VP, GDNF Clinical Development

Job not on LinkedIn

November 6

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

⏰ Full Time

🔴 Lead

👔 Vice President

Apply Now

Receive Emails with Similar Jobs

Asklepios BioPharmaceutical, Inc. (AskBio)

WebsiteLinkedInAll Job Openings

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.

501 - 1000 employees

Founded 2001

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 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 development and execution of the clinical strategy across GDNF and other CNS programs, ensuring that the overall scientific and medical content of each clinical study is scientifically rigorous, cost-effective sound and designed for success • Proactively work to identify clinical risks and implement risk mitigation strategies for complex gene therapy studies • Provide input to CDP development, in line with the Target Product Profile (TPP), for successful global regulatory approvals and market access • Partner cross-functional colleagues (including Clinical Operations, Medical Affairs, Pharmacovigilance, Regulatory, Commercial, Nonclinical, Drug Delivery and CMC) to design, execute and report clinical trials • Partner with Clinical Operations to co-chair the IPT CST to oversee, execute and deliver the end-to-end clinical development strategy in alignment with the overall product strategy and objectives • Provide clinical development input as a member of the IPT Brand Subteam • 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 • Lead the GDNF Clinical Development team during interactions regarding drug development, safety, marketing, regulatory filing, and other aspects of a CNS gene therapy product life cycle • As the neurology medical expert, participate in interactions with external stakeholders (e.g., regulatory authorities, KOLs, Data Monitoring Committee (DMC), advisory boards, patient advocacy groups) • Work collaboratively with Medical Affairs to prepare and present abstracts, manuscripts and presentations for external meetings and publications

🎯 Requirements

• MD, DO or equivalent, 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 • 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 • 401(k) retirement plans • Flexible work arrangements • Paid time off • Professional development opportunities