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An innovative pharmaceuticals professional with broad technical, operational and strategic knowledge and experience in evaluating and developing new medicines. Thrives on challenges, working consultatively while effectively leading cross functional international teams in conjunction with program stakeholders and opinion leaders. Proven strategic and operational track record in several pharmaceutical companies of establishing portfolios, building and leading multi-disciplinary matrix teams and establishing processes and structures for global clinical programs leading to regulatory successes in advancing new pharmaceutical products from concept to maturity.Adept at managing ambiguity and change in a fast-paced environment, applying broad knowledge of a variety of pharmaceutical asset classes and technologies to deliver results across multiple therapeutic indications. An excellent communicator with strong leadership and influencing skills who has proven ability to develop relationships and interact with individuals at all levels while maintaining high quality performance and delivery.
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Vp, Head Of Early DevelopmentAerskaDublin, Ie -
Vp Translational DevelopmentOchre Bio Jan 2023 - PresentOxford, GbA biotechnology company headquartered in Oxford, UK developing first in class RNA therapies for chronic liver disease. Responsible for establishing early asset strategy and subsequent execution from late biology validation / development candidate nomination through IND-enabling activities and early clinical studies, integrating scientific rationale, non-clinical/clinical development, CMC, regulatory and early commercial input. -
Chief Technical OfficerAfimmune Ltd Jul 2018 - Jan 2023Leopardstown, Dublin, IeA clinical stage biotechnology company developing novel assets in cardiometabolic, hepatic, hematological and related indications. Strategic and operational responsibility for all non-clinical activities from discovery phase biology through non-clinical IND enabling development to CMC supply oversight for clinical studies, leading a high performing team and managing key global stakeholder relationships and negotiations.• Established a portfolio of pharmaceutical assets and indications underpinned by major preclinical research and clinical, commercial and regulatory considerations.• Led scientific discussions with leading global regulatory bodies (FDA, EMA, BfARM, MHRA) resulting in successful fast track and orphan drug designations for key pharmaceutical assets, as well as agreement on abridged non-clinical plans.• Oversaw the multi-disciplinary development of assets through Phase 2, including scientific publication of data in high impact journals. • Led asset presentations and relationship building with pharma, investors and other stakeholders at global healthcare and scientific conferences.• Led evaluation of numerous assets from academia and biotech at various stages of development, including subsequent in-licensing of a novel oncology asset. -
Vice President Technical OperationsDs Biopharma Apr 2014 - Jul 2018Leopardstown, Dublin 18, IeA clinical-stage biotechnology company developing novel assets in immune-mediated inflammatory diseases with a focus on dermatology (AD, acne) and respiratory (COPD/IPF). Responsible for establishing from company start-up all pharmaceutical and clinical development operations, leading biology validation while building and leading a team, establishing a network of key opinion leaders (KOL) and consultants and developing and executing early clinical development plans. • Led the company operational start up, establishing operating model while building clinical/non-clinical operations teams.• Established, with commercial input, portfolio of commercially attractive pharma assets. • Drove the biology validation on lead compounds and subsequent successful filing of several new INDs, moving from candidate selection to first trials within 12 months.• Led the design, clinical execution and close out of key Phase 1 and Phase 2 clinical trials.• Presented clinical data at global scientific conferences• Completed numerous patent grants and publications.• Led repositioning of non-core assets into non-pharma space and successful out-licensing to a US commercial company (Nuvothera Inc). -
Product Development DirectorDs Biopharma Jan 2011 - Apr 2014Leopardstown, Dublin 18, Ie -
External Program DirectorMerrion Pharmaceuticals Plc Jun 2007 - Jan 2011Dublin, Dublin, IeAn oral drug delivery technology company with internal development assets in osteoporosis, oncology and thrombosis and co-development programs with leading pharma companies.• Directed the collaboration and managed key relationships with Novo Nordisk A/S leading to technology licensing deals for oral insulin and GLP-1 portfolios. -
Deputy Director Of FormulationsMerrion Pharmaceuticals Plc Jun 2007 - Dec 2010Dublin, Dublin, Ie -
Senior Formulation ScientistMerrion Pharmaceuticals Plc Feb 2006 - Jun 2007Dublin, Dublin, Ie -
Visiting LecturerTrinity College Dublin 2006 - 2007Dublin, IeGuest lecturer to undergraduate pharmacy students and pharmaceutical technicians -
Community PharmacistVarious Nov 2001 - Jan 2006Part Time Community Pharmacy Locum
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Formulation ScientistElan Pharmaceuticals 2001 - 2001Dublin 2, Ie
David Coughlan Skills
David Coughlan Education Details
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Trinity College DublinPharmaceutics -
Trinity College DublinPostgraduate Diploma In Quality Improvement -
AccaPostgraduate Diploma In Financial Management -
Trinity College DublinPharmacy
Frequently Asked Questions about David Coughlan
What company does David Coughlan work for?
David Coughlan works for Aerska
What is David Coughlan's role at the current company?
David Coughlan's current role is VP, Head of Early Development.
What is David Coughlan's email address?
David Coughlan's email address is co****@****ail.com
What schools did David Coughlan attend?
David Coughlan attended Trinity College Dublin, Trinity College Dublin, Acca, Trinity College Dublin.
What skills is David Coughlan known for?
David Coughlan has skills like Pharmaceutics, Formulation, Regulatory Affairs, Pharmaceutical Industry, Technology Transfer, Drug Delivery, Gmp, Drug Development, Biotechnology, Clinical Trials, Life Sciences, Lifesciences.
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