Genentech/Roche is seeking an Associate Medical Director/ Medical Director to participate in the development and execution of clinical initiatives within the hematology group in late stage development oncology, specifically on the anti-CD20/CD3 bispecific antibodies global development team. As Associate Medical Director/ Medical Director you will be responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within the Late Development Oncology organization. You will also participate in developing the long-range strategic plans for the molecule.
- Assisting in the overall management, planning, evaluation and documentation of projects and studies. Participation in on-going medicine development activities including:
- Developing and writing clinical plans and protocols ensuring scientific integrity.
- Preparation of regulatory documents and interaction with global regulatory authorities
- Monitoring and reviewing clinical data for safety and ongoing study conduct
- Analysis, presentation and interpretation of study data, with integrated assessment as compared with published data
- Participation in the preparation of abstracts, posters and presentations for scientific meetings, congresses, and interactions with Key Opinion Leaders
- Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations
- MD with Board Certification or eligibility in Hematology or Oncology and clinical practice experience required as well as strong scientific competence demonstrated by peer reviewed publications or production of clinical expert reports.
- Minimum of 3 years experience in clinical research required with experience in the pharmaceutical industry preferred, or deep expertise in hematologic malignancies in an academic research setting
- Past work experience of confirmatory drug development and evidence of having played a significant part in the preparation of international regulatory submissions and work with health authorities a plus; exceptional candidates without this level of experience may be considered on an individual basis
- Work with health authorities in outcomes measures, presentations, negotiations and submissions are important
- Demonstrated ability to interact effectively in a multifunctional multinational team setting
- Understanding of the business and regulatory aspects in pharmaceutical drug development
- To be successful in this role, you will have the following skills and experience:
- Solid experience in medical research including experience in conduct of global clinical trials
- Experience interpreting clinical data and generation of supporting regulatory submissions of clinical study documents
- Good communication and collaborative skills with experience at working with cross-functional and external groups, including researchers, clinicians and other stakeholders
- Proven track record of delivery of experimental or novel studies
- Confidence at presenting at internal and external strategy meetings
Note that this position can be filled in South San Francisco, Basel or Welwyn Garden