Apsida Life Science are currently partnered with a small, innovative Biotech organisation based in France that are developing a Monoclonal Antibody Immuno-Oncology focused drug platform. This company are at the forefront of a novel approach to fighting against this awful disease. They are currently on the search for an Interim Medical Director/Chief Medical Officer to define the clinical strategy and advance the drug into first-in-human.
- Provide medical vision and clinical leadership for the strategy and plan to advance the current and future products.
- Manage the overall clinical development for lead programs with an emphasize on early clinical development up to proof of concept.
- Collaborate cross-functionally in the preparation of the IND, CDP, clinical protocols, briefing books, investigator brochures and target product profiles.
- Ensure that the design, implementation and conduct of the clinical studies provide clear data and information that allows decision making and advancement of products’ development.
- Contributing to RFP and bid defence process for CRO selection
- Represent as medical expert on the disease state and assigned clinical trials in various scientific advice meetings with the EMA and FDA, or other regulatory bodies.
- Represent and manage the company’s clinical programs to diverse audiences including corporate partners, Board of Directors and other key stakeholders.
- Maintain understanding of competitors and clinical development in relevant therapeutic areas by attending key scientific meetings and tracking literature as appropriate.
- Build and foster relationships with scientific experts, opinion leaders and clinical investigators for strategic consultation; organize and chair clinical advisory board to strategise drug development paths that seek to deliver timely regulatory approvals.
- Collaborate with the company’s discovery research department to bring a medical perspective on emerging pre-clinical product candidates at stage gate #1.
- Actively assist in seeking product and/or technology alliances with appropriate pharmaceutical company partners to expedite the development of the firm’s assets.
- MD or MD/PhD within Life Science ideally Oncology
- 12-15 years biopharmaceutical industry experience leading clinical development
- Record of accomplishment including designing and conducting clinical studies in multiple therapeutic areas.
- Track record in early clinical development stages (phase I/II) including regulatory aspects and knowledge of late stage development up to NDA/BLA.
- Knowledge and experience in development of small molecules and monoclonal antibodies.
- Outstanding communication skills
- Willingness to join an innovative, scientifically driven and fast paced biotech.
- Good attention to detail and accuracy; trustworthy with highest integrity, committed to ethics and scientific standards.
For more information please reach out to me on the following details:
+44(0)203 854 4604