Director Of Programs And Operations jobs at Genentech - 162 jobs
Chief of Staff, Computational Center of Excellence (CoE)
Genentech 4.5
Director of programs and operations job at Genentech
Advances in AI, data, and computational sciences are transforming drug discovery and development. Roche's Research and Early Development organisations at Genentech (gRED) and Pharma (pRED) have demonstrated how these technologies accelerate R&D, leveraging data and novel computational models to drive impact. Seamless data sharing and access to models across gRED and pRED are essential to maximising these opportunities. The new Computational Sciences Center of Excellence (CoE) is a strategic, unified group whose goal is to harness this transformative power of data and Artificial Intelligence (AI) to assist our scientists in both pRED and gRED to deliver more innovative and transformative medicines for patients worldwide.
The Opportunity:
As a strategic leader within Roche's Computational Center of Excellence (CoE), the Chief of Staff plays a critical role in shaping and driving the CoE's vision, ensuring seamless execution of business strategy, and fostering cross-organizational collaboration. Reporting directly to the Head of CoE, this role acts as a key advisor and execution partner, enabling leadership effectiveness, driving strategic alignment across gRED and pRED, and enhancing the impact of computational sciences, data, analytics, and AI in drug discovery and development.
Strategic Partner
Act as a thought partner and trusted advisor to the Head of CoE on business, organizational, and operational strategies.
Organize and prioritize critical issues and required information for the Head of CoE to facilitate efficient decision-making.
Partner with the Head of CoE and CoE LT in strategic planning, policy development, and decision-making.
Manage SVP priorities and communications, ensuring efficient use of time and resources in advancing computational drug discovery goals
Serve as a spokesperson and advocate for the Head of CoE and their leadership team for internal and external global stakeholders at executive levels and across affiliates.
Drive cross-functional alignment across research, development, and computational teams in a timeline manner to ensure effective implementation of data science and machine learning initiatives
Lead special projects supporting SVP decision-making that require inputs from multiple research and computational disciplines
Identify potential risks and opportunities in computational drug discovery initiatives, propose mitigation strategies, and monitor progress against key performance indicators
CoE Leadership Team (CoE LT) Management
Manage CoE LT meetings, including preparing agendas, ensuring materials are sent in advance, time is well spent, and objectives are achieved. Provide guidance on meeting agendas for broader leadership meetings led by the Head of CoE. Lead and/or facilitate productive debates on key business planning and organizationally relevant topics
Ensure the SVP is well-prepared for internal and external meetings, including board meetings, scientific conferences, and partnership discussions
Develop and execute internal communication strategies that align computational sciences initiatives with broader Genentech drug discovery objectives
Maintain accurate confidential files and data records.
Lead the planning of CoE LT offsites and events.
Stakeholder Engagement and Cross-Functional Leadership:
Build and maintain relationships with key stakeholders across research, development, clinical, and external partnerships in the computational sciences ecosystem
Facilitate communication and collaboration between computational sciences teams and other drug discovery functions, ensuring alignment on critical decisions
Work with leadership in cascading computational sciences goals across the organization and ensuring alignment with overall drug discovery objectives
Track and manage computational sciences projects delegated across the company to ensure timely completion and strategic alignment
Build a strong network with other Chiefs of Staff across Genentech and Roche to facilitate execution of computational sciences initiatives
Foster a culture of collaboration, innovation, and continuous learning across computational sciences teams
Key Success Factors:
Build and maintain strong relationships with the Head of CoE, leadership team, and others in the organization to advise and influence outcomes.
Assist and communicate with executives in decision-making, program management, and initiative implementation.
Understand long term strategic, big-picture priorities while managing the detailed execution of deliverables.
Navigate ambiguous situations to unearth and address core issues or challenges.
Independently lead and drive cross-functional initiatives, projects, or programs at a leadership level.
Develop new approaches to address complex organizational challenges that impact CoE and beyond.
Facilitate resolution of issues relating to projects, priorities, and team dynamics.
Demonstrate creativity, independence, neutrality, and initiative in resolving issues.
Who you are:
Advanced degree in computational sciences, data science, AI, biology, chemistry or a related field or equivalent experience desired.
10+ years in computational sciences, AI, data analytics, drug development, or life sciences industry.
Proven ability to effectively partner with executive leaders in scientific/technical organizations.
Highly skilled in strategic thinking, planning, and execution.
Excellent written and verbal executive communication skills.
Exceptional influencing skills and a consistent track record of driving strategic opportunities and problem-solving.
Strong facilitation and problem-solving abilities, with a capacity to manage ambiguity.
Experience in leading organizations and people through significant change and prioritization.
Proven track record in all elements of people leadership-attraction, hiring, onboarding, development planning, performance management, coaching, and strategic talent evolution.
Strong ability to communicate and influence across global, regional, and local cultures and business units.
Ability to retain focus on long-term goals while addressing high-switching frequency for short-term actions.
Knowledge of Genentech or Roche culture, systems, and organization is a plus.
Travel Requirement:
This role requires up to 30-35% travel for meetings, conferences, and strategic engagements.
Relocation benefits are available for this job posting.
The expected salary range for this position based on the primary location of California is $201,300-$373,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
#ComputationCoE
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
$201.3k-373.8k yearly Auto-Apply 2d ago
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Director, TMTT Commercial Programs - Remote
Edwards Lifesciences Belgium 4.6
Juneau, AK jobs
A leading medical technology company is seeking a remote Director of Commercial Programs to oversee training for its TMTT Sales team. This role involves identifying training sites, managing training events, and ensuring compliance with contracts. Candidates should hold a Bachelor's or Master's degree and possess relevant field training or sales leadership experience in interventional cardiology. The position offers a competitive salary range of $198,000 to $280,000, with various benefits.
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$198k-280k yearly 2d ago
Global HRBP Director, Operations & People Strategy
Illumina 4.8
San Diego, CA jobs
A global genomics company seeks a Senior Director, HRBP for Global Operations in San Diego. This hybrid position involves managing HR strategies for over 3,300 employees globally, focusing on organization design, team effectiveness, and driving HR programs. The ideal candidate will have at least 20 years of experience, including international HR roles, with proven capabilities in developing teams and enhancing a diverse culture. Competitive compensation and benefits are offered.
