Kiadis Pharma is a biopharmaceutical company based in Amsterdam, The Netherlands. We focus on the treatment of blood cancers and inherited blood disorders aiming to make bone marrow transplantations, a risky procedure that is often the last hope for patients, safer and more efficient. This means we have a passionate team that is dedicated to make a huge difference for patients. If you are up to the challenge and would like to be part of our team, we are currently looking for a (Clinical) Product Development Lead to further strengthen our Medical & Clinical organization.
PURPOSE OF THE ROLE
ATIR 101 is our priority pipeline product that is currently in a global P3 study which currently is accruing in about 60 countries throughout EU, US and Asia. This position is essential to the successful development of ATIR 101. The Product Development Team Lead would manage the functional team who would address strategic decisions with respect to clinical development, life cycle management, CMC troubleshooting, supply chain and logistical issues, global regulatory strategies and data generation.
The Product Development Lead will provide:
• An integrated approach to the Clinical Development Plan
• Regulatory strategic
• Life cycle management strategy
• New data generation strategy
KEY TASKS & RESPONSIBILITIES
• Leading the “Product Team”, which includes Clinical, Medical, Commercial, Research, CMC, Supply Chain, Clinical Operations, Regulatory, Pharmacovigilance, and Quality.
• Full responsibility for the planning, implementation and daily operation of a drug development projects, including a focus on an imminent launch.
• Contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
• Direct and/or oversee the design and implementation of early stage clinical projects and ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
• Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.
• Serves as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for corporate sponsored studies, managing the process from protocol development through individual study report and integrated regulatory documentation.
• Provide oversight and guidance to clinical team activities at the Product Development Team, Commercial Team and Operational Team.
• Present study updates, interim results, and final headline data to the Chief Medical Officer and Management as required.
• Assist with various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
• Ensure that Serious Adverse Events are properly reported on a global basis.
• Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
• Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
We are seeking a well-trained clinician with strong leadership skills who is driven by science and the desire to collaboratively develop novel Immuno-Oncology therapies for cancer patients, and who has a mastery of the drug development process, protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully. This individual will have the opportunity for growth and development while working in a vibrant environment and “biotech” culture.
This position should be located in Amsterdam, however, a commuting scenario is something to consider.
• Minimum of 12+ years of experience in Clinical Development
• Solid track record in a senior leadership role in Clinical Development
• Relevant (Clinical) educational background (MD / PhD / PharmD), a cell therapy background is preferred
• Ability and experience excelling in a team-based, collaborative environment
• People and project management competences are crucial in this role
• Articulate, self-motivated and ability to effectively communicate orally and in writing
• Willingness to travel
• Fulltime availability
• English fluent, any additional European language is a bonus
A challenging position in an innovative, fast growing, biotechnology company. Working in a fast-paced dynamic environment brings the opportunity to make your own mark within the organization. You will be rewarded a competitive remuneration package, the opportunity for personal development and to contribute to make a huge difference for patients.
Interested in this position? Please apply through the application button.
Kiadis Pharma is a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients. Kiadis Pharma believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), thereby meeting a significant unmet medical need with its products.More about Kiadis Pharma