Senior Director, Clinical Pharmacology and Pharmacometrics (BB-09FD0)
Found in: Talent UK
Description:Senior Director, Clinical Pharmacology and PharmacometricsUK - Field Based – CambridgeUS - Field Based - VariousWe are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.About the role: This leadership role presents an exciting opportunity to establish new R&D capabilities to support our clinical, translational, and regulatory programs and thereby unlock the potential of cannabinoid science to transform the lives of patients and their families.The Senior Director, Clinical Pharmacology & Pharmacometrics, will leverage scientific, hands-on quantitative, and managerial skills and experience to lead and support to the clinical pharmacology team and build out this function to a state-of-the art department encompassing PK (clinical and pre-clinical), ADME (absorption, distribution, metabolism and excretion), translational biomarkers, and quantitative pharmacometric modelling. Special emphasis will be on innovation in the evaluation of complex botanicals and their properties, for example interactions between multiple active moieties and novel formulations. Responsibilities:Provide strategic leadership and guidance to the first-in-human and all clinical stage clinical development teams to achieve the optimal product profile for new entities, initial lifecycle formulations and in support of new indicationsProvide clinical pharmacology study expertise (study design, protocol concepts/protocols preparation, clinical phase oversight and reporting) within assigned programs to yield high value PK/PD insight for future critical decisions. Ensures study designs and portfolio of trials support the product development plans early and ensures that GW’s understanding of key cannabinoid and metabolites is taken into account by taking a portfolio view. Anticipates need for studies and creates a culture of timely initiation and execution of trials in the context of the overall product development requirements and recommends changes to plans and action based on study results.Create Model-Informed Drug Development (MIDD) research agenda and plans to accommodate a highly dynamic and ambitious early translational and pipeline enterpriseCollaborate with clinical development leaders, clinical and translational scientists, biometrics, regulatory, program management, clinical operations and preclinical research and discovery functions at GW to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended program outcomes.Identify and efficiently resolve program-specific issues.Increase capabilities for the analysis, interpretation, and timely reporting of clinical pharmacokinetic & pharmacodynamic trials internally and in collaboration with external vendors/academic groups. Support publication and reporting of appropriate clinical pharmacology data. Lead and own clinical pharmacology documentation for regulatory filings and label inclusion. Own the global company core clinical pharmacology data and positions for global labelling and regulatory purposes. This includes clinical protocols, Investigator Brochures, Clinical Study Reports, INDs, NDA/MAAs with respect to clinical pharmacology studies or data and their interpretation.Work with preclinical colleagues to ensure timely and adequate preclinical PK and ADME data support of the overall product and class of agent developmentOversee, manage, and facilitate all aspects of a Clinical Pharmacology studies, or other investigations as required to enable and anticipate needs for the Clinical Development Plan.Ensure timely and high-quality documentation, supported by Medical Writing, is readily available according to agreed program timelines in cooperation with the program management office leadership. Attend, testify and represent clinical pharmacology at advisory boards, investigator meetings, and regulatory agency meetings, as required.Oversee with the management of CROs and academic collaborators in the conduct of in vitro ADME studies in collaboration with relevant functionsCoordinate and own the timely development of high-quality and strategically aligned publication.Ensure that best regulatory practices and drug development precedent is assigned to all programs.Own and supervise clinical pharmacology input to regulatory filings including CTA/IND, Annual Report/General Investigation Plan, NDA/MAA and supplements/variations.Ensure that all clinical pharmacology studies are conducted in accordance with international regulatory and ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH).Ensure, in close collaboration with the PMO, on-time delivery for the database lock, data tables, listings and figures review and oversees CSR production in alignment with the PDP and CDP. Liaise with procurement and outsourcing staff with the clinical outsourcing to clinical vendors such as phase I units, labs, IRBs, and others.Position RequirementsPh.D., M.D. or equivalent qualification in life sciences with demonstrable focus and contributions in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant qualifications with at least 15+ years of experience in PK/PD, modelling and simulations, population PK, preclinical pharmacology and toxicology aspects of Clinical pharmacology experience within the biopharmaceutical industry will be a strong suit.Knowledgeable and experienced in deploying state-of-the-art technologies, modelling, simulations and software utilization to enhance and supplement current clinical pharmacology capabilities at GW.Experience in cannabinoid formulation, ADME, and pharmacology highly desirable.Strong knowledge of pharmacokinetics and modelling, multiple therapeutic areas with tangible experience in CNS drug development and hepatic and extrahepatic drug-drug interactions, pharmacodynamic principles, ADME concepts, bioanalytical principles and strategic integration of these data needed to support successful NDA/MAA filing and registration.Track record of successful clinical pharmacology support of drug approvals Strong communication skills and presentation skills, verbal and written are required. Excellent interpersonal skills and ability to function in a matrix team environment and managerial and leadership aptitude are essential. Some travel to key GW sites and to represent the company at regulatory and scientific meetings, will be required when appropriate. This is obviously dependent on the currently uncertain COVID situationAdvanced ability to successfully manage a full workload across multiple programs.The incumbent will be a self-starter and is comfortable with broad responsibilities in an entrepreneurial, fast-paced, small to mid-size company environment.Thorough knowledge of Food and Drug Administration (FDA) and European regulations.
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