VP, GDNF Clinical Development

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

📋 Description

• Report to the head of Global Clinical Development

• Serve as a key member of the GDNF Integrated Product Team (IPT)

• Formulate and execute the IPT’s clinical development strategy for programs that cover all phases of product development

• Collaborate across various departments including Program Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, Nonclinical, Drug Delivery, and CMC

• Create and manage global clinical development strategies that align with the company’s mission and values

• Build and lead a team of medical directors, serving as co-chair of the IPT’s Clinical Sub-team (CST)

• Oversee the creation and upkeep of essential study documents assigned to Clinical Development

• Collaborate with Pharmacovigilance and Safety teams to ensure ongoing assessment of the drug's safety profile

⛳️ Requirements

• MD, DO, or equivalent (as per 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, specialized 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 capability to establish strong scientific partnerships with both internal and external key stakeholders

• Strong leadership and effective communication skills, with a documented history of delivering high-quality projects/submissions in a global matrix environment within the pharmaceutical or biotech industries, or trial conduct in academic or clinical CRO settings

• Direct experience in organizing and managing scientific or clinical advisory boards

• Experience collaborating with Patient Advocacy Groups and other external stakeholders

• Proven experience in direct line management; overseeing team performance, encouraging professional growth, and promoting clinical development excellence within the organization.

🏝️ Benefits

• Opportunity for secondment

• Unique chance to broaden your experience

• Contribute meaningfully to AskBio’s mission

• Environment for employees to reach their fullest potential