Senior Manager, Clinical Operations Quality Assurance, Pharma and Medical Device (REMOTE)
Remote or Deerfield, IL job
This is where your work makes a difference.
At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your Role at Baxter:
As a skilled Senior Manager, Clinical Quality Assurance, you will lead our clinical quality assurance efforts across Baxter. You will be responsible for proactively anticipating regulatory changes, ensuring compliance with industry best practices, and driving process improvements in clinical trials for all products - pharmaceuticals and medical devices. You'll bring a strong understanding of clinical regulations, quality management systems, and industry trends.
What You'll Be Doing:
Clinical Quality Assurance Leadership:
Independently lead the development and implementation of clinical quality assurance strategies to ensure compliance with regulatory requirements
Proactively anticipate the horizon of regulations and ensure that current GCP/Clinical Trial practices reflect current and future industry practice
Provide clinical quality leadership, expertise, and support to Clinical Operations and the CMSO
Provide subject matter expertise to the MA teams and leadership regarding clinical quality matters with respect to the current regulatory landscape
Review and approve GQPs involving Human Subjects Research and Human Clinical Research
Quality Assurance Activities:
Plan and monitor quality activities for Clinical Trials, including all phases of clinical trials and post-market clinical studies
Conduct sponsor clinical sites and vendor assessments as required
Lead internal and/or regulatory audits of Clinical Trials and/or Clinical Operations
Handle clinical escalations, non-conformances, or CAPAs related to Clinical Trial operations and/or Clinical vendors
Manage New Supplier Request process for Clinical vendors
Consult and approve risk-based approaches developed by Clinical Leadership for human clinical research sponsored by Baxter
Assess impact of Field Actions on ongoing or planned clinical trials
Regulatory Compliance:
Interpret clinical regulations and provide guidance to Clinical Operations
Ensure compliance with regulatory requirements, including GCP, FDA & EMEA regulations, and other relevant standards
Serve as an interface for inspections, audits, and inspections relating to GCP compliance
Quality Metrics and Risk Management:
Assist in collecting quality metrics for adequate study oversight
Identify and assess regulatory and quality risks in activities and processes as necessary according to regulatory agency rules and guidelines and Baxter quality practices
Process Improvements and Initiatives:
Drive process improvements and initiatives in support of continuous process improvements
Maintain current and leading-edge expertise in quality management systems and quality techniques
Stay up-to-date with related quality legislation and compliance around clinical trials
Travel to regulatory agencies, industry conferences, and other external meetings as required (not expected to exceed 25%)
Your Team:
As the Senior Manager, Clinical Quality Assurance, you will report directly to the Associate Director, Clinical Operations, Operations & Governance, Worldwide Medical & Regulatory and work collaboratively with cross-functional teams to ensure the delivery of high-quality clinical data and reports.
Your Location:
The role is located at our global corporate headquarters in the greater Chicago, IL area northern suburb of Deerfield. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change. Alternatively candidates residing anywhere in the US will also be considered.
What You'll Bring:
• Bachelor's degree in a life science or related field is required
• Minimum 5-7 years of experience in clinical quality assurance, regulatory affairs, or a related field
• Experience in managing clinical quality assurance teams and developing quality management systems
• Experience in Clinical Trials, Phase 0 - IV.
• Experience in Pharmaceutical and Medical Device Clinical Trials
• Experience performing laboratory, GCP, GMP audits a plus.
• Strong knowledge of clinical regulations, quality management systems, and industry trends
• Ability to work independently and drive clinical quality assurance strategy and plans
• Experience with clinical data management systems and processes
• Strong leadership and communication skills
• Ability to analyze and interpret complex data
• Experience with quality management systems and auditing
#LI-JR1
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Auto-ApplySenior Medical (Science) Director, CVRM
Remote or South San Francisco, CA job
The Opportunity
The Sr. Medical Science Director/ Sr. Medical Director will provide exceptional clinical and scientific leadership for medical affairs activities, aiming to generate and communicate medical evidence that aids practitioners, patients, and payers in making informed health care decisions. The successful candidate exhibits outstanding communication and leadership skills and builds strong relationships with key stakeholders.
This position will also represent the US Medical function within cross functional teams and initiatives at Genentech, within the Roche global organization, and in external customer facing engagements. In addition to strong communication skills, this position requires the ability to lead fit-for-purpose teams in a matrix environment, flexibility in prioritizing work, and a mindset to engage in purposeful partnerships to solve complex multi-disciplinary challenges.
Key Responsibilities
Contribute to designing, executing, and monitoring tactics and activities laid out in the medical strategies and plans
Provide a medically sound and clinically meaningful perspective for regulatory and other scientific communications
Contribute to strategic medical plans, design of phase 3b/4 programs, integrated evidence plans, clinical study design and management
Scientific engagement with Genentech's internal and external stakeholders:
Congress Planning and Medical/Scientific Content Communications & Review:
Accountable for implementing strategy through medical tactics, tapping into the network of relevant expertise and insights
Maintaining an in-depth understanding of relevant medical strategy and clinical, patient/caregiver, payer and healthcare/market landscape
Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions.
Who you are
Required Qualifications & Experience
Advanced Clinical/Science Degree required (e.g. PharmD, PhD, MD etc.)
Minimum 5 years of relevant biopharmaceutical industry experience.
Understanding of and/or previous experience with all phases of drug development
Understanding of Medical Affairs domains including: principles and techniques of data analysis, data interpretation and assessment of clinical relevance, medical writing and reviewing, medical strategy development, external engagement planning and execution, etc.
Experience or relevant knowledge of pre-approval drug development trials and/or post-marketing medical evidence generation, including expertise in controlled and observational study designs, data analysis, and clinical/health economic interpretations
Understanding of the US health care environment and key stakeholders including the payer landscape, marketplace factors/dynamics, evidence-based medicine tools and practices, etc.
Proven record in developing strong relationships with external stakeholders (therapeutic area experts, external organizations, etc.)
Great team player; Highly collaborative; Good interpersonal and influencing skills; Can effectively and quickly establish rapport and influence without authority
Preferred Experience:
Expertise and industry experience in CVRM
Location / Travel Requirements
The position is located in South San Francisco. The position may require up to an additional 35% time traveling. This role can be eligible to sit remotely.
The expected salary range for this position based on the primary location of South San Francisco, CA is $198,600 - 471,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Relocation benefits are not available for this job posting.
This is a remote based role
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Auto-ApplyProject Specialist
Remote or Raleigh, NC job
This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your Role at Baxter
This dynamic role, in the healthcare software industry, is pivotal within Baxter Care Communications. The Project Specialists is a remote-based role, responsible for the planning, coordination, documentation, and execution of Hillrom Care Communications projects. This position will play an integral role in planning customer technology roadmaps and customer attainment strategy. Key activities include project planning, resource allocation and coordination, project risk assessment and mitigation, revenue forecasting, customer communication and internal partner management.
What you'll be doing
* Project management, planning & execution.
* Act with autonomy as the primary point of contact for all client project-related needs during an active implementation.
* Use project management software, conduct regular meetings, provide agendas and meeting minutes, and build and maintain project plans.
* Provide strong, proactive, project leadership and drive follow-ups.
* Supervise all required project metrics, and proactively identify, communicate, and resolve customer issues.
* Meet or exceed established PMO metrics including revenue forecasting, assigned project reporting/results, customer revenue/project count loads, and customer satisfaction reporting.
* Host in-person and remote meetings and translate technical information from technical to non-technical resources to meet project requirements.
* Understand the challenges facing each customer and offer custom solutions, while acting as a resource for sales team during long-term planning sessions.
