Gilead’s primary areas of focus include HIV/AIDS, liver diseases, serious respiratory and cardiovascular conditions, cancer and inflammation.

Associate Director, CMC Regulatory Affairs- Biologics

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

The Associate Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio.  This position will ensure “right first time” global approvals of CMC regulatory (Biologics) submissions, and “right to operate” by maintaining the global clinical or commercial submissions. In addition, you will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions. As a regulatory lead you will also be responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams.

KEY RESPONSIBILITIES:

• Responsible for preparing and/or overseeing the preparation of technically complex biologics CMC regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs CMC for investigational and commercial products, in line with ICH requirements, regional requirements, and scientific and company policies and procedures. Examples include supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and BLAs/MAAs for assigned territories.
• Work with the regional CMC personnel to develop a CMC submission plan in accordance with business objectives.
• Lead the development of the Regulatory CMC strategy, content, and submission timelines in accordance with business objectives.
• Provide strategic regulatory CMC advice to project teams for biologics submissions.
• Ensure cross-regional communication and transparency in the flow of CMC information that may affect regional regulatory strategy.
• Coordinate and facilitate development of regional Regulatory CMC strategy with affiliates for local meetings and interactions.
• Ensure up-to-date knowledge of biologics CMC regulatory requirements and communicate relevant changes in regulatory information to project teams and senior management in a timely manner.
• Initiate local process improvements and contribute to local and / or global process improvements, which may have a significant impact for the CMC Regulatory Affairs Department or other departments.

QUALIFICATIONS:

• A scientific degree with directly relevant professional experience in biologics development, global CMC Regulatory Affairs, and CMC technical areas of at least 10+ years with a BA/BS or 8+ years with an MA/MS or 2+ years with a PhD/PharmD
• Excellent organizational skills and ability to work on and/or oversee multiple projects with tight timelines.
• Knowledge of global CMC regulatory landscape.
• Application of sound and accurate judgment to make timely decisions.
• Ability to demonstrate strategic acumen and collaboration.
• Advanced communication and presentation skills.
• Capable of leading a team in preparation of complex regulatory submissions and maintenance of licenses.
• Work is performed under consultative direction towards corporate regulatory goals and objectives.

GILEAD CORE VALUES:

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

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*.

Data Lead, Manager

Data Lead, Manager

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Headquartered in Foster City, California, Gilead has operations in North America, Europe, Asia and Australia.  Gilead’s therapeutic areas of focus include cancer, HIV/AIDS, COVID-19, liver diseases and inflammation.

Role Overview

The Master Data Management Team are looking for a dynamic and motivated manager to be part of the Plant Level Data team.  The Plant Master Data team are responsible for ensuring the accuracy, integrity, and consistency of essential data across Gilead’s systems and platforms, for the La Verne Plant.  This position involves overseeing the management and monitoring of critical data for the plant, working with the cross functional teams responsible for data entry, and ensuring that the requirements and timelines set for the team are met.

 

Responsibilities include:

• Representing the Plant Data Team cross functionally on both Plant level and Global platforms.
• People leadership and team development
• Supervision of personnel, including organizing and prioritizing daily tasks and department activity, inclusive of training and documentation.
• Collaboration with SMEs across the organisation to define and support the implementation of data governance strategies.
• Developing and documenting process standardisation, data governance, cleansing, and data maintenance in line with data strategy goals.
• Works on problems ranging from semi routine to moderately complex in scope, where analysis of situations or data requires in-depth evaluation of various factors, good judgment is required in resolving problems and making routine recommendations.
• Exercises judgment within well-defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Works on more complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences – more future oriented/preventive analysis to proactively manage quality risks.
• Implements critical/ high impact assurance systems to proactively improve process performance.
• Participation in collaborative projects where required, interacting with internal and external resources as required.

