Position Summary
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.
Key Responsibilities
* 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.
* 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 to assure that 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 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 to deliver clinical programs that align to the 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 gain stakeholder support; encourage others to think differently and produce business solutions.
Basic Qualifications
* Medical degree with specialist training or board qualification/eligibility in Allergy and Immunology.
* Experience in the (bio‑pharmaceutical) industry experience in food allergy clinical drug development.
* Experience with planning clinical development for an asset and/or indication and a proven record of delivery of clinical trials and projects.
* Experience with 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.
Preferred Qualifications
* 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 teams.
* Familiarity with innovative trial designs, digital tools or decentralized approaches.
* Track record of clear scientific communication to diverse audiences, including regulators and payers.
Benefits
* Annual base salary ranging $284,625 to $474,375 for new hires in specified U.S. locations.
* Annual bonus and eligibility to participate in a share‑based long‑term incentive program.
* Health care and other insurance benefits for employee and family.
* Retirement benefits, paid holidays, vacation, paid caregiver/parental and medical leave.
Additional Information
This role is hybrid. You will be expected to work on a GSK site regularly (typically 2–3 days per week).
Equal Opportunity Employer
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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