At DiCE Molecules, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
Director, Clinical Pharmacology
MAIN PURPOSE OF POSITION:
The Director of Clinical Pharmacology will report to the CMO and work as part of our Research and Development team that is responsible for selecting indications, drug development, and undertaking controlled experiment and trials. This role will be instrumental in leading the planning, implementation, and analysis of pre-clinical and clinical pharmacology data as they relate to product development and research.
MAIN DUTIES AND RESPONSIBILITIES:
- Analyse and interpret preclinical and clinical PK data to inform dose selection and regimens in subsequent clinical trials
- Provide clinical pharmacology expertise and input into project teams and related documents including clinical development plans, protocols and amendments, Investigator Brochures, SOPs, case report forms, study reports, manuscripts, summaries for regulatory authorities, INDs, NDAs and sNDAs
- Plan, design, and direct phase 1 clinical pharmacology studies (e.g, DDI, BA/BE studies, etc.) and clinical pharmacology elements in efficacy/safety trials
- Facilitate selection of, negotiation with, and supervision of CROs/academic sites
- Build and lead the clinical pharmacology department as the company grows
- Perform literature reviews, write position papers, and prepare abstracts and manuscripts for scientific publications and proactively study relevant scientific literature
- PhD in Pharmacology or its relevant subjects; Biology, Physiology, Toxicology, Biochemistry, Biomedical sciences, etc.
- 10+ years of industry experience
- 5+ years in progressive leadership roles and building a team
- Strong understanding of nonclinical and clinical pharmacokinetic concepts and methodologies (small molecule experience preferred)
- Experience in Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches with a focus on Physiologically Based Pharmacokinetic (PBPK) modeling to inform clinical study designs for drug-drug interaction, special population, ethnic sensitivity, pediatric and biopharmaceutics studies. Expert knowledge of commonly used software for PBPK modeling required.
- Experience with development of PK and PK/PD strategies, PK/PD data analysis, interpretation, and reporting of PK and PK/PD data from clinical studies. Experience in designing strategic integrated clinical pharmacology & modeling simulation plans in support of development of small molecules.
- Experience in leading the design and execution of clinical pharmacology studies including bioequivalence, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels would be a plus.
- Established track record of Model Based Drug Development.
- Established track record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.
- Strong communication skills (verbal and written) and presentation skills are required
- Enthusiastic individual contributor with superior problem-solving, analytical and organizational skills
- Possess an entrepreneurial spirit and able to work in a dynamic environment with good interpersonal skills to inspire other functional contributors
- Proactive, energetic, flexible, hardworking and focused
- Promotes positive work environment and sets highest standards for business ethics and integrity
- Ability to multi-task, manage timelines, and adapt to rapid change
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.