Research Associate I
Myriad Genetics job in South San Francisco, CA
Job Schedule: Full time Responsibilities
Conduct and/or support research experiments under the supervision of a Scientist.
Conduct lab experiments/research to support and/or advance products, services and technology from initial feasibility through final protocol optimization, application testing and stability studies.
Method development and preparing SOPs as needed.
Procure chemicals, materials, and reagents.
Handle and prepare chemicals and biochemical reagents to perform experiments and develop methods and procedures.
Dispose of chemical/biological waste properly; maintain records as appropriate.
Calibrate and maintain scientific instruments and laboratory equipment.
Maintain an organized, detailed, and accurate record of all experimental procedures and data.
Data analysis including excel, tableau, flow cytometry, and image analysis.
Provide project status reports.
Review literature and apply advanced knowledge.
Qualifications
BS or higher degree in Biology, Chemistry, or related science with 0-10 years of experience in a research environment (preference for at least 3 years).
Experience must include performing experiments in areas such as Next Generation Sequencing (NGS), RT-qPCR, fluorescence spectroscopy, biomolecule conjugation, immunoassays, data analysis, and image analysis.
Demonstrated ability to plan, execute, analyze, and document research experiments.
Proficient in the use and maintenance of instrumentation for chemical and spectroscopic analysis, such as fluorescence spectroscopy, flow cytometry, UV-VIS, etc.
Organized, flexible, and able to multitask in an environment with aggressive timelines.
Ability to make experimental observations with a great attention to detail.
Ability to pipette is required.
Familiarity with liquid handling systems recommended, but not required.
Strong written and verbal communication skills. Position requires frequent communication in the form of verbal updates, reports, technical meetings, and presentations.
#LI-LP1
About UsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: ************** .
WE ARE AN EQUAL OPPORTUNITY EMPLOYER. Applicants and employees are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender,national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
Please answer all questions completely. Please do not provide any information not specifically requested on this Employment Application form.
Apply Here: **************************************************
PI182320066
Additional Information
All your information will be kept confidential according to EEO guidelines.
Production Laboratory Scientist
Myriad Genetics job in South San Francisco, CA
The Production Laboratory Scientist (PLS) is responsible for conducting laboratory processes that support specimen processing and testing. This position works with department management and quality team members to ensure that laboratory activities are defined, documented, and completed to support inspection readiness and that compliance is maintained through procedures, training, documentation, and continuous improvement projects.
The Production Laboratory Scientist (PLS) position works closely with our Clinical Laboratory Scientists (CLS) to process patient samples using our automated instrumentation. The PLS position may also assist our assay and hardware development teams with development and validation of new instruments and assays.
Available Shifts:
A1: Sunday-Wednesday 7:00am-5:30pm
A2: Sunday-Wednesday 11:00am-9:30pm
B2: Wednesday-Saturday 11:00am-9:30pm
Pay: $28.61/hr, plus additional pay for weekend days
Responsibility
Each employee's specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows:
Complying with the laboratory's technical, administrative, and safety policies and procedures.
Operating high complexity testing under the guidance of a Clinical Laboratory Scientist (CLS)
Processing patient samples using our automated platform under the guidance of a CLS
Participating in the laboratory's quality assurance plan, adhering to quality control and preventive maintenance policies, and appropriately documenting these activities.
Working as part of a team to produce repeatable quality results.
Maintaining a clean and organized laboratory space.
Participating in proficiency testing in the same manner as routine samples.
Participating in continuing education according to accepted laboratory standards.
Actively participating in successful and timely completion of training and competency assessment as outlined in the laboratory and departmental training programs.
Following the laboratory's policies and procedures whenever test systems are not within acceptable limits and documenting the problem and any corrective action.
Troubleshooting and identifying problems that may adversely affect test performance and/or reporting of test results by initiating corrective action and using the defined electronic system to make the required management notification.
Participates within the departmental team to resolve problems or implement projects.
Serves as a trainer on technical processes within the group.
Communicating with co-workers to ensure smooth and efficient workflow.
Performing setup, teardown, and preventative maintenance on laboratory equipment.
Preparing reagents for use on laboratory equipment.
Preparing labware for use on laboratory equipment.
Archiving and retrieving patient samples.
Working with a CLS to perform qualification protocols for recently repaired instruments.
Restocking laboratory inventory items.
Qualifications
Doctoral, bachelor's, or master's degree in medical technology or a chemical, biological, or clinical laboratory science.
Experience with laboratory operations and procedures (preferred but not required)
Familiarity with range of molecular biology techniques (qPCR, DNA extraction, DNA sequencing) and proficiency with molecular biology calculations (dilutions, DNA and protein concentration measurements, enzyme activity measurements) (preferred but not required)
Ability to adapt to changes in a fast-paced and evolving work environment.
Some schedule flexibility - occasional overtime hours may be required.
Basic proficiency with computers (Excel, other Office tools) and statistics.
Strong verbal and written communication skills.
Extensive documentation skills and attention to detail skills including the ability to develop and follow written procedures, the ability to organize information, ensures that data is recorded correctly and can be easily understood by others.
Physical Requirements
Lifting Requirements - medium work or exerting up to 50 pounds of force occasionally, 20 pounds of force frequently, and 10 pounds of force consistently. Physical Requirements - stationary positioning, moving, operating, ascending/descending, communicating, observing, reaching, and repetitive motion. Use of equipment and tools necessary to perform essential job functions. Hazards and Atmospheric Conditions - exposure to fumes, dust, extreme temperatures, wet and/or humid, noise, vibration, mists or gases, mechanical hazards, chemical hazards, electrical hazards, and radiant energy hazards. OSHA Category I - duties performed routinely requires exposure to blood, body fluid, and tissue.
EEO
We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.
