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All over the world, the company colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Our Clinical Pharmacology Leads have key roles to play in influencing the discovery and development of drugs. It is exciting, critical work and you could be part of it. the company is a leader in Model Based Drug Development, and we are expanding its influence in target validation and selection. We have an open position as Clinical Pharmacology Lead at our Neuroscience and Pain Research Unit in Cambridge, MA. The ideal candidate embraces model-based drug development - constructs, validates, and utilizes disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with other R&D partners. Clinical Pharmacology Leads are also responsible for planning and direction of clinical pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including protocol preparation; clinical phase oversight, and reporting).
• Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team as appropriate.
• Participate in implementing Model Based Drug Development using quantitative approaches to address complex questions arising during drug development spanning from target validation to analysis and interpretation of Phase II results.
• Responsible for providing the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team including plan, design and oversee clinical pharmacology studies with operational assistance from Clinical Research Operations.
• Fully knowledgeable about the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol.
• Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the CP study. Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off.
• Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis etc.
• Directs the planning of all relevant PK-PD analyses. Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics and statistics (as relevant).
• Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the clinical and Development teams and in regulatory documentation.
• Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings. Leads the resolution of clinical pharmacology queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
• Provides Clinical Pharmacology expertise to Discovery. During the pre-clinical stages of drug development works with Research to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exist to underwrite human administration.
• Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic.
• May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.
• May act as clinician for phase I studies or clinical lead / research project lead for specific drug development projects.
Strong quantitative skills and expertise (e.g. experience in mechanistic PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations)
• PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or other suitable post-graduate qualification
• 3-5 years of industry experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics
• Excellent written and verbal communication skills
• Demonstrated presentation skills
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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