PTC Therapeutics, Inc.
Associate Director, Pharmacometrics ( Remote) (Biotech)
Contributes to pharmacometrics strategies in support of drug development, which align with team goals and meet regulatory requirements (IND and NDA etc.).
As assigned, works with external CRO/consultants on outsourced modeling projects and addresses regulatory queries related to pharmacometrics.
Performs hands on modeling to support drug development, preclinical PK/PD model and exploratory analysis.
Represents clinical pharmacology & DMPK on multidisciplinary projects and provides scientific leadership and strategic direction to clinical programs.
Develops and writes relevant documents, specifically clinical pharmacology sections.
Collaborates closely with the functional groups within clinical pharmacology & DMPK and other stakeholders.
Effectively communicates pharmacometrics data and the relevance of this data to multidisciplinary project teams, management, and regulatory authorities as appropriate.
Ensures the scientific quality of pharmacometrics data in support of development program(s).
Performs other tasks and assignments as needed and specified by management.
* Minimum level of education and years of relevant work experience.
Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences, engineering, computer sciences or related disciplines and a minimum of 7 yrs of progressively responsible experience in pharmacometrics and model-informed drug development in a pharmaceutical, biotechnology or related environment OR a Master's degree in these same disciplines and a minimum of 10 years of progressively responsible experience in pharmacometrics and model-informed drug development in these same environments.
* Special knowledge or skills needed and/or licenses or certificates required.
Applied understanding and experience in pharmacometrics, clinical pharmacology, and pharmacokinetics.
Proficiency in modeling software, such as WinNonlin, NLME, NONMEM, R, etc.
Demonstrated ability to perform PK/PD, popPK, dose-response, exposure-response, PBPK and other modeling as may be required.
Experience leading projects.
Demonstrated ability to write study reports and contribute to the writing of regulatory documents.
Demonstrated ability to independently lead projects.
Ability to influence without direct authority.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
A strong understanding of regulatory guidelines for pharmacometrics to support drug development.
Ability to effectively and efficiently navigate conflicting priorities to adhere to project and team timelines.
*Special knowledge or skills and/or licenses or certificates preferred.
Proficient people and project management experience.
* Travel requirements
Up to 10%
**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.