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$104k-131k yearly est. 4d ago
Senior Director, Medical Excellence Strategic Programs
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
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. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Key Responsibilities
Medical Excellence Leadership
Partner with the Medical Excellence Leadership team to define and execute the global Medical Excellence strategy.
Lead initiatives that elevate consistency, quality, and impact of medical engagement planning, execution, and measurement.
Drive continuous improvement of Medical Affairs processes, tools, and operating models.
Collaborate with other GMSO teams including Digital, Insights and Analytics, Scientific Communications and Content Strategy, and Medical Affairs Technology to build programs that leverage the connection across capabilities.
Partner with Regional Medical Excellence to ensure consistent deployment and execution across the regional teams.
Develop and deploy frameworks, tools, and support that help local and regional medical teams translate global medical strategy into effective engagement plans.
Define standard methodologies, templates, and tools that optimize planning, execution, and measurement across all engagement channels (Field Medical, Medical Information, Digital, etc.).
Collaborate with Channel Leads (digital, personal, and print) to establish clear principles for channel selection, integration, and sequencing, ensuring the right interaction at the right time for the right stakeholder.
Support country and regional teams in operationalizing omnichannel approaches that align with scientific and compliance standards.
Process & Capability Development
Identify and improve cross‑functional Medical Affairs processes that enhance agility, effectiveness, and alignment.
Lead projects to simplify workflows, clarify decision ownership, and reduce duplication across global, regional, and local teams.
Partner with Learning & Development to design capability‑building programs (training, toolkits, playbooks) that embed best practices.
Drive continuous improvement through feedback loops, metrics, and lessons learned from across the organization.
Partner closely with cross‑functional leaders in Field Medical, Strategy and Operations, Medical Governance and Compliance to ensure process alignment and scalability.
Serve as a strategic adviser to global and regional medical leadership teams to drive adoption of best practices.
Lead global working groups and communities of practice that foster peer learning and consistency.
Act as a change leader, influencing, communicating, and embedding a culture of excellence across the global Medical Affairs network.
Measurement & Impact
Define and monitor key success metrics for Medical Excellence initiatives and engagement effectiveness.
Partner with analytics teams to design dashboards and scorecards that enable data‑driven decision making.
Ensure that process improvements translate into measurable enhancements in scientific engagement, compliance, and stakeholder satisfaction.
Worldwide Engagement Strategy Enablement
Develop and deploy frameworks, tools, and support that help local and regional medical teams translate global medical strategy into effective engagement plans.
Define standard methodologies, templates, and tools that optimize planning, execution, and measurement across all engagement channels (Field Medical, Medical Information, Digital, etc.).
Collaborate with Channel Leads (digital, personal, and print) to establish clear principles for channel selection, integration, and sequencing, ensuring the right interaction at the right time for the right stakeholder.
Support country and regional teams in operationalizing omnichannel approaches that align with scientific and compliance standards.
Collaboration & Change Leadership
Partner closely with cross‑functional leaders in Field Medical, Strategy and Operations, Medical Governance and Compliance to ensure process alignment and scalability.
Serve as a strategic adviser to global and regional medical leadership teams to drive adoption of best practices.
Lead global working groups and communities of practice that foster peer learning and consistency.
Act as a change leader, influencing, communicating, and embedding a culture of excellence across the global Medical Affairs network.
Qualifications
12 years of relevant experience with an Advanced degree (MS, MBA, PharmD, PhD or equivalent) in a scientific or business discipline.
10+ years of experience in Medical Affairs, preferably with global or regional leadership role.
Demonstrated success in Medical Excellence, process optimization, capability building, or strategic operations.
Proven track record leading cross‑functional initiatives that improve effectiveness and alignment.
Experience supporting engagement strategy or omnichannel medical planning strongly preferred.
Excellent communication, facilitation, and stakeholder management skills.
Strong analytical mindset and familiarity with metrics‑driven performance improvement.
Demonstrated ability to work effectively in a highly matrixed, global organization.
Personal Attributes
Strategic systems thinker, able to connect process design to business impact.
Collaborative and credible partner who influences without authority.
Change‑oriented leader who inspires confidence and adoption.
Comfortable operating at both conceptual and tactical levels.
Passionate about advancing scientific engagement and improving patient outcomes.
Impact of the Role
This position will help ensure that Medical Affairs operates as a strategic, insights‑driven, and impact‑focused function, fully aligned with Gilead's vision of transforming care for people with life‑threatening diseases worldwide. By embedding consistent frameworks, capabilities, and engagement excellence, this leader will help global and local teams work smarter, faster, and more cohesively, ultimately amplifying Gilead's scientific voice and medical impact.
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. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Benefits and Compensation
The salary range for this position is: $281,010.00 - $363,660.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: ******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Gilead Sciences is seeking a highly motivated, adaptable, and experienced Program and Project Management leader to start up a new state-of-the-art Single-Use DS Biologics Manufacturing facility in Foster City and integrate this facility with existing Foster City cGMP Manufacturing activities.
As the Foster City Manufacturing Operational Readiness Program Lead, you will design, build and manage the multi-year cross-functional program of activities and workstreams involved in transitioning Gilead's new Foster City biologics manufacturing facility from capital project into routine cGMP production. You will help ensure that the systems, people, and processes are in place to support clinical manufacturing and future commercial launches. This is a unique opportunity to shape the future of Foster City Manufacturing for Gilead and make a lasting impact on global health.
Job Responsibilities
Coordinate the creation of an Operational Readiness Program and reinforce a sense of purpose and ownership among all team members. Structure distribution of responsibilities across multiple workstreams within the program, drive prioritization and sequencing of workstreams, and partner with the Capital Project team to align operational and project timelines, deliverables, and resources.