Auto-ApplySenior Corporate Counsel, Contracts
Alameda, CA job
Senior Corporate Counsel, Contracts page is loaded## Senior Corporate Counsel, Contractslocations: Alameda, CAtime type: Full timeposted on: Posted Todayjob requisition id: JR6460**SUMMARY/JOB PURPOSE:**The Senior Corporate Counsel, Contracts takes a supporting role in setting the material terms of the many business transactions undertaken by the company, the drafting and negotiation of definitive and ancillary agreements reflecting those terms, and the organization of processes necessary and helpful for Exelixis to transact efficiently and effectively. This function also plays a transactional oversight role, working with Legal and operational colleagues to help ensure that the company's R&D activities and transactions are carried out with efficiency and reflect an appreciation for an appropriate level of business and legal risk.**ESSENTIAL DUTIES AND RESPONSIBILITIES:*** Drafts, reviews, and negotiates a wide range of contracts with a very high degree of independence in support of the Research and Development organizations (which may include confidentiality agreements, collaboration agreements, licensing agreements, consulting agreements, materials transfer agreements, simple and complex clinical trial agreements, clinical advisory board agreements, and various vendor services agreements, and manufacturing agreements for cGMP drug supply).* Acts as a legal point person for ongoing agreements in support of R&D efforts.* Reviews redlines, supervises negotiations and provides general guidance to junior attorneys and contracts managers.* Assists with maintaining up-to-date form agreements consistent with industry standards and applicable laws.* Identifies and defines operational and legal risks and is able to communicate those risks to appropriate internal decision-makers for discussion and resolution.* Cultivates strong and highly effective cross-functional relationships and communication with internal colleagues to effectively address legal and business questions.* Effectively represents the company.* Handles miscellaneous legal tasks on an as-needed basis.**SUPERVISORY RESPONSIBILITIES:*** No supervisory responsibilities but may provide direction to other individuals.**EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:****Education:*** BS/BA degree, preferably in life sciences or a related field; an advanced life science degree is preferred.* JD degree is required and a minimum of six to eight years of relevant experience.* Must be admitted to practice law, preferably in California.**Experience:*** Experience as an attorney in a law firm or in-house legal environment in biotechnology or pharmaceutical industry.* Complex contract drafting and negotiation experience required, including a significant volume of contracts in support of drug Research & Development activities.**Knowledge/Skills:*** Possesses clear and concise verbal and written communication skills and must have excellent interpersonal communication skills.* Strong computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint, etc.), document management systems, and redlining software).* Must be detail-oriented and have strong organizational skills.* Ability to handle multiple tasks simultaneously, with the ability to re-prioritize on short time frames. Can quickly separate the mission-critical from the nice-to-haves and the trivial.* Ability to make complex decisions based on the data available; drives to the finish on all projects.* Acts responsibly and conscientiously.* Works under pressure to meet specific deadlines.* Works well both independently and in a team environment; addresses differences fairly and equitably; treats everyone as a preferred internal client.* Dedicated to quality, reliability, and highest professional standards in all work tasks.* Must be a self-starter and quick learner.* Must have good judgment.**WORKING CONDITIONS:*** Primarily working indoors, in an office environment#LI-HG1*If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!*### ### Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $222,000 - $316,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.### **DISCLAIMER** The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.***We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.***Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too.
#J-18808-Ljbffr
Assoc Director, Manufacturing Operational Readiness
Foster City, CA job
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
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.
Associate Director, Manufacturing Operational Readiness
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.
The salary range for this position is: $195,670.00 - $253,220.00. 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.
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, 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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Auto-ApplyQuality Site Lead (Sr. Manager) - Foster City
Foster City, CA job
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 a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status.
Gilead Sciences is currently seeking a Quality Site Lead (QSL) to provide quality oversight of GMP activities at assigned Gilead CXOs, supporting the manufacture of Biologics intermediates, drug substances and drug products for clinical and commercial distribution. This role is needed to ensure Gilead's CXOs are proactively managed from a quality and compliance perspective.
Job Functions:
Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Gilead CXO partners/sites.
Assure CXOs meet Gilead's quality, regulatory and compliance standards, to ensure a sustainable delivery of quality products to patients.
Key representative on Product Quality Teams for assigned CXO.
Ensure contract manufacturers are compliant and ready for regulatory inspections and monitor progress during inspection. Support onsite inspections to ensure compliance and readiness, as needed.
Facilitates quality events for CXOs.
Partner with internal stakeholders such as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, and Regulatory Chemistry, Manufacturing and Controls (RA CMC), to identify solutions and processes and align with key partners on implementation of new requirements; proactively address.
Lead escalations for critical quality issues.
Evaluate current quality systems and processes and recommend and implement appropriate enhancements and trainings to ensure the achievement of Gilead long-term objectives.
Monitor CXO site trends, holding CXO accountable to established performance criteria and QAG requirements.
Ensure GMP documentation is accurate and compliant with internal and external standards and requirements.
Provide guidance to the business teams on regulatory requirements and assist where needed.
Participate on CXO Business Review Meetings (BRMs) as Quality's voice for the contract organizations' oversight.
Establish and foster meaningful Quality to Quality relationships between Gilead and CXOs.
Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion.
Partner with Manufacturing, Development, Global Supply Chain, Global QC and Outsourcing to deliver on the production plan.
Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.
Champion Quality Risk Management, identifying key risks impacting CXO performance.
Accountable for PAI/PLI readiness for assigned CXO sites.
Travel to CXO site(s) to provide Quality oversight of critical manufacturing activities, as .
Up to 20% travel based on strategic plan.
May manage a team of Quality Professionals.
Knowledge, Experience and Skills:
Knowledgeable in quality requirements pertaining to manufacturing, testing, packaging, labeling, facility, utility, equipment and process validation, cleanroom classification and qualification, new product introduction, multi-product facility control, contamination control strategy, technology transfer, contract operations, product release, disposition, and distribution.
In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally.
Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
Knowledgeable in Global requirement/standards for product registration and life cycle management of product quality.
Demonstrated ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.
Excellent verbal, written, and interpersonal communication skills.
Experienced in prioritizing workload to address competing projects and timelines.
Basic Qualifications:
8+ years of relevant experience and a bachelor's degree in science or related fields; or 6+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
Knowledge in technical and regulatory requirements pertaining to manufacturing, product lifecycle management, and outsourced operations a must.
Biopharmaceutical or Pharmaceutical experience a must.
Prior experience leading contract manufacturing/testing operations or overseeing contract manufacturing operations a must.
Experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred.
The salary range for this position is: $157,590.00 - $203,940.00. 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.
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, 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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Auto-ApplySr Sustainability Specialist
Foster City, CA job
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 Senior Specialist, Sustainability Engagement Program, will be a key driver of Gilead's internal sustainability culture. This role is focused on engaging our global workforce, embedding sustainable practices into our daily operations, and communicating our environmental initiatives effectively across the company. You will be responsible for coordinating employee-led green initiatives, developing programs for sustainable corporate events and travel, and creating compelling content to educate and inspire our colleagues.
Essential Duties and Job Functions
Employee Engagement: Develop and coordinate company-wide sustainability engagement campaigns and events. Act as the primary liaison and operational leader for Gilead's internal "Green Team" network, empowering employee champions to drive local initiatives.
Internal Communications: Create and manage a consistent pipeline of internal communications to build awareness and educate employees on our sustainability strategy, goals, and achievements. This includes writing articles, producing stories, and creating presentations.
Digital Content Management: Administer and refresh content for internal sustainability web pages, SharePoint sites, and other digital channels to ensure information is current, engaging, and easily accessible to all employees.
Sustainable Events: Partner with Corporate Travel, Meetings & Events, and Facilities teams to develop and execute strategies for more sustainable corporate travel, meetings, and on-site events.
Program Management: Support the broader sustainability team by coordinating projects, tracking key performance indicators for engagement programs, and gathering feedback to continuously improve and communicate on our initiatives.
Cross-Functional Collaboration: Work closely with key stakeholders to align sustainability engagement with broader company culture and communications efforts.
Knowledge, Experience and Skills Essential:
5+ years of relevant experience with a Bachelor's degree in Communications, Marketing, Environmental Studies, Sustainability, Business, or a related field OR 3+ years of relevant experience with a Master's degree.
Demonstrated experience in developing and executing employee engagement or internal communications campaigns.
Excellent written and verbal communication skills, with a proven ability to craft clear, compelling, and accessible content for a diverse corporate audience.
Experience managing digital content and platforms (e.g., intranet, SharePoint, or similar).
Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.
A passion for sustainability and the ability to translate complex environmental topics into relatable and actionable initiatives.
Proven ability to build relationships and collaborate effectively across different teams and functions.
