Job Code: USCD06
Position: PKDM Manager
Department: Clinical Development
Reports to: Executive Director, CMC Project Management & Strategic Alliance
Location: San Diego/Bay Area, California
Connect Biopharma is a global, clinical-stage biopharmaceutical company founded by a team with broad knowledge of the drug discovery industry and expertise in targeting immunological pathways. We are seeking a PK/PD scientist to contribute in a team environment as we leverage diverse analytical tools to characterize factors influencing the absorption, disposition, and pharmacodynamic properties of biologic therapeutics in development as drug candidates. Do you have a passion for identifying and solving scientific issues independently and within teams? Do you have experience with PK/PD or PBPK modeling and a desire to apply these skills to drug discovery and development? We need your skillset on our team.
- Provide PK/PD/Pharmacometrics and scientific leadership to project teams to support the selection of the right dose, patient population, and development strategies.
- Lead and support the preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis and interpretation, and study reports.
- Author relevant INDs, IBs, CTDs and other regulatory documents for development and registration of new drugs and line extensions across multiple geographies. This may involve direct interaction with FDA, EMA, PMDA and other regulatory agencies.
- Function as a project leader and subject matter expert in a multidisciplinary team environment with primary focus on the development of biotechnology therapeutics.
- Interact across groups and teams, regulatory agencies, and functional groups.
- Design, conduct, interpret and report study results.
- Communicate scientific data, both internally and in the scientific community
- Excellent understanding of clinical pharmacology (PK, PD and pharmacometrics) principles.
- Design and complete IND and BLA-enabling studies and reports to support regulatory submissions.
- A team player with critical thinking and demonstrated ability to collaborate and communicate with team members across broad disciplines.
- Specialized in PK/PD modeling and population-based analyses/simulations (hands-on experience for software such as NONMEM, S-PLUS, Clinical Trial Simulator, etc.)
- Excellent interpersonal, scientific, technical, and communication skills that enable effective management and resolution of complex, project-related issues involving multiple functional areas and levels of management.
- Experience in authoring regulatory documentation (IND, IMPD, CTX, etc) and interaction with regulatory authorities.
- D. in Pharmacokinetics/Pharmacodynamics or a related discipline in Pharmaceutical Sciences
- Experience using software such as WinNonlin, NONMEM, R, SimCYP or MATLAB.
- Industry (pharma, biotech, CRO, etc.) experience with PK/PD or PBPK modeling of monoclonal antibodies, peptides/proteins or fusion proteins.
- Understanding of immunoassay
- Experience with drug development and knowledge of regulatory processes.
- Prior experience working in an interdisciplinary team