VP, GDNF Clinical Development

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee global strategic clinical development initiatives for AskBio’s GDNF IPT, promoting cross-functional collaboration through open and constructive discussions.

• Direct, manage, and mentor a team of clinical development physicians.

• Assist in budget planning and management pertaining to clinical development activities in line with IPT objectives.

• Offer clinical development insights and ensure alignment with the CNS Drug Delivery IPT and GDNF IPT development strategies.

• Play a key role in formulating and executing the clinical strategy across GDNF and other CNS programs.

• Actively identify clinical risks and develop risk mitigation strategies for intricate gene therapy studies.

• Collaborate with cross-functional teams (including Clinical Operations, Medical Affairs, Pharmacovigilance, Regulatory, Commercial, Nonclinical, Drug Delivery, and CMC) to design, implement, and report on clinical trials.

• Oversee the creation and upkeep of essential 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 pivotal regulatory documents) ensuring high quality and consistency with CDP, TPP, and AskBio SOPs.

• Collaborate with Pharmacovigilance and Safety teams for ongoing assessment of the drug safety profile, including safety monitoring during clinical trials and signal detection from post-marketing surveillance.

⛳️ Requirements

• MD, DO, or equivalent (according to the current World Directory of Medical Schools), along with Neurology residency training.

• Minimum of 10 years of clinical development experience in an industry setting covering Phases I through III/IV.

• Proven track record and demonstrated excellence in IND/NDA/BLA submissions and approvals.

• Advanced clinical training, expertise, and clinical research experience in a medical/scientific domain, preferably with a focus on neurology.

• Comprehensive understanding of ICH-GCP, clinical trial design, biostatistics, and the regulatory framework for global strategy development.

• Proven ability to establish strong scientific partnerships with both internal and external key stakeholders.

• Demonstrated strong leadership and effective communication skills, with a history of delivering high-quality projects/submissions in a global matrix environment within the pharmaceutical or biotech industry, or through trial conduct in academia or clinical CRO.

• Practical experience in organizing and managing scientific or clinical advisory boards.

• Experience collaborating with Patient Advocacy Groups and other external stakeholders.

• Proven experience with direct line management, overseeing team performance, promoting professional development, and driving clinical development excellence within the organization.

🏝️ Benefits

• Health insurance

• Professional development opportunities