Vice President/Senior Vice President, Clinical Development

About Prilenia

Prilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a VP/SVP, Clinical Development to join its team in East Coast US / Europe (preferably NL) or Israel.

We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.

Pridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases.

About The Role

We seek an experienced Clinical Development Leader to join our team as VP/SVP, Clinical Development. This is a highly visible role that is responsible for leading the clinical development strategy across Prilenia’s clinical programs in various neurodegenerative indications, with emphasis on late-stage clinical development (phases 2b, 3 and 4).

The VP/SVP, Clinical Development will lead and define Prilenia’s clinical development strategy and plans, steer clinical trial design, and provide expert clinical development input to guide clinical operations and all other company activities including CMC, regulatory, scientific research etc.

The position will initially report to the CEO.

Roles And Responsibilities

• Develop clinical development strategy and Clinical Development Plans (CDPs), including scientific rationale, implementing regulatory input and advice from medical and patient advocacy groups
• Design high quality clinical trial protocols with a patient-centric focus, which are aligned with the CDP and product strategy. Seek and collaborate on CDPs and protocols with internal and external stakeholders including Regulatory, Clinical Operations, Commercial, and Research
• Contribute to regulatory strategy for clinical development programs Provide oversight of clinical studies, protocol implementation, medical data review, results interpretation, and reporting
• Lead and motivate cross-functional teams to execute clinical trials, including the upcoming phase 3 trial in ALS
• Help build and manage relationships with investigators to support execution of studies and patient recruitment
• Contribute to regulatory strategy, preparation and review of regulatory submissions
• Contribute to the development of medical and clinical publication plans and present clinical data at key meetings
• Collaborate closely with internal stakeholders, including R&D, regulatory affairs, and medical affairs, to integrate clinical development strategies into overall product development plans
• Contribute to regulatory submissions, publications, and presentations
  
  

Qualifications

• 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 umble
• 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)
  
  

Location/Time/travel:

• This is a full-time remote position in the East Coast US, Europe (preferably NL) or Israel.
• Flexible schedule with frequent calls across Israel, North America and Europe time zones
• Travel including internationally within US and Europe required