Associate Director, Clinical Scientist

2 weeks ago

Stevenage, United Kingdom GSK Full time

**Site Name**: USA - Massachusetts - Waltham, Home Worker - USA, UK - Hertfordshire - Stevenage, USA - Massachusetts - Boston, USA - North Carolina - Durham, USA - Pennsylvania - Philadelphia

**Posted Date**: Feb 7 2023

The **Associate Director, Clinical Scientist - Oncology** role within Global Clinical Oncology R&D responsibilities are 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**:

- 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.
- 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:

- 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.
- Work with external experts to develop abstracts, manuscripts and study design presentations.

**Why You?**

**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- Bachelor’s degree in life sciences or related discipline,
- 3 or more years of experience as a Clinical Scientist
- 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 working 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 (CROs)and external vendors
- Experience in project management

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- 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

**Why GSK?**

We’re uniting science, technology and talent to make a difference in more people’s lives, and revolutionizing the way we do R&D.

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as w

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