Desirable:
Experience in a corporate sustainability or corporate social responsibility (CSR) role is a plus.
Experience with event planning or developing sustainable procurement guidelines.
Familiarity with graphic design or video production tools for creating engaging content.
Experience working within a global, matrixed organization.
The salary range for this position is: $126,820.00 - $164,120.00. 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.
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, 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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Auto-ApplyIntern - PDM - Drug Product Pilot Plant
Foster City, CA job
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**
As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company's mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs.
**Key Responsibilities will include, but are not limited to the following:**
+ Work with plant operations team to understand solid oral dose manufacturing, current 3D printing applications and potentially identify new use cases
+ Use SolidWorks to create/modify 3D printed fixtures and components
+ Investigate material properties and technical specifications for various filaments, resins and post-processing agents
+ Assess potential risks and document in qualification roadmap
+ Showcase your work with a final presentation (PPT) near the conclusion of your internship
**Required Qualifications:**
+ Must be at least 18 years old
+ Must have a minimum GPA of 2.8
+ Authorized to work in the United States without Sponsorship now or in the future.
+ Must be currently enrolled as a full-time student in a Bachelor's/Master's at an accredited US based university or college
+ Must be a Rising Sophomore, Junior, or Senior in undergrad
+ Must be enrolled full-time in the Fall Semester at an accredited university/college after the completion of the internship
+ Must be able to complete a 10-12 consecutive week internship between May and August
+ Must be able to relocate and work at the designated site for the duration of the internship
**Preferred Qualifications** **:**
+ Preferred Degree qualification: **Undergrad**
+ Proficiency with SolidWorks and basic slicing programs
+ **Understanding of how to set up, calibrate and maintain 3D printers (FDM, SLA, SLS)**
+ Proficiency with MS Office Suite
+ Ability to identify issues and seek solutions
+ Ability to work both independently and collaboratively
+ Demonstrated commitment to inclusion and diversity in the workplace
+ Efficient, organized, and able to handle short timelines in a fast-paced environment
**Gilead Core Values:**
+ Integrity (Doing What's Right)
+ Inclusion (Encouraging Diversity)
+ Teamwork (Working Together)
+ Excellence (Being Your Best)
+ Accountability (Taking Personal Responsibility)
The expected hourly range for this position is $19.00 - $55.00.
Gilead considers a variety of factors when determining base compensation, including education level and geographic location. These considerations mean actual compensation will vary.
Benefits include paid company holidays, sick time, and housing stipends for eligible employees.
**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, 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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
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.
Associate Biostatistics Director (Biotech, Oncology)
Alameda, CA job
SUMMARY/JOB PURPOSE:
Applies extensive technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases. Uses initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design. Works collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials.
Essential Duties And Responsibilities:
Work with project team members on developing clinical protocol. Review CRFs, CRF edit checks and CRF completion guidelines. Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated. Review ADaM specifications and verify primary and secondary efficacy endpoints.
Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
Effectively manage CRO to ensure high-quality deliverables within timeline and budget.
Oversee programming of ADaMs and TLFs for the study.
Responsible for one or more studies with concurrent tasks and timelines.
Participate in the validation/QC of key study endpoint analysis and submission deliverables.
Apply appropriate regulatory guidelines to the projects.
Supervisory Responsibilities:
None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
PhD in related discipline and a minimum of 5 years of related experience; or,
Equivalent combination of education and experience.
May require certification in assigned area.
Experience/The Ideal for Successful Entry into Job:
Experience in oncology and study Phases I-III highly preferred.
Experience in Biotech/Pharmaceutical industry preferred.
Experience with managing CROs in the conduct of clinical trials.
Experience with statistical applications and clinical data management procedures in the conduct of clinical trials.
Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
Knowledge/Skills:
Knowledge of appropriate regulations, industry standards and guidance documents.
Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Exelixis.
Developed/reviewed SDTM/ADaM specifications
Strong SAS programming knowledge.
Guides the successful completion of major programs, projects and/or functions.
Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Develops technical and/or business solutions to complex problems.
Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
Performs a variety of complicated tasks with a wide degree of creativity and latitude.
Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
Has good general knowledge of other related disciplines.
Applies strong analytical and business communication skills.
JOB COMPLEXITY:
Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
Creates formal networks involving coordination among groups.
#LI-JP1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $166,000 - $236,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyInventory Specialist II
Alameda, CA job
SUMMARY/JOB PURPOSE: Completes activities related to the inventory management process in the ERP system. Supports Commercial Supply Chain with a focus on, but not limited to the creation of purchase orders from production planning, recording inventory movements in SAP through batch record reviews, reconciling inventory quantities from the different storage locations, updating or creating new master data and assisting global logistics with record keeping. Collects and analyzes data to make inventory decisions.
Essential Duties And Responsibilities:
* Reviews production plan outputs and creates Purchase Orders from those plans.
* Creates and maintains Master Data Records in the ERP system.
* Reviews batch record information from CMO to preform inventory movements in ERP.
* Maintains supporting documents for inventory movements.
* Reviews invoices for payment and rectifies accounts payable discrepancies relating to department purchase orders.
* Reviews inventory reports from CMO's and warehouse locations and reconciles with ERP inventory.
* Provides analysis of differences between inventory reports from CMO and SAP inventory.
* Performs inventory movements in ERP from analysis of the reconciliations.
* Performs inventory counts at warehouse locations as needed.
* Ability to collaborate effectively with cross functional teams
Supervisory Responsibilities:
* There is no supervisory responsibility.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* BS/BA degree in related discipline and a minimum of five years of related experience; or,
* Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
* Experience with direct purchasing and inventory movements
* SAP Materials Management experience
Knowledge/Skills:
* Strong Microsoft Office Skills; specifically, in Excel is required.
* Detail oriented with emphasis on accuracy and completion.
* Organizes and prioritizes numerous tasks and completes them under time constraints with limited supervision.
* Demonstrates ability to communicate effectively.
* Perform arithmetic calculations.
* Ability to use a personal computer and adapt to program changes efficiently.
* Follow step by step instructions, working instructions, and or SOP's.
#LI-EZ1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $88,000 - $124,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyAssociate Principal IT Product Lead - Data Engineering & Architecture
Alameda, CA job
SUMMARY/JOB PURPOSE:
The Associate Principal IT Product Lead - Data Engineering and Architecture will oversee Data Strategy, Architecture, and Engineering, key to Exelixis's success and ambition in launching innovative medicines to patients. This role drives strategy, execution, and operational excellence of the data ecosystem, aligning with business goals, data governance, and value delivery. Operating within a product-centric operating model, they will define roadmaps, foster collaboration, and lead agile teams to deliver impactful solutions that accelerate drug discovery, development, and commercialization.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Product Strategy & Roadmap (Product-Centric Focus):
Support the development and execution of the vision, strategy, and roadmap for Clinical and Operational data engineering and governance.
Partner with senior product leads and business stakeholders (e.g., R&D, Clinical, Supply Chain, G&A,) to gather insights, understand user needs, and translate them into clear product requirements and user stories.
Design and implement scalable data architectures using AWS, Databricks, and modern patterns like data mesh and Lakehouse.
Contribute to market research, competitive analysis, and technology assessments to inform product planning and identify innovation opportunities.