* Define a clear revenue management strategy that enables revenue goal attainment.
* Balance the backlog of your customer with knowledge of short, mid, and long-term orders.
* Ability to travel 10-20%.
What you'll bring
* Bachelor's degree in healthcare, IT, business, or related industry preferred
* Minimum of 5+ years of experience in project management; preferably with external customer projects.
* History working within customers' IT departments. Ability to discuss networking, virtual server deployments, IT security concerns, remote connectivity, and software deployment methodology.
* Health care environment experience desired.
* PMP or other industry related certification(s) a plus. Experience with consultative project management approach.
* Shown success with planning and a curiosity about synthesizing broad information into concise plans.
* Recognized leadership abilities with positive and self-motivated attitude.
* Ability to facilitate, lead and empower large, diverse groups without direct line authority.
* Ability to efficiently communicate critical instruction, both written and verbal.
* Positive demeanor and ability to work through complex issues, customer politics, and personalities.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $72,000 - $99,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Quality Control Specialist III (KLIMS), Analytical Operations
Frederick, MD job
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
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 Kite and help create more tomorrows.
**Job Description**
As a QC Specialist III supporting the KITE Laboratory Information Management System (KLIMS) program in the Quality Control (QC) group, this role will work within the Global QC KLIMS team to deliver and maintain KLIMS QC master data and provide support to the KLIMS program as needed.
The QC Specialist III will help drive global program priorities to achieve established system functionality goals, in addition to managing interactions and communications between site cross-functional personnel (QC, Quality Assurance, Warehouse, IT, etc.) as it relates to QC processes and the Fredrick site team.
Overall, this role is responsible for providing the technical expertise necessary to communicate and/or support maintenance of the established local site KLIMS program, related processes, and implementation of new system functionality of the LabVantage LIMS system as it relates to the Global and local site QC network.
This role is based out of our site in Frederick, Maryland.
**Responsibilities**
**Global Related:**
+ General
+ Support and resolve Kite LIMS (KLIMS) issues that impact TCF05 site and global operations.
+ Provide timely program level reporting on global KLIMS projects and/or Master Data update efforts (e.g. schedule adherence, risk awareness, issue escalation, etc.)
+ Serve as coordination and communication conduit for KLIMS related information between site business users, site IT, network site QC KLIMS Administrator and the Global KLIMS Program including but not limited to:
+ Business Process Change Requirements
+ System Outages (planned and/or unplanned)
+ Training Facilitation
+ Issue/Risk Escalation
+ Lessons Learned
+ Build KLIMS test methods
+ Review and update site KLIMS SOPs and WRKs related to KLIMS, as required.
+ Core QC LIMS Administrator oversees system function and use at the sites as they relate to the global processes.
+ Troubleshoot site related KLIMS issues in collaboration with the Global KLIMS Administrator and escalate to the global team as necessary.
+ Quality Management System
+ Support Quality Management System records (i.e., Deviations, CAPAs, Change Controls) related to KLIMS.
+ Provide Change Control support, as required. Including but not limited to Master Data and/or technical impact assessments.
+ Coordinate and perform root cause analysis on complex deviations, document the appropriate CAPA, and ensure that the resolution is effective.
+ Support inspections/audits for KLIMS specific topics, requests, or questions.
+ Projects
+ Supports KLIMS at the TCF05 site for the QC network and global program.
+ Collect improvement opportunities and associated requirements from the business and escalate to the appropriate global working team.
+ Work with business partners to raise enhancement requests and support business case development.
+ Active participation in global, workstream and delivery teams providing required input/feedback to ensure a successful evaluation and delivery of program enhancements.
+ Obtain cross-functional alignment on KLIMS related project requirements and resources to facilitate implementation and ongoing support.
+ Collaborate with QC KLIMS Admin Team to share global network specific knowledge and identify opportunities for improved global management and alignment of KLIMS application.
+ Master Data
+ Execute Master Data updates/changes related to global network as they arise.
+ Provide peer review support of Master Data updates generated by other QC KLIMS Admins and backup support for other sites as needed.
+ Generate any site-specific Master Data to support KLIMS functionality rollout at the TCF05 site.
**Basic Qualifications:**
+ Master's Degree and 3+ years' experience with LIMS (Lab Information Management Systems) in a GMP environment OR
+ Bachelor's Degree and 5+ years' experience with LIMS (Lab Information Management Systems) in a GMP environment OR
**Preferred Qualifications:**
+ LabVantage (otherwise Sample Manager, LabWare, StarLIMS or similar).
+ Familiarity with data review for routine analytical assays commonly performed on in QC laboratories; knowledge of more complex analytical methods such as Cell Based Assays, Flow Cytometry Assays, Microbiological assays, PCR is a plus.
+ Experience in areas such as sampling, pharmaceutical quality control lab, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance.
+ General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations
+ Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs.
+ Ability to critically think, lead complex topics in discussion, work independently, and/or as part of a team with internal and external teams
+ Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
+ Excellent skills in Microsoft Office, MS Project, MS Teams, SharePoint, Smartsheets, data analysis software, and other related applications
+ Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
+ Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Does this sound like you? If so, apply today!
The salary range for this position is: $107,185.00 - $138,710.00. Kite 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.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as 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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Chief of Staff & Director, Operations and Administration - Insights & Analytics
Remote or South San Francisco, CA job
** **Why Genentech** We're passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world's most complex health challenges and transforming society.
**Job Summary**
As Chief of Staff & Director, Operations and Administration for the VP of Insights & Analytics, you will serve as a strategic partner and operational leader at the heart of our mission to deliver impact through synthesized insights and products to CMG employees and customers, including patients across all therapeutic areas. You will partner with the VP to drive the strategy, business planning, operations, and cross-functional communications, ensuring our team is aligned, agile, and positioned for impact in a complex and evolving healthcare landscape.
You will lead a team of Operations Managers and Administrative Business Partners, fostering a culture of collaboration, growth, and adaptability. As a key member of the Data, Digital, and Analytics (DDA) Chief of Staff Leadership Team, you will help shape how we support the 300+ team members of DDA that enable the overall Commercial, Medical and Government Affairs (CMG) organization. Your leadership will enable talent development and deployment across the team as business needs shift.
**Key Responsibilities**
**Strategic Partnership & Advisory**
+ Serve as Chief of Staff to the Insight & Analytics VP and trusted advisor to both leadership teams (LT), translating strategic vision into actionable priorities.
+ Develop and operationalize strategies, ensuring alignment with broader DDA and CMG business objectives.
+ Gather insights and define communication and engagement models between all critical stakeholders.
**Operational Excellence**
+ Lead the planning and facilitation of LT meetings, leveraging agile practices to enable rigorous discussion, clear decision-making, and actionable outcomes.
+ Oversee business planning, resource allocation, and performance tracking, ensuring consistency and transparency in investment decisions and reporting.
+ Champion the integration of EveryDay AI and Product-Activation Operating Model work practices, driving continuous improvement and innovation.
**Cross-Functional Leadership**
+ Act as a connector and catalyst across CMG Operations, DDA Operations, and other key functions to optimize the CMG Operating Model.
+ Develop and implement a multi-channel communication strategy that advances the vision, strategy, and engagement across teams.
+ Partner with People & Culture and Operations roles across CMG to develop and execute people and engagement strategies.
**Team Leadership & Talent Development**
+ Lead and develop a team of Operations Managers and Administrative Business Partners, supporting their career growth and ensuring high-quality administrative support.
+ Foster a culture of learning, adaptability, and operational excellence within the team and across the network.
