Principal Scientist - Clinical Pharmacology, Modeling & Simulation
Amgen 4.8
Amgen job in South San Francisco, CA
Career CategoryScientificJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Principal Scientist - Clinical Pharmacology, Modeling & Simulation
What you will do
Let's do this. Let's change the world. The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Principal Scientist. In this vital role, you will drive innovative modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs. Your impact will extend across therapeutic areas such as oncology, rare diseases, obesity, and cardiovascular disease, and spans diverse modalities from small molecules and mAbs to innovative novel modalities.
The Principal Scientist will be Subject Matter Expert who will apply Quantitative Translational and Clinical Pharmacology approaches - such as Pharmacokinetic/Pharmacodynamic (PK/PD) modeling, Mechanistic-Physiologically Based Pharmacokinetic (M-PBPK) modeling, Mechanistic-PBPK-Pharmacodynamic (M-PBPK-PD) modeling, Quantitative Systems Pharmacology (QSP) modeling - integrated with emerging Machine Learning and Generative AI approaches - to innovatively guide optimal clinical drug development.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience
Or
Master's degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience
Or
Bachelor's degree and 6 years of Clinical Pharmacology and Modeling & Simulation experience
Or
Associate's degree and 10 years of Clinical Pharmacology and Modeling & Simulation experience
Or
High school diploma / GED and 12 years of Clinical Pharmacology and Modeling & Simulation experience
Preferred Qualifications:
PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or Chemical Engineering or equivalent professional degrees e.g. MD, PharmD).
5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
Hands-on experience in Quantitative Clinical Pharmacology approaches with a focus on PK/PD modeling, M-PBPK modeling, M-PBPK-PD modeling, and QSP modeling to inform clinical study designs, optimal dosage selection in target patient populations, characterization of drug-drug interactions, dosing in special populations, ethnic sensitivity, pediatric and biopharmaceutics studies. Expert knowledge of commonly used software for PK/PD, M-PBPK, M-PBPK-PD, & QSP modeling required.
Established track-record of Model Based Drug Development (MIDD).
Established track-record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.
Experience in leading the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.
Salary Range
162,988.00 USD - 192,921.00 USD
$144k-203k yearly est. Auto-Apply 60d+ ago
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Scientist - Cytometry & Imaging Sciences
Amgen 4.8
Amgen job in South San Francisco, CA
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Scientist - Cytometry & Imaging Sciences**
**What you will do**
Let's do this. Let's change the world. In this vital role you will have the ability to calibrate and operate multiparameter flow cytometers (including cell sorters), microscopes & related imaging platforms with the additional ability to teach others & personally learn additional relevant skills as appropriate.
+ The ability to operate analytical flow cytometry analyzers & sorters with primary emphasis and cell imaging platforms as a secondary emphasis ; identify instrument problems, perform basic troubleshooting / remediation & oversee field engineer remediation when required.
+ The ability to compile high complexity multiparameter fluorophore panels for legacy & full spectrum flow cytometers that maximize signal while minimizing fluorescence spillover.
+ The ability to guide / train others how to use the facility as well as to hold personal accountability for prioritized projects.
+ The ability to work in a biosafety level 2 plus laboratory environment, to maintain laboratory safety for everyone that accesses the laboratory & to initiate & complete risk assessments for new activities in the laboratory as appropriate.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a go-getter with these qualifications.
**Basic Qualifications:**
Doctorate degree PhD OR PharmD OR MD preferably with Cytometry experience or
Master's degree and 2 or more years of Cytometry experience or
Bachelor's degree and 4 or more years of Cytometry experience
**Preferred Qualifications:**
+ Education in the life sciences; Prior experience working in a biopharmaceutical company or academic projects with a biopharmaceutical sponsor.
+ Good documentation practices & scientific conduct as defined by standard operating procedures.
+ Ability to leverage varied AI/ML analytical platforms as they emerge into our industry & work in a team structure with data scientists in synergy.
+ A working knowledge of how to integrate flow & imaging cytometry efforts with adjacent single cell technologies (e.g., RNA seq, CRISPR screens, etc).
**What you can expect from us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
**Application deadline**
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
$108k-161k yearly est. 9d ago
Director, Quality
Gilead Sciences, Inc. 4.5
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.
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses
worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The PQL is a strategic matrixed leadership position responsible for end-to-end product quality strategy. The PQL will serve as an individual contributor and as the primary Quality representative on the PDM Product Strategy Team(s), and lead of the Product Quality Team. The candidate should have a scientific and technical understanding of drug development and commercialization and be able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization. The successful candidate must have experience in a biotechnology and pharmaceutical development environment and strong knowledge of cGMP quality systems. This is an on-site position based at our Foster City headquarters.
*Prior Quality leadership and technical management experience in development and/or commercial programs.*
Job Functions:
Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log.
Serve as the primary Quality representative in the PDM meeting.
Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones.
Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner.
Review and approve the strategy for change control(s) impacting the product/program lifecycle.
Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints.
Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option).
Provide oversight for changes to drug substance and drug product CMC details.
Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites.
Support drug substance and drug product technology transfer, and new product launches.
Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products.
Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams.
Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes).
Perform work that requires independent decision making and the exercise of independent judgment.
Serve as the delegate for Pillar Lead, as needed, for meeting and decision making.
Knowledge, Experience and Skills:
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.
In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality.
Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product.
Skilled at managing multiple projects and timelines and to facilitate meetings.
In-depth understanding and execution of Quality Risk Management.
Ability to track and follow up on actions.
Excellent in verbal, written and interpersonal communication skills.
Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way.
Ability to lead and influence a matrix-based cross-functional team.
Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined.
Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product
Basic Qualifications:
12+ years of relevant experience and a Bachelors degree in science or related fields;
OR
10+ years of relevant experience and an advanced science degree such as MS, MD,
OR
8+ years of relevant experience and a PharmD, PhD, in science or related fields
OR
8+ years of relevant experience and advanced business degree such as an MBA
Preferred Qualifications:
15+ years of relevant experience and a Bachelors degree in science or related fields;
Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment.
Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections.
Prior Quality leadership and technical management experience in development and/or commercial programs.
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the
way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current
performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and
realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding
them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses
worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The PQL is a strategic matrixed leadership position responsible for end-to-end product quality strategy. The PQL will serve as an individual contributor and as the primary Quality representative on the PDM Product Strategy Team(s), and lead of the Product Quality Team. The candidate should have a scientific and technical understanding of drug development and commercialization and be able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization. The successful candidate must have experience in a biotechnology and pharmaceutical development environment and strong knowledge of cGMP quality systems. This is an on-site position based at our Foster City headquarters.
*Prior Quality leadership and technical management experience in development and/or commercial programs.*
Job Functions:
Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log.
Serve as the primary Quality representative in the PDM meeting.
Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones.
Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner.
Review and approve the strategy for change control(s) impacting the product/program lifecycle.
Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints.
Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option).
Provide oversight for changes to drug substance and drug product CMC details.
Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites.
Support drug substance and drug product technology transfer, and new product launches.
Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products.
Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams.
Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes).
Perform work that requires independent decision making and the exercise of independent judgment.
Serve as the delegate for Pillar Lead, as needed, for meeting and decision making.
Knowledge, Experience and Skills:
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.
In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality.
Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product.
Skilled at managing multiple projects and timelines and to facilitate meetings.
In-depth understanding and execution of Quality Risk Management.
Ability to track and follow up on actions.
Excellent in verbal, written and interpersonal communication skills.
Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way.
Ability to lead and influence a matrix-based cross-functional team.
Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined.
Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product
Basic Qualifications:
12+ years of relevant experience and a Bachelors degree in science or related fields;
OR
10+ years of relevant experience and an advanced science degree such as MS, MD,
OR
8+ years of relevant experience and a PharmD, PhD, in science or related fields
OR
8+ years of relevant experience and advanced business degree such as an MBA
Preferred Qualifications:
15+ years of relevant experience and a Bachelors degree in science or related fields;
Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment.
Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections.
Prior Quality leadership and technical management experience in development and/or commercial programs.
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the
way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current
performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and
realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding
them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $210,375.00 - $272,250.00. 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:
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* 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.
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Job Requisition ID R0045721
Full Time/Part Time Full-Time
Job Level Director
Remote Type Onsite Required
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$210.4k-272.3k yearly 3d ago
Cell Culture Process Development Lead - Pivotal & Commercial
Gilead Sciences, Inc. 4.5
Foster City, CA job
A leading biopharmaceutical company in Foster City is seeking an Associate Director/Principal Scientist to lead cell culture development for biologics programs. The ideal candidate will have significant experience in process development and team management, with a Ph.D. or relevant degree. This role involves optimizing processes, mentoring team members, and ensuring compliance with regulatory requirements.
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$92k-120k yearly est. 4d ago
Director, HIV Community Liaison & Marketing
Gilead Sciences, Inc. 4.5
Foster City, CA job
A leading biopharmaceutical company in California is seeking a professional with strong marketing skills and an emphasis on HIV-related experience. The ideal candidate will work with external agencies and contribute to the development of impactful marketing programs. Applicants should have a bachelor's degree, extensive experience in marketing, and an ability to thrive in a fast-paced environment. The role entails collaboration, communication, and a sensitivity to the topics in the HIV market, with potential for domestic travel.
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$49k-62k yearly est. 2d ago
Senior Director, Medical Excellence Strategic Programs
Gilead Sciences, Inc. 4.5
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.
Key Responsibilities
Medical Excellence Leadership
Partner with the Medical Excellence Leadership team to define and execute the global Medical Excellence strategy.
Lead initiatives that elevate consistency, quality, and impact of medical engagement planning, execution, and measurement.
Drive continuous improvement of Medical Affairs processes, tools, and operating models.
Collaborate with other GMSO teams including Digital, Insights and Analytics, Scientific Communications and Content Strategy, and Medical Affairs Technology to build programs that leverage the connection across capabilities.
Partner with Regional Medical Excellence to ensure consistent deployment and execution across the regional teams.
Develop and deploy frameworks, tools, and support that help local and regional medical teams translate global medical strategy into effective engagement plans.
Define standard methodologies, templates, and tools that optimize planning, execution, and measurement across all engagement channels (Field Medical, Medical Information, Digital, etc.).
Collaborate with Channel Leads (digital, personal, and print) to establish clear principles for channel selection, integration, and sequencing, ensuring the right interaction at the right time for the right stakeholder.
Support country and regional teams in operationalizing omnichannel approaches that align with scientific and compliance standards.
Process & Capability Development
Identify and improve cross‑functional Medical Affairs processes that enhance agility, effectiveness, and alignment.
Lead projects to simplify workflows, clarify decision ownership, and reduce duplication across global, regional, and local teams.
Partner with Learning & Development to design capability‑building programs (training, toolkits, playbooks) that embed best practices.
Drive continuous improvement through feedback loops, metrics, and lessons learned from across the organization.
Partner closely with cross‑functional leaders in Field Medical, Strategy and Operations, Medical Governance and Compliance to ensure process alignment and scalability.
Serve as a strategic adviser to global and regional medical leadership teams to drive adoption of best practices.
Lead global working groups and communities of practice that foster peer learning and consistency.
Act as a change leader, influencing, communicating, and embedding a culture of excellence across the global Medical Affairs network.
Measurement & Impact
Define and monitor key success metrics for Medical Excellence initiatives and engagement effectiveness.
Partner with analytics teams to design dashboards and scorecards that enable data‑driven decision making.
Ensure that process improvements translate into measurable enhancements in scientific engagement, compliance, and stakeholder satisfaction.
Worldwide Engagement Strategy Enablement
Develop and deploy frameworks, tools, and support that help local and regional medical teams translate global medical strategy into effective engagement plans.
