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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Associate Director - Clinical Scientist

Clinical Research OperationsPosted on Nov 12
Full-timeUxbridge, UKNo salary listed

About the Job

Requirements

  • A degree in Life Sciences is required.
  • At least 5 years of experience in clinical science, clinical research, or an equivalent field is required.
  • Proficient knowledge of GCP/ICH guidelines, drug development processes, study design, and statistics is required.
  • Skill in programme-specific data review, trend identification, and data interpretation is required.
  • Familiarity with establishing and operating data monitoring committees, dose review teams, and independent response adjudication committees is required.
  • Excellent verbal, written, and interpersonal communication skills, with the ability to engage effectively across functions and seniority levels, are required.
  • The ability to lead team activities and matrix-based groups is required.
  • Strong critical thinking and problem-solving skills, with attention to quality and detail, are required.
  • Proficiency in medical terminology and medical writing is required.
  • A deep understanding of relevant disease areas, compounds, mechanisms of action, pharmacokinetics/pharmacodynamics, and biomarker and safety profiles is required.
  • Proficiency in Microsoft Word, Excel, PowerPoint, and electronic data capture tools such as RAVE and J-Review is required.
  • The ability to manage shifting priorities while remaining composed and professional under pressure is required.

Responsibilities

  • Lead planning and execution of study activities across multiple trials, exercising a high degree of autonomy.
  • Maintain deep protocol expertise and act as the clinical knowledge hub for the study team.
  • Collaborate on protocol and Informed Consent Form development, including writing, reviewing, and resolving cross-functional comments.
  • Oversee data generation and validation activities, including Case Report Form design, clinical data review, and query resolution.
  • Identify clinical data trends and escalate observations appropriately to the Medical Monitor.
  • Develop clinical narrative plans and review clinical narratives.
  • Support site-facing activities, including training and serving as the primary contact for clinical questions.
  • Contribute to drafting, reviewing, and validating Clinical Study Reports and regulatory documents, including Investigators' Brochures, DSURs, and regulatory responses.
  • Evaluate innovative trial designs in collaboration with the Medical Monitor and Clinical Indication Lead.
  • Support study committee activities, including Data Monitoring Committees.
  • Provide scientific and clinical leadership to supporting Clinical Scientists, co-lead study team meetings, and serve as a primary liaison with external partners.
  • Contribute to future clinical development planning.

Desired Qualifications

  • MD, PhD, PharmD, MS, RN, or equivalent scientific qualifications are preferred.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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