**Business & Financial Acumen**
+ Facilitate discussions around ROI, P&L, and resource trade-offs, ensuring the squad makes data-driven, impactful decisions.
+ Represent squad priorities with senior leadership, demonstrating executive presence and influencing outcomes at the highest levels.
**Who you are**
**Required Qualifications & Experience**
+ Bachelor's degree required; MBA or advanced degree in science, business, or related field preferred.
+ Minimum 10 years' experience in operations, communications, marketing, or digital within the pharmaceutical/biotech, tech, consumer, or related industry.
+ Demonstrated experience as a strategic thought partner to senior leaders and teams, with a track record of driving change and innovation.
+ Extensive project management expertise, including leading multiple complex, cross-functional initiatives.
+ Proven ability to build strong relationships, influence stakeholders, and foster collaboration across organizational boundaries.
+ Deep understanding of business performance metrics and financial drivers, with experience facilitating ROI and P&L discussions.
+ Exceptional written and verbal communication skills; adept at tailoring messages to diverse audiences.
+ Experience with agile methodologies and a willingness to adapt approaches in response to evolving business needs.
+ Commitment to compliance with corporate policies and guidelines.
+ Willingness to travel (
Location
+ This position is based in South San Francisco, CA, with possibility for remote work.
+ Relocation assistance is not available at this time.
_The expected salary range for this position based on the primary location of South San Francisco, CA is $166,500 - $309,100 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below._
Benefits (****************************************************
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Maintenance Tech II
Frederick, MD job
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
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 Kite and help create more tomorrows.
**Job Description**
We are seeking a highly motivated Maintenance Technician II to coordinate/execute maintenance activities in our new manufacturing and administration buildings in Frederick, Maryland. This position will provide support to the facilities and engineering team and assist in the operation and maintenance of the company's facility and equipment for production of cell-based therapeutics.
This position is to support 1st shift operations.
Flexible to work shift Sun-Wed: 6am-430pm or Wed - Sat 6am-430pm
**Responsibilities include, but are not limited to:**
+ Provide Subject Matter expertise as a Journeyman or Master Electrician for the state of Maryland.
+ Possesses an electrical acumen including understanding electrical single line diagrams, wiring diagrams, controls schematics and equipment specifications.
+ Performs installation, maintenance, and repairs of process manufacturing equipment.
+ Provides general maintenance support as designated by supervisor to include any or all the following areas: HVAC equipment such as boilers, air handling units, purified water system, air compressors, product storage; welding, fabricating, construction, and light electrical installations.
+ Possesses a mechanical and electrical acumen including HVAC, Purified Water system, facilities utilities, P&ID's, schematics, and equipment specifications.
+ Must exhibit proficiency with the Building Management System and its controls.
+ Perform monitoring of all EMS/BMS systems to ensure the facilities, equipment and environmental systems are within specified ranges and operating systems are functioning properly.
+ Observes deviations from systems specifications and works with Facilities staff to correct or resolve these discrepancies.
+ Independently locates and diagnoses failure, replaces defective components and performs basic troubleshooting using standard electronic equipment, detailed drawings, diagrams, sketches, specifications, prints, manuals and verbal and/or written instructions.
+ Uses a variety of hand, power and test tools and equipment.
+ Coordinates maintenance on critical systems/equipment with supervisor.
+ Creates or revises standard operating procedures, and maintenance job plans.
+ Complies with all safety regulations and current Good Manufacturing Practices (GMPs).
+ Is required to respond to emergency notifications via phone.
+ Maintain a safe work environment; work in a safe manner following all safety SOP's and wear Personal Protective Equipment as required.
+ Maintain accurate records, always keeping equipment and systems cGMP compliant.
+ Performs multi-shift work as required.
+ Additional duties as assigned.
**Knowledge and Skills:**
+ Operate Main switchgears up to 35kV or similar.
+ Control automation and PLC experience
+ EPA Universal CFC Certification
+ Ability to read blueprints, control drawings and logic controls
+ Ability to install relays and run wiring, conduits, and any light electrical work.
+ Ability to use temperature and relative humidity meters, data loggers, electrical volt and amp meters.
+ Self-starter with superior analysis and problem solving skills ranging from simple to complex situations.
+ Be forward thinking the ability to work with system & technical metrics, identify variances & deficiencies while improving maintenance program and performance.
+ Be proficient in MS Office suite
+ Demonstrates proficiency in current Good Manufacturing Practices (GMPs).
+ Possess good communications skills to explain information and influence others to secure successful implementation of Facilities and Engineering programs and directives as assigned.
+ Must have a strong work ethic and demonstrate dependability and timeliness
+ Willingness to put internal customer needs first
+ Have a high energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
**Basic Qualifications:**
+ Master's OR
+ Bachelor's and 2+ years of relevant experience OR
+ Associate and 4+ years of relevant experience OR
+ High School Diploma/GED and 5+ years of relevant experience
**Preferred Qualifications:**
+ 5+ years of experience in Building Management Systems, electrician, automation controls, energy management systems, or other related experience
+ Experience in a biotech or pharmaceutical company with direct experience with GMP facility operation preferred
+ Exposure to operations involving engineering disciplines including Electrical, Mechanical, Process, Civil, Structural, Environmental, and Industrial
+ Maryland Electrician Journeyman/Master license for Maryland.
+ Able to prioritize multiple task/priorities and the ability to work under specific time constraints are required.
+ Demonstrated understanding of systems needed to manage a GMP facility such as: HVAC, electrical, process systems, plumbing/piping, general maintenance, pest management, both interior and exterior
+ Must be able to lift, carry, push and/or pull 75 lb. of equipment or supplies
+ Must be able to stand, walk, squat, bend, kneel, climb, and or reach for 75% of a shift
+ Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
+ Business travel may be required.
The salary range for this position is: $80,325.00 - $103,950.00. Kite 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.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as 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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Corporate Development Analyst (Remote)
Remote or Gaithersburg, MD job
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I: Job Summary
The Analyst, Corporate Development will support the Cooperate Development team and Corporation with acquisition, licensing and partnering opportunities as well as strategic projects. Will identify and develop acquisition and licensing opportunities and support in the preparation of presentations for executive management teams. Provide strong financial acumen and valuation skills for assessment and structuring of M&A/BD opportunities.
II: Responsibilites
Identifying, screening and evaluating potential M&A opportunities to support M&A/BD deal pipeline
Performing market research and competitive analysis to support strategic decision making
Stay informed of key biopharma market trends and news impact Emergent or potential M&A/BD targets
Support the corporate development team in managing the overall M&A process from origination, through to diligence and contracting
Monitor and track acquisition targets, including creating company profiles and analysis
Leading, developing and maintaining financial models, performing valuations, and analyzing deal metric
Preparing presentations and reports for executives and stakeholders, communicating deal updates, and providing recommendations
Coordinate and assist in outreach activities to potential targets
Represent the company at external conferences and partnering events.
Propose and manage diligence budgets.
Support deal integration leads and collaborate with cross-functional teams to ensure seamless integration of new ventures and partnerships
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
Bachelor's degree required (ideally in Life Sciences or Business);
Minimum of 3-5 years relevant experience in business development, market research, , financial analysis, accounting and finance, investment banking, venture capital or a corporate consulting environment
Biopharmaceutical industry experience highly preferred
Strong quantitative analytical capabilities, consultative and problem solving skills
Working knowledge of biologics, pharmaceutical or healthcare industry is highly preferred
Ability to structure ambiguous problems into clear analytical frameworks while handling varying amounts of information, distilling key points and drawing clear conclusions
Exceptional organizational skills and the ability to work independently, with minimal supervision
Ability to creatively and diligently gather data into financial models that outline business cases, projections and scenarios pertaining to potential transactions
Effective interactions in a team or matrix environment with a variety of communication and working styles
Excellent oral and written communication skills
Ability to work with senior leaders and other cross-functional groups to build consensus necessary for successful planning decisions
Strong computer skills and proficiency in Excel, PowerPoint and Word
#LIremote
U.S. Base Pay Ranges and Benefits Information
The estimated annual base salary as a new hire for this position ranges from [$117,500 to $142,100]. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]
Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: *************************************************************
(*Eligibility for benefits is governed by the applicable plan documents and policies).
