Director, Oncology Bioanalytical Strategy Lead

What you will do

You will be located at one of our research hubs in the US, (Gaithersburg, MD or Boston, MA) where you will work alongside TA leads and stakeholders in CPSS, Translational Medicine, Research and Clinical development. In this role you will interact closely with Bioanalytical leads, CROs, study management, leadership team of iBA, CPSS functional representatives, other key stake holder functions to ensure quality and timely bioanalytical support of projects. This is a highly visible role, and you will be required to leverage your scientific knowledge and expertise, organizational and operational skills, while working with a range of stakeholder, and cross functional groups and gain alignment on strategies and deliverables.

You will need to use your experience and proven track record designing, developing, and delivering robust bioanalytical strategies with a specific focus on scientific oversight and delivery for our Oncology portfolio. You will also work with regulatory agencies and Health Authorities across a range of countries and geographies to mitigate risk, submit regulatory documents and respond to Health Authority questions.

As a Subject Matter Expert, you will be responsible for enhancing the IBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts. As a senior member in the iBA-global oncology strategy team you will be expected to contribute to strategic initiatives aimed at continued evolution and establishment of the department as a scientific leader/strategic partner.

Education/Experience

• Master's in immunology, molecular biology, or related studies with minimum of 10+ years relevant experience; OR
• PhD in immunology, molecular biology, or related studies with minimum of 7+ years relevant experience in Biopharmaceutical industry.

Experienced in serving as a project representative, worked with stakeholders, experienced in drug development process and regulatory filings.

Essential for the role

• Proven experience as a Subject matter Expert in regulated bioanalysis across a range of modalities PK (CK), PD and immunogenicity assessments (humoral and cellular).
• Experienced in regulated bioanalysis, in-depth knowledge of complex biologics and/or bioanalysis of ADCs and related modalities.
• Experienced as a bioanalytical lead in diverse project teams, defining, leading, and implementing robust bioanalytical strategy to advance the portfolio.
• Collaborated with stakeholders, providing solutions to challenges and mitigating risk.
• Skilled scientist able to discern the advantages of a range of analytical techniques such as Ligand binding assays, LC-MS, molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays.
• Experienced in assay transfer, scientific quality, and study conduct at CRO partners, data analysis and interpretation, delivery of preclinical and clinical data to project teams.
• Deep understanding of global regulatory expectations and guidance in relevant areas.
• Contributed to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs and experience in regulatory authority responses across multiple geographies.
• Interpretation of integrated and complicated datasets.
• Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment, ability to prioritize and manage resources.
• Both Line and Matrix management experience, ability to coach and mentor senior bioanalytical leads.
• Background in pharmaceutical clinical trial research.
• Proven publication and presentation record.
• Exceptional verbal and written communication skills.

Desirable for the role

• Radio conjugates, Cell therapy and or small molecule experience is desired.
• Strong scientific background in immunology, ability to support drug programs across multiple therapeutic areas, deeper expertise in flow cytometry.
• Experienced in partnering with operational functions within bioanalysis, clinical operations, external CROs to develop efficient processes for bioanalytical execution.

Benefits

• Qualified Retirement Program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage