Director, DMPK and Bioanalysis

at  Pharmaron

POSITION DESCRIPTION:

The Director of Drug Metabolism and Pharmacokinetics (DMPK) and Bioanalysis will oversee the scientific processes involved in conducting and executing in vivo pharmacokinetic (PK) studies, including associated bioanalysis and reporting/interpretation of PK parameters. Responsibilities include providing scientific direction, oversight, and guidance to technical staff supporting in vivo PK and bioanalytical studies. This leadership role entails expanding PK and bioanalytical capabilities to enhance existing services and serving as the technical representative during sales interactions with new and potential clients. To ensure industry relevance, the Director will stay updated on the latest advancements and maintain a comprehensive understanding of state-of-the-art DMPK models to meet industry demands effectively.

Primary responsibilities:

• Lead the delivery of PK and Bioanalytical studies within Pharmaron US Lab Services and grow the revenues for this service category.
• Work with BD and scientific leadership of DMPK to bring in and close new opportunities.
• Strengthen and expand PK and bioanalytical capabilities to grow our client base.
• Help evaluate opportunities as needed for new technology and implement/showcase new scientific initiatives to enhance capabilities.
• Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
• Train and mentor scientific staff.
• Provide senior level review of protocols, reports and related documents for appropriate scientific content and interpretation, in collaboration with other senior staff.
• Oversee and ensure report timelines are maintained and perform scientific reviews to ensure high quality study design and timely reporting.
• Ensure departmental policies, practices and procedures adhere to regulations as they relate to the conduct of preclinical studies.
• Establish harmonized policies and practices to ensure compliance with all applicable regulations and corporate policies.
• Contribute to recruitment of scientists, research associates, and support staff. Interview and participate in the selection of qualified departmental personnel.
• Recommend personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues.
• Prepare and/or approve appropriate personnel action paperwork.
• Monitor performance of direct reports and provide coaching as needed. Prepare and deliver salary and performance reviews. Develop short- and long-range operating objectives, organizational structure, staffing and budgetary requirements. Oversee the development of a departmental plan for backup and succession of key departmental personnel.
• Develop and recommend departmental budget for Management approval. Authorize expenditures in accordance with budget. Approve budget and expenses of subordinates.
• Direct the development and communication of departmental systems, SOPs, policies, and procedures. Partner with Human Resources to develop and approve departmental job descriptions; ensure communication of duties and responsibilities to employees.
• Perform all other related duties as assigned.

QUALIFICATIONS:

• PhD in pharmacokinetics, chemistry, biochemistry, or a related scientific discipline is preferred.
• Minimum of 5 years relevant laboratory experience in a contract research organization (CRO), biotechnology, or pharmaceutical environment.
• 3+ years of management experience, including staff management and development, and financial responsibility.
• Expertise in Bioanalysis across diverse molecule types, proficiency with the LCMS platform, and in the design, conduct, and interpretation of in vivo PK studies is a must.
• Experience with noncompartmental analysis (Phoenix WinNonlin) is required.
• Strong communication skills, attention to detail, and the ability to adapt in a dynamic team environment are essential for success.

• Lead the delivery of PK and Bioanalytical studies within Pharmaron US Lab Services and grow the revenues for this service category.
• Work with BD and scientific leadership of DMPK to bring in and close new opportunities.
• Strengthen and expand PK and bioanalytical capabilities to grow our client base.
• Help evaluate opportunities as needed for new technology and implement/showcase new scientific initiatives to enhance capabilities.
• Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
• Train and mentor scientific staff.
• Provide senior level review of protocols, reports and related documents for appropriate scientific content and interpretation, in collaboration with other senior staff.
• Oversee and ensure report timelines are maintained and perform scientific reviews to ensure high quality study design and timely reporting.
• Ensure departmental policies, practices and procedures adhere to regulations as they relate to the conduct of preclinical studies.
• Establish harmonized policies and practices to ensure compliance with all applicable regulations and corporate policies.
• Contribute to recruitment of scientists, research associates, and support staff. Interview and participate in the selection of qualified departmental personnel.
• Recommend personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues.
• Prepare and/or approve appropriate personnel action paperwork.
• Monitor performance of direct reports and provide coaching as needed. Prepare and deliver salary and performance reviews. Develop short- and long-range operating objectives, organizational structure, staffing and budgetary requirements. Oversee the development of a departmental plan for backup and succession of key departmental personnel.
• Develop and recommend departmental budget for Management approval. Authorize expenditures in accordance with budget. Approve budget and expenses of subordinates.
• Direct the development and communication of departmental systems, SOPs, policies, and procedures. Partner with Human Resources to develop and approve departmental job descriptions; ensure communication of duties and responsibilities to employees.
• Perform all other related duties as assigned