JOB TITLE: DIRECTOR / SENIOR DIRECTOR CLINICAL PHARMACOLOGY
DEPARTMENT: BIOMARKER & BIOANALYTICAL SCIENCES
LOCATION: SOUTH SAN FRANCISCO, CALIFORNIA / REMOTE
HI-Bio is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. We have a precision medicine approach akin to oncology and grounded in emerging human genetics. Our pipeline is strong and built through in-licensing and discovery. HI-Bio's team is made up of industry experts from science and technology. We are on a path to building the leading immunology company. To accomplish this, we are seeking top talent to join us on our journey.
We are seeking a Director / Senior Director of Clinical Pharmacology who will lead Clinical Pharmacology and Pharmacometrics activities across the portfolio at the program and study level for both ongoing and new studies. The successful candidate will help to build and shape the Clinical Pharmacology capability at HI-Bio by providing strategic and technical guidance to program teams and management.
- Lead the Clinical Pharmacology organization at HI-Bio, and, in partnership with the Vice President, Biomarker & Bioanalytical Sciences, and other key stakeholders, help shape the overall pharmacometrics strategy and infrastructure for the company.
- In collaboration with cross-functional stakeholders, develop, implement, and oversee the necessary Clinical Pharmacology systems, standards, and processes at HI-Bio.
- Lead and provide oversight for external Clinical Pharmacology vendors and/or consultants including evaluations, qualifications, selections, and ongoing monitoring of performance.
- Serve as the Clinical Pharmacology expert and representative in program teams and study teams as well as other forums (e.g. infrastructure, governance, etc).
- Develop, implement, and execute program and project-specific Clinical Pharmacology strategies for therapeutic candidates across all phases of development including pre-IND setting, early development healthy volunteer/FIH studies, pivotal Phase 2/3 studies, NDA/MAA/BLA submissions, and beyond (Phase IV, post marketing).
- Perform PK, population PK, PK/PD modeling, exposure-response analyses and clinical trial simulations in support of regulatory submissions, clinical trial design, and therapeutic dose justification.
- Coordinate and prepare Clinical Pharmacology related sections in all submission relevant documents such as IB, study protocols, study reports, IND dossiers documents, as well as publications.
- Represent Clinical Pharmacology in meetings with health authorities.
- Analyze, interpret, summarize, and present data to internal program teams, management, and external stakeholders including health authorities.
- Partner with bioanalytical team members as well as external suppliers/CROs for the development, transfer, and validation of bioanalytical assays.
- Collaborate with other functions across R&D to optimize non-clinical and clinical study concepts.
- Lead and oversee the progress of Clinical Pharmacology activities on clinical studies, effectively ensuring adherence to appropriate plans, processes, internal procedures, timelines, and budget.
EDUCATION AND QUALIFICATIONS:
- Advanced degree (e.g. Pharm. D., Ph.D., or M.D.) in Clinical Pharmacology, pharmacokinetics, pharmacometrics, pharmaceutical sciences, or a related field.
- At least 8 years of industry drug development experience in Clinical Pharmacology and/or a related function/role.
- Strong expertise in Clinical Pharmacology comprising PK, Immunogenicity, and related bioanalytics as well as PK/PD model-based drug development demonstrated by major regulatory filing experience (e.g. INDs, CTDs, NDAs).
- Proven ability to manage strategic, scientific, and operational aspects of development projects from a Clinical Pharmacology perspective.
- Capable of working independently with excellent communication and organizational skills.
- Ability to closely interact with other Biomarker and Bioanalytical Sciences team members as well as cross-functional development teams and HI-Bio management.
- Experience in biologic therapeutics and immunology/autoimmune disease preferred.
HI-Bio, Inc. is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all employees.
HI-Bio Inc. does not accept unsolicited resumes from any agency that we have not directly engaged on a specific role. Our managers and employees will not accept resumes sent directly from any agency/3rd party. Unsolicited resumes sent to HI-Bio, Inc. from recruiters do not constitute any type of relationship between the recruiter and/or recruiting agency and HI-Bio, Inc. and do not obligate HI-Bio, Inc. to pay fees should we hire from those resumes.