Genentech/Roche is seeking an Associate Medical Director to participate in the development and execution of clinical initiatives within the GYN and Breast group in late stage development oncology, specifically on the atezolizumab global development team. Atezolizumab is an anti-PD-L1 anti-tumor immunotherapy agent currently approved in some solid malignancies. It is being actively studied in GYN and breast malignancies.
As Associate 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. Important aspects of this role will be the ability to work cross-functionally and cross-organizationally with internal and external stakeholders, be able to work agilely in learning and developing novel clinical trial frameworks to deliver upon the CDP.
- Assisting in the overall management, planning, evaluation and documentation of projects and studies. Participation in on-going medicine development activities may include:
- 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
- On-going awareness of therapeutic landscape (internally and externally) with ability to to perform rapid assessment and modifications, as needed.
- Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations
- MD with Board Certification or eligibility in Gynecologic Oncology or Hematology/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 GYN 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
- To be successful in this role, you will have the following skills and experience:
- Solid experience in medical research
- 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
Roche is an equal opportunity employer.Research & Development, Research & Development > Clinical Operations