Define standard methodologies, templates, and tools that optimize planning, execution, and measurement across all engagement channels (Field Medical, Medical Information, Digital, etc.).
Collaborate with Channel Leads (digital, personal, and print) to establish clear principles for channel selection, integration, and sequencing, ensuring the right interaction at the right time for the right stakeholder.
Support country and regional teams in operationalizing omnichannel approaches that align with scientific and compliance standards.
Collaboration & Change Leadership
Partner closely with cross‑functional leaders in Field Medical, Strategy and Operations, Medical Governance and Compliance to ensure process alignment and scalability.
Serve as a strategic adviser to global and regional medical leadership teams to drive adoption of best practices.
Lead global working groups and communities of practice that foster peer learning and consistency.
Act as a change leader, influencing, communicating, and embedding a culture of excellence across the global Medical Affairs network.
Qualifications
12 years of relevant experience with an Advanced degree (MS, MBA, PharmD, PhD or equivalent) in a scientific or business discipline.
10+ years of experience in Medical Affairs, preferably with global or regional leadership role.
Demonstrated success in Medical Excellence, process optimization, capability building, or strategic operations.
Proven track record leading cross‑functional initiatives that improve effectiveness and alignment.
Experience supporting engagement strategy or omnichannel medical planning strongly preferred.
Excellent communication, facilitation, and stakeholder management skills.
Strong analytical mindset and familiarity with metrics‑driven performance improvement.
Demonstrated ability to work effectively in a highly matrixed, global organization.
Personal Attributes
Strategic systems thinker, able to connect process design to business impact.
Collaborative and credible partner who influences without authority.
Change‑oriented leader who inspires confidence and adoption.
Comfortable operating at both conceptual and tactical levels.
Passionate about advancing scientific engagement and improving patient outcomes.
Impact of the Role
This position will help ensure that Medical Affairs operates as a strategic, insights‑driven, and impact‑focused function, fully aligned with Gilead's vision of transforming care for people with life‑threatening diseases worldwide. By embedding consistent frameworks, capabilities, and engagement excellence, this leader will help global and local teams work smarter, faster, and more cohesively, ultimately amplifying Gilead's scientific voice and medical impact.
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Benefits and Compensation
The salary range for this position is: $281,010.00 - $363,660.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: ******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Gilead Sciences is seeking a highly motivated, adaptable, and experienced Program and Project Management leader to start up a new state-of-the-art Single-Use DS Biologics Manufacturing facility in Foster City and integrate this facility with existing Foster City cGMP Manufacturing activities.
As the Foster City Manufacturing Operational Readiness Program Lead, you will design, build and manage the multi-year cross-functional program of activities and workstreams involved in transitioning Gilead's new Foster City biologics manufacturing facility from capital project into routine cGMP production. You will help ensure that the systems, people, and processes are in place to support clinical manufacturing and future commercial launches. This is a unique opportunity to shape the future of Foster City Manufacturing for Gilead and make a lasting impact on global health.
Job Responsibilities
Coordinate the creation of an Operational Readiness Program and reinforce a sense of purpose and ownership among all team members. Structure distribution of responsibilities across multiple workstreams within the program, drive prioritization and sequencing of workstreams, and partner with the Capital Project team to align operational and project timelines, deliverables, and resources.
Evaluate industry best practices and select an appropriate program and project delivery model that supports the dynamic nature of a new facility startup and integrates with Gilead's existing governance and delivery frameworks.
Select and manage the tools, standards, business processes, documentation, metrics, and communications associated with the Operational Readiness Program.
Partner with IT and key stakeholders to pilot and implement innovative digital solutions for the Operational Readiness Program and Foster City Manufacturing.
Organize, prioritize, sequence, and track workstreams, activities, and resources necessary for Foster City Manufacturing to support startup and Engineering project deliverables.
Work with the Foster City Manufacturing Leadership Team, the Global Manufacturing organization, and senior leaders across PDM to develop a comprehensive Foster City Manufacturing site strategy document and own the portfolio of projects to achieve the site's long-term ambitions.
Actively participate in defining and communicating the Foster City Manufacturing mission and vision in alignment with Gilead's corporate values. Act as a change agent to foster an inclusive and high performing organization with a culture of curiosity, continuous improvement, and innovation.
Operate with an Enterprise-First mindset and a willingness to adapt and flex across functional boundaries as needed to achieve mission critical tasks.
Minimum Required Education, Years of Experience and Qualifications
Bachelor's degree in engineering, life sciences, or related field, and 10+ years of experience in biotech/pharma manufacturing or process development with a minimum of 2 years direct or matrixed people leadership experience. OR
Masters' Degree and Eight Years' Experience in biotech/pharma manufacturing or process development with direct or matrixed people leadership experience
5+ years of project and portfolio management experience utilizing both traditional and agile project delivery methodologies.
Strong understanding of cGMP compliance.
Strong business and financial acumen.
Proven experience successfully managing cross-functional teams and complex project timelines with significant components of uncertainty.
Demonstrated ability to thrive in a dynamic environment and collaborate across diverse technical areas.
Experience with Biologics Drug Substance manufacturing equipment and processes, Single-Use Technologies, and cGMP facility qualification and startup preferred.
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
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$130k-167k yearly est. 4d ago
Senior Leader, Biologics Analytical Development
Gilead Sciences, Inc. 4.5
Foster City, CA job
A leading biopharmaceutical company is seeking a Principal Scientist in Analytical Ops in Foster City, California. The role involves leading analytical development, mentoring scientists, and ensuring product quality for biologics. Ideal candidates will have extensive experience in analytical method development and a strong background in regulatory compliance. The position offers an opportunity to work in a collaborative environment that supports innovation and patient-centric solutions.
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$129k-163k yearly est. 4d ago
Director, Human Resources
Gilead Sciences, Inc. 4.5
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.
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
We are seeking a Director, HR Business Partner to partner with the U.S. Commercial organization. The Director will act as a strategic HRBP to Senior Business Leaders and Commercial Vice Presidents adopting a business-focused approach to translate objectives into actionable people plans, emphasizing organizational design, talent management, and capability building.
