Senior Medical Director (Immuno-Oncology)
Our client is an exciting biotech with industry leading partners and excellent funding. Their pipeline covers multiple therapeutic areas with a focus on Immuno-Oncology and Inflammation.
In order to continue their expansion plans we are helping them locate a Senior Medical Director with a strong background in Early Clinical Development.
- Provide strategic medical guidance and lead the development of immuno-oncology compounds in early phase
- Create clinical development strategies for new oncology agents combining medical knowledge with the expertise of colleagues in a wide range of other disciplines, such as Clinical Pharmacology or Biostatistics, to optimize the clinical development strategy
- Provide an early clinical development strategy that foresees and supports subsequent registration trials
- Lead multiple global project teams (matrix environment)
- Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret implications for clinical development, as articulated in the Investigator’s Brochure and First-in-Human protocol
- Develop clinical protocols for TCO compounds and develop the instruments needed to implement, interpret and report them. This includes for instance case report forms, report and analysis plans and clinical study reports
- Apply own medical knowledge to guide the safe, ethical and efficient conduct of the trials under own responsibility
- Be knowledgeable in Good Clinical Practice guidelines and internal SOPs• Liaise with outside experts, investigators, and regulatory authorities in oncology
- Write and review abstracts/manuscripts etc. for presentation/publications at internal/external meetings
- Participate in task forces to support continuous improvement and other management objectives
- Take operational responsibility for quality and compliance
- Is accountable for successful delivery of the early clinical development plan and associated clinical trials as assigned on time and to agreed standards of quality
Skills and Requirements:
- MD required
- Experience leading early phase Oncology Clinical studies within pharmaceutical/biotech industry
- Ability to design and lead trials independently
- Interpretation of preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology)
- Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials
- Proven ability to analyse and interpret efficacy and safety data relating to oncology
- Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology
- Excellent medical/scientific writing skills
- Effective written and oral communication skills
- Proven ability to matrix manage/lead/influence project teams of scientific and medical colleagues
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Yannick Dada on +44 203 854 0103 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.