If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our .
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
Director, GxP Auditing
Frederick, MD job
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
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 Kite and help create more tomorrows.
**Job Description**
We are seeking a Director for a GxP Auditing role. The Director of GxP Auditing will lead Kite's global audit program, overseeing the strategic planning, execution, and continuous improvement of GxP audits across the organization. This role includes managing a team of auditors, providing mentorship, performance evaluations, and long-term career development. The Director ensures compliance with global regulatory requirements, marketing authorization holder expectations, and internal quality standards.
+ Manages QA personnel, including organizing and prioritizing group tasks, performing training, writing performance reviews and guiding personnel in longer-term development.
+ Performs a wide variety of activities to ensure compliance applicable regulatory requirements, to facilitate compliance with regulatory agencies, customer and MA holder requirements.
+ Develops, implements, and maintains systems, programs and processes to ensure compliance with Current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), along with compliance of protocols, GMPs and safety regulations.
+ Responsibilities may include the approval of processes affecting all manufactured products into Europe and other countries.
+ Creates, implements, and qualifies current and new programs, policies, processes, procedures and controls to ensure that performance and quality of products conform to established standards and agency guidelines.
+ Reviews and approves training programs regarding implementation of quality systems.Interfaces with regulatory agencies as required, representing Kite to authorities and regulatory inspectorate bodies as required.
+ **Team Leadership & Development:** Lead and develop a global team of auditors, fostering technical growth, collaboration, and a strong compliance mindset. Provide coaching and direction to ensure consistent execution and professional development.
+ **Global Audit Strategy:** Define and execute a comprehensive audit strategy aligned with global regulatory expectations (FDA, EMA, MHRA, PMDA, PIC/S) and Kite's quality objectives. Ensure risk-based coverage across internal operations, suppliers, and contract manufacturers.
+ **Audit Execution & Oversight:** Oversee the planning, execution, and reporting of audits across all GMP subsystems, including Quality Systems, Production, Facilities & Equipment, Laboratory Controls, Materials, and Packaging & Labeling.
+ **Performance Metrics & Reporting:** Establish and monitor audit KPIs, trends, and effectiveness metrics. Present insights and risk signals to senior leadership and quality councils to drive informed decision-making.
+ **Regulatory Readiness & Inspection Support:** Lead audit readiness initiatives and support regulatory inspections, including post-inspection response and remediation planning.
+ **Continuous Improvement:** Maintain and enhance audit procedures, tools, and templates in alignment with ICH Q10, 21 CFR Parts 210/211, and evolving industry standards.
+ **Cross-Functional Collaboration:** Partner with Legal, HR, Regulatory, and Commercial teams to ensure compliance across business functions, including review of promotional materials and ethical conduct training.
+ **Training & Awareness:** Deliver training and guidance on compliance topics, fostering a culture of integrity and regulatory awareness across the organization.
**Basic Qualifications:**
+ PhD with 8+ years of relevant experience in the pharmaceutical industry OR
+ Master's degree with 10+ years of relevant experience in the pharmaceutical industry OR
+ Bachelor's degree with 12+ years of experience in the pharmaceutical industry OR
+ Associate's degree with 14+ years of experience in the pharmaceutical industry OR
+ High School Degree with 16+ years of experience in the pharmaceutical industry.
**Preferred Qualifications:**
+ 10+ years of relevant experience in the pharmaceutical industry and a BS or BA.
+ Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
+ Prior people management experience.
+ Experience with ATMPs, autologous manufacturing, and complex supply chains.
+ Certification in auditing (e.g., ASQ, IRCA) or regulatory affairs.
+ Familiarity with digital audit tools and data analytics platforms.
+ Demonstrates in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
+ Demonstrates substantial knowledge of industry best practices and trends.
+ Is comfortable interacting with regulatory agencies as needed and possess the ability to represent Kite in public forums.
+ Demonstrates excellent verbal, written, and interpersonal communication skills.
+ Able to travel up to 30% of the time
+ Expert knowledge of GMPs and regulatory requirements and expectations
+ Deep understanding of global GMP regulations, especially in cell and gene therapy environments.
+ Proven experience managing global audit programs and leading cross-functional teams.
+ Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
+ History of being accountable for actions and driving results
+ Good judgment and logical thought processes in collecting and synthesizing relevant data and information to make independent and timely decisions
+ Ability to communicate, influence, and escalate issues and decisions, as appropriate
The salary range for this position is: $191,250.00 - $247,500.00. Kite 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.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as 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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Clinical Education Manager (CEM), NC/SC Ecosystem
Remote or Charlotte, NC job
Clinical Education Manager (CEM) - NC/SC Ecosystem
From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver ever better health outcomes for patients while lowering overall healthcare costs. Our goal is to compel the customer to act on behalf of their patients while showing great commitment to the rare disease community, whose support is key. Utilizing innovative methods to identify patients who may benefit from treatment, we must take a highly strategic approach to patient access while assisting patients and their caregivers to navigate the healthcare system.
The Opportunity:
As a Clinical Education Manager (CEM), you bring clinical knowledge and expertise to the assigned franchise sales team. The CEM partners with Ecosystem partners, customers and patients to increase their knowledge and understanding of the assigned GNE brand(s); their benefits and use as these pertain to the relevant therapeutic area/disease state and approved indication(s).
You recommend opportunities to increase account knowledge of GNE brand(s) Provides input into marketing materials
You actively participate in local clinician groups
You provide training and education sessions regarding GNE brand(s) and their approved indication(s). Uses approved training/education materials
You partner with Therapeutic Area Managers in other ways/means by attending periodic account meetings; helping to further increase account knowledge of GNE brand(s)
This is a field based role that will cover the Greater Charlotte area, west to Asheville, and North to Winston-Salem. It is preferred that candidates live in one of these states for consideration
Who You Are:
You hold a Bachelor's degree or a Clinical degree (
RN, BSN or RT, or PharmD)
You have previous clinical experience directly supporting patients
You have 5+ years of field-based experience in patient services/reimbursement/pharmaceutical
You have strong communication skills including public speaking and presentation experience
You have knowledge and adherence to HIPAA guidelines, FDA requirements, and internal compliance guidelines
Preferred Qualifications:
You have clinical experience in the respiratory therapeutic area
You have previous work or sales-specific experience in the pharmaceutical, biotech, or related industry
Relocation Benefits are not available for this role
This is a remote position. This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.
The expected salary range for this position based on the primary location of North Carolina is $127,400.00 - $236,600.00.
Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
This position is eligible to earn incentive compensation that is calculated and paid in accordance with the applicable Incentive Compensation Plan for the role. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Auto-ApplySr Specialist, IT(Mulesoft Development)
Remote or Deerfield, IL job
This is where your work makes a difference.
At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
This is where your work makes a difference.
At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your role at Baxter:This is where my expertise drives business innovation
For you, it's all about the people. As a Sr. IT Specialist, your impact on patient care is always top of mind. Your desire for ambitious, purposeful work and eagerness to meet unforeseen challenges head-on provide robust opportunities to grow your career as a business-focused IT partner. Baxter trusts and appreciates your curious and collaborative problem-solving nature. You enjoy taking ownership of processes that enable the business to work and serve our customers more efficiently.
