VP, GDNF Clinical Development

🕒 il y a 27 jours

🌲 North Carolina – Distant

🌲 North Carolina – Remote

⏰ Temps Plein

🔴 Expert

👔 Vice-président

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Asklepios BioPharmaceutical, Inc. (AskBio)

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2001

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Asklepios BioPharmaceutical, Inc. (AskBio) est une entreprise de thérapie génique de premier plan, se concentrant sur le développement de traitements pour les maladies génétiques débilitantes. Entièrement détenue par Bayer AG, AskBio se spécialise dans les thérapies géniques à base de virus adéno-associé (AAV), visant à traiter diverses maladies neuromusculaires, du système nerveux central, cardiovasculaires, et métaboliques. L'un de leurs développements notables est l'AB-1003 (LION-101), qui a reçu des désignations de maladie pédiatrique rare et de médicament orphelin de la FDA pour le traitement de la dystrophie musculaire des ceintures de type 2I/R9. AskBio se consacre à l'avancement de la médecine génétique, avec un portefeuille solide de programmes cliniques conçus pour apporter des options thérapeutiques innovantes aux patients du monde entier.

Description

• 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.

🎯 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 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.

🏖️ Avantages

• Health insurance • Professional development opportunities