Medical Director/Sr Medical Director - Biotechnology - Oncology
Upsilon Global are partnered with an exciting immuno-oncology biotech that have developed proprietary T-Cell technology showing great efficacy in the treatment for both solid tumours and blood cancers.
In line with recent successes throughout their pipeline, and as part of a major growth phase, they are expanding their clinical development team and seeking a Medical Director/Sr Medical Director to join their team and help continue to drive the success of their application in both existing and new therapeutic indications.
Working closely with the CMO and other members of the core leadership team, you will lead Clinical Development strategic planning and drive innovation in trial design, taking a hands-on, operational approach, owning clinical programmes and acting as subject matter expert for the associated studies.
Whilst acting as the in-house subject matter expert for infectious diseases. Working closely with the core leadership team, you’ll work to shape the future of clinical development with their first-in-class therapy.
This is a truly exciting opportunity to join a rising organisation with such encouraging technology!
- Work with CMO and core leadership team to lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Non-clinical and Discovery Research for assigned studies
- Take ownership of clinical programmes as subject matter expert
- Assure clinical development plans are comprehensive, include key decision points, timely readouts, and risk mitigation for both near and long-term goals
- Plan and overall product strategy that meet ethical, scientific, safety, regulatory objectives
- Establish and maintain strong relationships with key opinion leaders and partners, to facilitate and support external collaborations
- Support site selection and site activation activities, including contacting investigators to discuss potential interest in assigned study, developing slides for site initiation visits (SIV), and performing SIVs as needed
- Provide medical oversight of assigned clinical studies including implementation, medical/safety monitoring, protocol compliance and medical data review
- Analyse and interpret data, identifying trends and signals, and synthesizing key learnings to impact subsequent phases of clinical development as well as to shape the translational medicine plans so they are complementary to the clinical development plans
Experience & Knowledge
- The ideal candidate is an MD, with certification in oncology, or a track record of exceptional achievement in oncological therapeutic development
- Strategic and critical thinker, with proven success in designing innovative clinical trials that have supported successful regulatory filings across US and Europe
- Experience developing trials from (mouse) pre-clinical/translational to phase I, and not just approved phase I therapeutics
- A hands-on, inspirational and motivational leader who can lead by example and drive the team and trials forward
- Track record of leading clinical teams and building mutually respectful relationships with colleagues; has the capability to listen to and integrate input from cross-functional teams and then make clear decisions
- Able to trouble shoot challenges and provide direction, guidance, and support to the team to deliver on near term goals
Education & Qualifications
- MD or MD/PhD with research training, oncology experience essential
- Working knowledge of basic and clinical science
- Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development.
- Broad understanding of oncology area; experience in immunology / immunotherapy highly desirable
- Experience in clinical operations/clinical development, and not solely medical affairs
- At least 10 years of relevant experience in clinical drug development across academia or pharmaceutical industry (must include experience conducting early phase trials)
- At least 3 years of experience as a medical monitor in a biotechnology/ pharmaceutical company, and/or CRO.
For more information, please apply or contact Upsilon Global directly on +44 203 875 9966.