Senior Manager, Global Regulatory Affairs, Precision Medicine

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

As an Senior Manager, Global Regulatory Affairs, Precision Medicine, you will help develop and execute Precision Medicine regulatory strategy in alignment with the drug global regulatory strategy and in compliance with the appropriate IVD regulations. You will need to work closely under the direction of the Precision Medicine Leadership, collaborate with the Biomarker diagnostics team and global/regional Regulatory liaisons, to support Precision Medicine global regulatory initiatives and offer guidance, as applicable. You will provide fit-for-purpose operational and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs, global registration, and market access. This role will operate on a hybrid 3 days a week on-site schedule in either Stockley Park or Cambridge.

Responsibilities:

• Represent Regulatory Affairs Precision Medicine or Dx Regulatory in cross-functional teams involved in the application of biomarkers and IVDs in drug clinical programs.
• Support implementation of business aligned Precision Medicine regulatory strategies to support Gilead assets from early development through registration and beyond.
• Maintain current understanding of changing global IVD and Companion Diagnostics (CDx) regulations, assess impact on drug development & registration activities.
• Provide Dx regulatory input to ensure compliance of diagnostics used in therapeutic trials with global and local regulatory requirements (such as US FDA and EU IVDR).
• Support preparation and filing of IVD Performance Study applications, SRD & IDE applications, HA briefing books, clinical protocols, study reports, ICFs, Investigator Brochures, IND applications, CTAs, BLAs, NDAs, PMAs, and labeling documents for drug and diagnostic products, in collaboration with Gilead internal functions, IVD partners and CROs.
• Contributes to Dx Regulatory QMS process improvements related to investigational devices which may have a significant impact on business.
• Support training related to the IVD/CDx medical devices & broader Precision Medicine initiatives.
• Ensures compliance with established practices, policies, processes, and any applicable regulatory requirements.

Basic Qualifications:

• Bachelor's Degree and extensive experience OR Masters' Degree and extensive experience.

Preferred Qualifications:

• PharmD/MS with relevant experience.
• BA/BS with relevant experience.
• Significant Regulatory, Quality, compliance or related experience supporting development of investigational IVD devices in a biopharma setting.
• Experience with immuno- and molecular diagnostics technologies.
• Experience leading cross-functional diagnostics teams.
• Experience with authoring procedures and implementing processes.
• Experience working in companion diagnostics projects is strongly preferred.
• Experience with global policy, IVD regulations (e.g., EU IVDR, 21 CFR Parts 820, 814, 812, 809, FDA’s LDT Rule, CLIA), standards (e.g. ISO 13485, ISO 20916, ISO 15189) and applicable guidelines (e.g., MDCG, EMA, FDA, etc.) as these apply to diagnostic development and authorization/clearance/approval.
• In-depth knowledge of applicable IVD regulatory requirements, international standards and guidance in the context of drug clinical development - ensure compliance with IVDR, adherence to GCP, and alignment with Medical Device QMS operations.
• In-depth knowledge of relevant Health Authorities (HA), as evidenced by past effectiveness and success with HA interactions.
• In-depth knowledge of the CDx co-development process, including key functions involved at various stages of development.
• Strong analytical skills, attention-to-detail, and writing skills, as evidenced through accomplishments in past roles.
• Strong interpersonal and communication skills, with ability to rapidly understand and adapt to different team dynamics.
• Proven ability and flexibility to work successfully in a team-oriented, matrixed environment.
• Strong organizational and project management skills (familiarity with MS Office Suite, SharePoint, Smartsheet, Lucid chart and other PM tools).
• Ability to travel, as needed.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account.