Location:
Northbrook, IL
Posted Date:
5/21/2012
Position Type:
BS FULL TIME
Job Code:
2000011122210
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Description
Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us!Astellas is announcing an Associate Clinical Program Director opportunity in our Deerfield, IL location.Provide high level Clinical Science input into clinical development strategies, the GMAP and other key global project team deliverablesDevelop operational strategies and ensure implementation of these strategies at the study and project levelsBe accountable for the effective oversight and performance of these activities to GDO and the Global Project TeamBe a member of the global core team as the Global Development Operations Lead (GDOL)The scope of this position is from due diligence through development and life cycle management for APGD global projects. There may be instances when this position would manage the clinical development activities for local projects.Provide strategic input into clinical development plans, GMAP and other key global project team deliverables through participation on global project teamDeliver and manage the operational plan including budget, resources and timelines to global project teamLeads and provides direction to GDO extended team members to ensure timely and optimal planning, execution and reporting of GDO responsibilities and deliverablesCollaborate with GSTATL, GMWRL and GML to ensure integrated and consistent approaches and performance within GDOEffectively collaborate with internal and external stakeholders, for example:Provide clinical operational input into due diligence initiatives and, in collaboration with the GCPL, early development activitiesProvide clinical operational leadership in the design, execution and reporting of P1b through P3 studies and for APGD-sponsored post-marketing studiesCollaborate and influence interactions with KOLs, medical affairs, marketing and other key stakeholders as appropriateProvide timely and accurate updates to GDO leadership during project reviews to contribute to optimal planning of resources, strategic and scientific application of expertise and effective functional support for assigned programsEstablish, ensure and foster effective communication channels across relevant stakeholders and functionsEnsure successful management of vendors; work effectively with study teams, outsourcing and other functions to ensure consistency and quality in vendor processes and execution across studies within the programEnsure integrated and optimal quality at the level of investigative sites, data and GDO deliverables in collaboration with other GDO team members and functions.Develop in-depth understanding of assigned therapeutic areas and facilitate transfer of knowledge to ensure operational excellence across programProvide specific coaching and mentoring to Senior Clinical Program Managers and Study Managers and provide performance feedback to functional management; this position may provide oversight to multiple Program ManagersParticipate in the creation of relevant competitive intelligence in assigned therapeutic areas to enable optimal recruitment strategies at the program levelParticipate in Clinical Science and GDO initiativesQuantitative Dimensions.Responsible for the preparation and management of budget, resources and timelines for assigned clinical programs. Responsible for program budgets up to $250M.Organizational context.Reports to the Director, Clinical Program Management or above. Position has no direct report responsibility but provides oversight and direction to extended team members for program deliverables and may provide supervision to Senior Clinical Program Managers assigned to his/her programs teams.
Requirements
BA/BS degree with at least 10 years clinical trial management experience; advanced degree (MS, PhD, PharmD) preferred with 7 years clinical trial management experienceMust have extensive expertise in developing operational strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.Must have extensive experience in performing multi-country clinical trials and a strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.Must be able to work across multiple molecules, indications and phases of development.Requires drug development project management as well as clinical trial management operational expertise.Must have proven and effective interpersonal, written and verbal communication skills, administrative skills and computer ability.Desired experience in one of the following therapeutic areas: Oncology, Infectious Disease, CNS or ImmunologyFluent in English. Moderate to high (25% to 35%) travel required.*cb
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