Evaluate industry best practices and select an appropriate program and project delivery model that supports the dynamic nature of a new facility startup and integrates with Gilead's existing governance and delivery frameworks.
Select and manage the tools, standards, business processes, documentation, metrics, and communications associated with the Operational Readiness Program.
Partner with IT and key stakeholders to pilot and implement innovative digital solutions for the Operational Readiness Program and Foster City Manufacturing.
Organize, prioritize, sequence, and track workstreams, activities, and resources necessary for Foster City Manufacturing to support startup and Engineering project deliverables.
Work with the Foster City Manufacturing Leadership Team, the Global Manufacturing organization, and senior leaders across PDM to develop a comprehensive Foster City Manufacturing site strategy document and own the portfolio of projects to achieve the site's long-term ambitions.
Actively participate in defining and communicating the Foster City Manufacturing mission and vision in alignment with Gilead's corporate values. Act as a change agent to foster an inclusive and high performing organization with a culture of curiosity, continuous improvement, and innovation.
Operate with an Enterprise-First mindset and a willingness to adapt and flex across functional boundaries as needed to achieve mission critical tasks.
Minimum Required Education, Years of Experience and Qualifications
Bachelor's degree in engineering, life sciences, or related field, and 10+ years of experience in biotech/pharma manufacturing or process development with a minimum of 2 years direct or matrixed people leadership experience. OR
Masters' Degree and Eight Years' Experience in biotech/pharma manufacturing or process development with direct or matrixed people leadership experience
5+ years of project and portfolio management experience utilizing both traditional and agile project delivery methodologies.
Strong understanding of cGMP compliance.
Strong business and financial acumen.
Proven experience successfully managing cross-functional teams and complex project timelines with significant components of uncertainty.
Demonstrated ability to thrive in a dynamic environment and collaborate across diverse technical areas.
Experience with Biologics Drug Substance manufacturing equipment and processes, Single-Use Technologies, and cGMP facility qualification and startup preferred.
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
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$130k-167k yearly est. 3d ago
Director, US Real World Evidence Center of Excellence
Gilead Sciences, Inc. 4.5
Santa Monica, CA jobs
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T‑cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.
Responsibilities
Lead study concept development and execution of incidence/prevalence, burden of illness and natural history of disease assessments for business and development and early‑development indications.
Provide strategic and tactical support for cross‑functional RWE development including registries and burden of illness/natural history of disease for regulators, payers and clinicians.
Provide leadership and oversight of non‑interventional study protocols, regulatory documents and scientific publications.
Provide excellent people leadership to the team, fostering a candid, constructive feedback culture, cultivating the team's development and investing in succession planning.
Adapt performance metrics and dashboards for RWE projects to quantify and enhance impact.
Provide expertise on RWE and observational research to cross‑functional teams including brand strategy teams for assigned brand/pipeline, newly launched and marketed product(s).
Assess research gaps and objectives across key partners and disease areas to determine proactive RWE/observational research strategy.
Possess superb communication skills with adaptability to address technical and non‑technical audiences, and comprehensive understanding of strategies to translate observational research methods and results for patient benefit.
Effectively manage internal and external stakeholder expectations regarding strategic objectives and execution of research.
Provide RWE expertise and input for regulatory filings (e.g., BLA, sBLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications, filing procedures or pharmacovigilance/safety inquiries.
Develop, execute and deploy integrated evidence generation plans, develop contingency plans, provide technical and strategic advice and meet milestones and budgets.
Provide RWE leadership in scientific forums and interact with clinical investigators, thought leaders, external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs and Commercial).
Benefits & Compensation
Salary range: $221,000.00 - $286,000.00
Kite considers a variety of factors when determining base compensation, including experience, qualifications and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary by role), paid time off and a benefits package. Benefits include company‑sponsored medical, dental, vision and life insurance plans.*
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit *******************************************************************
Equal Employment Opportunity Statement
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing or action, (c) consistent with the legal duty to furnish information or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. We promote and support individual differences and diversity of thoughts and opinion.
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Associate Director, CMC Regulatory Affairs - Biologics
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes medicines in areas of unmet medical need. We focus on HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. We seek to improve patient care worldwide and collaborate to achieve bold ambitions.
We value leadership, inclusion, and accountability. As a member of Gilead, you contribute to creating possible, together.
KEY RESPONSIBILITIES
Lead CMC regulatory strategy for one or more products.
Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation to ensure right first-time product submissions.
Oversee the execution of global CMC regulatory plans, coordinating with PDM, Regulatory Affairs, and Clinical Development to manage submissions and approvals.
Develop regulatory strategies and solutions for complex CMC challenges for clinical or commercial projects.
Interpret and implement ICH and other global guidelines to achieve an approved/harmonized regulatory control strategy.
Collaborate across CMC Regulatory Affairs, PDM, and other functional groups within Gilead.
Lead CMC strategies, assess risks, and develop contingency plans for major, complex applications.
Demonstrate Gilead Core Values and People Leader Accountabilities, upholding global CMC principles of integrity.
QUALIFICATIONS
A scientific degree with at least 10 years of relevant experience in biologics development, global CMC regulatory affairs, and CMC technical areas (BA/BS) or 8+ years with an advanced degree (MA/MS, PhD, PharmD, or MD).
Proven track record in executing and implementing CMC regulatory strategies for a molecule.
Knowledge of the global CMC regulatory landscape.
Judgment to make timely decisions; strong strategic acumen and collaboration skills.
Advanced communication and presentation skills.
GILEAD CORE VALUES
Integrity (Doing What's Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
Salary range: $182,070.00 - $235,620.00. Compensation is based on experience, qualifications, and geographic location. Benefits may include bonus eligibility, stock-based incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance. See ****************************************************************** for details.
For jobs in the United States
Gilead is an equal employment opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other protected characteristics. Reasonable accommodations are available for applicants with disabilities. For accommodations, contact ApplicantAccommodations@gilead.com.
Other notices: Know Your Rights poster; pay transparency; and related protections apply where applicable.
