Executive Director, Translational medicine

The Executive Director of Translational Medicine is responsible for leading all translational and biomarker efforts across Context Therapeutics' T‑cell engager solid tumor portfolio. This role provides strategic and scientific leadership to define the translational vision, ensure biomarker‑driven clinical development, and integrate deep immunologic understanding into program strategy from first‑in‑human through mid‑stage trials.

This individual will serve as the company's senior translational science leader and will partner closely with Clinical, Medical Affairs, Regulatory, and CMC teams to ensure translational excellence and mechanism‑driven insights across the development lifecycle. This position reports directly to the Chief Medical Officer.

This position is based out of our headquarters in Philadelphia, PA with at least 2 days per week in the office.

Responsibilities

 Job Responsibilities include, but are not limited to:

  • Lead end to end translational biomarker strategy for clinical programs, from pre IND through phase 1 and 2 programs, ensuring biomarker driven clinical development aligned to program timelines.

  • Oversee development, validation, and implementation of biomarker assays, including immune monitoring, tumor biology assessments, and patient stratification tools.

  • Collaborate with clinical and medical leads to design and execute clinical trial design and biomarker strategies that advance mechanistic understanding and inform dose optimization and patient selection.

  • Act as the primary translational science lead on cross functional development teams, influencing clinical strategy through biomarker and mechanistic insights with clarity and scientific authority.

  • Lead analysis, interpretation, and integration of multi modal translational datasets, including persistence, anti drug antibodies (ADA), immunohistochemistry (IHC), immune correlates, and pharmacodynamic endpoints.

  • Drive scientific innovation and identify novel biomarker opportunities to support patient stratification, pharmacodynamics, resistance mechanisms, and combination therapy rationale.

  • Prepare and present clear, data driven presentations for internal leadership, key opinion leaders, regulatory authorities, and external collaborators.

  • Manage CROs responsible for assay development and execution, including scope of work, budget planning, audits, quality oversight, and performance management.

  • Oversee central lab operations and biospecimen management, ensuring compliant handling, storage, tracking, and availability of samples for translational analysis.

  • Build and maintain productive relationships with cross functional team members, key opinion leaders, investigators, and external partners, fostering a culture of collaboration, accountability, and scientific rigor.

Requirements

  • PhD, MD, MD/PhD, or equivalent in Immunology, Oncology, Translational Medicine, or related discipline.

  • 10+ years of industry experience in immuno oncology translational medicine, biomarker development, or related fields; experience with T cell engagers, bispecifics, or related immunotherapies for solid tumors strongly preferred.

  • Deep expertise in T cell biology, immune monitoring, tumor biology, and biomarker strategy in clinical immuno oncology programs.

  • Proven track record supporting early clinical trials with patient derived translational insights and demonstrated success driving assay development and validation through CRO partners.

  • Experienced in managing external CROs and vendors, and leading central lab operations and biospecimen management. • Strong working knowledge of GLP/GCP and biomarker related regulatory expectations, including contributions to clinical protocols, investigator brochures (IBs), lab manuals, and clinical study reports (CSRs).

  • Strong data analysis experience with biomarker endpoints and biological datasets, and proficiency with platforms such as R, Prism, or Spotfire.

  • Excellent presentation and communication skills with a demonstrated ability to translate complex data into decisive recommendations and engage internal leadership, investigators, and external stakeholders.

  • Proven leadership in matrixed team environments with the ability to influence without authority and align scientific priorities across cross functional teams.

  • Comfortable operating in a fast moving, collaborative biotech environment.

About Context Therapeutics®

Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody.

Context Therapeutics is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.