Medical Director, Clinical Development
Calithera is seeking a Medical Director, Clinical Development to apply careful clinical and scientific judgement to plan and accomplish clinical development goals. The ideal candidate will interact with various groups, both within the company and external to the company, related to clinical research activities. Additionally, the optimal candidate will have strong experience in the pharmaceutical/biotech industry and the desire to proactively participate within a multi-disciplinary team of internal preclinical, clinical and commercial colleagues in a highly interactive, scientifically-oriented environment.
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.