Evaluate business impact, technical feasibility, compliance needs, and resource constraints to assist in prioritizing product initiatives.
Collaborate with engineering and data governance teams to ensure data architecture follows FAIR principles, is secure, and meets enterprise standards.
Product Development & Delivery (Agile/Product Team Leadership):
Support the Principal Product Lead in mentoring Business Analysts and other team members, encouraging a culture of ownership, innovation, and continuous improvement.
Contribute to managing the product lifecycle from ideation through launch and post-launch optimization, applying Agile methodologies (e.g., Scrum, Kanban) to ensure efficient delivery.
Assist in defining clear user stories, acceptance criteria, and product specifications that align with the product vision and business objectives.
Collaborate with engineering, architecture, and quality assurance teams to ensure the timely delivery of scalable, secure, high-quality, and governed data products.
Coordinate with external vendors and service providers to support alignment on product roadmaps and delivery operations.
Promote user-centric design by incorporating user research, usability testing, and feedback into product enhancements.
Translate business needs into scalable data solutions across clinical, supply chain, and operations domains.
Implement data governance frameworks for quality, lineage, and lifecycle management.
Stakeholder Management & Cross-Functional Collaboration:
Act as a key liaison between IT and business functions, helping to translate technical concepts into business language and vice versa.
Build collaborative relationships with stakeholders to support alignment of product vision, priorities, and outcomes.
Facilitate communication and coordination across product, business, and IT teams to support effective decision-making.
Represent the product team in cross-functional discussions and contribute to strategic initiatives as needed.
Operational Excellence, Quality & Compliance:
Support efforts to maintain the operational stability, performance, and security of data solutions in collaboration with IT operations and infrastructure teams.
Assist in managing vendor relationships and third-party software solutions that support the data and analytics portfolio.
Help ensure compliance with regulatory requirements (e.g., GxP, HIPAA, GDPR) and internal quality and security standards across product releases.
Contribute to quality assurance processes to ensure product releases meet defined standards.
Actively contribute to the Implementation and maintenance of robust data management & AI practices to protect sensitive information and ensure its accuracy and reliability.
Track and report on key performance indicators (KPIs) to assess product success, adoption, and business impact, and support continuous improvement efforts.
SUPERVISORY RESPONSIBILITIES:
No supervisory responsibilities.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
Bachelor's degree in related discipline and 11 years of related experience; or
Master's degree in mathematics or statistics or engineering, and 9 years of related experience.
PhD degree in a related discipline and 5 years of related experience; or
Equivalent combination of education and experience.
Experience/The Ideal Candidate will have:
Minimum of 6 years of experience supporting Enterprise IT enabling business functions.
Minimum of 8+ years of progressive experience in IT, with at least 6+ years in a leadership role focused on data architecture and engineering in a life science or pharmaceutical industry.
Proven experience leading product development teams in an agile/product-centric operating model is essential.
Strong understanding of the drug discovery or clinical development, or commercialization lifecycle within a pharmaceutical or biotechnology company.
Deep understanding of clinical and operational data in a life sciences or Pharma company, including experience creating physical and logical data models for analytics and data science teams that follow data standards.
Extensive experience in creating resilient data architectures on cloud platforms like AWS and Azure, integrating advanced data management solutions such as Databricks and Snowflake.
Experience with regulatory frameworks and compliance in a GxP environment.
Knowledge / Skills:
Exceptional leadership and team-building skills, with the ability to inspire and motivate diverse teams.
Strong strategic thinking and problem-solving abilities, with a data-driven approach to decision-making.
Excellent communication, presentation, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization.
Deep understanding of product management methodologies (e.g., Agile, Scrum, Kanban) and product lifecycle management.
Solid technical acumen with the ability to understand complex IT architectures and development processes.
Apply hands-on expertise with tools like Databricks, DBT, Glue, Kafka, Airflow, S3, Delta Lake, Redshift, Unity Catalog, and Atlan.
Develop with Spark, Python, SQL, and REST APIs using cloud-native services.
Ability to manage multiple priorities in a fast-paced, dynamic environment.
Occasional travel may be required to other company sites, conferences, or vendor locations.
#LI-EZ1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $167,000 - $237,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyAssociate Scientific Publications Director
Alameda, CA job
SUMMARY/JOB PURPOSE: Scientific Publications is a group within Medical Affairs with responsibility for development of scientific publications and publication planning. The Associate Scientific Publications Director plans publication strategy and works to develop, coordinate and execute publications tactics. This includes developing robust publication plans, and managing development of scientific presentations, and publications.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Operate in accordance with all Exelixis SOPs, including the Publications SOP, and promote the adoption of working standards consistent with Good Publication Practice.
* Contribute to strategic, operational and tactical planning for the Exelixis Publication Plan.
* May write and revise abstracts, posters, case reports, and manuscripts for submission to scientific congresses or peer reviewed journals.
* Work with publications and writing vendors as needed.
* Coordinate with internal and external stakeholders; ensure execution of abstracts, posters, oral presentations and manuscripts in accordance with timelines as set in the publication plan.
* Use the Datavision publications portal to monitor feedback on publications
* Collaborate with other members of the Medical Affairs organization (e.g. Medical Science Liaisons, Medical Information, Medical Research, etc) in support of their functional area deliverables.
* Attend scientific conferences to enhance therapeutic knowledge and to contribute to execution of Medical Affairs conference deliverables.
* Develop product and disease state expertise, keep abreast of the changing drug development environment.
* Other duties and responsibilities as assigned.
SUPERVISORY RESPONSIBILITIES:
* None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* Bachelor's level degree in related discipline and a minimum of eleven years of related experience; or,
* Master's level degree in related discipline and a minimum of nine years of related experience; or,
* Doctorate level degree (PharmD, MD, PhD) and a minimum of five years of related experience; or,
* Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
* Oncology experience preferred.
* Experience in pharmaceutical/biotech desirable.
* Significant experience with publication development and writing is required.
* Understanding of clinical trial design, interpretation of scientific data and communication via clinical and medical affairs channels, preferred.
Knowledge/Skills:
* Excellent organizational, time, and project management skills.
* Skilled medical/technical writer with attention to detail.
* Self-motivated, organized, problem-solving, solution-oriented, collaborative team player.
* Strong skills with regard to written and verbal communication of complex medical and scientific data to a variety of audiences.
* Strong interpersonal and collaboration competencies for interfacing with a wide range of internal and external cross-functional partners.
* Ability to foster relationships, build alignment, negotiate, and collaborate with internal and external stakeholders.
* Ability to work independently and manage multiple projects in a fast-paced and dynamic environment.
JOB COMPLEXITY:
* Works in a fast-paced, small-team environment that is growing and evolving. This position requires regular reprioritization of projects while adhering to timelines and achievement of deliverables.
WORKING CONDITIONS:
* Occasional travel required to support medical affairs activities at scientific congresses and company meetings.
