Associate Director of Clinical Sciences

About the role

This role within Global Clinical Oncology R&D serves as a clinical sciences leader on global oncology studies and contributes to program-level activities. Responsibilities include reviewing and enhancing clinical development plans, supporting regulatory interactions, ensuring compliance with ICH/GCP guidelines, and managing clinical data review.

Responsibilities

• Review and/or enhance the technical and scientific robustness of project level clinical development plans.
• Maintain compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for all products and services delivered for their designated studies.
• Contribute to development of end-to-end clinical development strategy.
• Assume responsibility for medical review of clinical trial data, both directly as needed and via oversight of delegated medical review.
• Monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participate in blinded review of data packages intended for IDMCs.
• Make decisions balancing risk/benefit with clear understanding of impact on the study and project; take action to mitigate risk where appropriate.
• Partner to build relationships and collaborate with oncology aligned staff in other global functions.
• Cultivate strong relationships and robust communication among the clinical study/project team and GSK’s Oncology Clinical Development Organization.

Qualifications

• Bachelor’s degree in life sciences or related discipline.
• 3+ years of experience in pharmaceutical/biotechnology industry or related clinical experience.
• Experience in a pharmaceutical industry or CRO environment in the clinical development process.
• Oncology clinical development experience, particularly in the area of immuno-oncology.
• Experience with study management, global regulatory guidelines and ICH/GCP.
• Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.
• Experience working with investigators, site staff, external experts, Contract Research Organizations and vendors.

Preferred Qualifications

• Advanced degree (MS, PharmD, PhD) or equivalent clinical research experience.
• Experience in clinical development across all phases of development (I-IV).
• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
• Excellent influencing and negotiation skills.
• Excellent leadership skills.