A global transformation is happening across our IT function-one where we are intentionally and thoughtfully reimagining how we partner with the business. Your expertise is a welcome addition and will be crucial in developing fresh solutions to optimize our technology for all of Baxter. You enjoy seeing the connection between the future and today as we look to simplify our technology landscape. Your past experiences and enthusiasm for innovation will help us streamline systems and initiatives, break down IT silos and work in an agile, hyper-collaborative model. To drive transformation, we will work smarter, not harder-which means you will be able to focus on value-driven outcomes while gaining regular exposure to the business as you grow your career with Baxter.
Your team:
We create value for Baxter by optimizing technology. It's why we are shifting our approach to a capabilities-first mindset. A leaner technology blueprint will help us drive speed, simplicity, and collaboration. Embracing new technologies and methodologies helps us to keep up with a constantly evolving market-which means we can continue to save and sustain lives across the globe.
We build relationships with one another to get the work done-winning, failing and learning together. We're an ambitious community of experts who are driven to improve our skills and deepen our knowledge. Our teams embrace workplace flexibility, combining the best of both on-site and remote work environments. Monthly check-ins replace annual performance reviews and offer a more personalized approach to your career development. Leadership encourages you to invest in yourself through a variety of learning opportunities. We move quickly, giving you the chance to grow and diversify your portfolio during times of change.
As a Sr. IT Specialist, you will have the opportunity to lead by example, and enjoy mentoring and learning from others. Here, you are trusted to manage your own time and are given opportunities to grow your career as you wish.
As Baxter transforms our IT organization into an innovative and strategic partner to the business, a key initiative is to invest in our IT talent in order to develop new skills and stronger business acumen. You are encouraged to take thoughtful action in developing your career and are given a myriad of resources to make that a reality. Think training, conferences, certifications, and support for advanced degrees. We live and breathe technology, but we also recognize space outside of work is needed. Take paid time off when you need to and come back refreshed so we can continue to save and sustain lives!
The Sr, Specialist, IT (Mulesoft developer) will work on the design of modern reusable APIs. This role is required to ensure that focus is given towards building and operationalizing highly reusable, performant, and secure APIs using Baxter API Management platform (MuleSoft Anypoint platform). The ideal candidate will have a deep technical understanding of API microservices, MuleSoft Anypoint platform, DevOps Pipeline and AWS. This role must be able to communicate with both technical and non-technical partners and have a passion for anything technology.
What You'll Be Doing:
Work on the design, build and operationalization of APIs aligning to business requirement.
Work with cross functional teams and help build awareness around API led integration.
Execute POC's on newer capabilities being released by the product vendors.
Enhance DevOps pipeline to support containerization of the Integration platform. Evaluate CloudHub 2.0.
Provide expert advice to project teams to resolve persistent issues.
Work with Enterprise Security, and Infrastructure teams (OS, Network, Storage, Database etc.) as needed to align to Baxter standards
Build requirements based on several message formats like X12, EDIFACT, XML, JSON, cXML etc.
Conduct Smoke testing and support System, Integration and User Acceptance testing.
Mentor developers and other team members.
What you'll bring:
Bachelor's degree in computer science, Information Systems, or related field
5+ years of experience in architecting, development of API led integration solutions.
Demonstrated ability on MuleSoft Anypoint Platform.
Demonstrated ability in DevOps engineering.
Preferred Experience:
Knowledge of Integration Architecture.
Understanding of API operations (GET, POST, PUT etc.).
Understanding of JSON and XML.
Understanding of working with Unix and Windows
Understanding of AWS
Knowledge of X12, EDIFACT, XML, JSON, PEPOL, cXML etc.
Understanding of database (SQL) - (PostgreSQL, Oracle).
Understanding of Security models like OAUTH, Basic authentication etc. strongly preferred
Understanding of REST and SOAP services, strongly preferred
A passion for all things tech with a drive to try out new things
Ability to work effectively in a matrixed organization.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 - 143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Auto-ApplyAssoc Director, Quality Control
Frederick, MD job
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
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 Kite and help create more tomorrows.
**Job Description**
Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
We are seeking a highly motivated individual to join us as an Associate Director, to lead Quality Control Analytical Tech Services group, reporting to the Senior Director, Quality Control in Frederick, MD. In this role, you will lead a group and work closely with the Senior Director and other Associate Directors on supporting commercial operations in CAR-T technology.
You will work on complex projects involving **qPCR/dd PCR, Flow cytometry and cell-based bioassays** and lead **efforts in automation development for analytical assays** . You will have cross-functional interaction with personnel from other groups such as Quality Assurance, Analytical Development, Manufacturing, Material Management (MM) and Corporate teams.
**Position Responsibilities (include but not limited to):**
+ Provide technical support, process trending and procedural updates
+ Lead method validation and method transfers support continuous improvement, to support method/product/invalid trending, and to investigate laboratory/assay related findings.
+ Lead and support method development, validations, and transfers
+ Support laboratory investigations, deviations, CAPAs, change control as needed
+ Assist in investigation, identify root cause for critical deviations and determine CAPA for QC as needed
+ Establish data analytics to serve as metrics for monitoring trends in methods, products, and invalids
+ Support incoming tech transfers from AD/PD as needed
+ Author technical reports and protocols in support of cGMP activities
+ Supervise, train, and mentor junior staff
+ Create and/or revise procedures, SOPs, and test methods as needed
+ Support equipment and software lifecyle process
+ LIMS development and integration
+ Provide technical expertise for AD/PD, QA, Regulatory, Manufacturing, and Supply Chain as needed
+ Support and participate inspection readiness plans and participate during compliance audits (internal and external) and regulatory inspections.
+ Follow technology changes, recommends new technologies, advises on technology purchases and implementation if appropriate.
+ Additional duties as assigned.
**Basic Qualifications:**
+ Advanced scientific degree (i.e. MD, PharmD, PhD) and 2+ years' experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
+ Master's Degree and 8+ years' experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
+ Bachelor's Degree and 10+ years' experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
+ High School Degree and 14+ years' experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment
**Preferred Qualifications:**
+ Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry
+ Well versed and experienced in bioanalytical methods working under GMP conditions.
+ Deep experience in applying GMP in QC lab in conformance to US, EU and ROW standards.
+ Experience in conducting investigations, writing deviations, implementing CAPA and initiating change controls.
+ Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP
+ Ability to effectively negotiate and develop collaboration within teams and amongst individuals.
+ Demonstrated ability to create and maintain highly functioning teams.
+ Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment
+ Comfortable in a fast-pace small company environment with minimal direction and able to adjust workload based on changing priorities.
The salary range for this position is: $165,495.00 - $214,170.00. Kite 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.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as 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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Lab Ops Specialist I
Frederick, MD job
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
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 Kite and help create more tomorrows.
**Job Description**
Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
**_****Shift is Wed-Sat 0700-1730_** **_****_**
**Responsibilities (include but are not limited to):**
+ Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
+ Work with internal and external resources to maintain lab in an optimal state.
+ Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.
+ Maintains laboratory instruments for calibration and routine maintenance
+ Author or revise SOPs, qualification/validation protocols and reports.
+ Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.
+ Provide updates at daily and weekly meetings.
+ Monitor the GMP systems currently in place to ensure compliance with documented policies.Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
+ Gather metric information for use in continuous improvement of areas of responsibility.
+ Perform other duties as required.
