VP, GDNF Clinical Development

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🕒 vor 3 Monaten

🌲 North Carolina – Remote

🌲 North Carolina – Remote

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Asklepios BioPharmaceutical, Inc. (AskBio)

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

Gegründet 2001

🏥 Gesundheitswesen

💼 Beratung

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

Asklepios BioPharmaceutical, Inc. (AskBio) ist ein führendes Unternehmen in der Gentherapie, das sich auf die Entwicklung von Behandlungen für schwerwiegende genetische Erkrankungen konzentriert. Als hundertprozentige Tochtergesellschaft der Bayer AG spezialisiert sich AskBio auf Adeno-assoziierte Virus (AAV)-basierte Gentherapien zur Behandlung verschiedener neuromuskulärer, zentralnervöser, kardiovaskulärer und metabolischer Erkrankungen. Eine ihrer bemerkenswerten Entwicklungen ist AB-1003 (LION-101), das von der FDA eine seltene pädiatrische Erkrankung und Orphan-Drug-Designations zur Behandlung von Gliedergürteldystrophie Typ 2I/R9 erhalten hat. AskBio widmet sich der Weiterentwicklung der genetischen Medizin mit einem umfangreichen Portfolio klinischer Programme, die darauf abzielen, Patienten weltweit innovative therapeutische Optionen zu bieten.

Beschreibung

• Lead the global strategic clinical development initiatives for AskBio’s GDNF IPT, fostering cross-functional alignment via open and collaborative discussions • Lead, manage, and mentor a team of clinical development physicians • Contribute to budget planning and budget management related to clinical development activities aligned with the IPT goals • Provide clinical development input and maintain alignment with the CNS Drug Delivery IPT and GDNF IPT development plans • Contribute to the development and execution of the clinical strategy across GDNF and other CNS programs • Proactively work to identify clinical risks and implement risk mitigation strategies for complex gene therapy studies • Partner with cross-functional colleagues (including Clinical Operations, Medical Affairs, Pharmacovigilance, Regulatory, Commercial, Nonclinical, Drug Delivery and CMC) to design, execute and report clinical trials • Manage the creation and maintenance of critical study documents assigned to Clinical Development (e.g., Clinical Study Protocols (CSPs), Investigator’s Brochures (IB), Informed Consent Forms (ICF), Risk-Based Medical Monitoring Plan, Clinical Study Reports (CSRs), and other key regulatory documents) with high quality and consistency with CDP, TPP and AskBio SOPs • Partner with Pharmacovigilance and Safety colleagues to provide continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance.

🎯 Anforderungen

• MD, DO or equivalent (based on the current World Directory of Medical Schools), in addition to Neurology residency training • At least 10 years of clinical development experience in an industry environment spanning Phases I through III/IV • Strong track record and demonstrated excellence in IND/NDA/BLA submissions and approvals • Advanced clinical training, expertise and clinical research experience in a medical/scientific area, preferably with a neurology focus • In-depth knowledge of ICH-GCP, clinical trial design, biostatistics, and regulatory framework for global strategy development • Demonstrated ability to establish strong scientific partnership with internal and external key stakeholders • Demonstrated strong leadership and effective communication skills with a documented record of delivering high quality projects/submissions in a global matrix environment in pharmaceutical or biotech industry or trial conduct in academia or clinical CRO is required • Firsthand experience in organizing and managing scientific or clinical advisory boards • Experience working with Patient Advocacy Groups and other external stakeholders • Demonstrated experience with direct line management; overseeing team performance, fostering professional development, driving clinical development excellence within the organization.

🏖️ Vorteile

• Health insurance • Professional development opportunities