For current Gilead employees and contractors: Please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0047307. Full Time/Part Time: Full-Time. Job Level: Associate Director.
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$182.1k-235.6k yearly 3d ago
Associate Director, Regulatory Affairs - Virology
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
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.
We believe every employee deserves a great leader. People leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
As an Associate Director, Global Regulatory Affairs, you will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the virology therapeutic area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early‑stage or other programs. You will lead Regulatory Submission Teams or other Regulatory Project Teams and represent Global Therapeutic Area Regulatory on cross‑functional core and sub‑teams. You will typically serve as a Gilead contact to and for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.
Position will be filled in either Foster City, CA or Parsippany, NJ.
EXAMPLE RESPONSIBILITIES:
As needed, represent Gilead in negotiations with regulatory authorities.
Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
Represent Regulatory Affairs and may serve as Regional Regulatory Lead or Global Regulatory Lead on cross‑functional/cross‑regional Regulatory Submission Teams; provide strategic advice and guidance to Regulatory Affairs and cross‑functional leaders and teams.
May participate on other Sub‑teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub‑team participation.
Define the regulatory strategy for multiple Gilead products or projects.
Proactively identify regulatory or related risks/issues and develop mitigation and/or contingency plans.
Oversee and guide the preparation, compilation and timely filing of regulatory submissions, requiring cross‑functional interactions for commercial or investigational products. Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendments and routine submissions (e.g., Development Safety Update Reports/DSURs, Investigator Brochure/IB updates, etc.).
Oversee and approve the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
Oversee and guide labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
Critically review documents for submission to regulatory authorities.
Provide matrix management and leadership to project teams.
Provide accurate and thorough input and recommendations into resource plans required to complete own deliverables. Track resources to ensure compliance with agreed resource allocation, including budgets.
Ensure own work complies with established practices, policies and processes, and any regulatory or other requirements.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience
PharmD/PhD with 2+ years' relevant experience.
MA/MS/MBA with 8+ years' relevant experience.
BA/BS with 10+ years' relevant experience.
Significant regulatory, quality, compliance or related experience in the biopharma industry.
Proven track record in effectively setting and directing the regulatory or related strategy to successful conclusion for one or more products or key markets.
Experience and proven effectiveness working and negotiating with regulatory authorities.
Significant experience participating in cross‑functional projects and teams with responsibilities related to clinical trials or other drug development activities.
Demonstrated abilities to effectively delegate and manage others, as evidenced through past matrix management responsibilities.
Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
Knowledge & Other Requirements
In‑depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.
In‑depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.
Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications.
In‑depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
Able to represent Gilead to regulatory authorities when managing standard and non‑standard negotiations.
Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post‑marketing.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong negotiation and conflict resolution skills.
When needed, ability to travel.
The salary range for this position is: Bay Area: $182,070.00 - $235,620.00. Other U.S. Locations: $165,495.00 - $214,170.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans.*
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For additional benefits information, visit: ******************************************************************
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status and other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected under Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT. YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT.
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$182.1k-235.6k yearly 2d ago
Associate Director, Regulatory Affairs CMC
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
Associate Director, Regulatory Affairs CMCJob Description
We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, CA site.
Responsibilities:
The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives.
Responsible for preparing and/or overseeing the preparation of complex regulatory CMC submissions for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Work collaboratively with cross functional matrix teams to develop a CMC submission plan in accordance with business objectives.
Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategies.
Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
Lead the preparation of risk assessments on major global CMC regulatory issues.
Provides regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises.
Coordinates and facilitates development of Regulatory CMC strategies with development and commercial project teams, affiliates for local meetings and interactions.
Proven ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends, and to drive and implement strategic policy decisions.
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Ensures project teams, line management, and key stakeholders are kept apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
Initiates process improvements, contributes to global process improvements, and support the development and maintenance of regulatory templates, best practices, and procedures.
Coach and mentor junior regulatory CMC RA staff.
Qualifications:
Requires a Bachelor's degree in a relevant scientific discipline and 10+ years of experience OR
(Preferred) Requires a Masters degree in a relevant scientific discipline and 8+ years of experience OR
(Preferred) Requires a PhD in a relevant scientific discipline and 5+ years of experience.
Candidate must have relevant experience in Regulatory Affairs CMC or other relevant industry experience. Experience in scientific/ technical field is preferred.
A proven track record of developing global CMC strategies in all phases of drug development including life cycle management.
Collaborative, proactive, and highly organized approach to work.
Demonstrated track record with strategic planning, problem solving, and working within a global matrix team environment, successfully managing CMC Regulatory activities and initiatives.
Deep understanding of global regulatory requirements and guidelines.
Excellent communication and interpersonal skills.
The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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The Patient Access Solutions Support Program team strives to deliver exceptional patient treatment experiences across multiple brands and therapeutic areas. We empower patients to realize their full treatment potential through support programs encompassing HIV, Liver and Oncology products.
Position Overview:
The Associate Director will be part of the Patient Access Solutions team and will be responsible for developing access and reimbursement materials to support the Gilead HIV Prevention Field Reimbursement Manager (FRM) team. This role will lead the direction and execution of FRM access and reimbursement materials, resources, and tools, ensuring alignment with market access strategy to address educational needs of the patient and healthcare providers office staff. Additionally, this position will collaborate closely with internal stakeholders such as marketing, national account team, trade and FRM teams to develop FRM patient support educational materials and access and reimbursement communication and training plans to address ongoing reimbursement challenges.
This position is responsible for the strategic oversight of the access and reimbursement resources for the HIV Prevention support program ensuring an effective provider experience. This leader needs to be able to design, plan, and pull through appropriate market‑leading resources and tools ensuring efficient, effective, compliant execution and manage continuous improvements on an ongoing basis. To do so, the candidate will be required to have familiarity with the relevant customer/market needs and solutions, including a strong understanding of compliance as it relates to patient support programs and Field Reimbursement Manager (FRM) teams.
