Director Clinical Scientist

Astrazeneca

7+ years

Not Disclosed

Boston

10 July 24, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director Clinical Scientist

Location: Boston, Massachusetts, United States
Job ID: R-201216
Date Posted: 30/05/2024

Are you ready to make a significant impact in Biopharmaceutical R&D? We are seeking a Director Clinical Scientist to join our team in Boston. This role focuses on providing scientific and clinical leadership in the development of Immunology Cell Therapy assets. You will contribute to groundbreaking medicine discovery and development, addressing some of the most complex unmet patient needs from early to late stages.

Key Responsibilities:

As the Director Clinical Scientist, you will lead the scientific design, execution, and interpretation of clinical trials within one or more development programs. Collaborating with colleagues across functions, including Study Physicians, Patient Safety, Regulatory Affairs, Clinical Operations, Translational Medicine, CMC, and Early Development groups, your expertise will be pivotal in regulatory document preparation and interactions with regulatory authorities. You will also be responsible for developing quality metrics and data review plans for assigned studies, supporting medical monitoring of trials, and ensuring scientific input aligns with Therapeutic Area (TA) standards.

Essential Skills/Experience:

Educational Background: Advanced scientific degree (M.S., Ph.D., Pharm.D., MPH, or equivalent) with a minimum of 3 years of industry experience in clinical development.
Therapeutic Area Knowledge: Advanced understanding of cell therapy, particularly in rheumatology or other inflammatory diseases.
Clinical Trial Experience: Proven experience in designing and conducting industry-sponsored clinical trials.
Methodological Expertise: Broad knowledge of clinical trial methodology, statistics, data analysis, and interpretation.
Scientific Support: Experience in developing and implementing cell therapy studies, including protocol and ICF development, electronic data capture database development, safety assessment, IB/DSUR submissions, and clinical data review. Proficiency in conducting scientific literature searches and evaluating peer-reviewed data.
Communication Skills: Ability to effectively communicate with internal and external partners, both orally and in writing.
Interpersonal Skills: Experience interacting with various levels of management, investigators, site personnel, clinicians, scientists, and cross-functional teams.

Desirable Skills/Experience:

Multidisciplinary Knowledge: In-depth understanding of the functions involved in cell therapy development, including research, clinical operations, clinical pharmacology, translational medicine, biostatistics, regulatory, safety, CMC, and commercial operations.
Integration Skills: Ability to proactively integrate multiple perspectives into the clinical development process to achieve optimal results.

At AstraZeneca, we believe that bringing together diverse teams fosters bold thinking and inspires life-changing medicines. Our in-person work environment, typically requiring a minimum of three days per week in the office, allows us to connect, work efficiently, and challenge conventional thinking. However, we also respect individual flexibility and balance these expectations with personal needs.

Why AstraZeneca?

AstraZeneca is committed to 'following the science,' backed by investment and bold decision-making. Here, your innovative discoveries have the potential to reach billions of patients globally. We are a team of leading specialists dedicated to scientific discovery and development, always striving for efficiency and searching for new knowledge and breakthroughs.

Ready to make a greater impact? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team that represents a wide range of backgrounds and perspectives. We believe that diversity enhances our work. We welcome applications from all qualified candidates and comply with all applicable laws and regulations regarding non-discrimination in employment, recruitment, work authorization, and employment eligibility verification.

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Director Clinical Scientist

Job Description

Job Title: Director Clinical Scientist

Key Responsibilities:

Essential Skills/Experience:

Desirable Skills/Experience:

Why AstraZeneca?

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