Director Clinical Development

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Job description

Do you want to be leading pivotal, cutting-edge trials to push a T Cell therapy through Phase II-III and launch?

I am partnered with a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer, using a broad suite of proprietary and modular T cell programming technologies. The company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defence mechanisms and eliminate these cells.

My client has a pipeline of product candidates in development for the treatment of haematological malignancies and solid tumours.

Want to know more? Read on further...

Role Summary:

The post-holder is responsible for the development and management of Adult Acute Lymphoblastic Leukaemia (ALL) clinical program(s) involving use of CAR T. This post holder will have dynamic interactions with the global leading experts in the field of ALL and CAR-T cell therapy and be responsible for the medical oversight and conduct of study/ies (e.g. FELIX). The post-holder will be a key member of the clinical development team.

Responsibilities:

* The AD/ Director, Clinical Development will conduct early and late clinical phase and Proof- Of-Concept clinical development trials, design new trials, assess clinical safety and efficacy data, and write clinical protocol, study reports, development of CTAs/INDs, Investigator Brochures, etc. Submit protocols to IRB/EC, and ensure collection and review of required essential study documents and reports.

* The AD/Director will serve as medical monitor and with other members of the clinical team will be responsible for providing medical oversight to study, including reviewing patient eligibly and incoming data. This individual will also assist in filing activities (e.g. FDA, EMA, MHRA), assist in conducting meetings with investigators and independent committees for the studies.

* Review all Severe Adverse Events and ensure medical review and reporting requirements are met. This role requires a high-performing physician-scientist familiar with clinical and translational research involving biomarkers and correlative laboratory clinical trial endpoints.

* This individual will be required to collaborate closely with relevant functions within and outside the organisation, including discovery, translational, and biomarker research scientists, toxicologists, drug safety specialists.

* Will be responsible for overall development, execution and monitoring of one or more clinical studies in parallel other support staff, as appropriate.

* Provides input to Clinical Operations, and develops trial-related Safety Management Plan (SMP). Work with safety, data management teams and Independent Data Monitoring Committee to make timely decision regarding study objectives. Implementing accrual initiatives, ensure timely and quality data entry, ongoing medical review and coding, and database locks for data monitoring committees and interim analyses, completion of the clinical study report. S/he gives input in site-selection, and contributes to investigator meeting presentations and site initiation visits.

* The AD/Director is also expected to establish strong working relationships and collaborations with external study investigators, key opinion leaders in drug development, and external partners.

* S/he evaluates scientific information and new ideas to assist in identifying new research and development opportunities.

* Monitor compliance with all company standard operating procedures (SOPs), GCP, EMA, FDA and applicable international regulations concerning clinical activities.

Experience:

* MD or MD and PhD with strong clinical research experience.

* Formal training in Oncology or Malignant Haematology (ideally Adult Lymphoblastic Leukaemia) with Board Certification or eligibility is required. Relevant experience in clinical research within the pharmaceutical industry is preferred.

* Significant knowledge of translational and clinical cancer research and its application to cancer drug development is of paramount importance. A working knowledge of the key areas of early drug development, including chemistry, biology, toxicology and early clinical development is required. Knowledge of clinical pharmacology and its relationship to decision making in early and late drug development is of value.

* Experience in oncology therapeutic area and in early oncology clinical trials is preferred. Basic and or clinical experience is immuno-oncology is highly preferred. Significant experience in development and implementation of clinical research protocols is preferred.

* Excellent written communication, oral communication, and presentation skills are also essential. The individual must have demonstrated ability to work in a matrix team environment.

* The willingness to travel up to 20% of the time is required.

Following your application Mollie Laurens-Chalmers, a specialist Executive Pharmaceutical Researcher, will discuss the opportunity with you in detail. She will be more than happy to answer any questions relating to the position and company, plus put a focus on career growth. The conversation can also progress further to discussing other opportunities, which are also available right now or will be imminently becoming available on the Executive Search or Medical Team here at Barrington James.

This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment.

Please click 'apply' or contact Mollie Laurens-Chalmers for any further information

Mollie Laurens-Chalmers

Executive Search Researcher // Medical Recruitment Resourcer

Email: MLChalmers (at) barringtonjames.com

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