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.
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, preNDA/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 + years' 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
Experience working with investigators, site staff, external experts, Contract Research Organizations and vendors.
Preferred Qualifications:
Advanced degree (e.g. MS, PhD, PharmD).
Clinical development experience across all phases of development (I-IV).
Excellent leadership skills.
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
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness
*LI-GSK
• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $144,750 to $241,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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