Director / Associate Director, Clinical Scientist

1 week ago

Collegeville, United States GSK Full time

**Site Name**: UK - Hertfordshire - Stevenage, Baar Onyx, GSK House, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence

**Posted Date**: Apr 22 2024

**_

Are you interested in a leadership opportunity to bring ground-breaking cancer therapies to patients by working with a team that unites science, technology, and talent? If so, this role may be for you

The Clinical Scientist will report to the Clinical Science Program Lead in Oncology Clinical Development. As a Clinical Scientist, you will be responsible for leading and/or contributing to the clinical strategy in the Clinical Development Plan and will be responsible for scientific oversight, per Good Clinical Practice, of sponsored studies in alignment with the Target Product Profile.

In this role, the Clinical Scientist will serve as a clinical sciences leader on global oncology studies and contribute to program-level activities. These responsibilities include the delivery of high-quality study design, understanding the analysis and interpretation of data throughout the study, leading and/or contributing to medical data review throughout the study lifecycle, and effective collaboration and communication across a matrix team and with senior leaders and external investigators.

**_ Key Responsibilities_**:

- Serve as a clinical science leader on global oncology clinical studies and contribute to program-level activities.
- Lead and/or contribute to study strategy and design, understanding the analysis and interpretation of data throughout the study, including medical data review throughout study conduct.
- Lead and/or contributor to the end to end of writing protocols, protocol amendments, informed consent forms, study reports, scientific abstracts and manuscripts, annual reports, and regulatory submission documents, among other study related documents.
- Effectively collaborate and communicate with study physicians and team members across clinical operations, regulatory affairs, biostatistics, clinical programing, safety and pharmacovigilance, precision medicine, clinical imaging, medical affairs, value evidence, epidemiology, project management, quality risk management, and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials.
- Develop trust and partnerships with external investigators and collaborators through excellence in communication, scientific understanding, and effective presentation of GSK Oncology purpose and objectives.
- Develop innovative strategies and solutions that contribute to the optimal development of clinical trials per Good Clinical Practice.
- Contribute to Oncology Clinical Development and GSK enterprise-wide initiatives and workstreams, as appropriate.

**_ Why you?_**

**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_

**_ Director level requirements:_**
- Bachelor’s degree in life sciences or related discipline.
- Director level experience in pharmaceutical/biotechnology industry or related clinical experience.
- In depth experience with clinical science, study management, global regulatory guidelines, and ICH/GCP.
- Experience in developing and writing study protocols, informed consent forms and clinical study reports, abstracts, manuscripts, and annual reports.
- Experience with clinical development from early stage through to regulatory submission and market support.
- Experience with collaboration and influence in a clinical matrix environment.
- Experience working with investigators, site staff, external experts, Contract Research Organizations and vendors.
- Clinical development plan management experience.

**_ Associate Director requirements:_**
- Bachelor’s degree in life sciences or related discipline.
- Experience in pharmaceutical/biotechnology industry or related clinical experience.
- Experience with clinical science, study management, global regulatory guidelines, and ICH/GCP.
- Experience in developing and writing study protocols, informed consent forms, and clinical study reports.
- Experience working with investigators, site staff, Contract Research Organizations, and vendors.
- Experience with cross functional leadership skills.

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- Advanced degree (e.g., MS, PhD, PharmD).
- Experience in Oncology Clinical Development/Clinical Science.
- Experience in the Pharmaceutical industry with specific experience leading a team with progressively more senior positions and responsibilities.
- Strong team leadership skills in matrix environments and effective communication with peers, external experts, and senior leaders.
- Experience managing, developing, and motivating a team to deliver clinical study results in a timely manner.
- Experience in setting high performance standards and measures, driving accountability throughout the function, and mentoring staff.
- Experience in various phase

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