Ability to proactively identify areas to contribute in a fast-paced and rapidly growing environment
  • Embody and live our core values: relentless, confidence with humility, courageous, insights to impact, togetherness.

Avadel is an Equal Opportunity Employer


Posted: 2022-01-07 Expires: 2022-02-08

Job Opportunities

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Senior Director Science Communications

Avadel Management Corporation
Chesterfield, MO 63005

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast