Director, Expanded Access Programs and Clinical Operations
United States / Europe / Israel
Clinical Operations /
Full time /
Remote
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 Director of Expanded Access Programs and Clinical Operations to join its team on the East Coast of the United States, Israel, or Europe.
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 are looking for a Director of Expanded Access Programs and Clinical Operations to join our team. This position will oversee and manage the global HD and ALS Expanded Access Programs (EAP) and Compassionate Use (CU) Programs as well as operations for ongoing clinical trials, manage complex projects to prevent, identify, escalate, and solve any obstacles, ensuring the Program is executed and managed according to plan. The ideal candidate will have strong analytical abilities, strategic thinking leading to quick and thoroughly thought-out actions, as well as flawless execution.
The position will report to the Head of Clinical Operations.
Roles and Responsibilities:
- Expanded access programs (EAP)/Compassionate Use (CU):
- Lead and execute the company’s expanded access policy and strategy in alignment with long-term company strategy.
- Partner with management and comms to ensure timely update of company position on expanded access programs and specific program status to various audiences.
- Develop and manage all EAPs/CU s in alignment with the company policy, strategy, and program status.
- Lead partnership with other Prilenia teams (e.g. CMC) and external vendors to assess EAP/CU demand forecast and ensure continuity of care.
- Accountable for management of EAP/CU requests, including intake and triage, ensuring timely decisions and effective communication within the company.
- Develop relevant SOPs and other operational processes required for compliant execution of EAP/CU. Ensure that appropriate operational standards and processes are implemented globally.
- Oversee EAP and CU vendors including relevant vendor selection, qualification, and management. and oversight.
- Provide operational support to ensure timely development, review, approval, and implementation of EAP/ CU including:
- Clinical Operations:
- Provide support and collaborate with the rest of the clinical ops team on high priority clinical operations tasks beyond EAP e.g. reviewing of monitoring reports and study documents, contribute to study plans, support study oversight etc.
- Overseeing, managing and coordinating drug shipments to EAP/CU sites.
- Providing protocol-related training to EAP/CU investigators and site staff .
- Providing project management/status update reports as needed .
Qualifications:
- BSc/MSc in scientific/clinical/medical field.
- 7 years of experience in clinical operations roles in biotech/pharma including specific experience in managing global expanded access programs.
- In-depth knowledge of relevant FDA regulations, EU regulations, GCP and ICH. guidelines and ability to implement them and build appropriate compliant processes.
- Experience in effectively managing expanded access and/or clinical trial teams which include multiple vendors.
- Experience in managing clinical trials/expanded access programs in orphan/rare diseases (neurology - preferred), with demonstrated success.
- History of building relationships and managing complex CRO/Vendors contracts including delivering feedback and holding others to timelines and deliverables while maintaining strong professional relationships. Experience working with academic CROs – a plus.
- Demonstrated history of conducting remote oversight/supervision effectively.
- Experience effectively working remotely with global and remote teams.
- Record of adopting and working with new IT systems and programs (e.g. various company and CRO systems).
Skills:
- Record of effectively meeting timelines and milestones in fast-paced, high-capacity, versatile and energetic environments while managing multiple parallel assignments with sense of urgency.
- Strong strategic planning, decision-making/problem-solving skills.
- Track record of thriving and adapting to ambiguity and a rapidly changing work environment.
- Reputation for working at multiple levels, engaging with senior leadership on clinical development strategy as well as conducting study level work with flawless execution.
- Outstanding listening, verbal, written and presentation communication skills; success translating and clearly communicating novel, complex messages to variety of internal (executives) and external stakeholders.
Location/Time Zones:
- This is a full-time remote position in East Coast of United States (preference for Boston area), Israel, or Europe; there may be occasional in person meetings.
- Flexible schedule with interactions across Israel, North America and Europe time zones.
