Executive Director, Clinical Sciences

This individual will manage a team of clinical scientists who play an important role in clinical development programs by contributing to the design, data collection, and reporting of clinical studies in a manner consistent with industry standards, applicable regulations and clinical development strategy. They may also be an individual contributor on one or more projects. This position assembles, interprets, and presents scientific and medical data.

• Lead, develop and manage a highly functional, productive, collaborative team of clinical scientists to ensure efficiency, quality, consistency and the achievement of timely deliverables across the programs, including but not limited to:
  • Create and train on standardized clinical science working processes.
  • Establish cross‑functional collaboration with medical directors, clinical & development operations, medical affairs, regulatory affairs, research, corporate affairs, commercial, external physicians, expert consultants, and contracted vendors.
  • Support medical directors in generation of strategic clinical development plans (literature/data review/advisor input)
  • Play a leadership role in the design of Phase 1‑4 clinical studies.
  • Own and manage the generation and drafting of protocols, protocol amendments, IBs, CSRs, clinical regulatory submissions, etc., partnering with a cross‑functional team, including but not limited to research, clinical & development operations and regulatory.
  • Lead clinical science contributions to BLA submission, including drafting content.
  • Oversee the review, analysis, and reporting of clinical data in collaboration with medical directors to enable internal decision‑making and regulatory filings.
  • Partner with cross‑functional groups to map out clinical and regulatory strategies. Provide input into statistical analysis plans and data displays in accordance with regulatory and strategic objectives.
  • Ensure data collection is consistent with/supportive of protocol and analysis plans.
  • Contribute to data cleaning efforts by performing clinical data reviews and providing training feedback to the Clinical Operations Team; provide guidance for issues that may impact clinical trials data generation, collection, and analysis.
  • Participate in planning for interim data analyses and reviews, including Data Monitoring Committee (DMC) meetings.
  • In collaboration with regulatory colleagues, compile submissions including clinical data summaries/analyses, such as briefing packages.
  • Own the development of Celldex scientific clinical presentations & publications (message development, message integration, content drafting, layout, internal and external review process, submission and speaker preparation), including but not limited to abstracts, presentations at medical/scientific meetings and manuscripts.
  • Hire, onboard, train, manage, and develop clinical scientist team
    • Manage clinical scientist resourcing across programs
  • Assume responsibility for individual deliverables as needed.

• MS/MA degree or equivalent in a scientific or health care field required. PhD’s preferred.
• 5–10 years of experience in a clinical research setting, including medical writing, protocol development, and oversight of (or close collaboration with) data management/analysis/reporting functions.
• Extensive experience authoring clinical protocols, regulatory documents (IND sections, clinical study reports, investigator brochures), as well as scientific publication and presentations.
• Experience with preparation of BLA.
• At least 4 years of experience in immunology & inflammation preferred.
• Demonstrated experience designing and executing clinical trials in all phases of clinical development, (Phase 1‑3, post‑marketing).
• Proven ability to design and execute clinical development plans and interpret data for decision‑making and external communication.
• Strong knowledge of GCP and the end‑to‑end drug development process, including nonclinical, CMC, regulatory, pharmacovigilance, data management and clinical operations.
• Experience recruiting, training, mentoring, managing and leading highly functional, productive teams.
• Strategic thinker with an execution‑focused mindset, well suited…