Vice President Clinical Affairs
We are currently looking for a Vice President for Clinical Affairs. The successful candidate will be responsible for the establishment of clinical development plans, select CROs and oversee clinical trial designs and clinical trial conduct from submission to reporting.
As VP Clinical Affairs, you will:
- Work as a strong partner with the COO and Hyloris’ management team and provide clinical leadership and strategic input for all clinical deliverables.Clinical deliverables include integrated clinical development plans, individual trial protocols, clinical data review and clinical components of regulatory strategies and dossiers.
- Drive execution of clinical programs, leading a team of Clinical Project Managers at Hyloris.
- Assess clinical objects in due diligence procedures for feasibility of new project proposals.
- Develop Clinical Development strategies (Phase 1 to Phase 3 clinical trials) for Hyloris’ projects based on project value, project cost and the current regulatory environment.
- Prepare clinical aspects and participate in scientific advice meetings with regulatory authorities, i.e. FDA.
- Lead selection of qualified CROs for clinical trial conduct.
- Assume overall responsibility for the clinical development budget.
- Organise effective sponsor oversight of all clinical trials sponsored by Hyloris and ensure GCP compliance.
- Be a member of Project Review Board.
Your professional profile
- Medical Doctor or Master’s Degree or higher in Biology or related field of Life Sciences.
- Minimum 10 years of experience in clinical development and related operations.
- At least 5 years of experience in leading clinical trials, including scientific aspects.
- Deep understanding of GCP and regulatory requirements for Clinical Trial Submissions.
- Experience in multiple therapeutic areas, including but not limited to cardiology, oncology, rare diseases etc.
- Experience with audits and inspections, particular pre-approval inspections by the FDA.
- Thorough understanding of the dynamics of the regulatory environment in the U.S. within and beyond FDA guidelines paired with ability to translate this into development tasks for all projects at Hyloris.
- A strong track record designing and steering clinical trials in multiple therapeutic areas.
- Languages: French or Dutch is an asset.
- Strong skills in clinical research, methodology and compliance and robust knowledge of regulatory requirements for clinical trials.
- Strong leadership across organisational boundaries and networks of third party service providers.
- A collaborative and independent working style, building partnerships with key stakeholders.
- Strong track record in Clinical Development and Clinical Operations.
ABOUT OUR COMPANY
Hyloris is a specialty biopharma company identifying and unlocking hidden potential in existing medications for the benefit of patients and the healthcare system. Hyloris applies its knowhow and technological innovations to existing pharmaceuticals and has built a broad proprietary product pipeline that has the potential to offer significant advantages over currently available alternatives. Hyloris currently has two partnered, commercial-stage products: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid analgesic for the treatment of pain. The Company’s development strategy primarily focuses on the FDA’s 505(b)2 regulatory pathway, which is specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This pathway can reduce the clinical burden required to bring a product to market, and significantly shorten the development timelines and reduce costs and risks. Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com and follow-us on LinkedIn.
Our talented staff work in accordance with our company values:
- We are proud of our entrepreneurial culture and foster open communication, mutual respect, professionalism and efficient decision-making and we believe that our multicultural organisation is one of our most important competitive advantages.
- We believe that timely and well considered decisions as a response to emerging opportunities and ideas is the key to our success.
- We believe that the success of the company lies in the competence, dedication, and motivation of each of our employees.
- We believe that freedom returns flexibility and empowerment returns commitment.
For more information about our company, please our website here www.hyloris.com. Motivation letter and CV can be sent to email@example.com.