Senior Director, Quality Policy & Advocacy
Scorpion Therapeutics, Washington, District of Columbia, us, 20022
Role Summary
The Senior Director, Quality Policy & Advocacy leads global internal and external-facing advocacy for Quality Policy, focusing on North American policy while aligning with global regulatory expectations. The role positions Gilead’s portfolio for regulatory and technical success, collaborates with cross-functional teams, and influences policy through external engagement with regulators, trade associations, and global health partners. The role requires strong external networks, strategic thinking, and the ability to translate complex regulatory issues for diverse stakeholders.
Responsibilities
Serve as a critical and recognized thought leader and contributor to the Quality Policy & Advocacy Office at Gilead Sciences.
Lead, coordinate, and represent the business in ICH, trade associations (e.g., PhRMA), and global technical associations (e.g., ISPE, PDA, DIA) with minimal oversight.
Lead development of Gilead’s global Quality policies and priorities, with a focus on North American facing assets.
Develop, advise global senior leadership, and implement solutions to address regulatory complexities and challenges across regions.
Present and articulate complex global Quality issues for resolution, maintaining regular communication with key global stakeholders and providing scientific/technical consultation within cross-functional teams.
Facilitate and support global project teams in identifying solutions for precedent-setting issues and ensuring understanding of local regulations and requirements.
Contribute to the strategic direction of broad global harmonization efforts and enable new technologies to benefit Gilead’s scientists.
Build and maintain a strong external network with regulatory authorities, nonprofit organizations, and academic institutions, with focus on European health authorities and cross-industry associations.
Coordinate strategy development with CMC Regulatory Affairs Policy Advisory and Intelligence Office.
Develop and implement external strategies for critical and precedent-setting initiatives (new technology, complex projects).
Serve as the policy point of contact for select partners and stakeholders and communicate timely information.
Independently lead key global implementation efforts and significant projects to ensure Gilead’s participation in external forums addressing global regulatory guidance.
Qualifications
A scientific degree with directly relevant professional experience in global Quality and related technical areas of at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, PharmD, or MD.
Demonstrated track record in impacting global Quality, developing Quality and regulatory strategies, and leadership in international regulatory/industry forums for external policy relevance.
Expert on global guidelines and regulations, with a focus on North American-facing topics (e.g., PhRMA).
Strong knowledge of ICH guideline interpretation and implementation; prior ICH experience is highly preferred.
Demonstrated organizational leadership skills at the functional level.
Excellent strategic acumen, collaboration, and communication skills.
#J-18808-Ljbffr
Responsibilities
Serve as a critical and recognized thought leader and contributor to the Quality Policy & Advocacy Office at Gilead Sciences.
Lead, coordinate, and represent the business in ICH, trade associations (e.g., PhRMA), and global technical associations (e.g., ISPE, PDA, DIA) with minimal oversight.
Lead development of Gilead’s global Quality policies and priorities, with a focus on North American facing assets.
Develop, advise global senior leadership, and implement solutions to address regulatory complexities and challenges across regions.
Present and articulate complex global Quality issues for resolution, maintaining regular communication with key global stakeholders and providing scientific/technical consultation within cross-functional teams.
Facilitate and support global project teams in identifying solutions for precedent-setting issues and ensuring understanding of local regulations and requirements.
Contribute to the strategic direction of broad global harmonization efforts and enable new technologies to benefit Gilead’s scientists.
Build and maintain a strong external network with regulatory authorities, nonprofit organizations, and academic institutions, with focus on European health authorities and cross-industry associations.
Coordinate strategy development with CMC Regulatory Affairs Policy Advisory and Intelligence Office.
Develop and implement external strategies for critical and precedent-setting initiatives (new technology, complex projects).
Serve as the policy point of contact for select partners and stakeholders and communicate timely information.
Independently lead key global implementation efforts and significant projects to ensure Gilead’s participation in external forums addressing global regulatory guidance.
Qualifications
A scientific degree with directly relevant professional experience in global Quality and related technical areas of at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, PharmD, or MD.
Demonstrated track record in impacting global Quality, developing Quality and regulatory strategies, and leadership in international regulatory/industry forums for external policy relevance.
Expert on global guidelines and regulations, with a focus on North American-facing topics (e.g., PhRMA).
Strong knowledge of ICH guideline interpretation and implementation; prior ICH experience is highly preferred.
Demonstrated organizational leadership skills at the functional level.
Excellent strategic acumen, collaboration, and communication skills.
#J-18808-Ljbffr