Medical Director / Sr. Medical Director
Kiadis Pharma is a global biopharmaceutical company. The headquarters is 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 Medical Science Liaison within the Medical - US team, location United States.
The Medical Director will report to Head of Medical and Clinical Affairs, North America, and will be responsible for the design, development, implement and oversight of all aspects of Kiadis’ clinical development program in N. America. The role also requires integration and close alignment with overall global corporate Clinical Development strategy. This role will be responsible for the evolution of clinical study concepts through study design and execution, data analysis and publication of final study results, including key opinion leader (KOL) and investigator engagement at all steps along the way. The role will lead all aspects of clinical document preparation, protocol development and amendment, study management and/or selection and management of a Clinical Research Organization (CRO), and medical monitoring. The development of a close relationship with Clinical Operations will be integral to the success of this role.
- Identifies, develops and maintains close professional relationships with influential key opinion leaders (KOLs) including physicians, researchers and clinical investigators within pertinent medical communities. Fosters the establishment and maintenance of external scientific advisers and assists in advocacy development within the hematologic malignancy and transplant world.
- Regularly participates in scientific exchange with KOLs/physicians/researchers and investigators in the field and during medical congresses to maintain a level of expertise necessary for success in this role.
- Liaises and cooperates closely with Pre-clinical and Clinical Operations in the execution of clinical development initiatives.
- Develops and maintains professional relationships with KOLs and investigators as participants in the clinical development of Kiadis’ assets including: advisors, investigators, lead investigators, safety and steering committee members.
- Identifies and develops strategically relevant clinical study concepts from conception through to study completion in alignment with corporate Clinical Development objectives, within pre-determined budget and study timelines.
- Develops Clinical content for advisory boards and steering committee presentations.
- Engages with external KOLs and investigators, internal stakeholders and contractors, to create clinical study protocols and study documents for submission to regulatory/ethics authorities.
- Responsible for the oversight of ongoing clinical studies including medical monitoring, data analysis, engagement with regulatory/ethics authorities and safety/data monitoring committees.
- Responsible for ensuring competent study oversight, acquisition and analysis of clinical study data and liaison with internal and external stakeholders in the interpretation, analysis and publication/presentation of study data.
- Responsible for the development of clinical study reports.
- Collaborates closely with Medical Affairs, Clinical Operations, Commercial and Regulatory colleagues to leverage clinical study data in support of regulatory filings and advancement of corporate objectives.
Education and Qualifications
- Medical Degree (MD) or another advanced degree, e.g., PhD or PharmD and minimum 10+ years pharmaceutical or related industry experience in Clinical Affairs with a proven track record in Clinical Affairs and Clinical Development is preferred. Experience with FDA and/or EMA regulatory processes is also preferred.
- Clinical Affairs and/or Clinical Development experience in Immunology/Oncology with a strong preference to those with experience in Hematologic Malignancies, Hematologic Transplantation and/or Immuno-Oncology especially with cellular therapies.
- Must possess extensive experience and a comprehensive understanding of the role of Clinical Affairs and be able to articulate their prior accomplishments in supporting Clinical Affairs strategy.
- Requires a confident, adaptable and independent personality that thrives in a dynamic, fast-paced result-oriented environment.
- Excellent presentation and communication skills both oral and written, including presentations to large audiences such as at symposia and congresses are required. Excellence in speaking, comprehending, reading and writing English is required. Proven ability to effectively communicate information at management/executive level.
- Excellent interpersonal, analytical, communication (written as well as oral), results oriented project management, facilitation and consultative skills to influence decision making.
- Requires working knowledge of Good Clinical Practices, Food and Drug Administration regulatory reporting requirements, and the regulations and laws governing the pharmaceutical industry.
- Ability to research and critically analyze complex scientific and clinical data, and the medical literature.
- Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence.
- Experience managing staff/direct reports.
- The ability to travel both nationally and internationally will be required, with variable schedules. Approximately 25% to 50% travel.