SVP, Development

The SVP of Development will report directly to our CEO and is responsible for nonclinical functions (Program Management, CMC, Pharmacology, Toxicology, Pharmacokinetics, and Regulatory) to support pipeline advancement from preclinical through potential regulatory approval. The SVP of Development works cross-functionally to develop and drive nonclinical strategy and study execution to support the development and commercialization of our T cell engager-based programs for solid tumors.

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:

  • Develop and execute nonclinical strategy, including CMC, Pharmacology, Toxicology, Pharmacokinetics, and Regulatory

  • Lead study design, execution, completion, and reporting

  • Generate and deliver high quality, timely data packages in compliance with global regulatory requirements

  • Build, manage, mentor, and refine the nonclinical organization

  • Prepare and submit successful briefing packages and investigational and marketing applications

  • Engage with global regulatory agencies to address scientific and regulatory nonclinical issues

  • Ensure global regulatory approval of products with optimized cost-effectiveness, compliance, and risk mitigation/ continency planning

  • Establish and maintain productive relationships with CROs and consultants for design, execution, interpretation, and reporting of nonclinical studies

  • Provide nonclinical development guidance to management on key issues related to nonclinical discovery and development

  • Budget and timelines for nonclinical studies

Requirements

  • MS, MSN, PharmD or PhD in biology, pharmacology, pharmacokinetic or related discipline

  • 15+ years of pharmaceutical/biotech industry experience in nonclinical pharmacology, drug discovery and development

  • Extensive experience in nonclinical study design and execution, global regulatory requirements (eg, FDA, EMA, MHRA, PMDA)

  • Experience in reviewing regulatory documents (IND and NDA/BLA)

  • Working knowledge and experience with CRO vendors and strong relationships within the nonclinical scientific community

  • Leadership, organizational, budgeting and resource management, and project management skills

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.