#LI-MB1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $158,000 - $224,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplySenior Corporate Paralegal
Alameda, CA job
DETAILS: The position will be an integral part of the Corporate Legal Affairs team with respect to all aspects of its securities and corporate governance practice, including the management of all corporate legal records. Some support of SEC filings, contracts, business transactions, employment and investor relations matters as assigned.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Develop and maintain standardized workflow checklists and calendaring system relating to SEC rules and processes and corporate governance matters and serve as a primary coordination resource for internal clients
* Assist the in-house legal and finance teams with preparation and review of all SEC reports and manage all related Sarbanes-Oxley (SOX) compliance procedures for the Corporate Legal Affairs team
* Help prepare and/or be a first reviewer on Section 16 filings and assist with filing procedures, as well as organize and maintain all related documentation for Corporate Legal Affairs records
* Serve as administrator for Securities Compliance Committee and manage rules, procedures and participant documentaiton/onboarding relating to Exelixis' Insider Trading Policy, Rule 10b5-1 Trading Policy and Change-in-Control and Severance Benefit Plan
* Oversee day-to-day management and maintenance of all Exelixis' corporate governance records (including corporate minute books, charter documents, entity management and service of process, as well as the preparation/procurement of necessary corporate formalities from Exelixis' senior management team and/or governmental authorities as may be needed)
* Coordinate preparation and review of materials for all stockholder, Board of Directors and committee meetings throughout the year (including visual presentations/talking points, meeting minutes/resolutions/written consents, committee charters, governance policies, annual performance assessments and D&O Questionnaires), and serve as primary manager for Exelixis' digital governance and virtual meeting platforms, as well as director compensation program
* Manage cloud transition of Corporate Legal Affairs electronic file management system corporate , working with rest of the team in creating standardized organizational framework, procedures and instructions, and continue to maintain and update files on a weekly or more frequent basis
* Support broader in-house legal teamand outside counsel with litigation activities, including document discovery, as needed
* Provide due diligence support for M&A and similar activities as needed
* Coordinate and assist with Corporate Legal Affairs training sessions and internal corporate strategy meetings, including materials preparation and delivery of presentations
* Assist legal team leaders with budget and invoice activities with respect to outside counsel and other vendors
* Other responsibilities as assigned
SUPERVISORY RESPONSIBILITIES:
* May supervise temporary employees, consultants and interns for certain projects.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* BS/BA degree in related discipline or certificate from an ABA approved paralegal program
Experience/The Ideal for Successful Entry into Job:
* Minimum of five years of corporate paralegal experience at a large law firm or within an in-house corporate legal department of a publicly traded company
* Experience drafting SEC reports (10-K, 10-Q, 8-K, proxy) is a plus
* Experience with presentations of corporate sustainability programs, or familiarity with GDPR, CCPA, HIPAA and other privacy laws is a plus
Knowledge/Skills:
* Familiar with SEC reporting processes and timelines (including equity compensation/Section 16 and Annual Stockholder Meeting matters) and experience using standard corporate legal resources, such as thecorporatecounsel.net or section16.net
* Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.), Box, CompareDocs or similar redlining software; experience using a board management software, Workiva and/or Smartsheet is a plus
* Applies strong analytical and business communication skills (both written and verbal)
* Highly organized, strong attention to detail and proofreading skills
* Demonstrates interpersonal skills and ability to work effectively independently and with others
* Ability to handle multiple tasks simultaneously and re-prioritize on short time frames with supervisor input
* Ability to follow verbal and written instructions with precision and accuracy
* Ability to develop and rigorously maintain a detailed and effective record-keeping system
* Ability to maintain confidentiality and handle sensitive matters
* Must have good judgment and a positive, can-do attitude
WORKING CONDITIONS:
* Ability to effectively manage multiple projects and competing priorities.
* Willingness to work in a fast paced and changing environment, meeting deadlines in an accurate and timely manner.
* Requires excellent attention to detail while not losing sight of the big picture.
* Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
* Networks with key contacts outside own area of expertise.
#LI-HG1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $127,500 - $180,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplySenior Finance System Analyst
Alameda, CA job
SUMMARY/JOB PURPOSE: The Senior Finance Systems Analyst serves as a key member of the Exelixis Financial Planning & Analysis (FP&A) department, tasked with the administration, maintenance, and ongoing user support of the Oracle Enterprise Performance Management (EPM) platform. This role ensures the reliability of the financial application, supports the execution of financial close, planning, and forecasting activities, and strives to deliver an intuitive and efficient user experience. The Senior Finance Systems Analyst reports directly to the Senior EPM Systems Director within the FP&A organization.
ESSENTIAL DUTIES/RESPONSIBILITIES:
* System Administration:
* Manage the day-to-day operations of the Oracle EPM application ensuring optimal performance and availability for users.
* Support critical financial processes, including monthly close and quarterly forecasting cycles, by managing the data loads, metadata updates, and system rollovers.
* Prepare, validate and upload statistical account data using Excel and Smart View.
* Perform application configuration changes, updates, and enhancements.
* Maintain and update application components such as metadata, business rules, calculation scripts, input forms, and standard reports.
* Partner with finance and IT teams on key projects, new implementations, and processes related to month-end close and Oracle EPM system integrations.
* User Support and Training:
* Provide support and training to internal users.
* Maintain system procedures and user documentations
* Security and User Management:
* Manage user provisioning, role assignments, and security settings.
* Conduct regular security audits and ensure compliance with internal controls.
* Technical Support and Maintenance:
* Monitor backups and scheduled tasks.
* Troubleshoot and resolve system issues.
* Coordinate with Oracle Support for technical assistance and issue resolution.
* Collaborate with IT on infrastructure projects.
* User Support and Training:
* Provide support and training to internal users.
* Maintain system procedures and user documentations
* Project Support:
* Assist with development, testing and rollout of new system functionality and modules
SUPERVISORY RESPONSIBILITIES:
* No supervisory responsibilities.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
* BS/BA degree in related discipline and 5 years of related experience; or,
* MS/MA degree in related discipline and 3 years of related experience; or,
* Equivalent combination of education and experience
Experience:
* 3-5 years of development, implementation, and support of Hyperion/Oracle EPM required
* 3-5 years of experience supporting finance organizations required
* Experience in biotech/pharmaceuticals industry preferred but not required
Knowledge, Skills and Abilities:
* Support and development skills across components of Oracle Hyperion/EPM Cloud, including Planning and Narrative Reporting, e.g. business rules, groovy scripts, Data Management/FDM, EPMAutomate.
* Excellent attention to detail and organizational skills.
* Financial close, planning, and forecasting expertise.
* Proficiency in Microsoft Office Suite (Excel).
* Quickly learn new systems and processes.
* Ability to build and manage relationships with user community.
* Customer-service orientation
Work Environment/Physical Demands:
Our office is a modern, open-plan space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
This position will not require travel.
#LI-EZ1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $123,000 - $175,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyRegulatory Affairs CMC Director
Alameda, CA job
SUMMARY/JOB PURPOSE:
Provide Regulatory Affairs CMC expertise and leadership for global commercial and development projects. Develop strategic approaches to enable succesful Health Authority submissions and communications. Work closely with the Pharmaceutical Operations and Supply Chain (PSC) organization, Quality groups, and cross-functional project teams on the CMC content for global applications (INDs, IMPDs, NDAs, BLAs, MAAs).
ESSENTIAL DUTIES/RESPONSIBILITIES:
Provide regulatory strategies, appropriate for the stage of product development, to PSC designed to maximize chances of successful and expedient registration with appropriate levels of CMC efficiency and flexibility.
