Project Leaders – Pharmaceutical Development - France, United States
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- 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).
- 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
- 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
- Status that permits working in Europe