PTC Therapeutics, Inc.
Senior Director, Pharmacometrics (Creative Design)
The incumbent works cross-functionally with internal departments and external resources, including but not limited to, PTC clinical, biostatistics, regulatory, medical writing, and discovery research functions, as well as external Contract Research Organizations (CROs). The Senior Director, Pharmacometrics is specifically responsible for performing, coordinating, and overseeing modeling and simulation, PK & PK/PD assessment in patients, interpreting data and providing timely pharmacometrics support to clinical development and regulatory registration.
The Senior Director, Pharmacometrics supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Primary duties/responsibilities:
Establishes pharmacometrics strategies in support of drug development, which align with team goals and meet regulatory requirements (IND and NDA etc.).
Acts as the subject matter expert and/or primary point of contact for outsourcing modeling projects and addressing regulatory queries related to pharmacometrics.
Hands on modeling to support drug development and preclinical PK/PD model.
Represents clinical pharmacology & DMPK on multidisciplinary projects and provides scientific leadership and strategic direction to clinical programs.
Develops and writes relevant documents.
Collaborates closely with the functional groups within clinical pharmacology & DMPK and other stakeholders.
Effectively communicates pharmacometrics data and their relevance to multidisciplinary project teams, management, and regulatory authorities.
Ensures the scientific quality of pharmacometrics data in support of development program.
Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Broad understanding and experience in pharmacometrics, clinical pharmacology, and pharmacokinetics
Proficiency in modeling software, such as WinNonlin, NLME, NONMEM, R, etc.
Expertise in modeling, such as PK/PD, popPK, dose-response, exposure-response, PBPK.
Experience in managing projects.
Demonstrated experience writing study reports and regulatory documents.
Demonstrated leadership ability.
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.
* Minimum level of education and years of relevant work experience.
Ph.D or PharmD in Pharmacokinetics, Pharmaceutical Sciences or related disciplines and a minimum of 12 yrs experience, of which atleast 6 years is in pharmacometrics and model-informed drug development in a pharmaceutical, biotechnology or related environment
* Special knowledge or skills needed and/or licenses or certificates required.
A strong understanding of regulatory guidelines for pharmacometrics to support drug development.
Ability to work with sometimes conflicting priority settings 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%
EEO Statement:
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.
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