Head Of Translational Sciences

Outpace Bio is a drug development company reimagining cell function through protein design to make cells the future of medicine. We believe that cells are naturally programmed by evolution to make the wrong decisions in cancer and autoimmune disease, and curative cell therapies will only be achieved by overcoming the default biological mechanisms that limit their efficacy and safety. Led by co-founders of Lyell Immunopharma, our world-class scientific team is developing smart cell therapies that reprogram complex biological processes in ways that small molecules and biologics cannot. We use protein design and synthetic biology to engineer cells to make better decisions inside the patient and to productively engage the endogenous immune system. Our unique partnership model allows us to efficiently explore diverse cell therapy modalities and accelerates clinical validation so that we can bring curative therapies to patients. We value passion for science, innovation, collaboration, inclusion, and respect.

At Outpace Bio, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences. We are committed to building an open, diverse, and inclusive culture for all employees. Recognizing that the best candidates do not always match all criteria of the job description, we encourage you to apply if you think you would be a good fit for the role and are inspired by our mission to cure disease by pushing the boundaries of biology.

Outpace is seeking a highly talented and experienced Head of Translational Science who shares our excitement about our science, is passionate about advancing novel therapeutics, champions our culture and honors our commitment to patients. Reporting to the Chief Development Officer, this is an opportunity for an experienced translational science leader to establish translational capabilities for Outpace and work within a matrix team across clinical and research functions in support of our clinical development activities. This role will require an ability to operate in a fast-paced, highly dynamic environment with partnerships that include both internal and external stakeholders. The successful candidate will leverage emerging translational leanings from our cellular therapy trials to aid our understanding of our Outpace technology platform.

The Head of Translational Science is an experienced leader in drug development in the areas of pharmacology, pharmacokinetics, bioanalytical assay and biomarker development. As an organizational leader, the Head of Translational Science is accountable for overseeing the Translational Sciences department including resourcing, budgeting, organizational design and operations to support the Outpace portfolio and corporate goals. The Head of Translational Science is accountable to provide the strategic direction and operational implementation for Translational Science.

Responsibilities (may include, but are not limited to):

• Leadership:

• Establish Outpace Bio's Translational Science function, balancing resource and capability needs for new and ongoing projects to enable successful and timely progress to data availability and interpretation.

• Oversee an outsourced translational science team that is responsible for: exploratory sample collection. storage and analyses, oversight and management of contract test labs performing GCLP and exploratory based bioassays and managing systems to ensure compliance with documented policies.

• Undertake scientific, administrative and managerial duties that could be reasonably expected of a Head of Department as required.

• Coordinate with the CSO and wider R&D team (as needed) to prioritize resources, timelines and deliverables on key projects ongoing within Translational Science and lab teams.

• Represent Translational Science to potential collaborators/partners as required by Business Development.

Strategic Execution and Planning:Develop and lead focused translational science strategy to incorporate quantitative, objective end points into clinical studies to demonstrate target engagement, pharmacodynamic regulation of pathways of interest, modulation of pharmacologic mechanism and biomarker plans to aid patient selection for cellular therapy products in clinical trials.Create a Translational Science Plan and ensure delivery of translational project milestones in accordance with the project development plan.Collaborate closely with the clinical team on research activities to support indication expansion, patient stratification, mechanism of action studies and asset differentiation.Select, validate, and develop clinical biomarkers and generate biomarker data based on the best available science and technologies to support dose selection (PK/PD), demonstrate proof of mechanism, and define novel mechanisms of resistance.Conduct needs assessments and develop subsequent strategies and plans for any companion diagnostic requirements; ensure integration with larger drug development plans.

Technical Capabilities:Responsibility for validation of biomarkers either through managing relationships with CROs or via delivery from in house Outpace Research and Development teams.Identify pharmacodynamic assays for use in the clinical setting to help define PK/PD/efficacy relationships.Define and execute on the translational elements of plans for Outpace projects including clinical assay development, assays for PK/PD assessment, biomarker strategy and ADA assessment.Lead development of the clinical lab manual and input to clinical protocols to ensure translational science objectives are met.Oversee the process of sample shipment and tracking of human samples.Collaborate with the clinical and data management teams to develop an integrated approach to data management including biomarker data.Contribute to writing and reviewing reports and documents related to the regulatory process including IND submissions and to meetings with regulatory bodies.

