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Job Details

Senior Director, Global Clinical Development for Immunology

Company: Advanced S&S (Medical / Clinical)
Location: London M4 corridor/South-East (near Heathrow)
Reference: TMADV / 150216EU1
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Benefits: On Appplication

Job Summary:

This role is on exclusive assignment to Advanced Search & Selection. Please contact Theo Moore or Matt Greig initially on +44 20 7801 3380 or +44 7918 679 405 (until 9.00 pm CET and Saturday mornings) or send a full CV and contact information to theo@advregulatory.com or matt.greig@advregulatory.com who will support your assessment and on-boarding process.

Requirements:

We have a fresh Challenge for an experienced Senior Director of Clinical Development with an expanding Biopharma that has a dynamic environment and an extensive pipeline within Immunology.

One of the special things about working here is that this organisation has the spirit of a start-up but with the infrastructure and stability of big Pharma, whilst also offering the opportunity to take the lead in global development initiatives in early and late stage through to filing.

As the Senior Director of Clinical Development, you will be operating as the Lead Clinical Development Representative for Missions within the Immunology franchise, assigned one or more NCE/NBEs and complex projects across multiple indications or partnered projects, with potentially a number of strong Clinical Program Directors reporting in or supporting you. 

You will be responsible and accountable for all clinical aspects of assigned program(s)/Mission(s), providing leadership of the relevant clinical program(s) from Phase 2-4, ensuring adequate planning, design, defense and implementation of the clinical development strategy including generation and appropriate revision of the Clinical Development Plan (CDP), clinical aspects of the Target Patient Value Profile (TPVP), and the Investigators Brochure (IB) to enable:

  • Successful filing, approval and launch of NCEs/NBEs
  • Additional regulatory approvals of new line extensions (indications or formulations) of registered compounds
  • Prompt identification of safety or efficacy results that warrant re-evaluation of project plan and/or potential termination prior to registration

Ideally you will be a highly motivated professional, ready to take the strategic clinical lead, working with Medical and Regulatory to oversee a number of compounds under your responsibility. It’s important that you have the energy, drive and expertise to make your thoughts heard in a global matrix environment and add value to an organisation that has already shown huge levels of innovation in its approach to growth, product development and patient-centricity for a highly rated product portfolio.

Salary and package levels are exceptional and include a strong six figure basic salary, fully expensed car with petrol card, LTIs, and bonus. There is also an extensive re-location package which includes accommodation and full dedicated one-to-one support.

Your qualifications and experience level for this role:

  • A relevant Master’s degree with a PhD preferred
  • Relevant experience in biopharmaceutical-clinical development is required, including oversight of the planning and simultaneous management and reporting of multiple clinical studies
  • Broad experience in writing and/or participation in the preparation of submission documents required (across or at timepoints along the continuum from original protocol to NDA/BLA to safety updates)
  • Experience in critical review of relevant development and regulatory documents outside the clinical arena required
  • Current knowledge of all aspects of the global clinical development processes and of the relevant therapeutic area required.

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If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3380.
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About Advanced

Advanced Search and Selection - Clinical and Medical Division has been operating since 2004. We are registered and licensed to recruit in the UK, Switzerland and Mainland Europe and we have offices in both the UK and Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory, Clinical and Medical Affairs.

We match professional candidates to the best permanent, contract and interim roles in the market and for more information about our company visit us at www.advregulatory.com.

If you wish to apply for this role please click Apply Now, or send your CV with a covering note to CV@AdvRegulatory.com. Alternatively to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the UK London office, on +44 (0)20 7801 3380.

Keywords / Key words: Medical, Medical Affairs, MA, Medical jobs, MA jobs, Medical Affairs jobs, Clinical Research, Clinical, Clinical jobs, Clinical Development, Project Management, Physician, Psoriasis

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Head Office Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3388
Website:  Visit Our Web Site

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