Job Description

My client is a clinical stage biotechnology company focused on delivering transformational therapies for patients with serious, genetically defined diseases. We differentiate ourselves through our proprietary chemistry platform that is enabling us to develop 1^st in class therapeutics for potential treatments in rare diseases.

Overview

My client is seeking a creative, resourceful and motivated Senior Director of DMPK and Clinical Pharmacology to lead the design, planning and execution of DMPK and clinical pharmacology studies.  This individual will be responsible for all aspects of DMPK and clinical pharmacology strategies spanning from early development (pre-IND) through late stage-development (Phase 3, filings worldwide, and lifecycle management). The individual will be a recognized subject matter expert in the field of DMPK and clinical pharmacology who can interpret PK/PD data and integrate PK, PD, safety, and efficacy data to ensure that appropriate dose and schedule decisions are made using model and simulation strategies. The candidate will represent the department at cross-functional team meetings, working in close collaboration with colleagues responsible for Regulatory, Toxicology, Bioanalytical, Biomarker, Data Science, and Clinical Operations.

RESPONSIBILITIES

• Responsible for the design, planning, and oversight, as well as the analysis, interpretation and reporting of results of Clinical Pharmacology and DMPK studies, including but not limited to drug-drug interaction, bioavailability, human ADME, bioequivalence, biosimilar, renal and hepatic impairment studies.
• Responsible for the preparation of documentation relating to clinical pharmacology (e.g. clinical pharmacology protocols, study reports, regulatory documents such as IBs, INDs, briefing packages for regulatory meetings and major sections of regulatory filings), and negotiation with Health Authorities worldwide regarding clinical pharmacology issues.
• DMPK and Clinical Pharmacology representative on clinical study and program teams and works in close collaboration with multidisciplinary team to progress drug candidates from R2D transition through preclinical and clinical development to successful approval.
• Interfaces with discovery research colleagues during pre-clinical stages of development to plan and ensure sufficient PK/PD knowledge exists for translation to clinic, including dose selection/rationale for phase I/first-in-human studies.
• Manages bioanalysis of drug concentration in animal and clinical samples.
• Responsible for anti-drug antibody strategy (ADA).
• Applies scientific knowledge and experience to cover a breadth of areas including the design, execution, and interpretation of ADME, CYP inhibition/induction, transporter, PK/PD and clinical pharmacology studies and prediction of human pharmacokinetics.
• Applies quantitative skills to support model-based drug development and address complex issues via modeling and simulation.
• Responsible for DMPK and clinical pharmacology contributions to regulatory documents and responses.
• Understands and effectively applies appropriate regulatory guidelines to drug development.

EDUCATION/EXPERIENCE

• PhD, Pharm D or equivalent in clinical pharmacology, pharmacokinetics, pharmacometrics or a related field with more than 10 years of relevant industry experience
• An outstanding track record of aptitude/problem solving in the field of DMPK and clinical pharmacology
• Experience designing phase I studies such as drug-drug interaction, bioavailability, human ADME, bioequivalence, biosimilar, renal and hepatic impairment
• Experience with PK/PD modeling and simulation is a must
• Prior experience in industry exploring or utilizing oligonucleotide synthesis is preferred 
• Experience working within a start-up or small biotech business environment is preferred

KEY SKILLS

• Demonstrates a sound knowledge of DMPK, clinical pharmacology and PK/PD principles
• Proficient in PK modeling software/platforms including, but not limited to, NONMEM, R and population PK/PD modeling
• Adept at presentation of clear and accurate reports for internal and external projects
• Ability to innovate and think creatively to support development activities and drug development process
• Capacity to work flexibly and efficiently in a dynamic, fast-paced work environment
• Collaborative and self-motivated team player
• Effective communication and interpersonal skills

To Apply

To apply for this role, please contact me, Christian or my senior colleague, Matt, on +1-908-332-9157 or send a full CV to Christian@AdvTalent.com and we will reply by return.

ADV Talent will help you each step of the way and know the stakeholders and line manager well and help you show you how to display your capabilities and strengths to your own benefit!