Title: Senior Director Physician, Hematology SKG Lead

Location: Boston or Gaithersburg

What will you do:

The clinical Hematology Safety Knowledge Group (SKG) Lead manages a diverse range of activities related to monitoring, diagnosis, and mitigation of drug/biological-induced hematologic toxicity in a matrix environment. The haematology safety expert develops and leads the Hematology SKG, a multidisciplinary team responsible for evaluation and interpretation of potential safety signals, development of proactive and reactive minimization measures related to hematologic toxicity, including development of best practices to mitigate risk to patients.

The role holder inspires, manages, and leads cutting edge drug/biological-induced hematologic toxicity projects on a global basis. The Hematology SKG Lead will be influencing the shaping of the organisation by providing strategic direction and applying a full understanding of global issues related to drug/biological-induced hematologic toxicity. The role impacts the entire function and the broader AZ organization.

Accountabilities:

• Acts as expert involved in the design, conduct, monitoring, data interpretation and reporting of potential clinical safety signals related to hematologic toxicity which arise during the conduct of clinical trials.
• Acts as expert in hematologic safety/toxicity to provide scientific and medical input to Global Patient Safety (GPS) activities, with special focus on cross-project and cross-TA activities of a scientific nature.
• Provides specialist clinical Hematology advice to AZ project teams consulting with the Hematology SKG
• Leads co-ordination of clinical input to Hematology SKG work internally and to external initiatives.
• Drives scientific research around drug-induced hematologic toxicity, ensuring the research projects related to drug-induced hematologic toxicity adhere to Good Clinical Practice and regulatory requirements.
• Leads development of strategies to ensure that scientific assessment, mitigation and prevention of risk to patients are on a leading pharmaceutical industry level
• Leads and endorses the development of scientific methods applied to a wide range of safety data related to hematologic toxicity and potential toxicities in new therapies/novel modalities with potential hematologic toxicity concerns.
• Incorporates current, up-to-date understanding of clinical hematology practice and literature.
• Leads the development of drug/biological-induced hematologic toxicity biomarkers/assessments
• Leads initiatives to increase cross-company knowledge of drug-induced hematologic toxicity through training and other activities
• Drives projects to enhance visualisation and presentation of hematologic toxicity/safety data
• Provides support, as needed, for discussions with internal governance and international regulatory bodies
• Contributes to develop better understanding and prevention of hematology toxicity/safety issues across functions within the company and across Pharmaceutical Companies and Regulatory Authorities.
• Has a strong presence at internal and external conferences and delivers key scientific publications
• Promotes safety sciences and clinical safety across projects and therapeutic areas

Essential skills:

• Medical degree or equivalent experience with strong clinical experience
• Specialty training in clinical hematology, board certification in the field of expertise, with > 5 years of clinical practice
• Proven Continuing Medical Education activities in the field of clinical hematology
• Solid knowledge of the pharmaceutical industry, drug development, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities
• Proven high quality scientific track record
• High level of interactive communication to set clear direction and directly advising others at a high level
• Enhanced cultural sensitivity to leading teams in a matrix environment
• Ability to balance business and clinical research objectives
• Excellent verbal and written communication skills
• Experience in leading cross-functional teams
• Strategic thinking
• Strategic influencing

Desirable skills:

• > 3 years of drug development and safety experience, the majority of which should be in industry, with clear evidence of delivery
• Experience working with regulatory agencies, preparing regulatory documents and overseeing submissions
• Understanding of specialty- specific requirements at various stages of lifecycle development and relevant regulatory guidance
• Demonstrated capability to lead implementation of new guidance and/or working routines within a complex organization in response to new or novel problems
• Extensive general medical knowledge and academic/research experience
• Involvement in relevant professional society activities, involvement at national/international meetings, and contributions to the literature
• Strong team-working skills and an ability to work collaboratively in a global pharmaceutical environment

Date Posted

04-Jul-2024

Closing Date

29-Sept-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.