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Project Leaders – Pharmaceutical Development - France, United States  

Company managed [?] Still accepting applications

Posted on : 04 April 2017

Project Description

Description:
  • As a Project Leader in Pharmaceutical Development, you will have overall responsibility for a development program, typically following the POC decision or assessment phase.
  •  As the coordinator of a development program, you will lead and / or participate in internal teams and external alliance partnerships
  • The main responsibilities include working with the internal laboratory, colleagues and / or external vendors / consultants for formulation optimization, process development, scale-up, troubleshooting, and technology transfer.
  •  You will also interact with company  colleagues and contract laboratories to plan, execute and report pharmacology/toxicology/pharmacokinetics studies.  
  • In addition, you will assist in the preparation of the nonclinical and CMC segments of regulatory filings (IND, NDA, and supplements).   



Responsibilities  
  • Develop preclinical strategies to accelerate development in an efficient manner. 
  • Develop operational plans together with alliance partners, lab team and business development team, including:  
    • realistic timelines 
    • budget and resource planning 
    • risk assessment 
    • contingency planning.   
  • With team members, design laboratory studies, protocols, and evaluations as necessary to support all aspects of pharmaceutical development, including technology transfer. 
  • Determine priorities for laboratory team conducting experiments as part of program development. 
  • Monitor and track projects against approved timelines and milestones, and ensure adherence to agreed-upon objectives and deliverables. 
  • Prepare and lead regular updates and planning meetings with internal teams and alliance partners. 
  • Regularly review program data with team and alliance partners. 
  • Write reports in English for internal, vendor, partner and/or regulatory use. 
  • Oversee activities at CROs for pharmacology, toxicology and pharmacokinetic and drug metabolism studies for assigned projects in compliance with applicable requirements. 
  • Trouble-shoot formulation development, process variability and scale-up related process issues. 
  • Consult scientific literature to resolve issues. 
  • Identify bottlenecks, surface issues, and proactively drive for their resolution. 
  • Lead contingency planning efforts and ad-hoc cross-functional task forces as needed for issue resolution. 
  • Provide accurate forecasting, tracking and adherence to program budget (headcount and external costs.) 
  • Ensure that all project data is accurate, up to date, and accessible on the server. 
  • Oversee lab teams, ensure appropriate training, monitor performance, and provide coaching / skill development. 
  • Represent the development project team on assigned transversal project teams and contribute to the development of overall strategies. 
  • Assist in preparation of preclinical segments of regulatory submissions. 
  • Consolidate and track project termination plans and ensure smooth transition of program to clinical development.  
  


Experience / Education
 
  • Engineering degree (Master’s level) or PhD in chemistry, polymer chemistry, biochemistry and / or 
  • PharmD, ideally with industrial pharmaceutical focus 
  • Significant experience in pharmaceutical development (more than 5 years preferred) 
  • Experience in drug delivery preferred 
  • Demonstrated experience in managing projects 
  • Experience in international and multidisciplinary teams  
  


Competencies
 

Skills 
  • Project management skills:  
    • Ability to accurately estimate time for specific tasks 
    • Ability to plan sequential and / or concurrent activities 
    • Ability to develop and manage budgets 
    • Ability to determine priorities within project plan 
    • Ability to work on several tasks simultaneously   
  • Understanding of ICH guidelines 
  • Knowledge of CMC regulations OR pharmacology, toxicology and pharmacokinetics 
  • Ability to coordinate a multidisciplinary team 
  • Strong interpersonal and communication skills for:  
    • Managing relationships and communication exchanges with alliance partners 
    • Effectively preparing and leading meetings with third-parties in English 
    • Effective international collaboration   
  • Ability to conduct scientific literature research to develop and optimize formulations, solve problems  


 Computer and language
 
  • Fluency in written and oral English 
  • Ability to write and edit scientific reports in English 
  • Proficiency in project management software 
  • Proficiency in MS Office, internet and email  
  


General work attitude
 
  • Effective functioning in a rapidly changing environment and adherence to the values, principles and mission of the company 
  • Consistency, precision, perseverance, listening skills 
  • Openness and ability to adapt to changing situations 
  • Strong team spirit and open sharing of all the information necessary to successfully achieve overall work goals 
  • Desire to continuously improve and progress 
  • Strong work ethic  
  


Work Authorization
 
  • Status that permits working in Europe