We are seeking well-trained clinicians with wide exposure to hematological malignancies and patients, with a great level of understanding of the basic science behind the various hemato-oncology diseases, and familiar with the existing and upcoming novel treatment modalities under evaluation in the Hemato-Oncology field such Cell Therapy, Antibody Drug Conjugates, and compounds targeting Cell Death pathways, Tumor Driver and Resistance, DNA Damage Response and Epigenetics, among others.

In addition, our candidate must have a good level of understanding of the drug development process, must be able to navigate comfortably and independently through all the tasks expected for a study physician with oversight over one or more clinical studies. The candidate must not only be well versed in the clinical aspects of hematological malignancies but must be familiar with the operational aspects of clinical development (preferably from the pharmaceutical industry end) .

The qualities above must be coupled with an excellent ability to interact with team members, to ensure good flow of deliverables and seamless collaboration with all functions involved in study and program execution.  The candidate must also be able to communicate and present data flawlessly both in writing and in oral presentations to various levels of internal governance bodies and to external scientific experts.

Finally, the study physician responsibilities are expected to be more than having oversight over the studies to which he/she has been assigned; we expect this candidate to be fully involved in strategic aspects of the wider program and to contribute on a regular basis to tasks with a wider spectrum and with impact on program level. For this, leadership skills and a positive proactive attitude are a must.

Our candidate will have the opportunity for growth and development while working in a vibrant environment, fully integrated into our unmatchable heme team, a team knowledgeable of the hem-onc field and passionate about hematology drug development.

Direct Responsibilities

Contributes to and is a key member of a high performing Clinical Development Team (CDT)

Leads medical data review of trial data, including eligibility review

Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)

Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives

Leads collaboration with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)

Fulfills GCP and compliance obligations for clinical conduct and maintains all required training

Clinical Development Expertise & Strategy

In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets

Provides oversight and medical accountability for one or a group of studies

Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists (CS)

Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)

Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs

Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature

Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape

Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others

Health Authority Interactions & Publications

Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Senior Clinical Trial Physician

Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with CSs

Requirements:

MD required

3 or more years of Industry experience and/or clinical trials experience is required.

Key Competency Requirements:

Ability to communicate information clearly and lead presentations in scientific and clinical settings

Subspecialty training in applicable therapeutic area desired

Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation

Expertise in drug development process

Expertise in the components needed to execute an effective clinical plan and protocols

Director level requires at least 3-5 years of experience in clinical research and/or Oncology drug development in pharmaceutical or CRO environment. (Less than 3 years of experience for Associate Director level)

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.