Therapeutic Area Head, Rare Disease

1 week ago


Guildford, United Kingdom Ergomed Full time

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 CROServe 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 sponsorsAdvocate for patient care and safety as well as for the sponsor organization while upholding standards of quality and ensuring that clinical operations remain financially viableCollaborate with internal and external experts to incorporate innovative approaches and industry best practices into rare disease trial design and planningWork closely with Business Development to contribute medical/scientific insights and thereby enhance Ergomeds ability to win new business opportunities in rare diseaseDevelop and present compelling narratives that highlight Ergomeds expertise and unique approach to prospective clients effectively demonstrating the value of our strategic solutions in rare diseaseLeverage 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 outcomesStay updated with the latest medical advancements industry trends and regulatory requirements ensuring compliance and driving innovationProvide mentorship guidance and development support to Operations team members involved with rare disease clinical trials enhancing their capabilities and expertiseConduct 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 trialSupport 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 designPartner with the full gamut of cross-functional operational colleagues to predict identify mitigate and manage potential challenges and issues that arise during study executionRepresent 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 journalsEstablish Ergomed as a recognized authority in rare disease clinical research within the broader pharmaceutical and clinical research landscapeQualifications : 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 presentation skills.Effective organizational presentation documentation and interpersonal skills.Strong business acumen and proven ability to navigate in a complex matrixed global environment.Ability to manage multiple tasks to meet deadlines in a dynamic environment.Solutions provider; converts challenges to opportunities. Additional Information : We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.  To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.  We offer: Training and career development opportunities internally  Strong emphasis on personal and professional growth Friendly supportive working environment Opportunity to work with colleagues based all over the world with English as the company language Our core values are key to how we operate and if you feel they resonate with you then Ergomed is a great company to join  Quality Integrity & Trust  Drive & Passion  Agility & Responsiveness  Belonging Collaborative Partnerships  We look forward to welcoming your application.  Remote Work : YesEmployment Type : Full-time Key Skills Arabic Speaking,Access Control System,Customer,Content Development,Insurance,Blogging Experience: years Vacancy: 1



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