About Ikena

Ikena Oncology (NASDAQ: IKNA) is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies and has a global strategic collaboration with Bristol Myers Squibb.

Summary

As the Medical Director, Clinical Development you will be a key member of our clinical development team and a major contributor to the development and execution of the clinical strategy for our Targeted and Immuno-oncology programs, providing clinical research support for programs as assigned.

You will collaborate with our management team on significant matters, often requiring the coordination of activities across organizational units, physicians, and external CROs and medical writers.

Your Role

  • You will design, contribute to the authorship and execute protocols in collaboration with scientific staff, medical writing, clinical operations, regulatory leaders, and with CRO partnerships
  • Assist in the preparation of the clinical portions of medical and regulatory documents to support the program including IND submissions, investigator brochures, medical reports, efficacy and safety summaries, background information and clinical study reports
  • Develop and build upon established relationships with outside clinical investigators and oncology key opinion leaders
  • Act as global medical monitor for assigned clinical trials including:
    • Overseeing medical/scientific aspects of assigned clinical trials, including identifying study sites, reviewing of eligibility data, reviewing patient profiles (safety and efficacy) on an ongoing basis, reviewing query generation, working closely with global Clin Ops, PVG, Data Management, Medical Writing, and related functions
    • Provide clinical support to other global clinical trial leads
    • Lead the assembly, review, analysis, and interpretation of study data
  • Work in a matrix environment in support of program development, including working cross-functionally with various disciplines necessary for successful drug development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics, data management, pharmacovigilance, and clinical operations
  • Contribute to the preparation of abstracts, presentations, and manuscripts
  • Act as medical expert representing Ikena when meeting with Health Authorities and academic institutions when required
  • Additional duties and responsibilities as required

Your Background

  •  MD or MD/PhD, with 3+ years’ industry experience in clinical roles required
    • Oncology development experience and Board certification in medical oncology strongly preferred
    • Experience with targeted and immuno-oncology therapeutics in the treatment of solid tumors strongly preferred
  • Team oriented, goal-driven, organized, and highly collaborative
  • Demonstration of analytic ability, interest in applied clinical research, ability to work effectively in multicultural, multifunctional and multinational teams
  • Demonstrated independence, initiative, and ability to thrive in a fast-paced environment
  • Proven experience in developing effective relationships with key investigators and KOLs
  • Proficient knowledge of GCP/ICH, study design, statistics, and clinical operations required
  • Experience writing, editing, and reviewing protocols, informed consent templates, study manuals, conference presentations, and journal publications
  • Excellent written and oral communication skills
  • Flexibility to travel approximately 10% – including visits to investigative sites, regulatory agencies, and attendance at major oncology meetings

Application Form