Director, Pharmacometrics

Director, Pharmacometrics
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.
This includes identification of appropriate modeling vendors 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, coordinating appropriate cross-functional discussions, and reviewing the technical aspects of modeling efforts and reports.
The Pharmacometrics Lead will also contribute to and review clinical modules for regulatory submissions, author and review 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 in module 2.7.2 for regulatory submissions.
Responsibilities
Serve as the Pharmacometrics Lead on early clinical development programs and work closely with ADTs to develop and implement early clinical development plans that incorporate model-informed drug development (MIDD) approaches and leverage principles of exposure-response to optimize dose selection and confirmation of the therapeutic dose, providing 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 data or concepts to provide development insights and facilitate strategic planning.
A minimum of 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.
Our Vision is clear:
A better and healthier every day for every woman.
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.
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
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Not applicable
Travel Requirements:
Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Number of Openings:
1
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