VP, GDNF Clinical Development

🕒 Maio 8

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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AskBio Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🧬 Biotecnologia

💊 Farmacêutico

💰 $2.656.252 Grant - Asklepios BioPharmaceutical em 2020-09

Biotechnology • Pharmaceuticals

A AskBio Inc. é uma empresa de terapia gênica em estágio clínico focada no desenvolvimento de tratamentos baseados em vírus adeno-associados (AAV) para doenças raras e genéticas. Subsidiária integral e operada de forma independente da Bayer AG, a AskBio avança programas desde a descoberta até a fabricação e desenvolvimento clínico, aproveitando capsídeos, promotores e tecnologias de fabricação proprietárias de AAV (por exemplo, Pro10™ e neDNA™). A empresa conduz ensaios clínicos (por exemplo, o programa AB-1009 para doença de Pompe de início tardio), colabora com parceiros acadêmicos e da indústria, e enfatiza a pesquisa orientada pelo paciente para atender às necessidades médicas não atendidas.

Descrição

• Report to the head of Global Clinical Development • Be a core member of the GDNF Integrated Product Team (IPT) • Develop and implement the IPT’s clinical development strategy for clinical programs spanning all stages of product development • Work cross-functionally with groups including Program Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, Nonclinical, Drug Delivery and CMC • Establish and oversee global clinical development strategies in alignment with the company’s mission and values • Build and manage a team of medical directors and provide leadership as co-chair of the IPT’s Clinical Sub-team (CST) • Manage the creation and maintenance of critical study documents assigned to Clinical Development • Partner with Pharmacovigilance and Safety colleagues to provide continuous evaluation of drug safety profile

🎯 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 Advocay 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

• Opportunity for secondment • Unique chance to broaden your experience • Contribute meaningfully to AskBio’s mission • Environment for employees to reach their fullest potential