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

GSK•Waltham, MA

14h•Hybrid

About The Position

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.