Executive Director, External Strategy & Science Advocacy
GSK
10 days ago
Remote friendly (Collegeville, PA)
United States
Patient Advocacy
Key Responsibilities
External Engagement & Partnership
- Lead Development Science’s non-product engagement strategy with regulatory agencies (FDA, EMA, PMDA, NMPA, ICH, and other global bodies) aligned to clinical development, data science/RWD-E, and modeling priorities.
- Represent the organization at industry consortia and trade associations (e.g., PhRMA, EFPIA) and cross-industry working groups.
- Build partnerships with academic/research institutions to co-develop innovative methodologies, data pipelines, and pre-competitive science.
- Engage government/public policy bodies on positions enabling responsible adoption of RWD/E, PROs, digital biomarkers, and novel trial designs.
- Assess industry collaborative proposals for merit/strategic alignment and coordinate internal evaluation and funding.
- Scan and interpret global regulatory guidance and translate implications for timely adoption.
Policy Development & Advocacy
- Develop/execute policy strategies for clinical trial innovation, AI/ML-enabled drug development, and RWD/E frameworks.
- Monitor regulatory/legislative landscape; translate implications into actionable intelligence.
- Author/contribute to submissions, white papers, public comment letters, and position papers.
- Partner to ensure coherent external messaging.
Technical Function Advancement & Leadership
- Champion external visibility of innovations in clinical development and data science (e.g., adaptive/decentralized designs, patient-centric endpoints, predictive models, generative AI workflows).
- Collaborate cross-functionally (clinical, biostatistics, AIML, data science, digital R&D) on external amplification.
- Support publication/conference thought leadership; promote technical skill resources.
- Set external engagement vision with leadership; advise on priority efforts; represent company on boards/committees.
Required Qualifications
- Advanced degree (PhD/MD/PharmD or equivalent) in life science, clinical, quantitative/data science, or related.
- 10+ years progressive pharma/biotech R&D experience with clinical development and/or quantitative/data science.
- 5+ years track record engaging regulatory/legislative/governing bodies on drug development, RWD/E, digital health tech, or novel trial methodologies; shaping policy outcomes.
- Ability to translate complex scientific/technical concepts for policy/regulatory/non-specialist audiences.
Preferred Qualifications
- Experience with trade associations/consortia (e.g., IMI, FNIH, OHDSI) or academic collaborations.
- Network within PhRMA, EFPIA, TransCelerate, or equivalent.
- Cross-functional leadership and stakeholder management.
- Familiarity with RWE, digital biomarkers, model-informed drug development, and/or decentralized trials.
- Published author or recognized scientific/policy spokesperson.
How to Apply
- Submit CV and a short cover letter describing relevant experience and why the role matters. Closing date: Wednesday 10th June.
External Engagement & Partnership
- Lead Development Science’s non-product engagement strategy with regulatory agencies (FDA, EMA, PMDA, NMPA, ICH, and other global bodies) aligned to clinical development, data science/RWD-E, and modeling priorities.
- Represent the organization at industry consortia and trade associations (e.g., PhRMA, EFPIA) and cross-industry working groups.
- Build partnerships with academic/research institutions to co-develop innovative methodologies, data pipelines, and pre-competitive science.
- Engage government/public policy bodies on positions enabling responsible adoption of RWD/E, PROs, digital biomarkers, and novel trial designs.
- Assess industry collaborative proposals for merit/strategic alignment and coordinate internal evaluation and funding.
- Scan and interpret global regulatory guidance and translate implications for timely adoption.
Policy Development & Advocacy
- Develop/execute policy strategies for clinical trial innovation, AI/ML-enabled drug development, and RWD/E frameworks.
- Monitor regulatory/legislative landscape; translate implications into actionable intelligence.
- Author/contribute to submissions, white papers, public comment letters, and position papers.
- Partner to ensure coherent external messaging.
Technical Function Advancement & Leadership
- Champion external visibility of innovations in clinical development and data science (e.g., adaptive/decentralized designs, patient-centric endpoints, predictive models, generative AI workflows).
- Collaborate cross-functionally (clinical, biostatistics, AIML, data science, digital R&D) on external amplification.
- Support publication/conference thought leadership; promote technical skill resources.
- Set external engagement vision with leadership; advise on priority efforts; represent company on boards/committees.
Required Qualifications
- Advanced degree (PhD/MD/PharmD or equivalent) in life science, clinical, quantitative/data science, or related.
- 10+ years progressive pharma/biotech R&D experience with clinical development and/or quantitative/data science.
- 5+ years track record engaging regulatory/legislative/governing bodies on drug development, RWD/E, digital health tech, or novel trial methodologies; shaping policy outcomes.
- Ability to translate complex scientific/technical concepts for policy/regulatory/non-specialist audiences.
Preferred Qualifications
- Experience with trade associations/consortia (e.g., IMI, FNIH, OHDSI) or academic collaborations.
- Network within PhRMA, EFPIA, TransCelerate, or equivalent.
- Cross-functional leadership and stakeholder management.
- Familiarity with RWE, digital biomarkers, model-informed drug development, and/or decentralized trials.
- Published author or recognized scientific/policy spokesperson.
How to Apply
- Submit CV and a short cover letter describing relevant experience and why the role matters. Closing date: Wednesday 10th June.