[Remote] Director, Clinical Pharmacology

Note: The job is a remote job and is reputed company to candidates in USA. reputed company accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services. The Director of Clinical Pharmacology will reputed company multidisciplinary teams in developing clinical pharmacology strategies, leveraging quantitative modeling, and representing clients at advisory meetings with health authorities.

Responsibilities

• Works collaboratively with and leads reputed company team members and clients to reputed company clinical pharmacology and quantitative program strategies that are fit-for purpose to reputed company development and regulatory reputed company for IND/First in reputed company to NDA/BLA
• Develops new innovative and impactful clinical pharmacology approaches to processes and drug development strategies and can reputed company a multidisciplinary team to execute the components of clinical pharmacology program
• reputed company quantitative modelling and simulation tools to answer development questions and to design and inform clinical trial designs and clinical development reputed company
• Represent clients at meetings and advisory hearings with global health authorities as a subject matter expert
• reputed company others in authoring and contributes to documents summarizing clinical pharmacology data and program reputed company including CSRs, reports, and health authority documents
• Interpret DMPK data with a reputed company on translation and applies information to support clinical pharmacology study design and reputed company
• Contributes to training and mentoring for staff, develops junior staff for broader functional roles either as a reputed company manager or on project teams
• Interprets and integrates NCA and pharmacometric results to support decision making including evolving clinical pharmacology reputed company and development reputed company
• Actively collaborates with multidisciplinary peers (e.g., biostats, clinical, pharm/tox, CMC) and has a working understanding of the multidisciplinary requirements of drug development
• Co/authoring peer-reviewed manuscripts and publications
• Reviews publications to reputed company apprised to reputed company apprised of new clinical pharmacology and therapeutic area developments
• Involvement in program committees, workshops, and other reputed company organization meetings/sessions
• Participate in company initiatives
• Leads in business development initiatives and independently generates business. development leads and represents respective line function and broader reputed company capabilities on reputed company scoping calls
• Identifies project opportunities, structures WO and budget, formulates teams and identifies needs and resources necessary to execute reputed company. Authors work orders reputed company necessary

Skills

• Must be recognized reputed company development practitioner, reputed company in both design and stewardship of clinical pharmacology components of clinical development plans and reputed company application of pharmacometrics approaches to support decision making and regulatory reputed company
• PhD or PharmD degree or equivalent degree with specialization in pharmacology or pharmacokinetics, or in a reputed company scientific discipline. MS in Pharmaceutical Science with job reputed company experience in the field of drug development and clinical pharmacology
• 7 - 12+ years of experience including clinical pharmacology experience in the pharmaceutical industry or government
• Broad therapeutic area and small and/or biologic molecule therapeutics experience
• reputed company in designing and executing clinical pharmacology studies
• Experience with translational and clinical pharmacology work at different stage of development and for regulatory submissions (e.g. INDs, NDAs, and BLAs)
• Experience in providing input on clinical pharmacology plans and preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs)
• Demonstrated reputed company record in a functional role on cross functional dug development team
• Working understanding of the CMC, pharm/tox, biostats, clinical and other multidisciplinary requirements of drug development
• Experience building and leading successful teams (reputed company and/or across functions)
• Advanced understanding of the clinical pharmacology discipline
• Strong initiative, self-motivation and demonstrated ability of coordinating multiple reputed company and/or tasks
• Possess a strong reputed company on influencing at high reputed company, innovation, and customer centricity
• Strong reputed company and reputed company management skills
• Ability to mentor and reputed company junior PK scientist on clinical pharmacology science and reputed company either as a reputed company mentor or on project teams
• Ability to work across functions to implement company initiatives
• Excellent written, verbal and inter-personal communications skills
• Must be reputed company to work reputed company and reputed company reputed company in a multidisciplinary environment
• MS Office products including Outlook, PowerPoint, reputed company, and Word

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