- Serve as the Pharmacometrics & Biopharmaceutics Lead on early clinical development programs and work in close collaboration with ADTs to develop and implement early clinical development plans that 1) incorporate model-informed drug development (MIDD) approaches and leverage principles of exposure-response to optimize dose selection and confirmation of the therapeutic dose, 2) ensures optimal formulation development through assessment of pharmacokinetic performance, 3) provides a comprehensive assessment of the pharmacokinetic profile of a given compound, including population pharmacokinetic (PopPK) assessment.
- Provide support for biowaiver and/or assessment of bioequivalence requirements for formulation or manufacturing site changes for the established brands.
- Identify formulation-related considerations for due diligence efforts.
- Ensure the appropriate bioanalytical vendors are selected to support development plans and that bioanalytical methods and reporting are consistent with regulatory requirements.
- Contribute to scientific communication and events.
- As needed, contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other cross-functional activities.
- Participate in interactions with Health Authorities, as appropriate.
- Responsible for translational aspects of the strategy and development of the Organon WH product portfolio, in line with Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and relevant Organon Standard Operating Procedures (SOPs).
- Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed.
- PhD or equivalent degree in pharmaceutics or related sciences.
- Exemplifies leadership qualities including effective communication and collaboration, integrity, and respectful interactions with Organon personnel.
- Excellent organizational and interpersonal skills.
- Ability to process and articulate complex ideas in a manner that can be clearly communicated to less technically trained individuals.
- Ability to prioritize and focus on important data and considerations to drive results and provide solution-oriented recommendations with an appropriate scientific rationale to address development challenges.
- Ability to connect seemingly disparate datum or concepts to provide development insights and facilitate strategic planning.
- A minimum of 5 years of experience in the pharmaceutical or biotech industry with in-depth knowledge of pharmacokinetics, pharmacometrics, biopharmaceutics, bioanalytics and clinical pharmacology.
- Demonstrated technical and scientific knowledge of pharmacokinetics, pharmacometrics, formulation development and biopharmaceutics, bioanalytical method development and validation and clinical pharmacology a discipline to facilitate clinical development of drug candidates or in the assessment of business development opportunities.
- Working knowledge of early clinical development and clinical pharmacology-, modeling- and bioanalytical-related regulatory guidelines and GxP requirements.
- Regulatory experience including the preparation of clinical submission modules and product labels with first-hand experience with agency interactions (meetings, briefing books and response documents).
- Experience with management and oversight of vendors responsible for supporting various outsourced research activities.
- Experience in working in project teams (preferably global).
- Experience in Women's Health strongly preferred.
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Director, Pharmacometrics and Biopharmaceutics Lead - Jersey City, United States - Organon
Description
Job DescriptionThe Position
The Director, Pharmacometrics & Biopharmaceutics Lead is responsible for devising the program-level modeling and simulation strategy and providing oversight thereof. The responsibility includes identification of the appropriate modeling vendors (fit-for-purpose) and serving as the point of contact, working with procurement and vendor management to facilitate contracting and onboarding of modeling vendors, providing oversight of the modeling process and coordinating appropriate cross-functional discussions, and review of the technical aspects of modeling efforts and modeling reports. The Director, Pharmacometrics & Biopharmaceutics also will have responsibility for ensuring that bioanalytical aspects supporting nonclinical and clinical studies are in place. This entails ensuring that the appropriate bioanalytical vendors are employed and managed, and the technical aspects of bioanalytical methods and validation are compliant with current regulatory standards and reporting. In addition, the Director, Pharmacometrics & Biopharmaceutics will provide formulation-related expertise for the established brands, diligence efforts and for early development pipeline assets. This includes preparation of healthy authority biowaiver requests for manufacturing site changes or active pharmaceutical ingredient or excipient supply source changes and/or assessment of associated bioequivalence requirements for the established brands.
The Pharmacometrics & Biopharmaceutics Lead will also be responsible for contributing to and reviewing clinical modules for regulatory submissions, contribute the authoring and review of Investigator Brochures, INDs, briefing books and other regulatory documents, as applicable. The Pharmacometrics & Biopharmaceutics Lead will be the primary author for module 2.7.1 for regulatory submissions and author the description of modeling summaries and provide interpretation thereof in module 2.7.2 for regulatory submissions.
Responsibilities
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
US and PR Residents Only
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For more information about personal rights under Equal Employment Opportunity, visit:
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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.
Search Firm Representatives Please Read Carefully
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Annualized Salary Range (US)
$150, $256,300.00
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
