GSK is expanding its oncology organization, and we are looking for experienced professionals to help us rebuild and grow our internal expertise! We have an exciting (and expanding) portfolio and are looking for clinical scientists who have a wide breadth of oncology and clinical development experience, with a particular focus on cell therapy. It’s a wonderful time to join our team because we have many opportunities to lead global studies in Phases 1-3 in the areas of immuno-oncology, cell/gene therapy and epigenetics. Apply to learn more!
This role within Global Clinical Oncology R&D will serve as a clinical sciences team leader on global oncology studies and contribute to program-level activities. Responsible for the delivery of quality study strategy and design, understand 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.
Key Responsibilities:
- 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.
- 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:
- 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.
- 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.
- Serves as a product, protocol and project subject matter expert to support internal and external customers.
- Work with external experts to develop abstracts, manuscripts and study design presentations.
Basic Qualifications:
- Bachelor’s degree in life sciences or related discipline, 3~5 years of 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 knowledge of 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
- Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors
- Excellent leadership skills
Preferred Qualifications:
- Advanced degree (e.g. MS, PhD, PharmD)
- 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
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
As a global healthcare company, we take on some of the world’s biggest healthcare challenges. By delivering a sustainable business, we provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We are committed to widening access to our products, so more people can benefit, no matter where they live in the world or what they can afford to pay. Each of our three businesses benefits from GSK’s commercial infrastructure, integrated supply networks and significant global presence.
As a global company, our reward packages are designed to meet the needs of our geographically diverse workforce. They are benchmarked against industry standards and relevant to your job, no matter where you live.
Our reward package includes:
- A competitive base salary
- An annual bonus that rewards you for your individual contribution to our strategy, as well as business targets
- Benefit programs designed to support you and your family, including access to healthcare and well-being programs, pension plan membership, savings programs, time off and childcare support
- Employee recognition programs which reward exceptional achievements
- Share ownership schemes which link your reward to GSK’s longer term performance
- A performance and development program that helps you identify what you need to do, and the behaviors you need to demonstrate, to achieve success.