**Basic Qualifications:**
+ Bachelor's Degree OR
+ AA Degree and 2+ years' experience in biotechnology or related field and Quality Control experience OR
+ High School Degree and 3+ years' experience in biotechnology or related field and Quality Control experience
**Preferred Qualifications:**
+ Meaningful knowledge of GMP, SOPs and quality control processes.
+ Identifying, writing, evaluating, and closing OOS's and investigations.
+ Proficient in MS Word, Excel, Power Point and other applications.
+ Excellent written and verbal communication skills.
+ Ability to communicate and work independently with scientific/technical personnel.
+ Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
+ Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
+ Preferred: Experience in the biotech and/or pharmaceutical industry.
+ Potential shifts are Sunday - Wednesday or Wednesday - Saturday. Business need may require alternate work schedule, such as swing shift hours.
The salary range for this position is: $69,445.00 - $89,870.00. Kite 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.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as 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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Manager, SEC Reporting & Equity (Remote)
Remote or Gaithersburg, MD job
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I. JOB SUMMARY
This Manager role leads the SEC reporting and equity plan administration functions, ensuring compliance with financial regulations and supporting investor communications. Coordinates audit activities, maintains SOX 404 processes, and advises on accounting developments.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Lead the performance of all aspects of SEC reporting, including preparation of 10Ks and 10Qs, completion of disclosure checklists, data gathering and footnote preparation, discussing comments on various filing documents, and review of XBRL tagging.
Support effective preparation of the quarterly earnings releases and other investor relations presentations.
Ensure all non-GAAP disclosures are consistent and reported in accordance with SEC regulations.
Manage all equity plans alongside the Legal and HR teams, including:
o Monthly stock-based compensation journal entries
o Equity reconciliations
o ESPP Purchases
o Personnel updates, grants, and exercises
Keep business partners abreast of developments in accounting and financial reporting and related company policies and positions through review of various publications, training sessions, and other forums.
Provide support to external auditors during audits and interim reviews. Coordinate requests, new and challenging areas, and manage the flow of information and documentation.
Assist with the maintenance and updating of Sarbanes-Oxley 404 processes and procedures.
Other special projects and duties as requested or assigned
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
BA/BS degree of equivalent
CPA Big 4 or large national accounting firm experience
5-8 years of relevant experience from public accounting and/or dynamic, public, multinational, and technology focused companies
Experience with Workiva for financial reporting; familiarity with SAP and/or OneStream is a plus.
Experience working in a SEC reporting or similar role
Excellent understanding of GAAP accounting principles, with a strong knowledge of SEC reporting regulations, stock-based compensation, and revenue accounting principles
Strong analytical skills and exceptional attention to detail.
Excellent project management, oral communication, analytical and written skills
Proven ability to collaborate cross-functionally and communicate effectively with executive leadership through presentations and written materials.
Strong organizational and time management skills, with a continuous improvement mindset.
U.S. Base Pay Ranges and Benefits Information
The estimated annual base salary as a new hire for this position ranges from [$117,500 to $142,100]. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]
Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: *************************************************************
(*Eligibility for benefits is governed by the applicable plan documents and policies).
If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our .
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
#remote
Clinical Trials Manager- Oncology
Remote job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
We are seeking a Clinical Trials Manager to sit at either our Foster City campus or remotely within the US.
Responsibilities:
Coordinating and supervising all aspects of a clinical study. Monitors clinical trial sites.
Assists Clinical Program Manager in overall study management.
Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
Maintains study timelines.
Contributes to development of study budget.
Contributes to development of RFPs and participate in selection of CROs/vendors.
Manage CROs/vendors.
Coordinates review of data listings and preparation of interim/final clinical study reports.
May contribute to development of abstracts, presentations, and manuscripts,
Ensures effectiveness of site budget/contract process.
May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
Assists in determining the activities to support a project's priorities within functional area.
Under supervision, may design scientific communications within the company.
Travel is required.
Additional:
Excellent teamwork, communication, decision-making and organizational skills are required.
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
Must be able to generally understand, interpret, and explain protocol requirements to others.
Must be able to prioritize multiple tasks.
May serve as a resource for others within the company for clinical trials management expertise.
Under general supervision, is able to examine functional issues from an organizational perspective.
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
Must have a general, functional expertise to support SOP development and implementation.
Specific Education & Experience Requirements:
5+ years of experience and a BS or BA in a relevant scientific discipline OR
3+ years of experience and a MS in a relevant scientific discipline
The salary range for this position is:
Other US Locations: $133,195.00 - $172,370.00.
Bay Area: $146,540.00 - $189,640.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Auto-ApplySr. Director, Medical Affairs - Remote
Remote or Gaithersburg, MD job
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
JOB SUMMARY
This Senior Director Global Medical Affairs will provide leadership and therapeutic area expertise for the opioid antidote therapeutic team in Medical Affairs. The Senior Director, Medical Affairs is responsible for leading and overseeing the generation, implementation and execution of medical and scientific strategy working closely with internal and external stakeholders and will provide leadership and oversight to the field based and remote Medical team. Activities will include, but are not limited to, setting medical affairs strategy, overseeing the planning and implementation of medical communication plans, oversight of the teams' objectives and deployment, and developing and fostering cross-functional with business units and KOL engagement. Support the US Medical Affairs team to execute the brand MA strategy; ensures accurate, robust, and appropriate medical/scientific exchange of knowledge. The Sr. Director Medical Affairs is a member and key contributor of the Global Medical Affairs Leadership Team.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
* This leadership position reports to the Global Vice President, Medical Affairs and is an integral member of the Global Medical Affairs Leadership Team.
Provides scientific review and oversight of therapeutic initiatives (ie, publications, educational programs, Field medical slides/materials and studies) for the opioid antidote therapeutic area and products to ensure information to health care providers and government stakeholders is accurate and fair balanced.
* Leads efforts in recognizing and integrating substantive relationships with KOLs and external stakeholders (government, managed markets, etc) to foster the identification of key opportunities for scientific growth and medical evidence for the support and/or expansion of their therapeutic area, and execution of joint initiatives such as research, publication planning, and continuing medical education.
* Oversee and/or participate in review of promotional and medical materials to ensure content is medically appropriate and compliant with internal and external requirements, as required.
* Participate in, support, and develop key global medical affairs strategies in conjunction with cross-functional teams. Provide ongoing and interactive technical and medical expertise to execute on these strategies and represent the medical/scientific perspective during respective cross-functional brand planning and product lifecycle meetings.
* Provides leadership for medical and clinical training of newly hired medical directors, vendors and newly hired sales representatives
* Develops, plans and manages content and educational deliverables such as advisory boards and KOLs engagement
* Partners with functional and project leaders in the execution of the medical affairs strategy
* Provide medical/scientific input to the brand team in support of marketing strategy and key commercial initiatives as well as to medical departmental activities
* Deliver scientific presentations and medical/scientific education programs internally and externally where/when requested.
* Collaborates with VP Medical Affairs to prepare and manage Medical Affairs budget.
* Maintains comprehensive medical/scientific knowledge of through literature and attendance at advisory boards and key medical/scientific congresses.
* Represents the Medical Affairs department at key medical/scientific congresses.
* Responds to medical queries from healthcare professionals and government stakeholders in domestic and international markets.
* Participates in the review of Investigator Initiated Trials and medical educational grants
* Adheres to all compliance requirements for this position.
* Undertakes ad hoc medical affairs projects as assigned by the VP, Global Medical Affairs.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
* MD, PharmD or PhD degree plus significant experience and leadership in medical affairs activities. Neuroscience experience preferred
* Minimum of 15 years' experience in medical affairs.
* Excellent interpersonal and communication skills to effectively interface with individuals cross-functionally at all levels, both within Emergent BioSolutions and in the medical/scientific community.
