Calithera is focused on discovering and developing small molecule drugs that slow tumor growth through controlling key metabolic pathways in the tumor and immune cells.
Tumor metabolism and tumor immunology are promising new interrelated fields for cancer drug discovery. Recent clinical successes have demonstrated the potential to slow abnormal cell growth and create fundamentally new therapies for cancer patients. Our investigational onco-metabolism medicines take advantage of the specific metabolic requirements of tumor cells and cancer-fighting immune cells.
Duties and Responsibilities
- Assist in the development and design of clinical protocols that meet appropriate scientific, regulatory, clinical and operational goals of the study in collaboration with other members of the project team and clinical investigators.
- Lead the authorship of clinical protocols and contribute to the development of case report forms that will provide adequate efficacy and safety information for clinical trials (Phase 1, 2 and 3).
- Provide input for pharmacokinetics and correlative science studies.
- Recruit, screen and select appropriate clinical investigators.
- Participate in investigator conference calls for clinical trials; maintain medical and scientific relationships with investigators in ongoing clinical studies.
- Assure that GCPs (good clinical practices) are followed.
- Maintain pharmacovigilance compliance.
- Monitor data for safety and efficacy trends
- Analyze, interpret and present on-going studies and published data to internal groups.
- Prepare (write and review) clinical correspondence with regulatory agencies.
- Contribute to the authorship and review of clinical study reports.
- Prepare clinical research abstracts, posters, presentations and publications for appropriate medical and scientific conferences.
- Prepare clinical portions of regulatory documents (INDs, etc.), investigator brochures and other clinical documents as needed.
- Participate in Advisory Boards, and attend national and international clinical meetings.
- Play an active role on project teams; represent the clinical function on cross-functional project teams.
Qualifications and Requirements:
- MD or MD/PhD, preferably with Board certification/eligibility in Oncology or Hematology.
- A minimum of four years of experience in the design and conduct of clinical trials (Phases I-III) preferably within the biotech or pharmaceutical industry.
- Experience in evaluating, interpreting and presenting complex scientific data.
- Expertise and consistent success in scientific or clinical research is desirable (as evidenced by appropriate higher qualifications, publications and relevant specialist accreditation).
- Excellent communication skills.
- Desire and demonstrated ability to work in a matrix type environment with cross-functional teams in a transparent environment.
- Strong training and interest in applying scientific principles to early stage and translational clinical research is a positive.
Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Interested candidates should submit their resume to email@example.com