Job Description Summary:

PTC Therapeutics seeks a highly motivated and qualified individual for the position of Associate Director, Clinical Pharmacology. The incumbent works cross-functionally with internal departments and external resources as part of PTC’s drug development teams. He/She in this position will primarily develop and execute clinical pharmacology and pharmacometric strategies across the PTC portfolio, participate in the design of clinical and relevant non-clinical studies, interpret, present and report clinical and non-clinical study results. 

 Job Description:

 Primary duties/responsibilities:

• Act as the lead clinical pharmacologist for multiple clinical stage programs.

• Develop an overarching clinical pharmacology strategy from IND to NDA (or BLA) to support regulatory submissions.

• Predict human PK parameters and exposure profiles using in vitro and animal PK data

• Estimate the maximum recommended starting dose (MRSD) based on toxicology study results for the first time in human trials.

• Implement optimal dose-finding strategies to ensure safe and effective advancement of clinical programs.

• Design and oversee clinical pharmacology studies to evaluate PK in special populations (such as pediatric and geriatric patients or those with renal and hepatic impairments)

• Design clinical drug-drug interaction and food effect studies following regulatory guidance

• Draft investigator’s brochures, eCTD modules, and clinical study protocols in close partnership with clinical operations, medical, regulatory, biostatistics, and medical writing professionals

• Perform PK analysis in non-compartmental model for the drug and/or metabolites

• Perform population PK/PD analysis and integrate this knowledge into the overall clinical development strategies

• Evaluate and select CROs and manage outsourced PK, PK/PD, and exposure-response analyses

* Minimum level of education and years of relevant work experience.

• Ph.D in a scientific discipline OR PharmD with atleast 10 years’ of combined post doctoral and Industry experience. A minimum of 5 years in clinical pharmacology, pharmacokinetics, pharmaceutical sciences or related is required.

* Special knowledge or skills needed and/or licenses or certificates required.

• Highly proficient in NCA PK analysis (such as Phoenix WinNonlin)

• Solid background in drug metabolism and pharmacokinetics.

• Strong understanding of clinical pharmacology concepts.

• Good understanding of formulation and toxicology.

• Familiar with regulatory guidance especially for drug interaction studies.

• Experience managing multiple projects with competing priorities.

• Experience with population PK, and PK/PD modeling software packages (such as Phoenix  NLME and Nonmem).

• Demonstrated experience in writing study reports and regulatory documents.

• Ability to influence without direct authority.

• Excellent verbal and written communication and skills.

• Ability to work independently and collaboratively.

• Analytical thinker with excellent problem-solving skills.

• Excellent management and interpersonal skills.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experiences in oncology and CNS therapeutic areas

• Experiences in multiple modalities (small molecules, biologics, and cell or gene therapies)

• Experience with common PBPK modeling software (such as GastroPlus)

* Travel requirements

Up to 10%. Position is currently remote and will work from South Plainfield in the future.

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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