The Director will be a member of the respective business leadership teams and the Global Commercial HRBP team to drive and implement workforce strategies that facilitate business success, promote an inclusive and high-performing culture, and embody Gilead's core behaviors and leadership accountabilities. This role reports to the Executive Director of Human Resources for Gilead U.S. Commercial.
This is a hybrid/office based role located in Foster City, California.
Specific job responsibilities
Directs the planning, development, implementation, administration and budgeting for a portion of a large client group, or a specific geographic area.
Challenges are unique and solutions may serve as a precedent for future decisions.
Provides support directly to senior management and defines the HR strategy for the client group or groups supported.
Advises company management on HR policy and program matters, making or recommending appropriate decisions, which may be significantly complex.
Initiates discussions regarding organizational changes and presents each of the HR specialty functional areas (training, compensation, benefits, etc.) when working with management.
Within client group, facilitates the management and development of the corporate culture and values, and leads employee and manager engagement initiatives to foster teamwork and enhance employee engagement.
Viewed as subject matter expert and maintains contacts with external sources to stay apprised of current trends and new legislative changes.
Accomplishes results as an individual contributor or through HR subordinates or specialist employees/CoE. May select, develop and evaluate HR staff to ensure the efficient operation of the function.
Develops concepts, techniques, and standards for flawless execution on the delivery of HR services including talent acquisition, performance management, talent reviews, compensation planning, and project management.
Develops new applications based on professional principles and theories.
Provides analysis and recommendations about the reengineering and optimization of the organizational structure, roles, process and resource allocation, and facilitates change management.
Designs, develops and implements communication strategy using various media. Ensures effective communication strategies are in place within the organization and builds two-way communication channels.
Proactively questions the decisions of management that impact the long-term direction of the client group.
Provides coaching support for site or client group leadership, building skills, knowledge, and competencies to achieve results and make employee-related decisions in a fast changing environment.
May be responsible for representing client group or site with labor unions and/or works councils to ensure compliance with relevant labor laws and a favorable climate with employee representative groups.
May require strong business knowledge as well as a sophisticated understanding of labor relations and union negotiation rules.
Knowledge
12+ years of relevant experience in the HR field and a BA or BS degree, preferably with an emphasis in HR or Business or 10+ years of relevant experience in HR with a master's degree.
Works under consultative direction toward long-range goals and objectives.
Assignments are self-initiated with very little direct supervision.
Excellent verbal, written, and interpersonal communication skills are required.
Must possess excellent influencing skills. Requires a thorough knowledge and understanding of Human Resources legislation/employment law, principles, policies, and procedures.
Must be able to develop solutions to a wide range of highly complex problems, which require an in depth degree of ingenuity, creativity, and innovativeness.
May require experience and ability to manage staff.
Must be able to exercise judgment and independently determine and take appropriate action within defined HR policies and procedures.
Specific education and experience requirements.
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $210,375.00 - $272,250.00. 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 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.
Job Requisition ID R0049454
Job Level Director
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$210.4k-272.3k yearly 4d ago
Strategic Partnerships Lead - Molecule Discovery & Licensing
Eli Lilly and Company 4.6
San Francisco, CA job
A global healthcare leader in San Francisco is seeking an Associate Director for their External Partnering team. This role focuses on driving molecule discovery and technology licensing, enhancing portfolio growth through new business opportunities. Candidates should possess deep knowledge in drug discovery, a minimum of 7 years experience in client services or sales within pharmaceutical environments, and strong relationship-building skills. Competitive salary range of $132,000 - $193,600 offered, alongside comprehensive benefits.
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$132k-193.6k yearly 14h ago
Exec Director- Global Supply Chain Strategic Sourcing and Supplier Management
Gilead Sciences, Inc. 4.5
Foster City, CA job
United States - California - Foster City Manufacturing Operations & Supply Chain Regular
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.
Exec Director, Global Supply Chain Strategic Sourcing and Supplier Management
FOSTER CITY, CA
Key Responsibilities:
Reporting to the SVP of Global Supply Chain, and part of the larger Pharmaceutical Development and Manufacturing organization (PDM), the ED Strategic Sourcing and Supplier management will lead a team of Supply chain professionals sourcing and leading our outsourced CMO network. This role is accountable for the strategic business relationships with external suppliers of both Development and Commercial services and/or materials. This includes ownership of the strategy, selection, and performance management of all suppliers providing API, SDD, OSD, BDS, sterile DP, and secondary packaging services as well as all suppliers of direct materials including medical devices, primary packaging, excipients, and manufacturing consumables. This role collaborates closely with all PDM functional groups including RA, Tech Dev, Mfg. Ops, QA, Product & Portfolio Strategy, and Global Supply Chain and is accountable for continuous improvement and ongoing collaboration with our suppliers through product lifecycle.
Responsibilities:
Development and Commercial Programs:
Own the strategic business relationship with suppliers of manufacturing services and direct materials including but not exhaustive:
Accountable for sourcing of strategic partners, contract negotiation and ongoing business relationship with the suppliers. (MSAs, SOWs, Supply Agreements, Pricing, etc.)
Lead strategic business discussions, long range supply and/capacity planning, and business development, through the product lifecycle and ensure financial discipline, win win and savings opportunities.
Participate and contribute into CD & OP and S & OP.
Management of supplier performance (monthly/annually) Key KPI: i.e., OTD, Batch Release First Time %). Deviation on time Closure (%), Batch Rejection Rate (%), Deviations per batch
The escalation points for Mfg. Ops team members for recurrent or chronic performance issues from suppliers
Lead quarterly / annual business review meetings (BRMs) with strategic/high suppliers
Lead the assessment and mitigation of supplier risks through regular supplier risk management processes
BCP plans with suppliers articulated and desk top exercises completed to ensure robustness
Responsible for preparation and tracking of RFPs/RFQs for new business with external suppliers and in consultation with functional stakeholders (Mfg. Ops, Tech. Dev. QA, etc.)