Key Responsibilities:
Creation and Execution of FRM Materials and Tools: Partner with key internal stakeholders to create and roll‑out strategic marketing materials for the FRM team to achieve Access and Reimbursement goals. Lead effort to roll out materials to FRM team.
Strategic Communications: Ensure materials are aligned with support program positioning, messaging, aimed at patients and healthcare providers, ensuring alignment with patient support experiences and strategic imperatives.
Analytics: Support FRM digital resources, portals, and tools for effective support of patient and provider access and reimbursement challenges.
Field Team Support and Collaboration: Collaborate with the Patient Support team, FRM team and Access and Reimbursement (A&R) colleagues to execute strategies, incorporating insights from payer landscapes, buy‑and‑bill models, and specialty pharmacy acquisition.
Agency and Partner Management: Work with Patient Support team to oversee agency relationships to drive creative excellence, ensuring quality deliverables that align with market access materials.
Annual Planning: Lead the annual planning process for patient and provider resources, identifying barriers to patient access and developing innovative solutions.
Governance and Compliance: Collaborate with Market Access, National Accounts, Legal, Medical, Regulatory, Brand and Trade teams, to ensure a comprehensive governance process for FRM Materials and initiatives.
Ensure all activities are conducted in compliance with relevant regulations and ethical guidelines related to patient access and reimbursement.
Qualifications:
Education: Bachelor's Degree in a relevant field is required.
Experience: At least 10+ years of marketing experience with a proven track record in strategic leadership roles.
Domain Expertise: Strong expertise in Patient and HCP support programs, Access and Reimbursement strategies, drug acquisition channels, and medical and pharmacy benefit design.
Analytical Skills: Exceptional analytical skills with the ability to translate complex business challenges into actionable strategies.
Leadership Ability: Demonstrated experience leading cross‑functional teams and influencing across the organization without formal authority.
Communication Skills: Excellent written and oral communication skills, capable of interacting and building relationships at all organizational levels.
Stakeholder Management: Proficient in managing various internal and external partnerships, maintaining effective relationships with agencies and vendors.
In‑depth knowledge of healthcare reimbursement practices, services, technologies, and related compliance and regulatory requirements.
Dealing with ambiguity
Proven experience developing and fully executing patient access programs.
Exceptional written, verbal and presentation skills
Building and leading teams
Leading without authority
Project management
Strategic planning and execution
Analytical thinking and problem solving
Comfortable with data analytics and presentation of findings
Financial budget management
Effective organizational management
Strong organizational skills; attention to detail
Proficient competency using Word, Excel and PowerPoint
Ability to multitask and manage multiple parallel projects.
Ability to work with minimal supervision.
Job Requisition ID: R0044625
Job Level: Associate Director - Full Time
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$132k-171k yearly est. 5d ago
Associate Director, End-to-End Global Supply Planning
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
A leading biopharmaceutical company is seeking an Associate Director, End-to-End Commercial Supply Planner to develop and execute supply plans. This role emphasizes collaboration with regional supply chain leads, utilizing tools like SAP ERP and Kinaxis RapidResponse. Ideal candidates will have extensive experience in supply planning within the pharmaceutical industry, along with strong analytical and communication skills.
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$132k-171k yearly est. 3d ago
Associate Director, Regulatory Affairs Advertising and Promotion
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross‑functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies.
You will manage the commercial regulatory strategy and execution of such for one or more high-volume and/or otherwise complex brands or therapeutic areas. You may manage, oversee, and review the work of one or more direct reports. You will represent the commercial regulatory perspective at and chair high-volume Promotional Review Committee (PRC) meetings for complex brands. You may lead local cross‑functional process improvements or other special projects. You will provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to promotional materials with regulatory agencies. You will communicate relevant updates or changes to cross‑functional leaders and teams.
EXAMPLE RESPONSIBILITIES:
Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate.
Serves as PRC Chair for one or more high-volume and complex brands or therapeutic areas.
Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.
Serves as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products, with managerial oversight, as appropriate.
May lead local cross‑functional process improvements or other special projects. May initiate and/or contribute to global process improvements.
Provides regulatory guidance on new marketing concepts, messaging, and campaigns.
Represents RA Ad/Promo at Regulatory Project Team meetings.
Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance.
Mentors RA Ad/Promo and cross‑functional team members as needed.
May have one or more direct reports.
Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
PharmD/PhD 4+ years' relevant experience.
MA/MS/MBA with 8+ years' relevant experience.
BA/BS with 10+ years' relevant experience.
For external candidates, 4+ years' experience in regulatory review of promotions for prescription drugs or other biologic products.
Significant experience leading development and execution of regulatory submissions of promotional materials for marketed prescription drug or biologic products.
Significant experience contributing to the development of commercial regulatory or related strategies, leading cross‑functional regulatory activities, and representing Regulatory to cross‑functional teams for multiple products.
Experience chairing/leading promotional review committees or other relevant regulatory governance committees.
Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus.
Line management (direct reports) experience is a plus.
Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
Experience working with external contractors supporting the work of regulatory affairs is a plus.
Experience authoring and/or implementing processes.
Significant experience participating in cross‑functional projects and teams.
Knowledge & Other Requirements
Demonstrates in‑depth knowledge of current trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects.
Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
In‑depth knowledge of promotional regulations and guidance for prescription drug and biologic products, including industry best practices and standards.
Working knowledge of relevant regulatory or related systems is preferred.
Demonstrates ability to rapidly learn new therapeutic areas.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong negotiation and conflict resolution skills.
When needed, ability to travel.
Job Requisition ID R0044546
Full Time/Part Time Full-Time
Job Level Associate Director
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A leading biopharmaceutical company is seeking an Associate Director, Incentive Compensation who will oversee the complete incentive compensation process for sales teams. The role involves collaborating with cross-functional teams, designing compensation plans, and ensuring accurate payouts. Candidates should have over 10 years of experience in relevant fields and strong analytical, communication, and project management skills. Experience in virology and oncology is preferred, alongside a solid educational background in finance or business.
