VP, GDNF Clinical Development

Asklepios BioPharmaceutical, Inc. (AskBio)

VP of GDNF Clinical Development leading clinical development strategy for gene therapy programs. Managing team and fostering cross-functional collaboration for regulatory approvals and launches.

Posted 5/8/2026full-timeRemote • North Carolina • 🇺🇸 United StatesLeadWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Health insurance
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical developmentIND submissionsNDA submissionsBLA submissionsclinical trial designbiostatisticsrisk mitigation strategiesclinical researchgene therapyCNS programs

Soft Skills

leadershipcommunicationcollaborationmentoringstakeholder engagementproject managementteam performance oversightprofessional developmentscientific partnershipproblem-solving

Certifications

MDDONeurology residency training