Senior Director, Clinical Development

The Senior Director of Clinical Development is a key member of the R&D leadership team and will spearhead the clinical development of Oncology programs, driving strategy and execution of first-in-human, dose-escalation and subsequent clinical trials. The Senior Director of Clinical Development will provide medical leadership to cross-functional teams across Clinical Operations, Regulatory Affairs, Translational Research, and other groups to advance our programs. The role serves as the clinical lead in engagements with FDA and other global agencies and represents the company in strategic partnerships and governance committees. The ideal candidate combines deep scientific and clinical expertise with an entrepreneurial mindset, a track record of innovative trial strategy, and proven leadership in an agile biotech setting.

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

Responsibilities

  • Medical Monitoring: Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).

  • Global Trial Design: Design and implement clinical trial protocols, including innovative dose-escalation schemes and adaptive design elements as appropriate. Ensure protocols meet scientific objectives and regulatory standards.

  • Global Trial Execution: Oversee global trial execution and site activation in collaboration with clinical operations. Monitor trial progress, address operational challenges, and ensure high-quality data collection. Interpret emerging clinical and translational data to identify safety, efficacy, and biomarker signals. Guide cohort expansion and next-step decision-making based on real-time data and pre-defined Go/No-Go criteria. Ensure early development plans are strategically designed to generate the data and insights needed to support a seamless transition into later-phase and potential registrational development.

  • Regulatory Interactions: Lead clinical interactions with health authorities (e.g. FDA, EMA), including preparation of IND/CTA submissions, briefing documents, and regulatory meeting packages. Respond to agency questions and integrate feedback into program strategy.

  • Communication: Identify and clearly communicate progress, risks, challenges, and potential strategic shifts to the Executive Team and other internal decision-making bodies, ensuring timely escalation when needed. 

  • Asset Development Strategy: Opportunity to participate in the development of the overall clinical development strategy for bispecific solid-tumor therapies, from IND filing through Phase 1 proof-of-concept (first-in-human studies) and later phase studies.

Requirements

  • MD or MD/PhD Board-certified/eligible in Oncology or Hematology.

  • A minimum of 5 years experience in oncology drug development, with proven leadership of early-phase (Phase 1) trials in solid tumors. Prior work with cellular therapies or bispecific agents is highly desirable.

  • Demonstrated success leading interactions with FDA and global regulatory agencies (e.g. submitting INDs/CTAs and guiding clinical strategy through review). Regulatory submission experience preferred.

  • Experience managing multi-site, multinational clinical trials and navigating international regulatory environments. Familiarity with ICH/GCP guidelines and global trial logistics.

  • Proven leadership in a biotech or pharmaceutical setting, with the ability to build and inspire high-performing teams.

  • Sophisticated scientific management skills and business judgment with an ability to evaluate alternatives, establish priorities and apply resources effectively.

  • Strategic thinker with a hands-on approach

  • Excellent verbal and written communication skills, including presentation of data to internal and external stakeholders. Track record of publishing or presenting clinical research.

  • Demonstrated ability to thrive in a small, fast-paced company environment. Resourceful problem-solving and ability to pivot strategies in response to new data or business priorities.

  • Travel as needed.

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 is headquartered in Philadelphia

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.