Director, HEOR

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Definium Therapeutics

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51 - 200 Mitarbeiter

Gegründet 2019

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

Definium Therapeutics ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das präzise psychedelisch-abgeleitete Therapeutika für psychiatrische und neuroentwicklungsbedingte Störungen entwickelt. Das Unternehmen konzentriert sich auf pharmazeutisch optimierte Formulierungen von Lysergid (LSD) und ein R-Enantiomer von MDMA, um Zustände wie schwere depressive Störung, generalisierte Angststörung und Kernsymptome von Autismus-Spektrum-Störung zu behandeln. Es treibt die Kandidaten mit einem wissenschaftlich fundierten, evidenzbasierten Ansatz durch präklinische und klinische Studien voran.

Beschreibung

• Leads the design, implementation and management of HEOR studies from concept development through publication. HEOR studies may include, but are not limited to, prospective research studies, patient interviews, and payer-focused tools (i.e. dossier, external facing assets) • Help identify evidence gaps and needs from regulatory, reimbursement and patient perspectives, resolve these challenges and translate strategic objectives into the HEOR / Real-World Evidence (RWE) plan • Directs the generation of necessary evidence to demonstrate product differentiation and values, and / or to support clinical development, regulatory needs through RWE and epidemiology studies in a timely and strategic manner • Work closely with other functions in cultivating strong internal partnerships, including research and development strategy, epidemiology, regulatory, policy, market access and medical affairs on the development on programs that support broad access and value • Support proactive engagement with payer advisors and KOL stakeholders including generating strategic insights on endpoints, PCOA, and trial design. Identify relevant PCOA endpoints and provide input to the clinical development plan • Psychometric validation of patient-reported outcomes and instruments • Help develop protocols for RWE (prospective and retrospective) analyses, PROs, surveys/patient interviews and provide innovative solutions on RWE for use as a synthetic/historical or concurrent control, including expertise on methodological considerations to account for confounding, missing variable, temporal or other biases and/or methodological challenges • Experience in evidence synthesis (in conducting systematic literature review, indirect treatment comparisons, gap analyses for effectiveness, meta-analysis) • Collaborate with Publications and other functions on development of real-world evidence publications for congresses and peer-reviewed journals • Provide project and vendor management support, including request for proposal, statement of work, vendor selection, legal & compliance issues, and budget tracking • Develop and maintain strong, collaborative relationships with the broader Definium organization and with external experts • Help support and manage deliverables such as value dossiers, reimbursement dossiers, reimbursement landscape analyses, consultant driven research projects • Ensure that deliverables are accomplished on time and within budget

🎯 Anforderungen

• Advanced degree (MS, MPH, MD, PhD, PharmD) in health economics, epidemiology, health services research • Minimum 5-7 years’ experience in HEOR in an industry setting, preferably in psychiatry or neuroscience related therapeutic areas • Excellent knowledge of market access environment and health technology assessment process in the U.S. and key European markets • Demonstrated experience in designing HEOR protocol elements both within phase III / non-interventional study programs and phase IV/post-marketing • Previous new product launch experience a plus • Demonstrated business and scientific acumen • Excellent analytic and problem-solving skills • Demonstrated ability to understand and effectively communicate scientific information • Ability to work independently, proven oral and written communication skills • Ability to work effectively in a fast-paced, collaborative environment • Aptitude to closely collaborate and bond with an entirely remote team, willing to travel on a regular basis for in-person team meetings (projected ~25% – 30% travel)

🏖️ Vorteile

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents • 401(k) program with company match and vesting after the turn of the first month after your start date • Flexible time off • Generous parental leave and some fun fringe perks!