In collaboration with Product and Portfolio Strategy team members, identify and manage strategic suppliers of manufacturing services in alignment with network supply chain strategies
Own the development and execution of supplier strategies for direct material suppliers
Identify and manage strategic suppliers of direct materials in alignment with approved CMT strategies
Establish quality and technical execution expectations with vendors
Segment our supplier and have a strategy for strategic and tiered suppliers.
Articulate digital roadmap and integration with key suppliers, plan and execute against it
Sustainability and resilience strategy articulated with key suppliers
Development/Clinical Programs:
Providing intel, options, and solutions; staying informed and knowledgeable of relevant Development CDMO and material supplier capabilities, offerings, capacities, etc. as they relate to potential or known Gilead pipeline needs
Leading site assessment teams (SATs) and/or category management teams (CMTs) for the assessment and selection of new service or material suppliers to meet Development program needs
Ensuring the full scope of supplier selections made during Development align with Commercial manufacturing and/or network strategies, as necessary.
Establish quality and technical execution expectations with vendors
Prepare and/or review agreements covering confidentiality, supply terms & conditions, and quality
Commercial Programs:
Providing intel, options, or solutions; staying informed and knowledgeable of relevant Commercial CMO and material supplier capabilities, offerings, capacities, etc. as they relate to Gilead Commercial supply needs
Leading site assessment teams (SATs) and/or category management teams (CMTs) for the assessment and selection of service or material suppliers to meet commercial Program needs
Qualifications:
Primary degree in Business, Science or Engineering discipline. Master's degree and/or professional qualifications in supply chain management desired.
15+ years of biopharmaceutical industry experience with at least 5 years of experience focused on management and leadership roles with contract manufacturers in a supply chain capacity.
Experience developing, implementing, and executing strategic plans and objectives for organizations and departments.
Solid understanding of current industry trends.
Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence, coaching, goal setting and performance management.
Strong business acumen. Capability to navigate and lead in a highly matrixed environment.
Demonstrated ability to understand complex and complicated situations and to strip out complications.
Effective communication skills, both written and verbal. Can make convincing arguments, inspire action, and bridge diverse cultures. Capable to communicate the world of PDM to people outside of PDM, and to communicate about the world outside of PDM to those inside.
Negotiation and conflict resolution skills.
A proven capability to contribute to your team's success through servant leadership.
A proven capability to contribute to the success of PDM and Gilead as a senior leader.
Gilead Core Values
Integrity (Doing What's Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
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$144k-193k yearly est. 4d ago
R&D Protein Footprinting Data Analysis Grad Intern
Amgen 4.8
Amgen job in South San Francisco, CA
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Protein Foot Printing Data Analysis Grad Intern - Biologics Engineering Statistics**
**What You Will Do**
Let's do this. Let's change the world. During this program, you will develop statistical and computational tools for protein fingerprinting data:
+ Review and evaluate published strategies for statistical analysis of footprinting MS data to draw valuable insights.
+ Design and implement a computational tool for automated statistical evaluation.
+ Benchmark performance across experimental designs and replicate structures.
+ (Preferred) Integrate the developed workflow into Amgen's internal MS data processing platform.
+ Present findings and recommendations to cross-functional scientists.
**What We Expect of You**
We are all different, yet we all use our unique contributions to serve patients. Are you a motivated and analytical student interested in applying computational tools to cutting-edge protein research this individual must have these qualifications:
**Basic Qualifications:**
Amgen requires that all individuals applying for a grad internship at Amgen must meet the following criteria:
+ 18 years or older
+ Graduated with a bachelor's degree from an accredited college or university
+ Currently enrolled in an MBA program for an MBA internship OR a Master's program for a Master's internship OR a PharmD program for a PharmD internship OR Ph.D. for a PhD internship from an accredited college or university and completion of the first year of MBA OR Master's OR Pharm D OR Ph.D. program before the internship starts
+ Enrolled in an accredited college or university following the potential internship
+ Must not be employed at the time the internship starts
+ Student must be located in the United States for the duration of the [ **internship**
**Preferred Qualifications:**
+ Currently pursuing a MS or PhD degree in Bioinformatics, Computational Biology, Statistics, Biostatistics, Data Science, Biochemistry, or a related field.
+ Proficiency in Python and CLI
+ Strong foundation in statistics, including experimental design, hypothesis testing, and application of statistical methods to mass spectrometry (MS) data analysis.
+ Prior experience with advanced proteomics mass spectrometry data
+ Strong analytical, communication, and teamwork skills.
+ Onsite working with a team based in Amgen South San Francisco, California.
+ Strong teamwork, communication, and organizational skills, with the ability to document data and code in electronic lab notebooks, presentations, and reports.
**What You Can Expect of Us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The base pay range for this opportunity in the U.S. is $30-$40 per hour
+ Build a network of colleagues that will endure and grow throughout your time with us and beyond.
+ Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
+ Participate in executive and social networking events, as well as community volunteer projects.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com -** **Please search for Keyword** **R-230569**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
**Sponsorship**
Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
$30-40 hourly 57d ago
Director, Global External Manufacturing, OSD
Gilead Sciences, Inc. 4.5
Foster City, CA job
* Performs as a leader within Global External Manufacturing to execute the network strategy. Responsible for tactical manufacturing strategy, execution of the business with external manufacturing organizations, and management of supplier performance* Partner in development of department strategy aligned with corporate and PDM goals into functional/departmental objectives to realize the targeted outcomes* Proactively and effectively leads collaboration with functions within and external to PDM to achieve corporate, cross functional, and departmental goals* In collaboration with Technical Development Organization, defines the technical requirements and actively partners with Global Supply Chain in selection of CMOs, and influences overall performance of the network CMOs to achieve Gilead's strategic and tactical business outcomes, including Key Performance Indicators* Proactively partners with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s)* Leads the regular, tactical management of CMOs to ensure Gilead's products are manufactured in accordance with the registered process and approved Master Production Record* Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control* Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability* May represent Gilead as a liaison between the company and various governmental agencies as required* Demonstrated track record in oral solid dosage drug product manufacturing and supply chain execution in the pharmaceutical industry* Expertise in supply risk management, possessing in-depth knowledge of industry and system best practices* Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance* Solid understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities and limitations for worldwide drug product manufacturing is a plus* Ability to travel internationally, including overnight, up to 10% of the time is required* Exceptional verbal and written communication skills, including ability to interact effectively with senior management* Demonstrated ability to understand and resolve complex situations* Proven leadership capability to contribute to the success of PDM and Gilead* 12+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering, an advanced degree in science, engineering, or business is desirable* An MBA degree can be substituted for 10 years of relevant experience, a Ph.D. degree can be substituted for 8 years of relevant experience
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$133k-182k yearly est. 14h ago
Director, Global Medical Affairs- Liver Diseases
Gilead Sciences, Inc. 4.5
Foster City, CA job
United States - California - Foster City
Medical Affairs Regular
Reporting to the Sr. Director of Hepatitis B and C Global Medical Affairs, this role is a key position within the Global Liver Inflammation, Respiratory Virology and Established Products (LIVE) Team. The individual in this role will be responsible for developing and driving the Medical Affairs strategy for the HBV and HCV therapeutic areas while ensuring alignment with the pan-liver approach of the LIVER team. The individual in this role must be able to work cross-functionally. To be successful in this role, the Director must be able to work cross-functionally in a fast-paced cross-functional environment.
An integral part of the HBV and HCV Global Medical Affairs strategy team, the individual will oversee and maintain the tenor of Gilead's communications with the scientific community, including ensuring the creation of high-quality slide decks, presentations at medical conferences, advisory boards, digital or face-to-face educational programs and other meeting and promotional materials. Support of therapeutic area development planning and external collaborations is also required. The Director must be able to engage in project execution as needed.
The key functions of this role
Develop, innovate and execute the Global HDV and Viral Hepatitis Medical Affairs Plans based on a landscape assessment of unmet needs, with cross-functional inputs from colleagues in Liver and Fibrosis Diseases Medical Scientists and Affiliate teams, Government and Public Affairs, Healthcare Policy, Clinical Research, Health Economics and Commercial functions
Review and advise on investigator-sponsored ISR proposals submitted to Gilead for funding
Collaborate with Medical Information to assure maintenance and creation of high-quality professional communications for healthcare professionals in response to unsolicited requests for product information
Assess medical education needs in the healthcare environment regarding Viral Hepatitis, Liver and Fibrosis and collaborate with Independent Medical Education Department to assure that appropriate programs are reviewed, supported and aligned with medical education objectives in a compliant manner
Work with Global Medical Affairs colleagues worldwide to pull through scientific and healthcare policy communications and publications from investigator-sponsored research projects
Specific Job Requirements
Subject matter expertise in viral hepatitis (particularly hepatitis B and C) is required
Experience with other liver diseases such as primary biliary cholangitis (PBC) is a plus
Establish credible knowledge base regarding current and new disease states and develop strategies to address unmet medical needs within the patient populations affected
Prepare presentation materials and present scientific data at internal and external Advisory Boards
Serve as an information resource to Gilead colleagues, including the Medical Scientists, including medical educational activities, grants and investigator-sponsored/collaborative studies
Provide medical and scientific leadership at key scientific meetings (e.g., AASLD, DDW, EASL, APASL)
Serve on Independent Medical Education (IMED) Review Committee to evaluate and give medical perspective on IMED proposals
Demonstrated medical research expertise through prior experience in a medical research function and/or peer-reviewed publications
Lead and execute on core medical affairs functions (i.e. the development of medical collateral such as slide decks, cover medical conferences, creation of medical symposia, response documents etc.)
Maintain regular contact with community advocates, government and policy officials and KOLs to identify data gaps, track study progress and communication deliverables
Ability to assess, understand and communicate continuously expanding medical and scientific information, as well as market knowledge
Global and affiliate-level experience as demonstrated by prior work in a global and/or local medical affairs setting
Anticipates future industry trends and opportunities, and proactively develops plans to address through Global MA strategy
Excellent analytical skills, demonstrated ability to identify and understand complex issues and problems and identify key findings from study data and publications
Ability to suggest solutions for issues encountered with clinical studies and other projects in area of responsibility
Other activities, as assigned, to support Global Liver and Fibrosis Medical Affairs
Excellent written, verbal and interpersonal, relationship-building and negotiating communication skills
Excellent strategic and organizational skills to support project planning across multiple activities, with ability to anticipate and prioritize workload on multiple ongoing projects
Excellent teamwork skills, both in leading and as part of a cross functional team. Organized; attention to detail and able to meet timelines in a fast-paced environment
Excellent analytical and problem-solving skills, demonstrated ability to identify and understand complex issues and problems and identify and query key findings from study data and publications
Prior experience with the execution of core medical affairs functions is a requirement (writing and developing effective presentations including abstracts, manuscripts, posters and slides and presenting at scientific meetings)
Must be fully cognizant of, and adhere to, regulatory and legal (Business Conduct) requirements for implementation science and other Medical Affairs activities
Able to work with autonomy and independence
Ability to work in a global environment which will require participation in meetings outside of standard work hours and occasionally, on the weekends to accommodate time zone differences
Knowledge, Experience & Skills
M.D., D.O., PhD (biological or pharmaceutical sciences) PharmD, with extensive experience in hepatology, infectious diseases, virology or clinical virology
> 5 years' experience in Medical Affairs and/or Clinical Research including Phase II to Phase IV studies; clinical trials management, medical monitoring and scientific expertise
Prior experience with the execution of core medical affairs functions is a requirement
Prior experience working globally, across different cultures is a plus
Prior experience with viral hepatitis, is a plus
Gilead Core Values
Integrity (Doing What's Right)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
Inclusion (Encouraging Diversity)
Due to the cross-functional nature of this role, strong skills in mentoring junior team members and working to build and foster teams, is critical. Demonstrated prior experience is a plus.
