VP, GDNF Clinical Development

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🕒 Maio 8

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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Asklepios BioPharmaceutical, Inc. (AskBio)

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2001

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

A Asklepios BioPharmaceutical, Inc. (AskBio) é uma empresa líder em terapia gênica focada no desenvolvimento de tratamentos para doenças genéticas debilitantes. Totalmente pertencente à Bayer AG, a AskBio é especializada em terapias gênicas baseadas em vírus adeno-associado (AAV), voltadas para o tratamento de diversas doenças neuromusculares, do sistema nervoso central, cardiovasculares e metabólicas. Um dos seus desenvolvimentos notáveis é o AB-1003 (LION-101), que recebeu designações da FDA de doença pediátrica rara e medicamento órfão para o tratamento da distrofia muscular dos cíngulos tipo 2I/R9. A AskBio está comprometida com o avanço da medicina genética, com um portfólio robusto de programas clínicos projetados para trazer opções terapêuticas inovadoras para pacientes em todo o mundo.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• Health insurance • Professional development opportunities