Clinical Research Director

Scorpion Therapeutics; Morristown (NJ); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Parental leave 14+ weeks

Job summary

Scorpion Therapeutics in Morristown, NJ, seeks a senior clinical development leader to shape and execute late-stage oncology programs.

You will lead cross-functional teams, author protocols, oversee studies, review regulatory documents, and communicate results to investigators and regulatory bodies.

MD degree with Hematology/Oncology fellowship, 3+ years pharma clinical research experience, and collaboration with external investigators are required.

Qualifications

• MD degree or equivalent.
• Fellowship in Hematology/Oncology or minimum 4 years Oncology Development experience.
• Pharmaceutical medicine expertise with at least 3 years industry or academic clinical research experience.
• Late-stage clinical development experience preferred.
• Ability to work with external investigators and multifunctional teams; regulatory/compliance experience.

Responsibilities

• Establish or adapt clinical development plan with investigators, advisors, and regulators.
• Lead and oversee execution of clinical development and studies.
• Author abbreviated protocols and review amendments.
• Review informed consent forms and trial disclosures.
• Lead study committees with operational support.
• Interpret study results and contribute to reports and summaries.
• Provide clinical guidance to Clinical Operations, Biostatistics, Translational Medicine.
• Contribute to regulatory and safety documents.
• Review/prepare NDA, IND/IMPD, DSUR, risk management plans.
• Prepare advisory committee materials.
• Author abstracts and manuscripts; support advisory board planning.

Skills

Oncology development

Regulatory knowledge

Education

MD degree

Hematology/Oncology fellowship

Job description

Main Responsibilities

• Establish or adapt clinical development plan, including discussions with clinical investigators, advisors, and regulatory authorities; plan contingencies.
• Lead, support, and oversee execution of clinical development and studies, including:
  • Author abbreviated protocols; review final protocols and amendments.
  • Review informed consent form, written subject information, and trial disclosure form.
  • Review study-specific committee charters; lead study-specific committees (with operational support).
  • Lead clinical interpretation of study results; contribute to clinical study reports and clinical summaries.
  • Provide clinical guidance to Clinical Operations, Biostatistics, and Translational Medicine.
• Contribute to regulatory and safety documentation and discussions:
  • Review/contribute clinical sections of Investigator Brochure, IND/IMPD filings, DSUR, and development risk management plans.
  • Contribute clinical sections of NDA/CTD, regulatory meeting briefing packages, PSP/PIP.
  • Participate in Advisory Committee preparation.
• Scientific data evaluation and authorship:
  • Author clinical abstracts, conference presentations, and manuscripts (as appropriate).
  • Support advisory board planning; present/discuss development strategy and clinical results (as appropriate).

Qualifications

• MD degree or equivalent.
• Hematology/Oncology fellowship or minimum 4 years Oncology Development experience.
• Pharmaceutical medicine expertise with at least 3 years industry or academic clinical research experience.
• Late-stage clinical development experience preferred.
• Demonstrated ability to work with external investigators and multifunctional teams; ability to meet regulatory/quality/compliance standards.

Benefits (as stated)

• Well-crafted rewards package; high-quality healthcare and prevention/wellness programs; at least 14 weeks' gender-neutral parental leave.