ARTO is again working with an innovative biotech company who are looking to progress their lead program through the clinic. With already strong data, they are looking for an experienced Clinical Development Physician to drive this program.
About the job:
* Provide strategic and operational medical leadership for Phase I and II clinical programs across cell and gene therapy/immunology portfolios, ensuring scientific integrity and patient safety throughout development.
* Lead end-to-end clinical development activities including protocol design, study execution, data interpretation, regulatory interactions, and clinical study reporting.
* Serve as the medical lead for early-stage clinical trials, overseeing dose escalation strategies, safety review committees, and benefit-risk assessments.
* Collaborate cross-functionally with Clinical Operations, Translational Sciences, Regulatory Affairs, Biometrics, and CMC teams to drive program milestones and development plans.
* Contribute to clinical development strategy, target product profiles, and lifecycle planning aligned with corporate and portfolio objectives.
* Build and maintain strong relationships with investigators, key opinion leaders, academic collaborators, and external partners within the biotechnology ecosystem.
* Support global regulatory submissions and interactions with agencies including the FDA, EMA, and MHRA, ensuring compliance with GCP and applicable regulatory standards.
Qualifications
* MD or equivalent medical degree, PharmD, or PhD in a clinical and/or scientific discipline
* Clinical background or sufficient industry experience within Rheumatology/Immunology
* A proven leader with roughly 10 years pharmaceutical/biotechnology industry experience in all phases of drug development
* Deep knowledge of the drug development process with a focus on clinical study design and management; ability to collaborate with, support, and oversee CROs
* Able to drive strategic thinking and plans for successful clinical trial outcomes
* Experience interfacing with the global regulatory authorities (incl. FDA, EMA) and respective standards, including hands-on experience in global drug development
* Recent experience of IND and NDA/BLA submissions strongly preferred
* Dynamic individual with excellent written, communication, and interpersonal skills
If you'd like to talk through this further, please reach out via the below email address