Senior Medical Director (Remote)
- Posted: over a month ago
About Avadel Pharmaceuticals plc
Who We Are: 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. Oxybate therapy is currently the standard of care for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients living with narcolepsy. However, currently approved 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. Our current lead drug candidate, LumryzTM (sodium oxybate) extended release for oral suspension (formerly known as FT218), applies our proprietary drug delivery technology to allow for a single bedtime dose, eliminating the need to have a forced awakening during the middle of the night and giving patients the chance for an uninterrupted night’s sleep. An extended-release medication sounds like a simple innovation, but it is what has been lacking for 20 years and we believe this will be transformative for people with narcolepsy. For more information, please visit www.avadel.com or check out narcolespydisrupts.com.
What We Do: LumryzTM 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 LumryzTM may be clinically superior to a formulation of sodium oxybate already approved by the FDA for the same indication.
The FDA granted a tentative approval to LumryzTM on July 18, 2022. Tentative approval indicates that LumryzTM has met all required quality, safety, and efficacy standards necessary for approval in the U.S. FDA’s final approval decision for LumryzTM is pending expiration or other disposition of a patent listed in FDA’s Orange Book that expires on June 17, 2023. Avadel’s market research suggests that LumryzTM has the potential to command a meaningful share of the multi-billion-dollar narcolepsy treatment market.
We are currently taking steps to accelerate the final approval of LumryzTM earlier than the expiry of the patent in June 2023, however, in either case, we are gearing up for our full launch now. We can’t wait to bring an innovative new treatment option to the narcolepsy community.
How We Work: At Avadel, patients are the reason we exist, and our employees are our greatest competitive advantage – our “secret sauce”. The way we work is as important as the results we achieve. Our employees work together as ONE team and live our Values, which is what makes working at Avadel so special and why we will win for patients. Our ONE Team approach fosters a culture based on being relentless for patients, having confidence with humility, being courageous, taking insights to impact, and togetherness. In everything we do, we live the Avadel Values so we can be our best for our patients, our community and each other.
We are seeking team members who have a passion for making a meaningful impact in the lives of patients. We need individuals who will dive in, roll up their sleeves, and join us in our mission to launch LumryzTM for the narcolepsy community and be part of building and shaping an exciting future together.
Avadel is seeking a Senior Medical Director to join our rapidly expanding organization as we launch LUMRYZ for people living with narcolepsy and expand our future portfolio. The Senior Medical Director will be a critical member of the Medical and Clinical Affairs leadership team and will serve as the key medical and scientific expert, working with cross-functional teams and external stakeholders for LUMRYZTM and future portfolio expansion. The individual in this role shapes the medical strategy, serving as a key collaborator with the head of medical affairs and the field medical affairs team. The successful candidate will have the proven ability to translate strategy into tactical plans and drive outcomes to success.
- Becomes the subject matter expert in narcolepsy and the treatment paradigm for managing this neurological disorder, including consideration of comorbidities
- Drives the medical affairs strategy, including the identification of areas where data generation may be needed
- Evaluates field medical affairs insights to further refine medical strategy; values input from this field-based scientific exchange
- Serves as a key resource for field medical affairs, including ongoing training and development of 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
- 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
- Active contribution/leadership for advisory boards
- Participates in review of independent medical education and investigator initiated research grant applications, focusing upon educational and research gaps, balancing needs with available budget
Experience and Qualifications:
- MD/DO with prior pharmaceutical industry experience, including promotional review and close collaboration with field medical affairs
- Preference for smaller biotech and launch experience
- Prior experience with sleep disorders preferred
- For the health and safety of our employees, customers, and community, vaccination against COVID-19 is required as a condition of employment for this position and you must provide valid proof of vaccination
Competencies and Behaviors:
- Team player with “does what it takes” attitude
- Excellent leadership and communication skills
- Ability to work within multifunctional/ multicultural groups
- Embody and live our core values: relentless, confidence with humility, courageous, insights to impact, togetherness
Avadel is committed to facilitating an open, honest, inclusive, transparent, and productive work environment where we work together as ONE team and ONE culture to be our best for patients, customers, and each other. Avadel is committed to equal employment opportunities and non-discrimination in employment. We believe that all employees and applicants should be treated with courtesy, dignity, and respect. Avadel does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, marital status, ancestry, gender, gender identity, pregnancy, status as a covered veteran, or any other characteristic protected by federal, state, and/or local law. It is our intent to comply with federal, state, and local laws, regulations, and guidelines in our employment practices and in our service to our clients. This policy applies to all terms and conditions of employment including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Avadel Management Corporation
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