Clinical Development Director

3 weeks ago

Collegeville, United States GSK Full time

**Site Name**: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence

**Posted Date**: Apr 12 2024
- Are you energized by the opportunity to partner with key leaders in global medical science to accelerate business performance across and drive global operational support? If so, this _**_Clinical Development Director_**_ opportunity could be an ideal opportunity to explore._

**We are seeking a Clinical Development Director for a clinical program in Liver Disease**. The Clinical Development Director will support the Clinical Development Lead (CDL) and clinical team to plan and execute a clinical program, consisting of late-stage studies in liver disease, with an opportunity to support multiple indications as part of this program’s life cycle management plans. You will work as part of a cross-functional team to deliver on a high-priority program, while also contributing to a dynamic and collaborative Clinical Research community of physicians and scientists.

This role will provide you the opportunity to lead key activities to progress your career.

**Job purpose and key responsibilities**:

- Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for asset(s) in development
- Ensuring alignment with and support of project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design aligned with IEP and CDP
- Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation, and value to patient.
- Providing effective support and oversight of evidence generation activities to assure patient safety and study delivery.
- Enabling robust protocol design, including selection of clinical endpoints, patient populations, and participant monitoring strategy
- Working with Clinical Operations to deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.
- Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
- Medical monitoring of ongoing studies (if an MD) and interpretation and presentation of clinical data for clinical study reports and publications
- Developing and maintaining relationships with program counterparts, including Commercial, Research, Regulatory, Clinical Operations, and Statistics
- Interfacing and influencing a diverse range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs, align to business strategy, and address patient needs.
- Gathering and supporting the integration of inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to clinical components of the Medicine Profile
- Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
- Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development
- Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Sciences
- Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members

**_ Why you?_**

Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

- MD
- Experience in clinical drug development with an understanding of the hepatology disease space, the underlying biology, and potential therapeutic targets, as well as current and future potential treatment options
- Clinical research experience; understanding of clinical development planning and running clinical trials from concept to publication.
- Knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area
- Experience with needs and priorities of regulators, payers, and prescribers in relevant market(s)
- Experience using new learning and digital tools to create innovation in other areas.
- Understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.
- Proven ability to utilize statistics and visualization techniques to interpret or analyze complex information and make correct inferences and conclusions.

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

- Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance.
- Demonstrated experience integrating genetic data to inform and guide clinical protocols.
- Experience designing interventional clinical studies in alcohol-related liver disease.

**#LI-GSK**

**Why Us?**

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