[Remote] VP, GDNF Clinical Development

Note: The job is a remote job and is open to candidates in USA. AskBio Inc. is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The Vice President of GDNF Clinical Development will be responsible for developing and implementing clinical development strategies across all stages of product development, collaborating with various functional teams to ensure successful regulatory approvals and commercial launches.

Responsibilities

• 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, Pharmacovigiliance, 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 alignement 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. May serve as a core member of the Safety Management Team (SMT)
• 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
• May support technical due diligence in Business Development & Licensing (BD&L) activities

Skills

• 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
• Advanced knowledge in gene therapy drug development, training or experience in neurosciences with the capability to innovate in clinical development study designs that provide robust clinical evidence to internal decision-makers and regulatory agencies
• Movement disorders fellowship training with clinical research experience
• Experience with radiographic evaluation of neurologic disease and biomarker development

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