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$132k-171k yearly est. 5d ago
Associate Director, Regulatory Affairs - Global Labeling
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product information and labeling updates, including other Development teams, Legal, Commercial, and external regulatory agencies.
You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic area. You will lead various Core Labeling Working Group (CLWG), Target Product Label (TPL), and U.S. Product Information (USPI) team meetings. You will represent RA Labeling across all organizational levels relevant to assigned products and/or other activities. You will manage, oversee, review, and approve the work of a team of direct reports. You will manage complex labeling negotiations with regulatory authorities. You will communicate labeling and other relevant updates or changes to cross-functional leaders and teams. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will train cross-functional partners and teams on labeling processes, policies, procedures, and standards, etc.
Key Responsibilities:
Individual contributor, with potential leadership opportunities to mentor and coach others, supporting their development and career interests.
Leads or otherwise contributes to the development of the labeling strategy for multiple products and indications.
Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology therapeutic area.
Provides strategic advice and guidance to cross-functional partners and stakeholders.
Leads and facilitates cross-functional labeling and related forums and meetings, such as CLWG, TPL, and USPI team meetings.
Leads or otherwise contributes to key system and process improvements.
Represents or otherwise oversees other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on joint labeling / safety meetings with partner companies.
Oversees and guides Company Core Data Sheet (CCDS)/USPI review, approval, distribution, and tracking. Ensures updates to the CCDS are implemented in the USPI.
Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories. Performs team and/or final review of ex-U.S. labeling.
Manages complex labeling negotiations with regulatory authorities.
Coaches and advises less experienced colleagues in completing their work and developing their regulatory capabilities.
Leads or otherwise contributes to special projects that advance the capabilities of Regulatory Affairs.
Trains other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling.
Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.
Preferred Qualifications:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Preferred Education & Experience
PharmD/PhD with 2+ years' relevant experience.
MA/MS/MBA with 8+ years' relevant experience.
BA/BS with 10+ years' relevant experience.
4+ years' experience in prescription drug labeling.
Significant regulatory experience in the biopharma industry is strongly preferred.
Significant experience working with a broad array of regulatory labeling documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products.
Significant experience contributing to the development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple medicinal products.
Experience in NDA/BLA labeling and labeling negotiations.
Significant experience participating in cross-functional projects and teams.
Experience authoring and implementing processes.
Line management (direct reports) experience.
Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
Knowledge & Other Requirements
In-depth knowledge of labeling requirements and guidance, including industry best practices and standards.
Demonstrates extensive understanding of competitor labeling, strong therapeutic area knowledge, and CCDS/USPI expertise.
Demonstrates ability to rapidly learn new therapeutic areas.
Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects.
Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects, and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills.
Strong negotiation and conflict resolution skills.
When needed, ability to travel.
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. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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$132k-171k yearly est. 3d ago
Global CRM Strategy Director | Life Sciences Enablement
Biomarin 4.6
San Rafael, CA jobs
A global biotechnology company in San Rafael seeks a Director, Global CRM Business Lead to shape and execute its CRM strategy. The role requires a strong background in CRM systems, particularly Veeva and Salesforce, and at least 10 years of experience in the biotech or pharmaceutical industry. Key responsibilities include leading CRM initiatives across business units, enhancing customer engagement, and ensuring seamless integration. This position offers a competitive salary range of $178,900 to $245,960 plus additional benefits.
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$178.9k-246k yearly 2d ago
Global CRM Strategy Director - Life Sciences
Biomarin Pharmaceutical Inc. 4.6
San Rafael, CA jobs
A leading biotech company in California is looking for a Director, Global CRM Business Lead to shape and execute the enterprise CRM strategy. Candidates should have over 10 years of CRM experience, particularly in the biotech or pharmaceutical sector, and be familiar with tools like Veeva and Salesforce. The role focuses on enhancing customer engagement through strategic leadership and effective data analysis. Competitive salary and a comprehensive benefits package included.
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$160k-240k yearly est. 3d ago
Director of Pharmaceutical Program Leadership
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
A leading pharmaceutical company is seeking an experienced project manager with extensive knowledge of drug development. This role requires the ability to manage complex project deliverables and lead cross-functional teams effectively. Candidates should have a strong background in pharmaceutical project management, excellent communication skills, and experience with diverse team dynamics. A Bachelor's degree and a minimum of 12 years of relevant experience within the industry are preferred. The position offers opportunities for significant professional growth within an innovative environment.
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$149k-193k yearly est. 5d ago
Director, Talent Management
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses
worldwide.
Director, Talent Management
About the role
The Director, Talent Management will lead in developing tools and approaches to support our Talent Management strategy, specifically related to identification and assessment of both talent and the role and/or capability needs for the future.
This role will work with the Talent, Development and Inclusion team, HR Business partners, People partners, HR Shared Services, and business leaders to develop innovative approaches, as well as clear discipline and practices to support talent development. The Director, Talent Management will partner in defining what we mean by talent and the role of talent in an AI-enabled workforce, inclusive ways to identify talent and targeted approaches to develop talent, depending on the segment.
The role will also partner to ensure we are aligning Talent to Value and diagnosing key talent requirements across the business to inform development focus and opportunities.
This role reports to the Global Head of Talent and Growth and is based in Foster City, California.
Responsibilities
Leads the team responsible for end-to-end yearly talent cycle with a focus on building a system and processes that enable high-performance, learning, growth, and engaged employees.
Ensures the continuous improvement and innovation of talent systems, programs, and processes incorporating stakeholder feedback.
Leads in the design, execution, and monitoring of the identification, assessment, and development approaches and solutions to improve the depth and capabilities of Gilead's global talent.
Manages the talent review, succession planning, and performance process from start-of-year goal setting to end-of-year conversations including the analysis of results and data. Monitors the subsequent assessment and development activities that support the organization in developing an adequate pool of talent.
Ensures approach to strengthens management's ability to identify and assess talent and support development planning.
Diagnoses critical needs across talent segments and develops innovative approaches to support accelerated development.
