Senior Manager, Clinical Pharmacology

Senior Manager, Clinical Pharmacology ESSENTIAL FUNCTIONS Conduct pharmacokinetics and toxicokinetics analysis to support preclinical and clinical drug discovery and development. Prepare study protocols, scientific reports, and presentations related to preclinical and clinical studies. Assist in developing clinical study and regulatory documents, e.g., protocols, analysis plans, INDs and NDAs. Generate standard operating procedures (SOP) and work instructions. Comply with SOPs and all relevant regulatory guidelines. Manage PK (and PD) analysis software packages (e.g. Phoenix WinNonlin, PK Submit, and relevant packages) and data archiving system (e.g. DS integral). Provide direct support for the operational and project leadership activities as assigned by the manager. Evaluate and select Contract Research Organizations (CROs) and actively oversee outsourced PK, PK/PD, and exposure‑response analyses. KNOWLEDGE/SKILLS/ABILITIES REQUIRED * Minimum level of education and years of relevant work experience. PhD/PharmD in a relevant scientific discipline with a minimum of 5 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education. Hands‑on experience with non‑compartmental (NCA) PK analysis to support preclinical and clinical pharmacokinetic/toxicokinetic studies. Proficiency with PK analysis software packages (such as Phoenix WinNonlin). Demonstrated experience in writing study reports and regulatory documents. Excellent planning, organization and time‑management skills, including the ability to support and prioritize multiple projects. Excellent verbal and written communication skills with the ability to influence without direct authority. 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 management and interpersonal skills. *Special knowledge or skills and/or licenses or certificates preferred. Drug metabolism and bioanalysis experience preferred. Experience in R, DS Integral, and NONMEM are highly preferred. Data‑handling skills and solid understanding of clinical database structures, such as SDTM and ADaM. *Travel requirements 0-10% Expected Base Salary Range: $127,600 - $160,600. The base salary offered will be contingent on assessment of the candidate's education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short‑and long‑term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans. 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. #J-18808-Ljbffr