Critically review CMC-related submissions to Health Authorities and provide regulatory guidance to PSC. Ensure submissions to regulatory Health Authorities are complete, of high quality, and compliant with applicable regional regulations while enabling appropriate CMC flexibility.
Work with teams to develop responses to review questions from FDA and other regulatory authorities.
Track progress of submission review and approval stages across multiple clinical studies and countries.
Lead any required CMC-related meetings with Health Authorities working closely with PSC. Provide briefing book templates, collaborate with PSC on meeting prep sessions, and manage the live meeting with the Health Authority.
Track and manage through completion Health Authority facing regulatory actions and commitments throughout the product life cycle.
Facilitate transition of core Module 3 documents to regional formats for submission Ex-US.
Liaise with other members of the Regulatory Affairs department to coordinate CMC changes with other aspects of the development programs.
Maintain regulatory compliance through adherence to change control procedures and completion of regulatory impact assessments.
Monitor CMC regulations and guidance to assess relevant changes and implications to current and future development and commercial activities.
Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimization and efficiency commensurate with departmental and company growth.
People management responsibility and oversight (through direct reports and/or as an individual contributor) of other compliance-related initiatives within Regulatory and cross-functionally.
Provide leadership within the Regulatory department, including identifying and managing through completion, departmental and cross-project initiatives and regulatory obligations.
Liaise internally with members of Exelixis' functional departments.
Liaise externally with vendors, partners, and joint development collaborators.
SUPERVISORY RESPONSIBILITIES:
None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
Bachelor's degree in related discipline and a minimum of thirteen years of related experience; or,
Master's degree in related discipline and a minimum of eleven years of related experience; or,
PhD degree in related discipline and a minimum of eight years of related experience; or,
Equivalent combination of education and experience.
Experience:
Knowledge, Skills and Abilities:
Develops and manages plans, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high quality work.
Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work.
Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one to one situations and effectively presents information to cross-functional groups of colleagues.
Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.
Manages effectively performing teams, facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.
Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals.
Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.
Plans and executes multiple activities.
Considers alternative methods and contingency plans to avoid potential issues.
Designs and implements solutions to address project level challenges, taking into consideration the broader impact.
WORKING CONDITIONS:
Travel approximately 15%
#LI-MB1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $191,500 - $271,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyAssociate Clinical Contracts & Oncology Outsourcing Director
Alameda, CA job
SUMMARY/JOB PURPOSE: The Associate Outsourcing Director will be a Category Manager within the Strategic Sourcing and Procurement (SS&P) department based on the category(ies) they are assigned. This individual will be a main business point of contact for their categories and will be responsible for providing leadership and operational execution and oversight of the category and vendor pool.
SS&P Category Management and Sourcing team is responsible to manage strategic approach to procurement and ensure informed sourcing decisions to overall optimize spend, maximize relationships, minimize risk & enable business objectives. The Associate Director will support forming strong partnerships with business leaders and to provide team guidance and operational oversight to develop and maintain category sourcing strategies which leverage the company's growing purchasing power to drive greater efficiencies, economies of scale, and strategic relationships as we seek to become a global, multi-product oncology company.
SS&P department manages outsourcing leveraging a category-based approach. Categories are established based on consolidation of like-services and areas of spend spanning Exelixis enterprise from: Discovery, Development, General and Administrative, Information Technology, Commercial, etc. For each category, there will be a Category Manager assigned which reports to the Director.
Clinical Services Category
The Associate Outsourcing Director will be a Category Manager for the Clinical Services category. This role will be a key point of contact for all Development Operations' and other R&D departments' outsourcing needs and activities with Clinical Research Organization and related Vendors, such as: CRO's (clinical trial operations), Development Operations (eTMF; trial performance and optimization; patient recruiting and retention; site financial services), IRT, EDC, IDMC and Clinical Operations Headcount Augmentation.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Work with SS&P leadership to support the development and maintenance of SS&P business processes and policies.
* Support and provide thought leadership to drive category strategy development working with SS&P leadership and the business units.
* Develop and build trusted and collaborative stakeholder relationships with increasing levels of senior management engagement within the business units.
* Provide business units advice, expertise, and support.
* Lead vendor evaluation activities (RFIs and RFPs) and selection process including facilitation of vendor capability presentations, software demonstrations, bid defense meetings and vendor award notifications. Drive associated process development and optimization.
* Develop more mature contracting models and support option analysis or and development of strategic partnership options.
* Lead vendor contracting process in collaboration with key internal and external stakeholders, including scopes of work, budgets, and payment schedules and out of scope management; PO initiation, revision (increases, decreases), and close-out; contract and budget lifecycle.
* Ensure a robust framework is established for supplier contract and budget management and conducting regular business reviews.
* Help maximize value of vendor relationships and minimize business risk for critical services post contract through support or leadership of supplier relationship management efforts.
* Collaborate with Strategic Supplier Relationship team(s) or business as appropriate to ensure effective management of vendor costs, value improvements, supplier performance, quality, timelines, and risks throughout the contract lifecycle.
* Support triage, resolution, and/or escalation of vendor relationship, performance, quality, and/or other issues received from SS&P category team members, Exelixis Business Owners, and/or vendors.
* Act as SS&P lead on meetings with stakeholders and suppliers, especially in Vendor Governance or regularly scheduled Business Reviews.
* Build, maintain, and grow business relationships with current and prospective vendors through honesty, integrity, and trust.
* If applicable to category, represent SS&P at Exelixis Project Team meetings.
* Liaise and partner with Exelixis' Legal department and Business Owners to ensure vendor contract terms and conditions adequately address all business needs and requirements for services and protect Exelixis', SS&P's, and Exelixis' Business Owners' interests prior to contract execution.
* Manage end-to-end SOW and associated contract development and execution workflow for low-risk contracts leveraging the Legal Contract Lifecycle Management (CLM) system. Drive associated process development and optimization. Drive associated process development and optimization.
* Liaise and partner with Exelixis' Legal department to ensure timely execution of vendor Confidential Disclosure Agreements, Master Services Agreements, Services Agreements, Work Orders/Task Orders, Amendments, Change Orders, Completion of Service Letters, Termination Letters, and other types of contracts.
* Liaise, partner, and collaborate with SS&P's Operations function on vendor payment status, financial reconciliation, and contract close-out processes.
* Partner with FP&A and Accounting to support vendor accrual and forecasting process.
* Other duties and responsibilities, as assigned.
SUPERVISORY RESPONSIBILITIES:
* No Supervisory responsibilities.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
* Bachelor's degree in related discipline + eleven (11) years of related experience; or,
* Master's degree in related discipline + nine (9) years of related experience; or,
* Doctoral degree in related discipline + five (5) of related experience; or,
* Equivalent combination of education, training, and experience.
Experience:
* Experience in the pharmaceutical and/or biotechnology industry(ies) required.
* Experience in pharmaceutical and/or biotechnology R&D outsourcing, purchasing, supplier relationship management and/or procurement role(s) required.
* Supervisory/management experience preferred.
Knowledge/Skills:
* Must have strategic and operational procurement knowledge (e.g. processes, operations, negotiations, best practices, models, markets, services, risks, and trends) and working knowledge (pharmaceutical and/or biotechnology industry related knowledge a plus). As applicable to designated categories of responsibility, experience should be from relevant background within pharmaceutical and/or biotechnology industry.
