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AskBio Inc. · 5 hours ago

VP, GDNF Clinical Development

Durham, NC

Full-time

Onsite

Director/Executive

10+ years exp

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, overseeing global clinical programs, and leading a team of medical directors to ensure successful regulatory approvals and commercial launches.

BiopharmaBiotechnologyHealth CareManufacturingMedicalMedical Device

Growth Opportunities

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

Qualification

Clinical development experienceIND/NDA/BLA submissionsNeurology expertiseICH-GCP knowledgeClinical trial designBiostatistics knowledgeRegulatory framework knowledgeLeadership skillsPatient advocacy experienceScientific partnershipEffective communicationTeam managementCollaboration skills

Required

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

Preferred

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

Company

AskBio Inc.

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives.

Founded in 2001

Chapel Hill, North Carolina, USA

501-1000 employees