Director, Clinical Pharmacology

Fore Biotherapeutics US Inc•Philadelphia, PA

10h•$205,000 - $250,000•Remote

About The Position

The Director of Clinical Pharmacology is responsible for the subject matter expertise, operational management, execution of Clinical pharmacology and pharmacokinetics development initiatives for registrational programs in oncology, including Phase 1-3 development, population PK, and model informed drug development. Responsibilities include: the development of Clinical Pharmacology plans, the design, data analysis to characterize PK profile and reporting of clinical pharmacology results, and oversight of modeling and simulation activities (if outsourced) and/or modeling of exposure-response relationships for safety and efficacy in support of dose justifications, decisions, and future study designs. Provide input to global regulatory authority documents, including clinical trial protocols, investigator brochures, regulatory queries, and submission dossiers. Maintain state-of-the-art fluency in emerging clinical pharmacology study design and leveraging modeling and simulation approaches and technologies through awareness of emerging literature and involvement with external training. Routinely present findings both internally and externally, and including publications at scientific/medical congresses and peer-reviewed journals, and supporting the product label. Develop internal working standards and procedures.

Requirements

PharmD or PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics or a related field.
At least 8-10 years of drug development experience (or equivalent) with at least 3 years in clinical pharmacology.
In-depth knowledge of pharmacokinetics and related analysis software programs.
Knowledge of regulatory guidance documents/standards, extensive familiarity with ICH/FDA/EU guidelines for DMPK and experience with regulatory agency interactions
Hands on experience in PK analysis, data visualization, and population PK/PD analysis
Operational experience in clinical pharmacology with experience in vendor/CRO relationships.
Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
Demonstratable ability to operate independently in an entrepreneurial environment
Excellent interpersonal skills and problem solving/decision making skills.
Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
This is a 100% remote position.
Must have a proven track record of successfully working remotely in a regulated industry.
Strong communication skills and the ability to collaborate virtually across departments are essential.
Reliable internet connection and a dedicated, distraction-free workspace are required.

Responsibilities

Accountable for determining scope, design, planning and implementation of program-specific pharmacokinetic studies, including developing or oversight for appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization.
Responsible for interpretation and reporting of clinical pharmacology data including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling as required by the program to aid in dose selection, trial design, and/or program decision-making.
Authoring and reviewing drug development plans and regulatory filings (INDs, NDAs, IBs etc), as the clinical pharmacology subject matter expert for a given product/program.
Developing the overall CPP strategy and supporting regulatory milestones to gain alignment with health authorities and drive execution within the project team accordingly.
Contributing to and reviewing clinical pharmacology-related sections of Statistical Analysis Plans
Responsible for writing or reviewing the reports or the appropriate sections of the following documents: Clinical Study Reports, Investigator Brochures, Population PK and/or Exposure-Response reports. Academic publications, including scientific meeting abstracts and peer-reviewed articles.
Provide support/implementation of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes
Represent Clinical Pharmacology on project and clinical study teams, providing input to program-specific clinical pharmacology study planning and implementation.
Support the safety management team and signal detection/assessment activities, including consideration for exposure-response and ADME as relevant to the safety profile.
Develop and nurture effective, positive, and productive relationships with CROs and cross-functional teams internally (Clinical Development, Biostatistics, Clinical Operations, Regulatory).
Identify and manage consultants and vendors supporting clinical pharmacology studies