Data Generation and Interpretation: Lead the prioritization for sample procurement and use in different assays. Lead primary analyses of translational studies.

Vendor Management: Leverage dependable CRO's and your network of collaborators to generate high quality science, enabling data driven decisions. Identify, establish and manage an external network of third-party vendors and/or collaborators to access and develop required assays, models and capabilities at the right time to fully enable project plans.

Budget Management: In close collaboration with Finance develop the Translational Science aspects of program budget forecasts. Provide oversight of Translational Science with respect to all budgets, contracts, agreements, vendor payments and processes to conduct translational studies in a cost-efficient manner.

Risk Management: Proactively identify potential risks and develop and implement action plans to avoid or mitigate program risks and make appropriate trade-offs of balancing risks with study deliverables, timelines and costs.

Professional Attributes: Build strong, collaborative, and dynamic relationships with co-workers of diverse backgrounds and expertise; ability to function at a high level in a team setting whether leading the group or acting as an individual contributor. Work closely with across matrix organization including Research and Development, Clinical Development, Clinical Operations, CMC, Regulatory Affairs, Quality Assurance, Program Management, and other functional areas to advance pipeline and effectively execute trials in the Clinical Development Plan.

Qualifications-Required:

• 8+ years MD and/or PhD and in a senior translational science role in Immunology, Cancer Biology, Cell Biology, or relevant discipline.

• 5+ years of experience in drug development in industry, oncology drug development a plus; relevant management experience required.

• Proven track record of scientific leadership and achievement in translational science with recent experience in cell therapy or immuno-oncology.

• Demonstrated evidence and knowledge of delivery of target engagement/proof of mechanism assays for use in early clinical trials to support dose selection.

• Previous experience in the design and execution of translational science strategy and plans for oncology projects requiring patient selection.

• In depth understanding of PK/PD/efficacy relationships and an ability to utilize preclinical data to inform clinical studies Creative and innovative leadership with a sharp objective intellect and experience balancing big picture thinking with detailed analysis.

• In-depth knowledge of translational science or early drug discovery, ideally with expertise in cell therapy or T cell biology.

• Highly developed problem solving and risk management skills.

• Ability to multitask, drive, manage, execute and independently deliver results for complex multi-functional projects.

• Familiarity with data management tools and software for analyzing data sets from various assay formats.

• Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical and immunogenicity assay development)

• Understanding of the entire therapeutic development process, including clinical and non-clinical study design, use of immunologic surrogates, assay development and importance of target product profile.

• Ability to execute on plans to tight timelines and ensure delivery.

• Experienced at managing external collaborations/partnerships, as well as mentoring teams/individual scientists in the achievement of project goals.

• Demonstrable track record of successful research supported by publications (peer reviewed publications, oral presentations, posters & patent filings)

• Excellent communication (written and verbal), influencing, and interpersonal skills.

• Passionate, inclusive, open-minded, collaborative and forward-thinking

• Organizational and time-management skills, including demonstrated ability to manage multiple and competing priorities in a fast-paced environment.

• Ability to travel domestically and internationally.

Qualifications-Preferred:

• Experience working with FDA is a plus, specifically as it relates to combined applications for drugs and companion diagnostics.

$220,000 - $260,000 a year

Full Time Employees (and their eligible dependents) may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, and 401k plan. In addition, employees may receive stock option grants to be outlined in their offer of employment. Outpace employees enjoy flexible PTO, paid sick leave which complies with local requirements, and twelve paid holidays throughout the calendar year. Outpace also offers a generous paid parental leave policy to all regular full-time employees.

Outpace Bio is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.

To protect the safety of our employees, Outpace Bio requires all new hires to submit proof of full vaccination (per CDC guidelines) from the COVID-19 virus before commencing employment. Employees can submit requests for medical or religious exemption so that Outpace Bio can consider possible accommodations. An accommodation request must be submitted at the time an offer is extended.