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Interim Clinical Development Physician, GI, Cambridge
Client:
CK Group Location:
Cambridge, United Kingdom Job Category:
Other EU work permit required:
Yes Job Reference:
c74ac0075fea Job Views:
10 Posted:
23.01.2025 Expiry Date:
09.03.2025 Job Description:
Interim Clinical Development Physician, GI CK Group are working in partnership with Nxera Pharma UK Limited (formerly Sosei Heptares), to recruit a Clinical Development Physician, based in Granta Park, Cambridge. Company: Nxera Pharma is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally, focused on therapeutic areas in inflammation diseases, neurology and immunology. RESPONSIBILITIES: Contribute to early clinical strategy and provide clinical translational leadership, designing and executing early-phase clinical trials with integrated biomarker strategies for GI/immunology programs. Serve as the medical expert for IBD clinical trials, providing ongoing medical monitoring and ensuring the safety and well-being of trial participants. Review and assess clinical data, including adverse events, and ensure compliance with protocols, GCP, and regulatory requirements. Provide medical input into study protocols, Investigator Brochures, informed consent documents, and clinical study reports. Engage with investigators and key opinion leaders (KOLs) to provide medical and scientific guidance throughout the trial lifecycle. Implement, manage, and interpret clinical trial results and exploratory biomarker endpoints to inform clinical strategy. Ensure compliance with FDA, EMA, ICH, and GCP guidelines, as well as internal SOPs. Collaborate with preclinical and translational medicine teams to design preclinical and biomarker experiments that align with clinical development goals. QUALIFICATIONS: As a Clinical Development Physician you will require: MD or equivalent medical degree with extensive experience in early-phase clinical development, particularly in phases 1 and 2. Proven expertise in GI and immunology therapeutic areas, with a strong focus on Inflammatory Bowel Disease (IBD). Demonstrated success in designing and executing clinical trials with biomarker integration and translational strategies. Experience in working within a small biotech environment, showcasing adaptability, resourcefulness, and the ability to manage multiple responsibilities in a fast-paced setting. Strong understanding of regulatory requirements for early-phase trials, including experience in MHRA, FDA and EMA interactions. Excellent communication skills, with the ability to engage effectively with internal teams, investigators, and KOLs. A collaborative and hands-on approach to problem-solving, with demonstrated leadership in cross-functional project teams. Strong analytical and critical thinking skills to evaluate clinical and biomarker data to drive decision-making. Familiarity with emerging trends in GI and immunology research and a passion for innovative therapeutic development.
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Client:
CK Group Location:
Cambridge, United Kingdom Job Category:
Other EU work permit required:
Yes Job Reference:
c74ac0075fea Job Views:
10 Posted:
23.01.2025 Expiry Date:
09.03.2025 Job Description:
Interim Clinical Development Physician, GI CK Group are working in partnership with Nxera Pharma UK Limited (formerly Sosei Heptares), to recruit a Clinical Development Physician, based in Granta Park, Cambridge. Company: Nxera Pharma is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally, focused on therapeutic areas in inflammation diseases, neurology and immunology. RESPONSIBILITIES: Contribute to early clinical strategy and provide clinical translational leadership, designing and executing early-phase clinical trials with integrated biomarker strategies for GI/immunology programs. Serve as the medical expert for IBD clinical trials, providing ongoing medical monitoring and ensuring the safety and well-being of trial participants. Review and assess clinical data, including adverse events, and ensure compliance with protocols, GCP, and regulatory requirements. Provide medical input into study protocols, Investigator Brochures, informed consent documents, and clinical study reports. Engage with investigators and key opinion leaders (KOLs) to provide medical and scientific guidance throughout the trial lifecycle. Implement, manage, and interpret clinical trial results and exploratory biomarker endpoints to inform clinical strategy. Ensure compliance with FDA, EMA, ICH, and GCP guidelines, as well as internal SOPs. Collaborate with preclinical and translational medicine teams to design preclinical and biomarker experiments that align with clinical development goals. QUALIFICATIONS: As a Clinical Development Physician you will require: MD or equivalent medical degree with extensive experience in early-phase clinical development, particularly in phases 1 and 2. Proven expertise in GI and immunology therapeutic areas, with a strong focus on Inflammatory Bowel Disease (IBD). Demonstrated success in designing and executing clinical trials with biomarker integration and translational strategies. Experience in working within a small biotech environment, showcasing adaptability, resourcefulness, and the ability to manage multiple responsibilities in a fast-paced setting. Strong understanding of regulatory requirements for early-phase trials, including experience in MHRA, FDA and EMA interactions. Excellent communication skills, with the ability to engage effectively with internal teams, investigators, and KOLs. A collaborative and hands-on approach to problem-solving, with demonstrated leadership in cross-functional project teams. Strong analytical and critical thinking skills to evaluate clinical and biomarker data to drive decision-making. Familiarity with emerging trends in GI and immunology research and a passion for innovative therapeutic development.
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