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Position:
Director, Clinical Pharmacology

Employer:
PTC Therapeutics

Description:

Job Description Summary:

 The Director, Clinical Pharmacology leads, and actively contributes to, the development and execution of clinical pharmacology and pharmacometrics strategies across the PTC portfolio; participates in the design of clinical and relevant non-clinical studies; and interprets, presents and reports clinical and non-clinical study results.   


The incumbent works cross-functionally with internal departments and external resources on clinical pharmacology and pharmacometrics related matters as part of PTC’s drug development teams.

The Director, Clinical Pharmacology ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

 Job Description:

 ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

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

  • Leads, and actively contributes to, the development of overarching clinical pharmacology strategies from IND to NDA (or BLA) to support regulatory submissions.

  • Leads the development of, and implements, optimal dose-finding strategies to ensure safe and effective advancement of clinical programs, including FIH dose selection, dose escalation and dose recommendation for the phase II and registration trials.

  • Leads, and actively contributes to the design and execution of clinical pharmacology studies to evaluate PK in special populations. This includes, but may not be limited to, pediatric and geriatric patients or those with renal and hepatic impairments as examples.

  • Leads, and actively contributes to, the design and execution of clinical drug-drug interaction and food effect studies following regulatory guidance.

  • Drafts Investigator’s Brochures (IBs), eCTD modules, and clinical study protocols in close partnership with clinical operations, medical, regulatory, biostatistics, and medical writing professionals.

  • Leads and performs PK analyses in non-compartmental model for the drug and/or metabolites.

  • Contribute to population PK/PD analyses and integrates this knowledge into the overall clinical development strategy(ies).

  • Evaluates and selects Contract Research Organizations (CROs) and manages/actively oversees outsourced PK and PK/PD.

  • Coaches and mentors team members.



Qualifications/Experience:

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

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

  • PhD in a relevant scientific discipline OR a PharmD and a minimum of 8 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education.

 

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

  • Demonstrated understanding or, and experience applying, clinical pharmacology concepts.

  • Familiar with regulatory guidance especially for drug interaction studies.

  • Highly proficient in performing NCA PK analysis.

  • Demonstrated expertise in developing and executing drug metabolism and pharmacokinetics studies.

  • Experience with common PK/PD modeling software packages (such as Phoenix WinNonlin.)

  • Demonstrate understanding of formulation and toxicology.

  • Experience managing multiple projects with competing priorities.

  • 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. 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. 

  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. 

  • 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, NONMEM).

 

* Travel requirements

Up to 10%

 

*Physical requirements (only note if the job requires physical capacity beyond general office work)

Office -based position (some flexibility)

**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.

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.



Location: USA - New Jersey - South Plainfield; USA - California - Mountain View

Contact: https://ptcbio.wd5.myworkdayjobs.com/PTC_Careers/job/USA---New-Jersey---South-Plainfield/Director--Clinical-Pharmacology_R2149

Post Date: 5/13/2022 11:10:48 AM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 10/7/2022; Admin Logon
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