If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.MedImmune
is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As Associate Director
/ Director, Clinical Development Scientist - Oncology
in Gaithersburg, MD,
you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and ResponsibilitiesThis is a unique opportunity to join MedImmune at a time of tremendous growth and acceleration in the immune-oncology biologics portfolio. This is a fast-paced and dynamic work environment where the Clinical Scientist will assist in the design and execution of Oncology clinical programs. The Associate Director/Director, Clinical Scientist, you may serve in various roles including membership on clinical trial teams and clinical project sub-teams and may serve in leadership roles within these teams, and may be a representative on the Product Development Team (PDT). . You will work in a cross functional environment with representatives from other involved line functions as well as Late-Stage Development. Additionally, you will contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
You will have a clear understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, the principles of translational medicine, and how to work effectively within cross-functional teams ensuring their success. We are seeking a well-trained scientist/clinician with strong leadership skills who is driven by science and the desire to develop novel immuno-oncology therapies for cancer patients. You will have the opportunity for growth and development while working in a vibrant environment and "biotech" culture.
Responsibilities include: The preparation of key product documentation to include to include protocols, the Clinical Development Plan, and regulatory submission documents as required. Developing the key elements in of data review plans, along with performing medical data review during study execution as well as leading the collection and analysis of adverse events. Operational support for clinical studies to include involvement in site selection, working with CROs and other 3rd party vendors regarding endpoints, participation in investigator meetings, study risk management, etc... Internal and external collaborations.Essential Requirements For Associate Director, Clinical Development Scientist level:
For Director, Clinical Development Scientist level:
- PhD, or Master's degree in health science field, PharmD, MD, or other relevant advanced degree in a health science field
- At least 1-2 years of experience in clinical research and/or drug development in the therapeutic area of the position.
For both levels:
- PhD, or Master's degree in heath science field, PharmD, MD, or other relevant advanced degree in a health science field.
- Minimum two years of experience in clinical research and/or oncology drug development in pharmaceutical or CRO environment.
- Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or hematology.
- Excellent oral and written skills, strong interpersonal and listening skills
- Results driven to achieve creative and sound outcomes
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross functional environment.
- Ability to make sound and timely decisions; agile in learning and action oriented.
- Ability to relate to colleagues and associates at all levels both inside and outside the organization.
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
Next Steps - Apply today!
- Immuno-oncology development experience
- Experience in molecular oncology and/or translational science
- Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; able to build effective teams; experience managing and developing others
- Ability to make sound and timely decisions; agile in learning and action oriented
- High level of emotional intelligence; able to deal with ambiguity
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.