* Deep experience in KOL management and engagement activities.
* Strong patient and customer focus in daily activities.
* Effectively manages members of Medical Affairs team. Must be proactive and organized, keeping team members well informed and aligned with departmental objectives.
* Strong awareness of compliance guidelines regarding scientific interactions and promotional practices with healthcare professionals and government stakeholders.
* Maintains a high level of productivity and innovation.
* Establishes appropriate priorities to achieve timely completion of assignments, while keeping expenditures within budget.
U.S. Base Pay Ranges and Benefits Information
The estimated annual base salary as a new hire for this position ranges from $234,500 to $283,700. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]
Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: *************************************************************
(*Eligibility for benefits is governed by the applicable plan documents and policies).
If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.
WE BELIEVE IN OUR VALUES
* Lead with Integrity
* We gain trust and confidence through ethics, quality, and compliance excellence
* Stand shoulder to shoulder no matter what
* We combine our best thinking and communicate openly to support each other.
* Own it always
* Every person at Emergent is engaged and accountable for delivering on our commitments.
* Break through thinking
* We take smart risks, pursue innovation and challenge ourselves to constantly improve.
* Compete where it counts
* We set the right goals and respect each other as we conquer them together.
Maintenance Tech I
Frederick, MD job
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
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 Kite and help create more tomorrows.
**Job Description**
We are seeking a highly motivated Maintenance Technician I to execute maintenance activities in our commercial manufacturing facility in Frederick, Maryland. This position will provide support to the facilities and engineering team and assist in the operation and maintenance of the company's facility and equipment for production of cell-based therapeutics.
This position should be able to support Second or Third shift operations:
Flexible to work swing shift Sun-Wed/Wed-Sat: 4pm-230am or Night Shift 8pm-630am
**Responsibilities include, but are not limited to:**
+ Support process equipment operations across MSAT, Manufacturing, and QC functions in a cell therapy facility.
+ Monitor Building Management Systems (BMS) to ensure environmental and equipment parameters remain within specified limits.
+ Respond to system alerts and alarms; perform initial diagnostics and coordinate troubleshooting to maintain operational continuity.
+ Identify and resolve deviations from system specifications in collaboration with Facilities staff.
+ Perform basic installation, maintenance, and repair tasks on manufacturing and QC equipment.
+ Diagnose equipment failures, replace defective components, and troubleshoot using standard tools, schematics, and documentation.
+ Maintain accurate, cGMP-compliant records of all maintenance and system activities.
+ Utilize hand tools, power tools, and electronic test equipment effectively.
+ Conduct general maintenance tasks across facilities, utilities, HVAC, purified water systems, and product storage areas.
+ Coordinate and execute maintenance on critical systems with supervisor oversight.
+ Adhere to all safety protocols and wear required PPE; maintain a safe and compliant work environment.
+ Respond to emergency notifications as needed.
+ Ensure timely completion of maintenance work orders in line with operational standards.
+ Perform additional duties as assigned, including but not limited to multi-shift operations as required.
**Basic Qualifications:**
+ Bachelor's OR
+ Associate and 2+ years of relevant experience OR
+ High School Diploma/GED and 3+ years of relevant experience
**Preferred Qualifications:**
+ Solid mechanical and electrical knowledge, including HVAC systems, utilities, and schematics.
+ Able to read blueprints, control diagrams, and logic controls.
+ Familiar with HVAC/controls and or electrical principles.
+ Skilled in basic wiring, relay installation, and use of diagnostic tools (e.g., meters, data loggers).
+ Strong problem-solving, analytical, and troubleshooting abilities.
+ Proficient in Microsoft Office; effective communicator with a strong work ethic.
+ Customer-focused, dependable, and proactive in identifying and resolving issues.
+ Have a high energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
The salary range for this position is: $74,715.00 - $96,690.00. Kite 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.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as 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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Director, Clinical Development (MD)
Remote or 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 Sciences, we're driven by our mission to discover, develop, and deliver innovative therapeutics that improve the lives of patients worldwide.
Job Description
You will typically lead multiple components of clinical trial programs in immunology clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.
We will consider levelling this role up to a Director if it aligns with experience.
This is a site-based role at our global headquarters in Foster City, CA. We offer a hybrid environment with optional Mondays and Fridays the ability to work from home.
EXAMPLE RESPONSIBILITIES:
Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
Coordinates the collection and assimilation of ongoing data for internal analysis and review.
Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
Presents scientific information at scientific conferences as well as clinical study investigator meetings.
Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience
MD or equivalent with 2+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
Experience in phase 1 and 2 clinical trials is preferred.
Board certification in rheumatology/dermatology/gastroenterology or allergy and immunology is preferred, including familiarity with systemic autoimmune diseases.
Experience in the biopharma industry is preferred.
Experience leading small cross-functional project teams in clinical research or development.
Experience taking the lead on study concept and protocol design, regulatory filings, medical monitoring, clinical publications and presentations is preferred.
Proven effectiveness managing clinical project deliverables through matrix management.
Knowledge & Other Requirements
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
The salary range for this position is: $261,375.00 - $338,250.00. 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 a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Auto-ApplyCorporate Development Analyst (Remote)
Remote job
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I: Job Summary
The Analyst, Corporate Development will support the Cooperate Development team and Corporation with acquisition, licensing and partnering opportunities as well as strategic projects. Will identify and develop acquisition and licensing opportunities and support in the preparation of presentations for executive management teams. Provide strong financial acumen and valuation skills for assessment and structuring of M&A/BD opportunities.
II: Responsibilites
* Identifying, screening and evaluating potential M&A opportunities to support M&A/BD deal pipeline
* Performing market research and competitive analysis to support strategic decision making
* Stay informed of key biopharma market trends and news impact Emergent or potential M&A/BD targets
* Support the corporate development team in managing the overall M&A process from origination, through to diligence and contracting
* Monitor and track acquisition targets, including creating company profiles and analysis
* Leading, developing and maintaining financial models, performing valuations, and analyzing deal metric
* Preparing presentations and reports for executives and stakeholders, communicating deal updates, and providing recommendations
* Coordinate and assist in outreach activities to potential targets
* Represent the company at external conferences and partnering events.
* Propose and manage diligence budgets.
* Support deal integration leads and collaborate with cross-functional teams to ensure seamless integration of new ventures and partnerships
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
* Bachelor's degree required (ideally in Life Sciences or Business);
* Minimum of 3-5 years relevant experience in business development, market research, , financial analysis, accounting and finance, investment banking, venture capital or a corporate consulting environment
* Biopharmaceutical industry experience highly preferred
* Strong quantitative analytical capabilities, consultative and problem solving skills
* Working knowledge of biologics, pharmaceutical or healthcare industry is highly preferred
* Ability to structure ambiguous problems into clear analytical frameworks while handling varying amounts of information, distilling key points and drawing clear conclusions
* Exceptional organizational skills and the ability to work independently, with minimal supervision
* Ability to creatively and diligently gather data into financial models that outline business cases, projections and scenarios pertaining to potential transactions
* Effective interactions in a team or matrix environment with a variety of communication and working styles
* Excellent oral and written communication skills
* Ability to work with senior leaders and other cross-functional groups to build consensus necessary for successful planning decisions
* Strong computer skills and proficiency in Excel, PowerPoint and Word
#LIremote
U.S. Base Pay Ranges and Benefits Information
The estimated annual base salary as a new hire for this position ranges from [$117,500 to $142,100]. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]
Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: *************************************************************
(*Eligibility for benefits is governed by the applicable plan documents and policies).
If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.
