Chief Medical Officer

TauRx Pharmaceuticals Ltd is focused on the discovery, development and commercialization of products for the diagnosis and treatment of neurodegenerative diseases caused through protein aggregation.  Its lead product is LMTX^®, the first Tau Aggregation Inhibitor (TAI) targeting the Tau pathology of Alzheimer’s Disease.

The roots of TauRx lie in the scientific research undertaken by co-founder Professor Claude Wischik at Cambridge University and the University of Aberdeen from 1985-2000. This work led to the first identification of Tau protein as the constituent of the neurofibrillary tangles originally discovered by Alzheimer, and to the discovery of the first TAI’s as potential treatment for AD. TauRx was established in 2002 with investors from Singapore with the aim of discovering novel approaches to the treatment and diagnosis of AD as well as other neurological diseases characterized by abnormal aggregation of Tau and other proteins within the brain.

Since its inception, the company has raised almost US$600m to fund its programs.  Of this, US$112m was raised in November 2012 through a strategic investment from the Genting Berhad group (a Malaysian conglomerate), primarily to initiate the Phase 3 program; a further US$250m was raised from new and existing investors during 2013-2015 to support completion of the Phase 3 program. A recently completed rights issue raised a further $70m to fund the ongoing clinical development program.  The first of the two planned clinical studies, a 6-month biomarker study with a PET imaging endpoint, is currently underway with results expected in the spring of 2019.  It is the Company’s intention to seek a public listing for its shares at an appropriate time. The company is also in discussions regarding commercialisation opportunities for LMTX^® with potential partners.

This role is vacant due to a change in family circumstances of the current Chief Medical Officer.

Job Purpose

• Plan, implement, oversee and deliver results of clinical trials (Phase I – Phase III) according to agreed time-lines, to an acceptable level of quality (per regulatory requirements and data integrity guidelines) and to agreed budget
• Provide safety oversight / management of pharmacovigilance and medical monitoring  of all TauRx clinical trial subjects during their participation in regulatory approved TauRx studies and subsequent expanded access programmes
• Share in the public communication of clinical study results through the co-authorship of papers for submission to peer-reviewed journals, the delivery of presentations at scientific conferences and participation in discussions with KOLs and potential industry partners and investors.

Accountabilities

• Assess, manage and develop TauRx Clinical Development team.
• Ensure effective cooperation and coordination of TauRx Clinical Development activities with those of other TauRx functions.
• Ensure that sufficient resource, including TauRx staff and/or contractors, is available to conduct the Phase I to Phase III clinical programme.
• Identify, evaluate and select clinical research organizations and other contractors for the provision of clinical trial services.
• Manage and contribute to the discussions of Data Safety Monitoring Boards (DSMB), ensuring that their composition and functionality meets regulatory requirements and accepted Industry best practice.
• Monitor and ensure ongoing compliance of TauRx Clinical Development function staff with TauRx quality assurance system, including function-specific core policies and standard operating procedures, and lead their on-going improvement.
• Monitor and act as appropriate to ensure that the safety of subjects on TauRx clinical trials is safeguarded by an effective drug safety infrastructure and that safety information is monitored, evaluated and provided to regulatory authorities as required
• Conduct all activities according to regulatory requirements, global guidelines and TauRx policies and procedures.
• Contribute clinical insight to internal scientific discussions and participate in drafting scientific papers reporting clinical study results.
• Participate in the creation of applications to regulatory authorities for marketing approval for TauRx’s drug products and in meetings with regulators.
• Communicate clinical study results and underlying TauRx technology at medical conferences, and to potential strategic partners and investors.

Education, Experience and Skills

Education

• Scientific degree (preferably at master’s or doctoral level) or medical degree

Experience

• Minimum 15 years in pharmaceutical R&D with experience of multi-disciplinary drug development including internationally and in a variety of therapeutic areas.
• Experience in oversight of multiple clinical development service providers, including development of scopes of work and negotiation and on-going management of budgets and payment schedules.
• Experience of drug safety and medical monitoring.
• If medically qualified, experience of clinical work with own responsibility, preferably in neurology or psychiatry

Skills / Knowledge

• Thorough knowledge of the applicable GxP regulations, FDA Good Clinical Practices, ICH Guidelines, Local Regulations and Guidance’s.
• Industry knowledge – understands the pharmaceutical industry and the overall drug development process.
• Scientific Knowledge – fundamental understanding of scientific methods and thought processes.
• Regulatory Knowledge – understanding of the EU and FDA regulations and ICH requirements governing the international pharmaceutical industry.
• Management Knowledge – broad-based skill set with respect to people and organisational management.
• Flexibility in adapting to the realities of a small organization with global ambitions and limited resources.

To apply please send your CV to Ailsa Sutherland at fwb@fwbparkbrown.com