Basic Qualifications:
6+ years of relevant experience and a BS/BA. OR 4++ years of relevant experience and a MS.
Preferred Qualifications:

• Prior experience in pharmaceutical industry is preferred.
• Previous experience in leadership with people manager skills
• Successful candidate will be extremely detail oriented, have strong analytical skills, and the ability to consistently achieve high levels of accuracy within a dynamic environment.
• Team player, with the ability to work well with people at various levels local and global.
• Strong knowledge of Good Manufacturing Practices (GMPs)
• Excellent verbal, written, and interpersonal communication skills.
• Strong computer, organizational, and project management skills.
• Able to work independently.
• Demonstrates attention to detail and accuracy.
• Excellent organisational and communication skills are considered critical in executing the role successfully.

 

 

The salary range for this position is: $123,930.00 – $160,380.00. 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*.

Sr. Clinical Trials Manager, Clinical Operations (Oncology)

CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead’s products.

 

**This position can be based at either Parsipanny, NJ or Foster City, CA. This is NOT a remote position***

 

RESPONSIBILITIES: 

• In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
• Communicates with functional peers regarding project status and issues and ensure project team goals are met
• Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.
• Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report
• Coordinates data review to support interim/final data analysis
• Participates in study strategy development.
• Maintains study timelines.
• Contributes to development of study budget.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors,investigators and study coordinators on study requirements
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management).
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
• May participates in the recruiting and hiring process for CTMs and supports their professional development
• May mentor other junior team members
• Coaches members of a work team and ensures adherence to established guidelines

 

KNOWLEDGE:

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Demonstrated analytical and problem-solving skills
• Complete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
• Familiar with standard medical / scientific terminology.
• Ability to communicate in a clear and concise manner.
• Ability to support a team-oriented, highly-matrixed environment.
• Ability to execute multiple tasks as assigned.
• When needed, ability to travel.

 

EXPERIENCE:

• BS/BA degree in nursing, science or health related field with 6+ years of trial management experience – OR –
• MS/MA degree in nursing, science or health related field with 4+ years of trial management experience

 

PREFERRED:

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
• Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
• Highly developed leadership skills to successfully lead a clinical study team
• Ability to deal with time demands, incomplete information or unexpected events
• Must display strong analytical and problem solving skills
• Attention to detail
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
• Meets all requirements for Clinical Trial Manager (CTM) position with demonstrable proficiency.

Prevention Specialist, HIV – Minneapolis North

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead’s mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As a Prevention Specialist within Gilead’s – Minneapolis North, you will represent Gilead’s products and services to a defined customer base. Your focus will be on generating and growing sales by consistently achieving or exceeding sales targets within a specific geographic area. This role emphasizes a comprehensive account management approach, engaging healthcare practices through in-person representation, face-to-face meetings, and strategic partnerships.

You will establish strong working relationships with healthcare providers and deliver timely disease awareness information, clinical updates, and education on healthcare changes. The ability to distill complex clinical concepts into easily understood messages tailored to diverse audiences is essential. Success in this role depends on strong presentation and communication skills and a proven track record of effectively interacting with healthcare professionals.

This unique opportunity supports the Minneapolis North territory, including Minneapolis, St. Paul, and Osseo.

Key Responsibilities:

Account Management & Sales Strategy:

• Build strong relationships and engage healthcare providers across various touchpoints, ensuring a holistic understanding of their needs and maximizing the impact of Gilead’s products.
• Develop and execute a comprehensive territory business plan that meets customer needs and achieves sales goals. Continuously monitor sales progress, adjusting strategies as necessary to meet and exceed targets.

Product & Disease State Expertise:

• Maintain a deep understanding of Gilead’s products, competitive products, and the complexities associated with the therapeutic area’s disease state.
• Actively promote the appropriate use of Gilead products to healthcare professionals, adhering to Corporate, PhRMA, and OIG guidelines.

