About Prilenia
Prilenia Therapeutics, a clinical-stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is seeking a General Manager, Germany, to join our European Leadership Team.
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 anticipating a regulatory filing in HD in mid-2024 in the EU and preparing for a global Phase 3 clinical trial in ALS.
Pridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia believes pridopidine’s novel mechanism of action as a sigma-1 receptor agonist also gives it potential in numerous other neurological diseases.
To learn more about our story and company culture, visit us at https://Prilenia.com
About the Role
We are seeking a highly motivated, experienced and dynamic General Manager to lead our operations in Germany. The ideal candidate will have a strong background in the bio-pharmaceutical industry, particularly in rare diseases, and a proven track record of driving business growth and operational excellence. As the General Manager, you will be responsible for developing and executing strategic plans, overseeing all aspects of the German operations, and ensuring the achievement of business objectives, and you will be representing our company within the German market. You possess strong people and leadership skills. You have a proven track record of working cross-functionally with the European Leadership.
This role will initially report to the SVP, Commercial.
Prilenia has offices in the U.S., Israel and The Netherlands. Prilenia is a flexible organization that is mostly remote and encourages team members to work in the ways that make them most effective, with a focus on our common goals and getting the job done.
Strategic Leadership:
- Develop and implement the overall business strategy for the German market, aligned with the company’s global objectives.
- Identify and evaluate market opportunities, trends, and competitive landscape to drive growth and expansion.
- Build and maintain relationships with key stakeholders, including healthcare providers, regulatory authorities, and patient advocacy groups.
Operational Management:
- Oversee day-to-day operations, ensuring compliance with all regulatory and legal requirements.
- Manage the P&L for the German business, optimizing financial performance and resource allocation.
- Lead and develop a high-performing team, fostering a culture of collaboration, inclusiveness, innovation, and accountability.
Commercial:
- Develop and execute sales, and marketing strategies to maximize market penetration and product adoption.
- Ensure alignment with medical strategies and create joint and focused approach
- Ensure effective communication of the value proposition of our therapies to healthcare professionals and patients.
- Monitor and analyze sales performance, providing insights and recommendations for improvement.
- Lead the appropriate Market Access Strategy for the German market
Regulatory and Compliance
- Ensure compliance with all local regulatory requirements and industry standards.
- Oversee the submission and approval of marketing authorizations and other regulatory filings.
- Maintain up-to-date knowledge of regulatory changes and their potential impact on the business.
Stakeholder Engagement:
- Represent the company at industry events and meetings.
- Engage with patient advocacy groups to support initiatives that increase awareness and diagnosis, enhance patient care and access to therapies, and advocate for patient/caregiver needs.
- Be an advocate for rare neurodegenerative and neurodevelopmental diseases to various stakeholders
- Act as the primary point of contact for key opinion leaders, payors, governmental officials, media and healthcare providers.
Key Qualifications
- Bachelor’s degree in Life Sciences, Business Administration, or a related field; advanced degree (MBA, PhD, MD) preferred.
- Minimum of 10 years of experience in the pharmaceutical or biotech industry, with a focus on rare diseases. (additional start-up and launch experience and in neurology/neurodegeneration are a plus)
- Proven track record of successful leadership and business management, preferably in a general manager or hands-on senior executive role.
- Strong understanding of the German healthcare system, regulatory environment, and market dynamics.
- Excellent strategic thinking, analytical, and problem-solving skills.
- Exceptional communication, negotiation, and relationship-building abilities.
- Reliability and flexibility
- Leadership experience with a demonstrated ability to start, build and develop teams
- Demonstrated ability to plan and execute in a nimble and lean launch setting
- Written and verbal communication skills
- Fluent in German and English.
Location/Time/Travel
- Full-time, mainly remote position in Germany
- Flexible schedule with frequent calls across North America, Israel and Europe time zones
- Up to 30% travel expected, including international
What We Do
Prilenia is a clinical-stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders.
Our lead asset is Pridopidine, a first-in-class oral drug candidate with an established safety profile and potential in multiple movement disorders and neurodegenerative diseases affecting adults and children.
Pridopidine is currently being evaluated for the treatment of Huntington’s disease in our global Phase 3 PROOF-HD trial, and for the treatment of ALS in the Phase 2/3 HEALEY platform trial.
The company is led by Dr. Michael Hayden, MD, PhD, the founder of five biotech companies and previous President of Global R&D and Chief Scientific Officer at Teva. Michael has directed the development of multiple innovative drug products, leading to 35 approvals between 2012-2018.
The Company is based in Naarden, the Netherlands, Herzliya, Israel and Boston, MA in the U.S.