Vice President, Clinical Development

October 20, 2024

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Prilenia

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Prilenia is dedicated to developing new treatments for patients and families facing neurodegenerative diseases and neurodevelopmental disorders, such as Huntington’s disease and amyotrophic lateral sclerosis (ALS). They focus on harnessing the brain's neuroprotective capabilities, particularly through the activation of the sigma-1 receptor (S1R), to restore impaired pathways in the brain. Prilenia is advancing scientific research and exploring potential treatments to provide hope and improve the lives of patients and their families.

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 $43M Series B on 2021-11

📋 Description

• About Prilenia • Prilenia Therapeutics, a clinical-stage biotech company focused on developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a VP/SVP, Clinical Development. • We are a flexible, fast-moving team advancing a potential therapy poised to impact patients' lives. • Our lead product candidate, pridopidine, holds Orphan Drug Designation in Huntington’s disease (HD) and Amyotrophic lateral Sclerosis (ALS). • Pridopidine has the potential to be the first treatment to address HD disease clinical progression. • We seek an experienced Clinical Development Leader as VP/SVP to lead clinical development strategy across neurodegenerative indications, emphasizing late-stage clinical development.

🎯 Requirements

• At least 7 years clinical development experience in neurodegeneration including at least one role in SMID biotechs. • Prior experience with ALS required • Advanced degree (e.g., MD, PhD, PharmD) or equivalent required • Proven record of successful design, execution, close out and reporting of Phase 2 and 3 clinical trials. • Deep understanding of clinical trial design, execution, and regulatory requirements, particularly in rare disease areas • Demonstrated strategic and critical thinker, with success in designing clinical trials that have supported regulatory filings • Established links with the medical community globally and locally, with proven ability to develop close working relationships with KOLs • Outstanding communication skills, professional presence, and ability to engage effectively with stakeholders at all levels • Hands-on expert who likes to roll up his/her sleeves • Collaborative and able to motivate and energize cross functional team members to achieve goals together • High change agility with ability to operate effectively in ambiguous circumstances, open minded, with a can-do attitude • Excellent project management skills: self-motivated and can prioritize multiple tasks and goals to ensure the timely, on-target accomplishment of deliverables • Proven track record of successfully leading late-stage clinical development programs including rare indications through regulatory approval • Management experience, including managing direct reports and external advisors and contractors, building matrix teams, and leveraging relationships with clinical and commercial teams • Broad working knowledge of industry compliance requirements in US and EU, clinical trial design and strategies, and medical information process • Demonstrated ability to thrive in a fast-paced, dynamic virtual environment, adapting to evolving priorities and challenges • Has the gravitas, confidence, and executive presence to operate with business leaders. Self-confident and humble • Brings strong scientific credibility, coupled with business acumen, and the ability to roll up sleeves and dig into the details • Experience interfacing with regulatory agencies, thorough knowledge and understanding of regulatory requirements for pharmaceutical product development and approval in more than one key region (i.e. US, Europe)