* Must have a working knowledge of financial processes and operations, including but not limited to budgeting, accruals, forecasting, financial analyses, financial reporting, capital expenditures, invoicing, payment terms, purchase requisitions/purchase orders, importation/exportation fees, taxes, currency exchange rates, and inflation (pharmaceutical and/or biotechnology industry a plus).
* Must have working knowledge of contracts, including but not limited to legal terms and conditions (e.g., legal decisions vs. business decisions) and contract exhibits (e.g., scopes of work, budgets, payment schedules, quality agreements, data privacy addendums) (pharmaceutical and/or biotechnology industry a plus).
* Knowledge of pharmaceutical and/or biotechnology industry regulations (e.g., FDA, MHRA, EMA, ICH GCP) and financial regulations (e.g., Sarbanes-Oxley Act, GAAP) a plus.
* Must have knowledge and proven success in negotiation, change management, and stakeholder collaboration in contracts with increased expense and risk.
* Must be a self-starter, fast learner, solid collaborator, and solid team player with the ability to work independently with minimal supervision.
* Must have solid strategic thinking, analytical, negotiation, financial, problem-solving, decision-making, time management, change management, and organizational skills with demonstrated ability to work in a fast-paced environment and adapt to changing business plans and priorities.
* Must have solid interpersonal, verbal, and written communication skills, including confidence and ability to provide clear and concise verbal and written communications and facilitate presentations to Exelixis' and vendors' individual contributors, functional managers, department heads, senior executives, and C-suite executives.
* Must have solid ability to focus on details and provide high-quality deliverables.
* Must have solid ability to identify and communicate issues and risks.
* Must have solid focus on customer service and solid ability to build and maintain relationships.
* Must have solid ability to influence without direct authority.
* Must have solid computer skills, including knowledge of Microsoft Outlook, Word, Excel, and PowerPoint, as well as ability to quickly learn new software systems.
* Experience with Ariba, Agiloft or similar contract lifecycle management system, Jira Service Management preferred.
* Must embrace Exelixis' core values: Be Exceptional, Excel for Patients, and Exceed Together.
WORKING CONDITIONS:
* Travel: May include occasional travel to:
* Other Exelixis corporate office locations (< 5%); and/or,
* Current and/or prospective vendor offices and facilities (< 5%).
* Environment: primarily working indoors, performing clerical work
#LI-EZ1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $146,000 - $208,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplySenior Scientist, Quality Control- Microbiology (Small Molecule)
Foster City, CA job
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, 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.
**QC Microbiology:**
The QC Microbiology Senior Scientist is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides support for strategic leadership and oversight of daily microbiological operations. The role will contribute to monitoring QC test method execution and the microbiological lifecycle management.
The role is accountable for refining QC procedures across Gilead's small molecule and biologics manufacturing network, ensuring global cGMP compliance. Responsibilities also include managing clinical and commercial microbiological sample shipping and testing logistics and data entry from CTLs/CMOs into Gilead's LIMS.
**Department:**
Global Quality Control - GQC-Biologics and Small Molecules
**Job Responsibilities: **
+ Experience with Small Molecules Quality Control microbiology and extensive knowledge of industry best practices and trends.
+ In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
+ Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
+ Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.
+ Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
+ Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.
+ Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.
+ Demonstrated the ability to influence process and outcomes across functions.
+ Willing to support future laboratory work.
**Basic** **Qualifications:**
+ PhD in Microbiology, Chemistry, Biochemistry or related field with 2+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR
+ MS in Microbiology, Chemistry, Biochemistry or related field with 6+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR
+ BS in Microbiology, Chemistry, Biochemistry or related field with 8+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR
+ Associate's degree in Microbiology, Chemistry, Biochemistry or related field with 10+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR
+ HS degree with 12+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring.
**Preferred Qualifications:**
+ Preferred 2+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring.
+ Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting microbiological trends in industry.
+ Knowledge and experience in Small Molecule Oral Solid Dose and Sterile Small Molecule manufacturing.
+ Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
+ Strong organizational and planning skills.
+ Shows excellent verbal and written communication skills and collaborative interpersonal skills.
The salary range for this position is: $157,590.00 - $203,940.00. 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.
**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, 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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
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.
Strategic Supplier Relationships Director
Alameda, CA job
SUMMARY/JOB PURPOSE: The Strategic Supplier Relationships Director is responsible for optimizing partnerships within multiple areas; including (but not limited too) full service CRO providers, central and local laboratories, interactive response technology, pharmacovigilance and data management service providers. This individual is the key point of contact for Product Development and Medical Affairs departments. This leader is responsible for optimizing our ways of working with our suppliers, focusing on outsourcing engagement, operational effectiveness, and governance. They support teams in the delivery, overall success and adherence with the partnership goals, vision and contractual obligations. This role also serves as Subject Matter Expert (SME) on day-to-day partnership related activities. The Strategic Supplier Relationships Director acts as a strong change agent that can prioritize, problem-solve, simplify and effectively enable positive results within the partnership.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Partner with PDMA departments and SSP to help define, implement and continually improve CRO outsourcing strategies, tactics and operations with strategic partners.
* Optimize ways of working including:
* Development of CRO manual and best practices
* Adherence to best practices
* Define and manage performance and quality metrics across the partnership
* Implement issue escalation and resolution pathways
* Lead governance meetings from the operational level and down for partnership. Including developing the focus, materials, and finalizing the minutes. Act as key partner with SSP for executive governance.
* Cultivate innovation opportunities in order to address future state needs by having an in-depth understanding of the structure, strategy and needs of Product Development and Medical Affairs and co-ordinate work requirements.
* Demonstrate partnering behaviors for all associated with the relationship. Address and problem- solve systemic issues occurring in the partnership to bring appropriate awareness and to drive resolutions and improvements Integrate lessons learned through the alliance into forward activities.
* Build and maintain relationships with internal and external key business partners to assure Strategic relationship remains healthy. Ensuring goals, objectives and results are monitored, celebrated, or raised at relevant governance forums for support.
* Develop a strategy for prioritizing the improvement of processes within the Strategic Relationship.
* Act as a trusted business advisor, thought partner and project manager on key initiatives as needed.
SUPERVISORY RESPONSIBILITIES:
* None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* Bachelor's degree in related discipline and a minimum of 13 years of related experience; or,
* Master's degree in related discipline and a minimum of 11 years of related experience; or,
* Doctoral degree in related discipline and a minimum of 8 years of related experience; or,
* Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
* Typically requires a minimum of 11 years of related experience and/or combination of education/training and experience.
* Experience in biotech/pharmaceutical industry required.
* Experience in biotech/pharmaceutical industry: CROs, R&D outsourcing, purchasing or procurement roles required.
Knowledge/Skills:
* In-depth knowledge of biopharmaceutical industry regulations, standards and best practices.
* Poise and confidence to provide verbal and written communications and formal presentations to Exelixis' and external vendors' executives, senior management, functional management and individual contributors.
* Must be a self-starter, quick learner, strong collaborator and team player with ability to work independently with minimal supervision.
* Must have excellent analytical, strategic thinking, problem-solving, time management, change management and organizational skills with demonstrated ability to work in a fast-paced environment and adapt to changing business plans and priorities.
