Clinical Development Director - Collegeville, United States - GSK

GSK

Verified Company

Collegeville, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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

Posted Date:
Apr

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 datadriven 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 alcoholrelated liver disease.

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