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Senior Therapeutic Lead Immunology - Lead MD for Late Phase Clinical D Nr ref.: /JOBS.pl Senior Therapeutic Lead Immunology - Lead MD for Late Phase Clinical Development Programmes *** Multi NMEs *** RA JIRA PsO AxSpA UC ____________________________________________________________________________________________ This role can be based in in Europe (2 locations), the UK South East or USA (2 locations); full red carpet relocation is available for this role within the USA, UK, mainland Europe or from international regions if you have the relevant expertise - with full visa and tax support. ____________________________________________________________________________________________ You will be a senior physician / clinician with expertise in immunology and have led other MDs, as a clinical programme lead, or disease area expert and now be seeking to work in a company which can offer a global role, with 2 biological compounds in late phases and 7 more coming through and a small team which to expand and work with. The remit of this role is to act as an expert and lead strategist to the different projects coming through, which obviously include the key EOP2 / POC to Ph 3 design phase, as well as the end of Phase 3 to filing for both NMEs and new indications, there is a busy period coming up in this role! You will have exemplary leadership skills as this role has both accountabilities and major areas where you influence decisions both through your direct reports, senior and project committee involvements (you will take on molecules from early medicines through to pivotal studies, filings, launch and handover), as well as through the wider matrix teams, for a role which reports to a commercial svp level person not another MD or CMO. The company is geared around the needs of the patient, and where you will provide strategic insights is in this area, how to design clinical trials which give good data readouts above and beyond the specific requirements for regulatory submissions, and how to balance this without making the protocols clunky. You will join in time to see out the major Ph 3 design of a NME which is highly tipped, as well as prepare the group for expansion as there are several NMEs coming in from the early medicines group (you share the 2a space with these individuals, 2b and on is your group). In terms of credibility, you will have seen at least one major NME from P3 to filing, although this could be equivalent to a succession of new clinical indications, be extremely well connected in the inflammation space with KOLs, regulators, experts as well as be able to show major participation / leading of regulatory agency meetings for critical discussions and alignment of designs. The role is open to clinicians in industry or MDs who have done this in the past, may be rotated to medical affairs and would like to come back to late phase development. Where MDs / PhDs Imm or MDs and Specialists / Board Certified individuals are invited to apply, but equally MDs with multi-NME expertise in Immunology and Inflammation are also sought for this role - we invite you to apply! The role reports to an ex Wyeth / Pfizer and Centocor senior commercial head, who is highly capable, experienced and supportive, without blurring lines of accountability, and has a successful track record with biologicals and earlier, traditional compounds. ____________________________________________________________________________________________ To apply in the first instance, please contact Theo Moore on (0) or send a full CV to stating your current package and expectations and preferred location. We operate extended days to cover the US timezones and you will be attended to by calling from the US (til 4 pm EST) and from Europe on (til 9.30 pm CET). ____________________________________________________________________________________________ About Advanced Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK, Switzerland and Bulgaria. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs, Clinical Development, Medical Affairs, QA, Commercial and Commercial Operations. Keywords / Key words: Rheumatologist, Dermatologist, MD, PhD Imm, Senior Clinical Director, Senior Medical Director, Clinical Development, Clinician, Physician. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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