Associate Director of Clinical Sciences

Clinical Sciences Leader, Global Clinical Oncology R&D

This role within Global Clinical Oncology R&D will serve as a clinical sciences leader on global oncology studies and contribute to program-level activities. Responsible for the delivery of quality study strategy and design, understanding the analysis and interpretation of data throughout the study, including leading clinical data review ongoing throughout study conduct. Responsible for the end to end of writing protocols (protocol concept to final study report) delivery.

Contributor to informed consent forms development and other study related documents.

Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Review and/or enhance the technical and scientific robustness of project level clinical development plans.
• May support regulatory interactions, including contributing to briefing documents, presentations, addressing questions and responses.
• Ensure 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/or via oversight of delegated medical review.
• 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 which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
• Actively partner to build relationships and collaborate with oncology aligned staff in other global functions.
• Responsible for cultivating strong relationships and robust communication among the clinical study/project team and GSK's Oncology Clinical Development Organization. This includes training, education, onboarding as well as problem solving in the conduct of clinical trials.
• Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
• Study design and interpretation of study results that provide data to adequately address questions concerning efficacy/effectiveness, safety, applicability to targeted patient population, and clinical and commercial value that are consistent with the compounds' phase of development while ensuring that patient safety is of paramount concern and that regulatory requirements are incorporated through:
• 1. Accountability for Study Team members/stakeholders, as appropriate and regulatory reporting at the study level by providing leadership at study level to assure overall safety of the study subjects.
• 2. Drive/Contributing to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents.
• 3. Serving as a product, protocol and project subject matter expert to support internal and external customers.
• 4. Working with external experts to develop abstracts, manuscripts and study design presentations.

Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• 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
• In depth 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 Qualification If you have the following characteristics, it would be a plus

• Advanced degree (MS, PharmD, PhD) or equivalent clinical research experience. Clinical development experience across all phases of development (I-IV).
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
• 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

Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Cross-Departmental Collaboration, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Scientific Presentations