POSITION: Program Lead Clinical Development - Physician
LEVEL: VP / Senior Director
LOCATIONS: Houston, TX USA, or Tübingen / Munich, Germany
PACKAGE: up to $300,000 DOE, plus bonus, stock, relocation, and a range of other benefits
Compass Life Sciences have partnered with a cutting-edge Immuno-Oncology Biotechnology company with offices across Europe and the US to oversee the recruitment of a talented, medically qualified Clinical Programme Leader. The organisation has a number of assets in early phase clinical trials with further advancing through late stages of pre-clinical development, innovating new treatments using next generation TCR therapies. Having completed public listing earlier in the year, there are significant plans in place to bring their assets to market and they are looking for an experienced Immuno-Oncology Programme Physician to be integral in this.
Reporting directly into the Chief Medical Officer, you will have responsibility for a growing pipeline of autologous TCR-T cell assets, bi-specific T cell engagers, and allogenic TCR-transduced gamma/delta T cells. You will have oversight of the generation of the Clinical Development plan from first testing in human, to Recommended Phase 2 Dosage (RPh2D), clinical proof of concept, and registration trials.
Key Responsibilities include
Protocol design including selection of the patient population and benefit risk assessments.
Development and maintenance of strong relationships with investigators and Key Opinion Leaders (KOLs).
Leadership of the clinical matrix team which is part of the interdisciplinary early development team.
Assessment and response to regular and urgent inquiries on patient eligibility criteria or safety events.
The assessment of safety events together with safety experts and pharmacovigilance function.
Generation of responses to requests for information from regulatory agencies for all medical aspects of the assigned trial protocols.
Non-voting member of DSMBs.
Presents patient level data from assigned programs to senior management.
Key stakeholder of interdisciplinary development teams with strong interface/cooperation with Clinical Operations, Non-physician Clinical Scientists, Regulatory Affairs, Drug Supply, Translational Medicine, Program Management, Medical Affairs, and the Commercial groups once in place.
To be considered for this role, our client is looking for a range of experience in both research and clinical development. You should be able to evidence.
M.D. or Medical Qualification coupled with a strong scientific background in Immuno-Oncology and/or oncology cell therapy.
Experience working within industry within early-stage drug development
Physicians with backgrounds within academia that have limited industry experience will be considered provided there is demonstrable relevant experience in clinical testing of engineered T-Cell products.
Experience in clinical testing of cell therapy products in oncology
Experience in treatment of patients with multiple solid cancers.
Ability to coordinate tasks and effectively work with multiple stakeholders.
Excellent organization and time management skills.
Manage issues proactively, manage conflicts, and mitigate risk.
Strong oral and written communication skills.
To learn more about this position or to express your interest in being considered, please either apply now, or email an up to date CV / Resume coupled with a cover letter to David Jolley at firstname.lastname@example.org, or call +44(0) 7738 586 627, or +44(0) 2393 877 358.
Compass Associates Ltd, trading as Compass Life Sciences are a Recruitment Consultancy working on this permanent vacancy.