- Waltham, MA
- Collegeville, PA
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 portfolio and are looking for Clinical Operations Indication Leads who have a wide breadth of oncology and clinical development experience. It’s a wonderful time to join our team because we have many opportunities to lead global studies and programs in Phases 1-3 in the areas of immuno-oncology, cell/gene therapy, epigenetics and synthetic lethality.
Role Description: Accountable within the Oncology Global Clinical and Study Delivery (GCSD) team for alignment of the execution strategy across projects and studies within a designated indication. Responsible for strategic delivery of studies within the designated indication.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Collaboration with Clinical Operations Asset Leads (COALs) and Clinical Scientist Leads (CSLs) at the timepoint of Clinical Study Idea to contribute cross-project indication expertise.
- Partnership with COALs through concept protocol generation to define the optimal study delivery strategy.
- Interaction with protocol development stakeholders to incorporate indication-specific intricacies and lessons learned across studies/projects.
- Creation of an Indication focused forum across COALs and Study Delivery Leads to share Indication expertise, optimize delivery strategy and drive consistent ways of working across teams.
- Creation of strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring and pre-Clinical Development, to ensure consistent approaches to study delivery, data collection and reporting across a defined indication.
- Contribution of relevant knowledge of scientific and medical literature in the defined indication area to apply to operational goals.
- Contribution of strategic leadership to the GCSD Oncology Leadership Team to drive study delivery efficiency and performance.
- Representation of GCSD on the Disease Area Strategy Team (indication specific) which spans all functional areas.
The role may:
- Have accountability for the management, performance and motivation of direct reports.
- Have primary responsibility for delivery of a program of studies (or indication-specific group of studies) and be key point of contact for portfolio leaders in the Oncology Therapeutic Area (e.g. Early Development Leaders, Medicine Development Leaders, and/or Project Physician Leaders, as appropriate).
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in life sciences or related discipline
- At least 10-15 years of oncology clinical operations experience
- Experience in developing and writing study protocols, study procedure manuals, informed consent forms and clinical study reports
- Study management, global regulatory guidelines and ICH/GCP experience
- Experience working with investigators, external experts, Contract Research Organizations and vendors
- Lung Cancer Expertise
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
- Excellent leadership skills
- Excellent influencing and negotiation skills
- Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
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.