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Global Head of R&D
The Global Head of R&D will provide scientific advice to the executive management team, the CEO and the Board to support the strategy of the company. Next to this, he/she will steer, manage and develop the Generic product development programs and oversee the performance of development activities from R&D handover to regulatory approval for US and EU projects. Leading, managing and developing the R&D teams in the corporate offices and the development laboratory will also be part of the responsibilities.
- Work as a strong partner with the CEO, the Management Team, the Board, and external scientific advisors to advice on scientific aspects of proposed business strategies.
- Act as a key member of the product development team and provide high-level strategic advice to the executive management and the business development department to support the strategy as well as day-to-day operational decisions.
- Provide assessment of scientific competency of CDO’s, CRO’s, CMO’s and CTO’s.
- Take an active role and lead the scientific aspects of any activities related to due diligence and acquisition of products, projects, portfolios and other assets.
Process development, implementation, improvement and execution
- Develop and document principles for efficient and balanced development programs for all new projects considering project value, project cost and the current regulatory environment.
- Develop and implement risk-managed fast-tracking development program standards for strategic key projects.
- Develop and implement strategies to optimize the quality of and speed of development projects.
- Ensure scientifically and independent rigorous review of projects at initiation and throughout their course and implement ongoing improvements and refinement of processes to support the performance (time, cost and quality) of projects.
Internal R&D team management
- Undertake direct responsibility of the R&D team and provide strong leadership in organizing the team, workload, laying out roles and responsibilities, training, mentoring, evaluating performance and recruiting according to the company strategy and values.
- Provide day-to-day supervision to the R&D team and provide specific solutions and advice to address challenges and hurdles encountered during the execution of development programs.
- Establish training programs for the R&D team to improve the project efficiency and quality.
- Supervise, coach and mentor new members in the R&D team.
Internal development laboratory supervision
- Ensure that the principles for efficient and balanced development programs are implemented in the laboratory.
- Ensure that the quality of work in the laboratory is in line with company expectations.
- Supervise the laboratory manager in his/her daily function.
Skills and personality
- Scientific degree in chemistry, pharmacy or pharmaceutical technology, level of Ph.D. or higher.
- Minimum 15 years of experience with Generic drug product development for the USA in the fields of formulation, manufacturing process and/or analytical method development of conventional chemical- as well as small-molecule peptide medicines. Broad experience with pharmaceutical forms within the space of liquids (injectables, orals, nasals and ophthalmics).
- Strong skills in chemistry and drug product formulation as well as robust knowledge of manufacturing facilities, manufacturing technologies and equipment, their suitability and limitations.
- A strong scientific track record of delivery of key development milestones, leading to ANDA filings and approvals within the last 2 years.
- Strong analytical skills, good negotiation- and diplomatic skills, enabling and optimistic can-do spirit.
- Strong interpersonal skills, a collaborative and trust enabling working style, a strong track record of mentorship of scientific staff, and an enthusiasm for building partnerships among key stakeholders.
- Change ambassador, networker, result driven, innovative
- Organizational aptitude to build, lead and develop an outstanding team.
- Adaptability, flexibility, independence and resourcefulness to both lead a big vision strategy while also willing to roll-up-sleeves and multi-task in order to thrive in a growing environment.
minimum 10 years
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