Job Requisition ID R0044735
Full Time/Part Time Full-Time
Job Level Director
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Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Scientific Associate Director, Clinical Pharmacology
What you will do
Let's do this. Let's change the world. The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Scientific Associate Director at its South San Francisco, CA location. In this vital role you will be responsible for the development and implementation of the Clinical Pharmacology and Pharmacometric strategies for cutting-edge innovative therapeutic modalities including Bi-specific T-cell engagers, Bi-specific antibodies, oncolytic viruses, antibody-drug-conjugates as well as traditional small molecules, mono-clonal antibodies and therapeutic peptides.
The Scientific Associate Director, Clinical Pharmacology will be a Subject Matter Expert who will apply innovative Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches and clinical pharmacology strategies and principles to guide optimal drug development. In this vital role, you will be an expert in new drug development and will apply Model-Based Drug Development and principles of quantitative clinical pharmacology to ensure optimal drug development and will represent the Clinical Pharmacology, Modeling & Simulation Department at the global drug development teams. Your expertise will include application of Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling, Mechanistic PK/PD modeling and Quantitative Systems Pharmacology (QSP) modeling to new drug development and you will ensure development of safe & effective dosing regimens for various patient sub-populations & also to ensure optimal new drug development.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology and 4 years of Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
Or
Master's degree in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology and 7 years of Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry
Or
Bachelor's degree in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology and 9 years of Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
Preferred Qualifications:
* PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or equivalent professional degrees e.g. MD, PharmD).
* 4+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
* Hands-on experience in Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches with a focus on Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling to inform clinical study designs for drug-drug interaction, special population, ethnic sensitivity, pediatric and biopharmaceutics studies. Expert knowledge of commonly used software for PBPK modeling required.
* Experience in leading the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.
* Established track-record of Model Based Drug Development.
* Established track-record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
* A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
* A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
* Stock-based long-term incentives
* Award-winning time-off plans
* Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.
Salary Range
210,133.00 USD - 244,435.00 USD
$123k-159k yearly est. 3d ago
Senior Regulatory Compliance Lead - Medical Devices
Johnson & Johnson 4.7
San Jose, CA job
A global healthcare company is seeking a Principal Regulatory Compliance Specialist in San Jose, California. The role involves maintaining compliance programs, managing internal audits, and supporting external inspections. Candidates should possess a Bachelor's degree with 5+ years in a regulated environment, along with strong communication and analytical skills. Experience in Quality Systems and a background in engineering are preferred. This position may require up to 10% domestic travel.
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$112k-149k yearly est. 3d ago
Director, PDM Infrastructure - Foster City
Gilead Sciences, Inc. 4.5
Foster City, CA job
United States - California - Foster City Manufacturing Operations & Supply Chain Regular
KEY RESPONSIBILITIES
Reporting to th e Senior Director , Pharmaceutical Development and Manufacturing (PDM) Operations Management , the Director , PDM Infrastructure will lead the team responsible for the key non-GMP systems that have an outsized impact on how we store, find and access non-GMP information in PDM. SharePoint ( G.Share ) and PDM apps like the PDM Team Rostering application ( G.Force ) will the initial areas of focus. PDM has generated a great deal of important non-GMP information ; being able to find and access such information easily and consistently across PDM will improve efficiency and speed . Success in this role depends on ongoing solicitation of feedback from PDM stakeholders and continuous improvement .
FOCUS AREA S
Lead the G.Share Sites and G.Share Business Apps teams
Assess and prioritize current non-GMP infrastructure for knowledge sharing and identify areas for continuous improvement
Serve as a member of the PDM Operations Management Leadership Team , connecting work that the PDM Infrastructure team does with the broader PDM Operations Management strategy
Implement strategy and plan for enabling more efficient and consistent access to non-GMP information across PDM , making it easier and more efficient for PDM staff to get their work done
Work effectively with partners in I T, with clearly defined roles & responsibilities. This role is not a technical systems role; it is the business side of information infrastructure and access
BASIC QUALIFICATIONS:
A degree in life sciences or a relevant business area with 12+ years of varied post-graduation experience in Pharmaceuticals, Biosciences or a related industry. Or MS with 10+ years of relevant experience. Or PhD with 8+ years of relevant experience.
Strong business acumen, with demonstrated capability to translate information infrastructure to improved efficiency
Strong experience with SharePoint and web-based information storage and access
Demonstrated capability to navigate and lead in a highly networked environment and experienced with the required elevated level of influencing skills.
Elevated communication skills, both written and oral. Strong presenter capable of engaging with, and facilitating conversations with, the senior leaders in the organization.
Negotiation and conflict resolution skills.
Experience developing, implementing, and executing strategic plans and objectives for departments, especially in a highly networked environment.
Solid understanding of current industry trends.
Experience leading a non-technical team that interfaces with technical teams
Leadership qualities of the successful candidate include the following: collaboration, accountability, cross-functional engagement and influence, program management, strategic vision, goal setting and performance management.
PREFERRED QUALIFICATIONS:
Demonstrated capacity to understand complex problems and to implement solutions that are as simple as possible.
Experience with knowledge management
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Job Requisition ID R0046747
Full Time/Part Time Full-Time
Job Level Director
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$165k-234k yearly est. 4d ago
R-151888 Associate Software Engineer - Scientific Platform and Computing
Amgen 4.8
Amgen job in South San Francisco, CA
Additional Information
All your information will be kept confidential according to EEO guidelines.
$86k-111k yearly est. 4h ago
Director, Device Engineering
Gilead Sciences, Inc. 4.5
Foster City, CA job
Director, Device EngineeringUnited States - California - Foster City Manufacturing Operations & Supply Chain Regular
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Specific Job Responsibilities
Build, lead, and inspire a high-performing team o f engineers, fostering a culture of collaboration, accountability, innovation, and continuous development within the device development function.
