Job Description
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to identify and isolate a molecule that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics understanding of how formulation impacts exposure of compounds in humans spanning the oral and non-oral portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and execute a comprehensive biopharmaceutics strategy that leverages cutting edge in vitro, in vivo and in silico physiologically based pharmacokinetics (PBPK) and PK modeling tools, while advancing the underlying biopharmaceutics science within the organization and the external scientific community.
Key Responsibilities:
- Develop a team with demonstrated leadership skills, biopharmaceutics technical & domain expertise, and effective communication skills.
- Responsible for sub-functional strategic planning, coordinating, and execution of initiatives supporting the interfaces between the biopharmaceutics team and various discovery and development departments.
- Collaborate in a fast-paced, integrated, multidisciplinary team environment with key stakeholders.
- Proactively identify key biopharmaceutics risks at each stage of drug product development.
The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists. The successful candidate will effectively partner with Biologics and Biopharmaceutics leadership and extended leadership teams to implement strategy, conduct scientific research, and resource programs in a phase appropriate manner. The incumbent will be responsible for the recruiting, appraisal, and development of personnel under their supervision to their full potential. The Director selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under their direction within the framework of Company policy.
Essential Knowledge, Duties & Responsibilities for the Director Include:
- Biopharmaceutics expertise supporting delivery of small molecule, peptides and biologic modalities.
- Review and approval of data and technical documents.
- Ability to recruit, select, develop, and mentor talent.
- Strategic and critical thinking to advance biopharmaceutics strategy across the portfolio.
- Project management skills.
- Attention to technical detail.
- Build collaborations across internal departments and key stakeholders.
- Manage the departmental budget.
Qualifications:
- Ph.D. in relevant field with minimum of 10 years of industrial experience or a B.S. or M.S. with minimum of 12 years of industrial experience.
- Advanced knowledge in pharmacokinetics and understanding of principles of physiologically-based pharmacokinetic modeling.
- Experience with regulatory submissions including writing / review of regulatory filings.
- Strong influencing and communication skills.
- Demonstrated self-motivation to take ownership and accountability of issues.
- A track record of scientific publications in the field.
Preferred Experience and Skills:
- Hands-on experience with PBPK modeling software is highly desired.
- Experience in regulatory compliance expectations across all phases of product development.
- Demonstrated leadership skills and organization design.
- Ability to engage and align other stakeholders outside the project team.
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