Job Type
Full-time
Description
Title: Director or Senior Director, Precision Immunotherapy /Biomarker
This role involves pioneering first-in-class therapeutics that activate the right immune response to promote lifelong protection against cancer. The approach targets the Vß TCR chain to unleash rapid, potent, and long-lasting anti-tumor immune responses safely and effectively. The versatile, proprietary bispecific fusion protein platform selectively delivers the right activation to the right T cell subsets, customizable to patient needs with its tunable properties, with an initial focus on advanced solid tumors and broad applicability beyond.
Role: Director or Senior Director, Precision Immunotherapy /Biomarker
Please note that this is an in-person, in-the-office role with some flexibility.
The Director or Senior Director of Precision Immunotherapy and Biomarker serves a leadership role and is responsible for developing and implementing global novel biomarker and companion diagnostic (CDx) strategies across the portfolio, encompassing related clinical development, regulatory and commercial strategy, technical test evaluation, IP, and business considerations to support the product approval according to agreed deliverables, timelines, and budget. Reporting to the Chief Development Officer, this role collaborates closely with leaders/teams across Discovery, Immunology and Translational Science, and Clinical and Product Development organizations.
Who are we looking for?
- You are energetic and passionate about novel biomarker and companion diagnostic (CDx) strategies professional who likes to think outside of the box, challenge the norm, and is passionate about the company's mission of discovering and developing new medications.
- You are a resourceful self-starter and team player with a strong results orientation.
- You consider yourself a guru in all the critical companion diagnostic strategists for a clinical-stage organization.
- You can develop trusting relationships to gain support and achieve results at all levels of the organization.
What are we looking for?
- A driven professional who knows how to work and contribute to an ever-changing working environment.
- A collegial individual who enjoys working in close collaboration with leaders in the research, development, manufacturing, quality, clinical, and administrative areas of the company.
- A critical thinker who can analyze possibilities and solutions, make pragmatic trade-offs, and a "big picture" innovator who can recognize possibilities.
- A willingness to learn new things, adapt to new ways, and go with the flow.
- A person who thrives in a small company atmosphere.
- Ability to determine task priority and maintain established deadlines.
What are we offering?
- Reporting to the best subject matter in the field with years of experience and depth validated by multiple approvals and commercialization.
- Membership within a growing, CARING, and collegial organization.
- Being part of a passionate, involved, and cutting-edge Finance Team.
- Exposure to pioneering science and the discovery of drugs to help treat patients with cancer.
Requirements
Responsibilities:
- Develop and implement global biomarker and CDx strategies to optimize the design and conduct of clinical trials to support the efficient development and regulatory approval of immunotherapies. These strategies include but are not limited to, selecting the most optimal indication/patient population based on the rationale cutoff of various biomarkers tailored to different disease settings, establishing early signs of efficacy, and evaluating patient or disease factors that correlate with therapeutic responses.
- Participate in project and leadership meetings and lead the CDx strategy to ensure all clinical trial test development and validation milestones align with the clinical development strategy.
- Proactively provide insight into novel ways to incorporate biomarkers into clinical designs while reducing complexity and patient burden.
- Collaborate with internal and external stakeholders and experts and engage regulatory agencies in a timely manner to support the development of biomarker and CDx strategies.
- Partner with Translational Science group to ensure implementation of CDx strategies in early clinical trials and identification of additional CDx approaches from early data generated in phase 1 trials.
- Identify and select potential CDx vendors/partners and provide oversight and delivery of validation of selected CDx assays, ultimately delivering high-quality data from clinical trials on time to obtain regulatory approval.
- Collaborate with clinical operations and sample management to ensure that CDx testing and data generation comply with all regulatory requirements.
- Author, coordinate, and prepare the biomarker-related content of study reports, including authoring, reviewing, or supporting regulatory filings (e.g., biomarker-directed sections of clinical protocols, Investigator's Brochures, and clinical study reports), making project presentations and publications where appropriate.
- Stay current with scientific and precision immunotherapy/biomarker/CDx literature and investigate, create, and develop novel biomarker strategies to advance projects.
- Provide high-level updates and advice to senior management, including evaluating and interpreting precision immunotherapy/biomarker data and their potential impact on programs and clinical/regulatory strategy.
Education and Experience:
- Advanced degree (Ph.D., M.D., M.D./Ph.D., Pharm.D.), with a focus on oncology and 12+ years' experience in Oncology biomarker /CDx and clinical development, preferably in the immune-oncology area.
Other Preferred Skills:
- An advanced understanding of CDx and related biomarkers and application to clinical development of immuno-oncology therapies is an essential requirement.
- Demonstrated track record in biomarker discovery and development (i.e., leading the design, implementation, execution, and interpretation of cancer biomarker studies, including biomarker assay/platform development, validation, and clinical application).
- Track record of successfully managing end-to-end CDx drug development projects, including managing CDx vendors/partners.
- Familiarity with state-of-the-art CDx technologies applicable to cancer biomarkers or immunophenotyping, such as next-generation sequencing, immunohistochemistry, immunofluorescence, flow cytometry, in situ hybridization, gene expression profiling, and digital image analysis.
- Demonstrated working knowledge of design controls, analytical, clinical, and manufacturing process validation requirements for IVDs, GCP, GLP, and GMP requirements; working knowledge of requirements for US and global regulatory submissions related to IVDs for use in clinical trials and commercialization of companion diagnostics.
