Assoc Director/Director Early Clinical Development Oncology - PI
If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
AstraZeneca has taken the worldwide biologics research and development of MedImmune and incorporated into one 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 – Oncology in Gaithersburg, MD, or Granta Park, Cambridge UK, 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.
AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
This is a unique opportunity to join AstraZeneca at a time of tremendous growth and acceleration in the oncology biologics portfolio. This is a fast-paced and dynamic work environment where, with increasing levels of responsibility, you will be responsible for medical monitoring of ongoing clinical trials, the planning and conduct of clinical trials, providing long-range clinical development planning, planning and managing of clinical research projects and clinical development programs in oncology, collaborating with and providing clinical input and expertise to pre-clinical and translational sciences, and setting and achieving goals and meeting timelines in accordance with corporate goals and budgets. You will serve as the project Medical Monitor while working in a cross functional environment with representatives from other involved line functions as well as Late-Stage Development. 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 be a well-trained clinician with strong leadership skills who is driven by science and the desire to develop novel immuno-oncology therapies for cancer patients, and have the opportunity for growth and development while working in a vibrant environment and “biotech” culture. Additionally, you will have a clear understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.
Specific duties and major responsibilities include the following: Serve as medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance; Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports; Responsible for assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in light of developments in the area of clinical and pharmaceutical oncology; Collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products; Provide leadership on cross-functional product development team(s) as experience allows; Participate in identification, selection and conduct of negotiations with clinical research centers and investigators; Participate in the selection and management activities of CROs; Supervise project team members in planning, conducting and evaluating clinical trials; Oversee planning and management of investigator meetings, advisory boards and other scientific committees.
NOTE: This position can be located in either the US (Gaithersburg, MD) or UK (Granta Park, Cambridge)
- MD (with current medical license preferred)
- Board Certification in Oncology or Hematology (OR board eligible in medical oncology)
For Associate Director level:
- At least 1-2 years of experience in early clinical research and/or oncology drug development in an academic, pharmaceutical or CRO environment
For Director level:
- At least 2-5 years of experience in early clinical research and/or oncology drug development in pharmaceutical or CRO environment.
- Immuno-oncology early clinical development experience (FIH, Ph I, Ph II clinical development experience)
- Experience in molecular oncology and/or translational science
- 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
- High level of emotional intelligence; able to deal with ambiguity
- 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
Next Steps – Apply today!
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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.