Champion a systems-based approach to product development, ensuring that all combination products are treated as integrated systems encompassing drug, device, user interface, and delivery performance.
Influence and collaborate effectively across the organization, including with clinical, regulatory, quality, commercial, and manufacturing teams, to align on product strategy, development priorities, and risk management.
Reinforce and communicate the value proposition of drug-device combination products, advocating for user-centric design, differentiated delivery platforms, and the strategic role of devices in enhancing therapeutic outcomes.
Ensure robust design control and risk management practices are followed across all device programs, in alignment with global regulatory requirements (e.g., FDA, EMA, ISO 13485, ISO 14971).
Establish and maintain strong relationships with external partners and suppliers, ensuring alignment on technical requirements, timelines, and quality expectations.
Required Education & Experience
Bachelor's Degree and Twelve Years' Experience
OR
Masters' Degree and Ten Years' Experience
OR
PhD and Eight Years' Experience
Preferred Experience
Experience leading combination product development projects and managing device engineers .
A Bachelor's Degree in Mechanical Engineering , Chemical Engineering, Biomedical Engineering, or a related scientific field and a minimum of ten (10) years of relevant industry OR a Master's Degree and a minimum of eight (8) years of relevant industry.
Experience with the development and commercialization of combination products.
Working knowledge of FDA, EMA, and cGMP standards for combination products.
Strong verbal, written, and interpersonal communication skills .
Able to write clear, concise, and error-free documents.
Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
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
We are seeking a dynamic and people-focused Director of Device Development to lead a team of engineers in the design and delivery of parenteral drug-device combination products, including prefilled syringes and autoinjectors. This role is centered on building a strong team culture, fostering cross-functional collaboration, and reinforcing the strategic value of combination products as integrated product systems. The ideal candidate will be a skilled leader who can influence across the organization, drive alignment, and champion the role of device innovation in enhancing patient outcomes. This is a high-impact leadership position with a strong emphasis on team development, organizational influence, and strategic execution.
Specific Job Responsibilities
Build, lead, and inspire a high-performing team o f engineers, fostering a culture of collaboration, accountability, innovation, and continuous development within the device development function.
Champion a systems-based approach to product development, ensuring that all combination products are treated as integrated systems encompassing drug, device, user interface, and delivery performance.
Influence and collaborate effectively across the organization, including with clinical, regulatory, quality, commercial, and manufacturing teams, to align on product strategy, development priorities, and risk management.
Reinforce and communicate the value proposition of drug-device combination products, advocating for user-centric design, differentiated delivery platforms, and the strategic role of devices in enhancing therapeutic outcomes.
Ensure robust design control and risk management practices are followed across all device programs, in alignment with global regulatory requirements (e.g., FDA, EMA, ISO 13485, ISO 14971).
Establish and maintain strong relationships with external partners and suppliers, ensuring alignment on technical requirements, timelines, and quality expectations.
Required Education & Experience
Bachelor's Degree and Twelve Years' Experience
OR
Masters' Degree and Ten Years' Experience
OR
PhD and Eight Years' Experience
Preferred Experience
Experience leading combination product development projects and managing device engineers .
A Bachelor's Degree in Mechanical Engineering , Chemical Engineering, Biomedical Engineering, or a related scientific field and a minimum of ten (10) years of relevant industry OR a Master's Degree and a minimum of eight (8) years of relevant industry.
Experience with the development and commercialization of combination products.
Working knowledge of FDA, EMA, and cGMP standards for combination products.
Strong verbal, written, and interpersonal communication skills .
Able to write clear, concise, and error-free documents.
Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
The salary range for this position is: $210,375.00 - $272,250.00. 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:
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* 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.
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Job Requisition ID R0045917
Full Time/Part Time Full-Time
Job Level Director
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$210.4k-272.3k yearly 1d ago
Grad Intern - R&D Pathology Lab
Amgen Inc. 4.8
Amgen Inc. job in South San Francisco, CA
Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Grad Intern - R&D Pathology Lab
What You Will Do
Let's do this. Let's change the world. During this program, you will work with the Pathology group in South San Francisco, CA to help develop and implement specialized tissue-based assays to support specific questions on target expression and preclinical model development.
* Maintain accurate laboratory records and follow all laboratory safety and compliance guidelines.
* Working with a mentor to perform immunohistochemistry (IHC) staining and contribute to assay optimization and validation.
* Manage databases and input information, data, and records.
* Utilize image analysis software to generate quantitative data.
* Present internship findings at the conclusion of the program.
What We Expect of You
We are all different, yet we all use our unique contributions to serve patients. This research opportunity is for motivated candidates who have demonstrated a strong interest in research in the health sciences.
Basic Qualifications:
Amgen requires that all individuals applying for a grad internship at Amgen must meet the following criteria:
* 18 years or older
* Graduated with a bachelor's degree from an accredited college or university
* Currently enrolled in an MBA program for an MBA internship OR a Master's program for a Master's internship OR a PharmD program for a PharmD internship OR Ph.D. for a PhD internship from an accredited college or university and completion of the first year of MBA OR Master's OR Pharm D OR Ph.D. program before the internship starts
* Enrolled in an accredited college or university following the potential internship
* Must not be employed at the time the internship starts
* Student must be located in the United States for the duration of the [internship
Preferred Qualifications:
* Degree concentration(s): Life Sciences, Biology or related field
* Strong communication, both written and verbal
* Hands-on experience with tissue-based assays, such as immunohistochemistry (IHC), or in situ hybridization (ISH).
* Ability to work both independently and collaboratively in a multidisciplinary environment.
What You Can Expect of Us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The base pay range for this opportunity in the U.S. is $30-$40 per hour
* Build a network of colleagues that will endure and grow throughout your time with us and beyond.
* Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
* Participate in executive and social networking events, as well as community volunteer projects.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com - Please search for Keyword R-230336
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship
Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.
Salary Range
*