Executive Medical Director- Inflammation and Fibrosis Clinical Development, Early Pipeline Unit

GSK•Upper Providence, PA

1d•Hybrid

About The Position

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. An Executive Medical Director is sought to provide clinical and scientific leadership for potential new, established, and emerging indications for advanced stage assets in the food allergy portfolio. As Executive Medical Director you will: Work with medicine teams to plan and assure delivery of clinical research and development activities Work with early development teams to plan clinical development programs and establish efficient collaboration enabling seamless transition from early to late phase of development

Requirements

Medical Degree with specialist training or board qualification/eligibility in Allergy and Immunology.
Experience in (bio-)pharmaceutical industry experience in food allergy clinical drug development
Experience with planning clinical development for an asset and/or indication. Proven record of delivery of clinical trials and projects
Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules
Line/matrix management experience

Nice To Haves

Experience integrating translational biomarkers or companion diagnostics into clinical plans.
Prior success leading global clinical trials and regulatory submissions.
Experience coaching; mentoring and development; and a record of inspiring and motivating high-performance team.
Familiarity with innovative trial designs, digital tools or decentralized approaches.
Track record of clear scientific communication to diverse audiences, including regulators and payers.

Responsibilities

Lead the end-to-end clinical development strategy for a drug or program. Manage specific clinical development plans for product(s) and/or indication(s) in specific therapy/disease areas
Contribute to the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for an asset in development. Be accountable for the clinical components of the Target Medicine Profile (TMP)
Provide strategic leadership, for example in assuring that the clinical study designs are aligned with the IEP and CDP, and consider the scientific rationale, regulatory requirements, product development plan and commercial goals
Establish and deliver to clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics
Serve as a clinical point of contact for senior management and senior level matrix teams
Contribute to the strategic and organizational initiatives in Clinical Development
Contribute to Business Development activities, including due diligence projects
Support technical and leadership development of Clinical Sciences staff via direct line management, mentoring and coaching
Interface with and influence a range of scientific external experts (e.g., regulators, payors, CROs, subject matter consultants, investigators) to deliver clinical programs that align to our business strategy and address patient needs
Lead and be accountable for the evaluation of the probability of technical success (PTS) of clinical studies/programs
Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients
Assess benefit/risk at the study and/or project level. Take action to mitigate risk where appropriate
Make substantial contributions to global regulatory interactions and files, including briefing documents, presentations, submission documents, and responses to questions
Champion implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and produce business solutions