WE BELIEVE IN OUR VALUES
* Lead with Integrity
* We gain trust and confidence through ethics, quality, and compliance excellence
* Stand shoulder to shoulder no matter what
* We combine our best thinking and communicate openly to support each other.
* Own it always
* Every person at Emergent is engaged and accountable for delivering on our commitments.
* Break through thinking
* We take smart risks, pursue innovation and challenge ourselves to constantly improve.
* Compete where it counts
* We set the right goals and respect each other as we conquer them together.
Sr Manager, Medical Affairs Technology (Medical Review Platforms, Veeva/MedDocs)
Remote or Raleigh, NC job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. We strive to transform and simplify care for people with life-threatening illnesses around the world. Gilead's portfolio of products and pipeline of investigational drugs includes treatments for HIV/AIDS, COVID, HBV, HCV, HDV, Oncology and Cell Therapy as well as Inflammatory Diseases co. Gilead is a patient centric, science focused company.
Reporting to the Executive Director of Global Medical Affairs Technology, this individual will be responsible for driving delivery of technologies and platforms to meet Medical Affairs customer relationship and performance measurement needs. This leader partners with Medical Affairs Excellence, Medical Affairs Affiliate leaders, Global Medical Strategy and Operations Leaders and the IT organization to implement technology solutions. This role advises internal stakeholders on how to enable business capabilities with enterprise technology tools. Key to the success of this role is aligning tools to performance expectations, continuously adapting compliant, efficient and effective technologies to the changing business needs, and working within a matrix environment to cultivate tool advocacy with senior leadership.
While specific system responsibilities may change over time, our initial need is for an expert in Material Review platforms (Veeva MedInquiry, VeevaVault, MedDocs, etc).
Responsibilities include but are not limited to:
* Lead the implementation and ongoing maintenance of specific technologies and platforms that enable business process and decision making.
* Establishes and maintains the roadmap for your assigned technologies by leading the internal idea generation, external benchmarking, and technical evaluation process with support from the ED of Medical Affairs Technology.
* Work collaboratively with the Medical Affairs, Medical Excellence, Medical Governance, and other Medical Affairs Technology leads to help generate meaningful business requirements and design technical solutions that meet those requirements.
* Support technology tool maturity by refining processes, delivery templates, and tools with key regional stakeholders based on business needs
* Provide project level leadership by managing scope, timelines, communication, testing, and risks associated with the assigned portfolio.
* Lead technology implementations with aggressive timelines, broad scope, and high impact according to established business needs while reporting on the project status and budget to the Executive Director of Medical Affairs Technology
* Be the primary source of education and inspiration about ways to leverage technology solutions by being the expert in your assigned platforms and defining new ways it can accelerate Medical Affairs outcomes.
* Balance the needs of the platform (performance, scalability, cost, data integrity) with the requests of the business (new functionality, speed to market, integrations) during roadmap planning and while advising on solution design
* Establish and maintain cross-functional communication channels, work practices and processes with internal stakeholders relevant to accomplishing business outcomes
* Advise and/or participate in cross-functional governance, standards and SOPs for global MA technology tools and capabilities
* Balance long-term vision with short-term delivery while making decisions to invest/build/sustain to catalyze the organization to deliver on the business outcomes
Knowledge, Experience and Skills:
* College degree with 3-5 years business experience in CRM, Analytics or Technology modernization and LEAN methodology delivery practices
* Hands on experience administering and deploying platforms for Material Review (Veeva MedInquiry, VeevaVault, MedDocs) preferred.
* Additional certifications in Veeva, or Business Process Automation
* 2+ years global/in-market Pharma/Biopharma experience preferable
* Experience implementing or upgrading to modern technology platforms inclusive of AI integration/utilization.
* Demonstrated practical and technical experience in business case development, planning, implementation, operation, and management of digital and mobile initiatives.
* Experience shaping end to end field experience delivering creative and simple solutions to complex problems
* Excellent communication skills, including the ability to break down complex structures and ideas into consumable concepts for a diverse set of stakeholders, from entry to expert level
* Demonstrated excellence in developing effective creative solutions to complex problems
* Demonstrated excellence in delivering skilled communications around change management that build system adherence
* Demonstrated excellence in building and maintaining relationships with senior leaders
* Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
* Uncompromising ethical standard and conduct
* Able to motivate and foster cross-functional collaboration
This is a site based role in Foster City, CA at our global headquarters. We will also consider candidates at our facility in Raleigh, NC. Due to the needs of the business we cannot offer remote work for this position.
The salary range for this position is:
Bay Area: $169,320.00 - $219,120.00.
Raleigh: - .
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Auto-ApplyDistrict Business Manager, Capital
Washington, DC job
At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. We are driven to find new ways to change lives for the better and to keep working toward a world without limit for all.
We are driven to change the way we experience life, because we believe everyone deserves to experience the very best of being humann.
At MannKind, our Values serve as the foundation of our culture. They define who we are, how we act, and guide our interactions every day-both with each other and the customers we serve. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. MannKind is proud to be a different kind of biopharma company, it is one that treat people like people, not patients.
Position Summary:
MannKind Corporation is currently seeking a high performing District Business Manager (DBM). In this position the DBM will be responsible for the strategic development and performance management of a region with the goal overdelivering and exceeding sales targets. Lead, direct and manage the activities of sales representatives with a geographic area. Drive accountability across the team to achieve revenue and profit growth. Manage expenses in a fiscally responsible manner. Participate in national, regional, and local strategic meetings as well as lead meetings with respective teams. The candidate can be located in Washington, D.C./Capital Region.
Principal responsibilities:
* Demonstrated ability to build and lead
* high performing sales teams and consistently exceed sales goals.
* Lead a team of Sales Representatives to promote product(s) to targeted physicians and account to achieve or surpass sales goals.
* Work with Sales Representatives on a consistent basis, providing actionable feedback and field-based coaching to elevate performance.
* Recruit, develop and retain top tier talent committed to delivering business results. Direct the Territory Business Manager in the strategic acquisition, growth and retention of targeted business within the assigned geographic area
* Develop plans that effectively execute corporate strategy at the district level with measurable KPIs
* Work with Leadership to define and establish clear performance behaviors and measurable actions that will lead to sales acceleration in the geographic area
* Fully engage with key customers by developing and implementing growth strategies that support the growth of assigned product(s)
* Participate in and contribute to commercial team planning sessions as requested, acting as the voice of field execution and driving aligned business plans. Operate within Compliance Guidelines at all times
* Responsible for observing all Company, Health, Safety and Environmental guidelines
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Education and Experience Qualifications:
* BA/BS with 7-10 years of experience or MS/MBA with 5-7 years related experience or an equivalent combination of training and related experience
* 3+ years of District Management experience in pharmaceutical sales
* track record of consistent quota achievement and territory growth
* Analytical mindset with the ability to leverage data to optimize sales strategies and team performance. Strong business acumen and understanding of customer needs
* Excellent communication skills, including written, oral as well as presentation capabilities
* Experience in developing people
* Team oriented with strong leadership capabilities
Why Join MannKind Sales Team?
You have the unique opportunity to manage your territory with complete ownership and accountability of its sales results and performance. We welcome entrepreneurial salespersons who are excited about the unique and varied role with total office account management, sales responsibilities, and patient training. At MannKind you are encouraged to build relationships with colleagues across the business and own your career advancement and continued development. At MannKind we offer a competitive total compensation package, health, vision, dental benefits, 401k matching program, and financial benefits including employee stock purchase program, quarterly and Annual TBM awards, sales contests, and the opportunity to compete for the Annual Circle of Excellence.
#LI-Remote