Job Description

Our client, IntegerBio , is an early-stage biotech company based in Gaithersburg, Maryland, the center of the BioHealth Capital Region, just outside Washington, D.C.

IntegerBio is driven by a commitment to scientific excellence and our core values to Create Possibilities, Operate with Care & Candor, and Execute Purposefully. Led by industry veterans, we are a highly collaborative team focused on advancing our lead asset into the clinic, with a shared passion for transforming scientific innovation into meaningful outcomes. If you’re inspired by bold science, purposeful execution, and working in an environment where teamwork and transparency thrive, we’d love to hear from you. Come join us and do the best work of your life.

The Opportunity: Integer is seeking a scientific leader in translational science with industry experience to advance the development of our programs through research into clinical development. This successful candidate has demonstrated skills in developing and executing translational science strategy, partnering with internal colleagues and managing out-sourced translational research handled by CROs to support clinical development efforts. This leadership opportunity requires proven competence in core translational science domains (biomarker discovery, PK/PD and efficacy endpoints). The incumbent will be a key contributor to regulatory documents and collaborate and support clinical trial design.

Required education and experience:

• PhD in Virology or Immunology or related field, with 10+ years relevant experience (including most recently at least 5 years in industry) and strong publication record

Reports to Chief Scientific Officer

Responsibilities:

Lead Translational Science Strategy

• Develop and Execute Translational Strategy: Collaborate with the scientific and clinical teams to design and implement a translational strategy for our portfolio of immunovirology assets, with a focus on advancing our lead program into clinical stages. Provide guidance on prioritizing translational projects, focusing resources on those with the highest potential for clinical success. Determine which translational studies to run with a CRO and which to do in house if any.
• Pre-IND Planning: Oversee planning and execution of all translational work needed for the IND application, ensuring alignment with regulatory guidelines.
• Cross-functional Collaboration: Act as a bridge between research and clinical development, working closely with colleagues and consultants in virology, immunology pharmacology, toxicology, and clinical development and operations to ensure alignment and readiness for clinical progression
• Biomarker Discovery and Validation: Lead efforts in identifying and validating biomarkers for patient selection, efficacy (both predicting and measuring), and safety. Ensure biomarker strategy is integrated into clinical trial design and supports clinical endpoints. Engage with CROs and other partners for biomarker analysis, bioinformatics, and patient sample analysis
• Pharmacokinetics and Pharmacodynamics (PK/PD): Direct preclinical PK/PD studies to establish dose ranges and bioavailability for candidate therapies, ensuring that data supports dosing rationale for IND filing.
• Model Development: Contribute to development and characterization of disease models to understand therapeutic mechanisms and support preclinical proof-of-concept studies.
• Data Analysis and Interpretation: Review, interpret, and communicate preclinical and translational data to stakeholders, including executives and investors, to inform decision-making.

Regulatory Engagement and Compliance

• Regulatory Submission Support: Prepare scientific data packages for regulatory submissions, including study reports, data summaries, and scientific rationales to support the IND application.
• Regulatory Filings: Collaborate on development and submission of preclinical data packages to meet IND requirements, including writing, reviewing, and overseeing the preparation of regulatory documents.
• Interactions with Health Authorities: Participate in interactions with regulatory agencies (e.g., FDA pre-IND meetings) to present and defend the translational strategy and data supporting clinical development.
• Compliance and Quality Standards: Ensure that translational research meets all regulatory, ethical, and quality standards necessary for clinical trial approval.

Clinical Development and Trial Design Input

• Trial Design and Biomarker Integration: Collaborate with clinical teams to inform clinical trial design, focusing on the inclusion of biomarkers, endpoints, and translational hypotheses that address the mechanism of action and patient outcomes. Ensure appropriate primary, secondary and exploratory endpoints.
• Patient Selection Strategy: Contribute to the development of patient stratification and inclusion/exclusion criteria based on biomarker data, target engagement, or disease models.
• Support Clinical Trials: Provide translational insights for the initial clinical trial phases, advising on data interpretation, biomarker readouts, and adjustments to improve clinical efficacy. Provide insights on bioinformatics and data management for analyses associated with clinical studies.

Technical Competencies

• Design, develop and validate key translational assays to support clinical trials
• Bio-marker discovery and validation
• Early Clinical Trial Design and Biomarker Integration
• Pharmacokinetics and Pharmacodynamics
• Disease Model Development
• Patient Selection
• Data Analysis and Interpretation
• Regulatory Submissions
• Engagement with Regulatory agencies

Professional and Management Competencies

• Ability to work cross functionally in a team-oriented environment
• Skilled project manager
• Skilled in mentoring, coaching and managing others
• Ability to manage Clinical Research organizations to deliver complex projects that are scientifically excellent, on-time, on-budget while maintaining all quality and compliance requirements
• Excellent written and communication skills

Work environment and physical demands: This is an office-based position. Standing/sitting at a desk for the majority of the day with breaks as needed, heavy lifting is not expected/required.

FLSA Classification Exempt

Salary Range - Director, Translational Science $147,707 – $243,670

Individual base pay depends on various factors, including for example, an applicant’s education, experience, skills, and abilities, as well as internal equity and market data. The salary may also be adjusted based on applicant’s geographic location. This role is eligible for additional incentive compensation, including merit increases, annual bonus (depending on individual and company performance) and a new hire equity grant. Benefits include paid vacation and holidays; paid sick leave; health benefits including medical, prescription drug, dental, and vision coverage. Employees are eligible for these benefits on their first day of employment.

IntegerBio is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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