Collaboration & Teamwork:

• Partner effectively with local cross-functional colleagues (field reimbursement managers, medical scientists and other field team members) to ensure a seamless customer experience through access, acquisition, administration and operational support with Gilead products
• Collaborate externally with healthcare organizations and partner companies, including co-promotion efforts, to enhance product reach and drive sales results.
• Demonstrate the ability to build and maintain strong internal and external working relationships, ensuring seamless collaboration across departments and organizations.
Leadership & Compliance:
• Model and uphold Gilead’s compliance standards and ethical behavior, demonstrating peer leadership within the team.
• Ensure adherence to regulatory agency, state, federal, and company policies, procedures, and business ethics. This includes timely reporting of adverse events to Gilead’s Drug Safety and Public Health department.
• Ensures all department personnel are fully informed of and in compliance with Gilead commercial compliance policy, all applicable federal and state laws and guidance relating to product promotion and information dissemination, including, but not limited to, the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration’s implementing regulations, the Federal Anti-Kickback Statute, the False Claims Act, PhRMA, Corporate Code of Business Conduct and the Office of the Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers

Customer Engagement & Reporting:

• Leverage advanced influencing and relationship skills to drive sales outcomes
• Build solid relationships and establish long-term partnerships with healthcare providers.
• Perform all required administrative tasks, including reporting call activity and customer information in the designated systems, submitting expenses, and managing the territory budget.
• Continuous Learning & Development:
• Exhibit a passion for learning and retaining technical and scientific product information, staying updated on industry trends and changes in the therapeutic area.
• Demonstrate a self-motivated drive to surpass personal goals and consistently exceed performance standards while working autonomously.
• Experience in selling a Buy and Bill product with proven sales success

Inclusion & Diversity Commitment:

• Actively contribute to Gilead’s ongoing Inclusion & Diversity efforts, fostering an inclusive environment within the team and the broader organization.

Skills and Competencies Needed:

• Advanced Communication Skills: Effectively conveying complex clinical information to diverse audiences.
• Sales Acumen: Proven track record of achieving or exceeding sales targets in a competitive pharmaceutical environment.
• Technical & Scientific Proficiency: Strong understanding of the therapeutic area, including disease states, treatment protocols, and competitive landscape.
• Cultural Awareness: Demonstrates cultural awareness, empathy, and sensitivity in addressing needs across diverse customers; comfort engaging in conversations in the sexual health space
• Collaborative Matrix Teamwork: Ability to lead within a cross-functional matrix environment, prioritizing the team’s success and patient access over individual recognition, fostering cross-functional collaboration. Proven ability to collaborate with local cross-functional colleagues to optimize experience for the account.
• Collaboration & Partnership Skills: Demonstrated ability to build and maintain effective partnerships both internally across departments and externally with other organizations to drive sales and achieve business objectives.
• Leadership & Ethical Conduct: Demonstrated ability to lead by example in compliance and ethical behavior.
• Autonomy & Initiative: A self-starter who can work independently and is driven to exceed expectations.
• Patient-Centric Focus: Embodies a collaborative leadership approach wholly dedicated to ensuring patient access and positive outcomes through teamwork, placing patient and team success at the forefront.
• Account Management Expertise: Proficiency in managing and growing key accounts through a strategic, holistic approach
• Multi-Product Experience: Experience managing a multiple product portfolio

Basic Qualifications:

High School and Nine Years’ Experience
OR
Associates Degree and Seven Years’ Experience
OR
Bachelor’s Degree and Five Years Experience
OR
Master’s Degree and Three Years Experience

• Ability to engage in travel as may be reasonably required, including regular travel within the assigned area (and, to the extent applicable, satisfaction of any requirements associated with such travel).
• Satisfaction of any onsite visitation requirements of healthcare practitioners within an assigned area, if applicable (which may include but not be limited to, by way of example, vaccinations, drug and background screenings, and any other requirements that certain healthcare practitioners may adopt).
• To perform this job successfully, the employee must be able to perform each essential duty satisfactorily. The above-mentioned requirements represent the knowledge, skill, and/or ability necessary for success. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
• A valid driver’s license is required

Preferred Qualifications:

• BA or BS degree
• A minimum of 4 years of pharmaceutical, biotech or healthcare industry sales experience
• Possess superior selling skills focused on highly competitive markets
• Proven and consistent track record of meeting/exceeding sales objectives, preferably in specialty markets
• Successful performance and collaborative leadership with account-focused cross-functional local teams
• Experience in selling injectable physician-administered products
• Familiarity with the managed care landscape and its impact on business