VP, GDNF Clinical Development

🕒 May 8

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

👔 Vice President

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Asklepios BioPharmaceutical, Inc. (AskBio)

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2001

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading gene therapy company focused on developing treatments for debilitating genetic diseases. Wholly owned by Bayer AG, AskBio specializes in adeno-associated virus (AAV)-based gene therapies aimed at treating various neuromuscular, central nervous system, cardiovascular, and metabolic diseases. One of their notable developments is AB-1003 (LION-101), which has received FDA rare pediatric disease and orphan-drug designations for treating limb-girdle muscular dystrophy type 2I/R9. AskBio is dedicated to advancing genetic medicine, with a robust portfolio of clinical programs designed to bring innovative therapeutic options to patients worldwide.

📋 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Health insurance • Professional development opportunities