Partners with HR Business Partners, and People Partners to embed Talent to Value practices and ensure oversight of Value Creating roles. Supports in identifying critical challenges to support and enable success in the role.
Works across the Talent, Development and Inclusion COE to ensure talent identification, assessment and development practices are integrated and supported.
Monitors the development of key talent and coordinates with HR Business Partners and People partners to have development plans in place and achieved while ensuring readiness for next likely assignment.
Takes a key role in the coaching and development planning for key leadership talent.
Partners with Talent Acquisition to ensure proactive planning and prioritization for pipelining where key gaps are identified in succession planning and/ or where key roles require.
Continually monitors bench strength and ensures plans are in place to address gaps.
Expertise
12+ years with BS/BA; 10+ Years with MS/MA or MBA
Progressive experience in talent management and/or human capital experience people / leadership development (in either an HR internal role or HR consulting role working directly in Human Capital or Leadership/ talent management consulting)
Experience advising and guiding leaders and managers in talent and leadership practices in a global environment.
Expertise in designing, integrating, and operationalizing talent management/development across a global organization.
Leadership Capabilities
Demonstrated ability to build relationships and influence across a matrixed, global organization, responding quickly to change and adapting/operating in ambiguous environment.
Ability to leverage data and insights to diagnose, define focus and align opportunities.
Takes a proactive, long-term perspective in design and developing approaches to deliver outcomes for the business.
Seeks diverse perspectives, experiences and insight; creates an environment of trust and openness.
Has a customer focused approach and embeds into mindset, practice and methodology.
Excellent oral and written communication skills; able to simplify and integrate complex concepts and ideas.
Demonstrates development focus by seeking feedback and acting on it and providing feedback to others.
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. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ****************** for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster.
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$167k-245k yearly est. 5d ago
Executive Director - Viral Hepatitis
Gilead Sciences, Inc. 4.5
Foster City, CA jobs
Executive Director - Viral HepatitisUnited States - California - Foster City Clinical Development & Clinical Operations Regular
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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Executive Director - Viral Hepatitis
At Gilead, we are driven to develop lifesaving products that make a difference for patients around the world. Every day, we transform the promise of science and technology into breakthrough, innovative therapies that have the power to cure, prevent or treat disease. As a research-based biopharmaceutical company, we are revolutionizing healthcare by bringing medicines to patients in the areas of unmet need including virology, respiratory diseases, liver diseases, hematology and oncology, and inflammation. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives.
POSITION OVERVIEW:
This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for HBV and HDV infection. The Executive Director, Clinical Development, position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide expertise in clinical HBV and HDV medicine. You will lead a portfolio of clinical trial programs in virology clinical development for viral hepatitis. You may act as or oversee other Development Leads across the assigned project portfolio. You will be accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across your project portfolio. You will lead or otherwise oversee and direct the development, implementation, and execution of the clinical development strategy for the assigned molecules/products, which will include development of the Target Product Profile and Clinical Development Plan. Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations.
KEY RESPONSIBILITIES
The executive director will play a key role in all stages of development for product programs from the drug discovery stage through product registrations worldwide.
Strategic input and oversight for ongoing and planned product trials/collaborations within the viral hepatitis portfolio
Strategic input and oversight of the HDV programs
Strategic input into the HDV and HBV cure programs
Develop and execute Phase 1, 2, and 3 clinical trials and provide scientific expertise
Serves as a member of the hepatitis leadership team
Report to VP of Hepatitis/Respiratory and Emerging Viruses who has direct responsibility for the overall strategy, clinical and scientific development activities
EXAMPLE RESPONSIBILITIES:
Leadership role in clinical strategy and execution of all hepatitis treatment, cure studies, translational programs, and research collaborations with close relationships with the research team
Key member of a team responsible for all scientific aspects of conceptualizing, planning, and executing trials.
Routinely represents the assigned molecules/products in cross-functional steering and/or governance committees.
May lead the Global Development Team (GDT) for assigned molecules and/or assign GDT leadership to direct reports to ensure clinical development project deliverables and timelines are consistently met.
May act as a core team member on the Program Strategy Team or assign this role to direct reports to ensure appropriate clinical development input and direction into the full lifecycle management of assigned products.
Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules/products.
In general, serves as the lead for communications, both written and oral, with health authorities.
Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations.
Presents scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring scientific publications.
Key insight and involvement in the evaluation of business development opportunities.
Develops thought leader and other external relationships that can guide short- and long-range clinical development strategies and direction for multiple molecules, the disease or therapeutic area overall.
Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
Provides scientific and clinical guidance to Research, Biology, Virology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff.
Typically manages a team of direct reports.
May lead two or more specific components of organizational strategic initiatives.
MINIMUM EDUCATION & EXPERIENCE
MD or equivalent with 8+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.
Experience in viral hepatitis is preferred; however experience performing clinical research studies in those with chronic liver diseases, inflammation/fibrosis, immunology is also considered.
Experience in the biopharma industry is strongly preferred.
Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting, or academia, including short- and long-range strategic planning, governance, and oversight.
Extensive experience taking the lead on clinical study plans, protocol design, regulatory filings, clinical publications, and presentations.
Line management (direct reports) experience is required.
Extensive experience interacting with and presenting to executives is strongly preferred.
Demonstrated excellence leading large-scale, complex short- and long-range strategies in life sciences, healthcare, consulting, or academia.
KNOWLEDGE & OTHER REQUIREMENTS
Has an expert-level of knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans.
Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
Strong leadership skills with an ability to set vision, lead change, and mentor others.
Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives.
When needed, ability to travel.
The Gilead Difference
Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. But it's just what we do that gives us an edge, it's how we do it. We expect everyone at Gilead to lead by example, guided by our core values:
Integrity - Doing What's Right
Inclusion - Encouraging Diversity
Teamwork - Working Together
Accountability - Taking Personal Responsibility
Excellence - Being Your Best
The salary range for this position is: $324,615.00 - $420,090.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.*
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
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$324.6k-420.1k yearly 2d ago
Digital Operations Senior Manager - Web
Genentech 4.5
Director of programs and operations job at Genentech
** Why Genentech We're passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity, and creativity while boldly pursuing answers to the world's most complex health challenges and transforming society.
