The Position
This position can be 100% remote in the US
The Director, Pharmacometrics 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 Pharmacometrics 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 Lead will be the primary author for the description of modeling summaries and provide interpretation thereof in module 2.7.2 for regulatory submissions.
Responsibilities
- Serve as the Pharmacometrics 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 and 2) provides a comprehensive assessment of the pharmacokinetic profile of a given compound, including population pharmacokinetic (PopPK) assessments.
- Develop high-quality modeling and simulation strategy and content: author/review/approve modeling and simulation analysis plans and outputs, interpretation, and presentation of key findings.
- Participate in interactions with Health Authorities, as appropriate.
- Participate in the translational aspects of the strategy and development of the Organon 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.
Required Education, Experience and Skills
- 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 five years of experience in the pharmaceutical or biotech industry with in-depth knowledge of pharmacokinetics, pharmacometrics, and clinical pharmacology.
- Experience using relevant software such as Phoenix, NONMEM, R, SimCYP, Gastroplus, Monolix, Python, MATLAB, or similar platforms.
- Demonstrated technical and scientific knowledge of pharmacokinetics, pharmacometrics, and clinical pharmacology disciplines 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).
Preferred Experience and Skills
- Experience in Women’s Health strongly preferred.
Who We Are:
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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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)
$150,600.00 - $256,300.00
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
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
Requisition ID: R529560
