Therapeutic Area Head Rare Disease

Company Description

Ergomed is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.  

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia 

Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.  

We have nourished a true international culture here at Ergomed.  

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives.  

Job Description

As the Therapeutic Area Head Rare Disease, you will play a crucial role in driving the success of new business proposals, as well as clinical trial delivery by combining medical/scientific expertise, standard of care knowledge, awareness of emerging therapeutic trends, a patient-centric focus, and regulatory expertise. You are the titular therapeutic expert in rare disease across the entire organization, and as such you are involved in all efforts to optimize our commercial and operational success in rare disease.  You are highly visible to both internal and external stakeholders in generating and communicating thought leadership at internal Ergomed forums, academic and industry symposia, publications, as well as digital promotions.

• Key medical/scientific leader responsible for the rare disease input informing the corporate strategy of Ergomed CRO
• Serve as the Head of the Ergomed Rare Disease Center of Excellence leading therapeutic and operational subject matter experts providing innovative medical and therapeutic insights to sponsors
• Advocate for patient care and safety, as well as for the sponsor organization, while upholding standards of quality and ensuring that clinical operations remain financially viable
• Collaborate with internal and external experts to incorporate innovative approaches and industry best practices into rare disease trial design and planning
• Work closely with Business Development to contribute medical/scientific insights and thereby enhance Ergomed's ability to win new business opportunities in rare disease
• Develop and present compelling narratives that highlight Ergomed's expertise and unique approach to prospective clients, effectively demonstrating the value of our strategic solutions in rare disease
• Leverage your comprehensive understanding of rare disease therapy clinical development, incorporate the sponsor context, therapy characteristics, disease indications, scientific/medical knowledge, and regulatory requirements, to support the design of strategic plans for successful trial outcomes
• Stay updated with the latest medical advancements, industry trends, and regulatory requirements, ensuring compliance and driving innovation
• Provide mentorship, guidance, and development support to Operations team members involved with rare disease clinical trials, enhancing their capabilities and expertise
• Conduct rare disease training to Medical Affairs staff so that they are fully aware of the medical considerations needed to support drug safety for the given clinical trial
• Support the Clinician Engagement function to gather insights from key opinion leaders in diverse geographic regions, to better inform our understanding of the standard of care, the clinician/investigator experience, the attractiveness of the scientific endpoints under investigation, and the viability of the protocol design
• Partner with the full gamut of cross-functional operational colleagues to predict, identify, mitigate, and manage potential challenges and issues that arise during study execution
• Represent Ergomed by attending industry meetings, speaking engagements, participating in booth exhibitions, professional associations, public forums, etc, and by publishing scientific or industry related articles in peer-reviewed medical journals
• Establish Ergomed as a recognized authority in rare disease clinical research within the broader pharmaceutical and clinical research landscape

Qualifications

• MD or PhD (MBA also preferred)
• Expertise and extensive clinical research experience in rare disease on a global basis.
• Strong and broad network of key stakeholders and KOLs in rare disease around the world.
• Previous experience in a CRO environment, with a proven track record of driving significant rare disease business growth.
• In-depth knowledge of Regulatory Authority regulations and strong understanding.
• Strong leadership and communication, verbal, and prese