* Strong interpersonal, verbal and written communication skills.
* Strong attention to detail.
* Ability to identify and communicate issues and risks.
* Excellent presentation skills.
* Ability to build and maintain strong relationships.
* Ability to influence without direct authority.
* Excellent computer skills, including advanced knowledge of Microsoft Excel, Word, PowerPoint and Outlook.
* Embraces Exelixis' core values: Be Exceptional; Excel for Patients; Exceed Together.
JOB COMPLEXITY:
* Responsible for driving changes in ways of working across a complex network of stakeholders and SMEs.
* Ensures processes are efficient and minimizes burden on business owners across the clinical landscape to ensure the quality of outsourced services.
WORKING CONDITIONS:
* May include occasional travel (less than 10%) to current and/or prospective vendor facilities.
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $187,500 - $266,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyAssociate Scientific Regulatory Writing Director
Alameda, CA job
SUMMARY/JOB PURPOSE (Basic purpose of the job):
Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Examples include clinical and nonclinical summaries for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports, and other types of complex cross‑functional documents and reports as needed.
ESSENTIAL DUTIES/RESPONSIBILITIES:
Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing content. Integrates various sources of information into a uniform style and presentation for the intended audience.
Incorporates diverse reviewer feedback while ensuring high quality of content organization, including completeness, clarity, coherence, conciseness, consistency, and accuracy.
Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and in‑text tables.
Assigns and supervises partner regulatory editors for all document tasks unrelated to writing.
Proposes and manages timelines for the document development process from initiation through approval.
Oversees the assembly of appendices for regulatory submission documents as needed.
Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams.
Provides writing guidance to internal teams based on organizational goals and company policy, with responsibility for results.
Peer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team members.
Contributes to SOP and work instruction development and review for the Regulatory Science Communications team.
Other duties as needed.
SUPERVISORY RESPONSIBILITIES:
No direct reports.
Supervises work of junior writers and regulatory editors on document tasks.
May direct and review the work of contract writers as needed.
May mentor less experienced writers.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
BS/BA degree in related discipline and a minimum of eleven years of related experience including industry; or,
MS/MA degree in related discipline and a minimum of nine years of related experience including industry; or,
PhD in related discipline and a minimum of five years of related experience including industry; or
Equivalent combination of education and experience.
Active AMWA member with certificate or certification preferred; BELS certification a plus.
Experience:
Experience in Biotech/Pharmaceutical industry preferred.
Prior regulatory/medical/technical writing experience within the biotech, pharmaceutical, or CRO industry.
Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions (e.g., IND/NDA/BLA/MAAs, clinical protocols, CSRs, IBs).
Experience and use of electronic literature tools to obtain scientific/medical abstracts and publications.
Familiarity with therapeutic area of oncology.
Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards.
Advanced knowledge of AMA style, medical terminology, and clinical data analysis.
Knowledge, Skills and Abilities:
Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results. Takes pride in delivering high quality work.
Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete complex work.
Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to groups of departmental colleagues.
Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution.
Manages effectively performing teams to achieve common objectives. Engages internal stakeholders to establish productive collaborative relationships.
Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.
Capable of managing the execution of multiple tasks.
Ensures appropriate prioritization and execution for area of responsibility.
Proactively anticipates, prioritizes and resolves task-related challenges.
Designs and implements solutions to address task-related challenges, taking into consideration the broader impact.
Work Environment/Physical Demands:
Environment: primarily working indoors.
Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
#LI-MB1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $148,500 - $209,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplyDirector, Statistical Programming Standards & Infrastructure
Alameda, CA job
SUMMARY/JOB PURPOSE (Basic purpose of the job):
The Director of Statistical Programming Standards & Infrastructure provides strategic leadership and oversight for the development, implementation, and maintenance of global statistical programming standards, tools, and infrastructure. This role ensures compliance with regulatory requirements, industry standards (e.g., CDISC), and internal quality processes. The Director will partner with cross-functional teams, including Biostatistics, Clinical Data Management, and IT, to drive innovation, efficiency, and consistency in statistical programming deliverables across studies and submissions.
ESSENTIAL DUTIES/RESPONSIBILITIES:
Define and execute the vision for statistical programming standards and infrastructure aligned with organizational goals.
Establish governance for global programming standards, tools, and processes.
Oversee creation, validation, and lifecycle management of global macros, standard programs, and reusable code libraries.
Ensure adherence to SDLC principles for all programming tools and infrastructure components.
Drive initiatives to enhance automation, scalability, and efficiency in programming workflows.
Collaborate with IT to maintain robust, secure, and compliant programming environments.
Ensure deliverables meet CDISC standards (SDTM, ADaM) and regulatory requirements (e.g., FDA, EMA).
Oversee quality control processes for CRO deliverables and internal outputs, including datasets and TLFs.
Partner with Biostatistics, Clinical Data Management, and other stakeholders to align standards and infrastructure with clinical development needs.
Serve as subject matter expert for programming standards during audits and regulatory inspections.
Lead and mentor a team of statistical programmers and standards specialists.
Manage resource allocation, training and career development for team members.
Identify emerging technologies and best practices to advance programming capabilities.
Champion process improvements and standardization initiatives across the organization.
SUPERVISORY RESPONSIBILITIES:
Directly manage a team of statistical programming standards and/or infrastructure.
Provide leadership, coaching and performance management to ensure team success.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
BS/BA degree in a related discipline and a minimum of 13 years of relevant experience; or,
MS/MA degree in a related discipline and a minimum of 11 years of relevant experience; or,
PhD in a related discipline and a minimum of 8 years of relevant experience; or,
Equivalent combination of education and experience.
Experience:
Extensive experience in pharmaceutical/biotech statistical programming, including NDA/BLA submissions.
Proven track record in developing and implementing programming standards and infrastructure.
Strong proficiency in SAS/Base, SAS/Stat, SAS/Macro; programming experience in R and Python is a plus; experience with CDISC standards and SDLC.
Familiarity with oncology clinical trials preferred.
Knowledge, Skills and Abilities:
Strategic thinking with ability to translate vision into actionable plans.
Strong leadership and team management skills.
Good managerial and organizational skills.
Excellent communication and collaboration abilities.
Knowledge of appropriate FDA regulations, industry standards and guidance documents.
Understands clinical research process, trial designs, and the development of protocols and analysis plans.
Experience authoring SOPs and work instructions.
Works on highly complex problems requiring strategic analysis and innovative solutions.
Influences organizational policies and practices related to statistical programming standards and infrastructure.
Networks extensively with internal and external stakeholders to drive alignment and adoption of standards.
Work Environment/Physical Demands:
Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
#LI-JP1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $198,000 - $281,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Auto-ApplySenior Corporate Counsel, Securities & Governance Leader
Alameda, CA job
A leading biotech company based in Alameda, CA, is seeking a Senior Corporate Counsel to manage corporate governance and securities law compliance. The candidate will lead a small legal team, ensuring adherence to SEC and Nasdaq regulations, preparing essential corporate documents, and providing legal support across the organization. Ideal applicants should possess a JD degree, be admitted to practice in California, and have 6-8 years of relevant experience. Competitive compensation and comprehensive benefits included.
#J-18808-Ljbffr