VP, GDNF Clinical Development

🕒 il y a 27 jours

🌲 North Carolina – Distant

🌲 North Carolina – Remote

⏰ Temps Plein

🔴 Expert

👔 Vice-président

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AskBio Inc.

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501 - 1000 employés

🧬 Biotechnologie

💊 Pharmaceutique

💰 €2 656 252 Grant - Asklepios BioPharmaceutical en 2020-09

Biotechnology • Pharmaceuticals

AskBio Inc. est une entreprise de thérapie génique en phase clinique, spécialisée dans le développement de traitements basés sur le virus adéno-associé (AAV) pour les maladies rares et génétiques. Filiale à 100 % de Bayer AG, opérant de manière indépendante, AskBio fait progresser des programmes depuis la découverte jusqu'à la fabrication et le développement clinique, en s'appuyant sur des capsides, des promoteurs et des technologies de fabrication AAV propriétaires (par exemple, Pro10™ et neDNA™). La société mène des essais cliniques (par exemple, le programme AB-1009 pour la maladie de Pompe à début tardif), collabore avec des partenaires académiques et industriels, et met l'accent sur la recherche axée sur les patients pour répondre aux besoins médicaux non satisfaits.

Description

• 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

🎯 Exigences

• 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.

🏖️ Avantages

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