Who We Are
Digital Experience is shaping the future of how Genentech connects with our patients and customers by harnessing the power of digital innovation and human-centered design. As healthcare evolves, we are bold in our approach - leveraging cutting edge AI, advanced digital engagement, end-to-end content management, and omnichannel technologies and operations to create seamless, personalized, and meaningful experiences for our patients and customers. This is your opportunity to lead transformative change, integrating advanced technology with strategic vision to drive impact at scale. If you are passionate about redefining the healthcare experiences and building something extraordinary, we want you on this journey. Let's redefine what's possible together!
This combined team, in collaboration with key partners, builds solutions to serve Marketing, Customer Engagement, Medical Affairs, Public Affairs & Access ("CMG"), and other patient- and customer-facing teams across CMG to shape and drive a seamless, consistent, meaningful, and compliant experience for patients and customers across our interactions. The team is specifically accountable for:
● Defining omnichannel solutions, shaping engagement strategies, designing, operationalizing, and producing seamless, consistent & meaningful patient and customer experiences.
● Accelerating, connecting, and enabling the development of digital solutions that enhance the patient and customer experience across CMG.
● Advancing the mission of seamless, consistent & meaningful patient and customer experiences that maximize patient impact while keeping compliance at the forefront.
The Opportunity
The Digital Operations Senior Manager - Web is accountable for designing processes and governing operations that allow for the seamless execution of web experiences as part of integrated digital campaigns. This role works closely with the Director, Digital Operations and Business Product Owner to design and build processes that support the Web roadmap and optimal campaign delivery. In addition, this role works to optimize existing processes to ensure maximum efficiency and scale. A successful candidate will have demonstrated experience
creating and optimizing standards and solutions, with a focus on optimal customer quality, speed, and cost-effectiveness at scale across a portfolio of products.
Key Responsibilities
● Be a valued thought partner by sharing operational insights to influence requirements for new capabilities, product offerings, and the overall product roadmap, where applicable.
● Lead operations when launching products - new features and enhancements , ensuring they are effectively integrated into workflows.
● Explore new ways to improve processes or expand the current capability or product by collaborating with other teams.
● Understand the user experience by developing efficient or automated ways to collect user feedback (e.g., incidents, failures, etc.) and ensure timely resolution, in collaboration with RDT Technical Lead and Customer Experience (CX) team. Communicate status updates to maintain high levels of user satisfaction. Partner closely with Activation to define a mitigation strategy.
● Seamlessly engage the appropriate cross-functional partners, performing regular reviews and updates to products to determine if the process needs to be improved or iterated. Be an advocate for the process.
● Deeply understand operational best practices both within and outside the organization & industry, and develop strategies for implementation across product & user workflows
● Anticipate or surface roadblocks and barriers and develop mitigation strategies to address them proactively and escalate in a timely manner.
● Maintain and support products in their steady state, ensuring quality and usability.
● Leverage deep subject-matter expertise & knowledge of user needs to shape product & process enhancements
● Define and manage Hypercare support resources as needed to support any new feature releases, including automated processes.
● Oversee knowledge management to ensure that all team members have access to the necessary information and resources.
● Engage with Activation and Learning and Skill Development, leveraging deep subject-matter expertise to provide input into stakeholder trainings (AOR, marketing, field members, etc) as necessary.
● Collaborate with other Product Operations Leads and/or Managers to implement and adhere to standardization and consistency in processes and ways of working across Products (when applicable).
● Ensure adherence to in-market error reporting compliance practices.
● Influence Operations Leads and/or Managers to advance overall enterprise operations roadmap (such as workflow, Adverse Event reporting, enterprise campaign delivery, UAT practices, etc).
● Monitor reported issue trends and provide strategic recommendations for the product roadmap to enhance product offerings.
Who You Are
Minimum Candidate Qualifications & Experience
● Bachelor's degree in business, operations, technology, operations, science, marketing, or a related field, or equivalent experience.
● 5 years of experience in strategy & operations, process operations, product operations, digital operations, or equivalent experience.
● Proven experience in project management and operational support.
● Strong understanding of SOPs and compliance processes.
● Experience with data analytics tools and methodologies.
● Strong problem-solving skills and attention to detail.
● Ability to adapt to new technologies and drive process improvements.
● Experience driving operational excellence through implementation of workflows, automation, scaling, and process optimization.
● Exceptional communication, collaboration, and community engagement skills.
● Proven ability to resolve incidents, gather feedback, and maintain high user satisfaction in a fast-paced environment.
● Strong analytical skills with the ability to monitor and interpret operational data trends and provide actionable insights for improvement.
● Experience overseeing knowledge management and user support initiatives.
● Demonstrated success in managing complex projects involving cross-functional teams and external vendors.
Additional Desired Candidate Qualifications & Experience
● Advanced degree, or equivalent experience (e.g., MBA or related graduate-level qualification).
● Experience in the healthcare or pharmaceutical industry or another highly regulated industry.
● Expertise in User Acceptance Testing (UAT) and Quality Control (QC) processes to ensure product reliability.
● Expertise in workflow optimization and automation tools (e.g. Jira), including AI-driven solutions for task management, process enhancement, and seamless collaboration across teams.
● Knowledge of compliance standards and regulatory frameworks relevant to operations and product workflows.
● Demonstrated ability to manage vendor relationships, including Service Level Agreement (SLA) governance.
● Proficiency in leveraging operational data to measure success metrics (e.g., speed, cost, quality) and improve performance.
● Understanding of privacy compliance frameworks (e.g., OneTrust, GDPR, CCPA) as they relate to web and mobile operations.
Location
● This position is based in South San Francisco, CA, however a remote work option will be considered for US candidates who live outside of the Bay Area.
_The expected salary range for this position based on the primary location of South San Francisco, CA is $136,100 and $252,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below._
Benefits (****************************************************
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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .