Executive Director, External Strategy & Science Advocacy
GSK
12 hours ago
Remote friendly (Waltham, MA)
United States
Patient Advocacy
External Engagement & Partnership
- Lead non-product engagement with regulators (FDA, EMA, PMDA, NMPA, ICH, etc.) aligned to clinical development, RWD/E, and modeling priorities.
- Represent the organization in consortia/trade associations (e.g., PhRMA, EFPIA) and cross-industry working groups.
- Build strategic partnerships with academic/research institutions to co-develop methodologies, data pipelines, and pre-competitive science.
- Engage government/public policy bodies on responsible RWD/E, PROs, digital biomarkers, and novel trial designs.
- Assess/coordinate evaluation of industry collaboration proposals and associated funding.
- Scan emerging regulatory guidance and translate implications into coordinated adoption.
Policy Development & Advocacy
- Develop/execute policy strategies for clinical trial innovation, AI/ML-enabled development, and RWD/E frameworks.
- Monitor regulatory/legislative landscape; brief R&D leadership with actionable intelligence.
- Author/contribute to submissions, white papers, public comments, and position papers.
- Coordinate external messaging with legal, regulatory strategy/policy, and government affairs.
Technical Function Advancement
- Champion external visibility of innovation in clinical development and data science (incl. advanced statistics, predictive models, generative AI workflows).
- Support publication/conference thought leadership; promote technical capability development.
Leadership & Organizational Impact
- Set external engagement vision and integrate into R&D strategy; advise on priority advocacy.
- Represent the company on external boards/committees/steering groups.
Required Qualifications
- PhD/MD/PharmD or equivalent in life science/clinical/quantitative/data science (or related).
- 10+ years pharma/biotech R&D with clinical development and/or quantitative/data science.
- 5+ years engaging regulatory/legislative bodies re drug development, RWD/E, digital health, or novel trial methods (including shaping policy outcomes).
- Ability to translate technical concepts for policy/regulatory/non-specialist audiences.
Preferred Qualifications
- Experience with trade associations/consortia (e.g., IMI, FNIH, OHDSI); networks with PhRMA/EFPIA/TransCelerate.
- Cross-functional leadership/stakeholder management.
- Familiarity with RWE, digital biomarkers, model-informed drug development, 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: Wednesday 10 June.
Compensation/Benefits (US)
- Base salary: $206,250–$343,750 (Cambridge/Waltham/Rockville/San Francisco) or $187,500–$312,500 (other US locations). Annual bonus; eligibility for share-based long-term incentive; benefits include healthcare/insurance, retirement, paid holidays/vacation, and paid caregiver/parental/medical leave.
- Lead non-product engagement with regulators (FDA, EMA, PMDA, NMPA, ICH, etc.) aligned to clinical development, RWD/E, and modeling priorities.
- Represent the organization in consortia/trade associations (e.g., PhRMA, EFPIA) and cross-industry working groups.
- Build strategic partnerships with academic/research institutions to co-develop methodologies, data pipelines, and pre-competitive science.
- Engage government/public policy bodies on responsible RWD/E, PROs, digital biomarkers, and novel trial designs.
- Assess/coordinate evaluation of industry collaboration proposals and associated funding.
- Scan emerging regulatory guidance and translate implications into coordinated adoption.
Policy Development & Advocacy
- Develop/execute policy strategies for clinical trial innovation, AI/ML-enabled development, and RWD/E frameworks.
- Monitor regulatory/legislative landscape; brief R&D leadership with actionable intelligence.
- Author/contribute to submissions, white papers, public comments, and position papers.
- Coordinate external messaging with legal, regulatory strategy/policy, and government affairs.
Technical Function Advancement
- Champion external visibility of innovation in clinical development and data science (incl. advanced statistics, predictive models, generative AI workflows).
- Support publication/conference thought leadership; promote technical capability development.
Leadership & Organizational Impact
- Set external engagement vision and integrate into R&D strategy; advise on priority advocacy.
- Represent the company on external boards/committees/steering groups.
Required Qualifications
- PhD/MD/PharmD or equivalent in life science/clinical/quantitative/data science (or related).
- 10+ years pharma/biotech R&D with clinical development and/or quantitative/data science.
- 5+ years engaging regulatory/legislative bodies re drug development, RWD/E, digital health, or novel trial methods (including shaping policy outcomes).
- Ability to translate technical concepts for policy/regulatory/non-specialist audiences.
Preferred Qualifications
- Experience with trade associations/consortia (e.g., IMI, FNIH, OHDSI); networks with PhRMA/EFPIA/TransCelerate.
- Cross-functional leadership/stakeholder management.
- Familiarity with RWE, digital biomarkers, model-informed drug development, 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: Wednesday 10 June.
Compensation/Benefits (US)
- Base salary: $206,250–$343,750 (Cambridge/Waltham/Rockville/San Francisco) or $187,500–$312,500 (other US locations). Annual bonus; eligibility for share-based long-term incentive; benefits include healthcare/insurance, retirement, paid holidays/vacation, and paid caregiver/parental/medical leave.