JOB TITLE: Program Team Lead
DEPARTMENT: Portfolio Strategy & Management
LOCATION: South San Francisco, California
TYPE: Full-Time (Onsite / Hybrid)
HI-Bio, Inc. 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. We have a precision medicine approach akin to oncology and grounded in 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 clinical development. 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.
HI-Bio is seeking an accomplished leader to steer our lead program, felzartamab, in late-stage development. This highly critical role will provide leadership to felzartamab and will lead the program through late-stage development and regulatory interactions and submissions. Felzartamab is a monoclonal anti-CD38 antibody in development across a number of autoantibody-driven immune-mediated diseases, including primary membranous nephropathy (PMN), IgA nephropathy (IgAN), antibody-mediated rejection (AMR) and lupus nephritis (LN). As Program Team Lead for Felzartamab, this person will oversee strategy and execution for the asset across all indications.
This individual will play an integral role in building and leading efficient and collaborative cross-functional teams to achieve program goals. This is a critical and highly visible role, making a substantial contribution to the company. This position will report into the Portfolio Strategy & Management lead.
- Develop, maintain and drive planning to help deliver on felzartamab’s pipeline-in-a-product potential collaboratively with other relevant functional teams and with support from program management
- Work with company leadership to set direction and goals for the program and apply keen business strategy to manage multiple indications and make key tradeoff decisions
- Lead and coordinate the program core team, create and develop the program strategy and plan, including prioritization
- Development timelines, aid in budget and resource planning, and drive risk assessment and contingency plans
- Work effectively across a matrixed team to deliver program goals
- Generate/review components of key documents in support of regulatory submissions
- Be accountable for the quality of the teams’ output, consistently driving to generate the highest quality with the highest integrity in order to enable clear decision making for the company
- Co-author and ensure quality of all key clinical documents (e.g., CSRs, Integrated Safety Summary, Integrated Efficacy Summary, Clinical Overview, etc)
- Drive decision-making and resolution of issues within the team and through the company governance process
- Analyze and interpret data expertly together with clinical and biometrics teams, and clearly communicate results both internally and externally
- Anticipate internal and external drivers of change
- Challenge assumptions, timelines and expenses at the program level; pressure test plans; and create alternative scenarios to enable strategic and operational agility
- Integrate team activities to enhance program value, together with portfolio strategy, market planning, operations, finance and company management to drive scenario planning and articulation of alternatives to aid effective decision making
- As needed, from time-to-time act as spokesperson for the program and represent program internally and externally
- Identify bottlenecks, surfaces issues, and proactively drive for their resolution, and leads contingency planning efforts
- Manage timely escalation of key issues
EDUCATION AND QUALIFICATIONS:
- MD, PhD or MD/PhD with demonstrated experience developing antibody therapeutics in early and late stage clinical trials; experience driving immunology and/or nephrology programs is a plus
- Expertise in successful drug development and at least 5 years of industry experience
- Demonstrated experience in authoring and reviewing clinical study documents in support of regulatory submissions, in support of major regulatory submissions (eg, NDA, BLA)
- Advanced knowledge and experience in Late Development, ranging from protocol design - through execution of pivotal registrational studies in nephrology and/or immunology
- Strong decision-making skills and highly organized
- Excellent leadership skills and proven ability to effectively work in a cross-functional/matrix environment
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.