What are the responsibilities and job description for the Director, Biopharmaceutics position at MSD Malaysia?
Director, Biopharmaceutics
Apply remote type Not Applicable locations USA - New Jersey - Rahway time type Full time posted on Posted Yesterday time left to apply End Date : January 31, 2025 (27 days left to apply) job requisition id R310271
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.
The successful candidate :
- Should have a vision to develop a team, demonstrated leadership skills, biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory environment.
- Will be responsible for sub-functional strategic planning, coordinating, and execution of initiatives supporting the interfaces between the biopharmaceutics team and various discovery and development departments.
- Will need to collaborate in a fast-paced, integrated, multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impact.
- Proactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and / or biologics, conducting hypothesis-based assessment employing a rigorous integrated approach, driving the development of in vitro-in vivo relationships and preclinical-to-clinical translation in bioperformance of formulations.
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, step across boundaries and resource programs in a phase-appropriate manner. The incumbent will be responsible for the recruiting, appraisal, and development of personnel under her / his supervision to their full potential. The Director selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under her / his direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary. The candidate will also have a proven track record of developing talent from a diverse scientific background and will have the ability to advance our commitment to a diverse and inclusive work environment. Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence and compliance mindset.
Essential Knowledge, Duties & Responsibilities for the Director Include :
Qualifications : Education :
Required :
Preferred Experience and Skills :
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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