Senior Director, Clinical Development

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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

• Provides clinical science leadership within assigned teams or programs • Manage the design, planning and execution of clinical trial program(s) as needed with minimal guidance • Is able to play a leadership role in subject matter expertise when interacting with global health authorities • Has deep familiarity with registration submission strategies and can manage the Clinical needs for all submissions as needed • Leads the study design, implementation and execution of clinical trials on assigned programs. Is responsible for the preparation of clinical study synopses and serves as a major contributor to the writing of protocols/major amendments, the design of data collection systems, the interpretation of clinical data, and the preparation of final clinical study reports • Works cooperatively with project team members to provide clinical development expertise and leadership • Responsible for identifying and cultivating relationships with relevant national and international thought leaders to further project goals • In partnership with Regulatory Affairs and Project Management, oversee and ensure the quality, coordination and timeliness of clinical sections of IND's, Investigator Brochures, CTA's, ISS', ISE's and clinical expert reports, including writing and editing • Responsible for providing or supervising medical monitoring activities for all human clinical trials including support of adverse event reporting and safety management • Responsible for ongoing benefit/risk assessment, monitoring adherence to protocols, helping in the investigation of protocol deviations and providing leadership for monitoring activities related to execution of the protocol or program • Provides medical/clinical information for inclusion in reports submitted to regulatory authorities and supports the authoring of regulatory documents • Develops relationships with investigators and external organizations and experts to optimize study design and executions

🎯 Anforderungen

• Doctoral level degree (PhD, MD, PharmD, PsyD) required • 6+ years of relevant clinical development experience • Experience in CNS development (Psychiatry or neurology) strongly preferred • Possess strong knowledge of the clinical development process • Possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business • Experience in small molecule development • Experienced in data review and analysis, presentations (internal and external) and regulatory writing (IND, CTD sections) • Experience building strong relationships within cross-functional groups to achieve results • Proven ability to identify and solve relevant problems related to clinical development • Experience in clinical research for psychiatry, addiction psychiatry, and addiction medicine programs, strongly preferred. • Background and proven relevant experience in engaging with clinical trial strategy and trial management • Understanding of the drug development process including technical, business, and regulatory issues. • IND experience strongly preferred • Diplomacy and professionalism, ability to build positive relationships both with company leadership and external experts • Able to command respect from peers and subordinates, capable of highly independent work as well as being a team player and role model • Excellent interpersonal, verbal and written communication skills • Proven ability to work remotely and with remote internal and external interdisciplinary teams • Problem-solving and strategic planning skills • Excited by innovative ideas in clinical research space • Self-motivated, resourceful with a ‘get the job done’ attitude in a fast-paced team environment

🏖️ 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!