Vice President, Clinical Development

2 days ago

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Prilenia

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💰 $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)