Senior Study Physician, Immuno-Oncology - PI
Study Physician, Immuno-Oncology
Location: Gaithersburg, Maryland
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity, even in the most difficult situations because we are committed to doing the right thing.
This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines.
In Global Medicines Development (GMD), our mission is to transform innovative molecules into medicines that change lives. We are responsible for enabling the business to make critical pipeline and investment decisions, to ensure they select the right molecules to progress and to seize the right life-cycle management opportunities –generating the data required to drive regulatory submissions for new medicines and expanded indications and generating the evidence that shows their true value. With the transformation of our late stage pipeline, we have an incredible number of opportunities. Now, more than ever, it’s critical that we deliver exceptional performance and drive the best and most transformative programmes for every drug project. Our operating model is focused on achieving this.
AstraZeneca is a leader in IO combination therapy, with a pipeline focused on exploring the potential of immuno-oncology combinations.
Our differentiated strategy of combining IO therapies is leading in key tumour types such as non-small cell lung cancer, head and neck cancer, and bladder cancer, where combined checkpoint blockade will address a significant unmet need for patients who may not benefit from monotherapies. We believe our unique IO development program will play a critical role in continuing to redefine the cancer treatment paradigm, potentially replacing the need for chemotherapy.
Main Duties and Responsibilities:
You will manage global or regional studies within the Immuno-Oncology franchise and will be involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with Good Clinical Practice (GCP) and regulatory requirements. You will have a strong clinical and specialty background in Oncology and/or Immuno-Oncology and will be a peer among the industry, medicine and/or academic community within the field of pharmaceutical medicine and/or area of Immuno-Oncology specialty. You will provide expert scientific and clinical input to teams in the Immuno-Oncology therapeutic area under the direction of the Group Director with a matrix relationship to the Medical Science Director (MSD).
You will be a trial level physician and medical monitor for clinical studies, have responsibility for protecting the integrity and conduct of clinical studies whilst also providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators. You will provide strategic/tactical specialist input to clinical development and commercialization programs and data interpretation and maintain up to date awareness of all important advances within a given disease area through scientific literature, attendance at critical meetings and relationships with Key Opinion Leaders (KOLs). You will ensure that all work is carried out with regards to AstraZeneca standards and external regulations, establish and maintain communications with prominent clinical investigators in field of expertise and liaise with internal and external medical community to follow developments within your area of expertise. You will also represent AstraZeneca, as directed, at high level external steering or organizing committees.
- Graduate of a recognized school of medicine with an M.D. degree or equivalent.
- Board Certification or Eligibility in Oncology is required; specialty training and/or clinical experience and strong academic track record in Immuno-Oncology, Tumor Immunology, or Immunotherapy is preferred.
- Three (3) or more years of direct industry drug development experience or 3-4 years’ post fellowship clinical trial experience in an academic setting collaborating with pharmaceutical sponsors.
- Prior successful track record of performing and delivering results on drug development projects led by you.
- Experience in designing, monitoring and implementing clinical trials and interpreting trial results, including an understanding of biostatistics and safety reporting.
- Ability to conduct a large study as part of a global team.
- Ability to function within a matrix environment; to contribute to decision-making and reaching alignment in order to meet challenging timelines.
- Ability to work collaboratively and to respect other working cultures, including academic partners.
- Ability to communicate effectively with internal stakeholders as well as external partners and collaborators; good presentation skills.
- Understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence those decision points.
- Ability to work across projects and to foster interactions between teams.
- Interpersonal skills that influence and shape the image of the organization.
- Understanding of the interplay between clinical development, lifecycle management, commercial objectives and regulatory requirements.
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.