What Jobs are available for Diagnostics in Chicago?
Showing 6 Diagnostics jobs in Chicago
Medical Assistant - Community Testing
60684 Chicago, Illinois
Rush University Medical Center
Posted 4 days ago
Job Viewed
Job Description
**Job Description**
Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: Community Testing
**Work Type:** Full Time (Total FTE between 0.9 and 1.0)
**Shift:** Shift 1
**Work Schedule:** 8 Hr (8:00:00 AM - 4:00:00 PM) _This position will occasionally be asked to support community events outside of these hours._
Rush offers exceptional rewards and benefits learn more at our Rush benefits page ( on Bonus:** $3,000
**Pay Range:** $9.50 - 29.73 per hour
Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush's anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.
**Summary:**
The Medical Assistant is responsible for assisting Physicians, Mid-Level Practitioners, and Registered Nurses with the evaluation, management, and treatment of patients in an ambulatory care setting. The Medical Assistant assumes responsibility for maintaining patient flow, the upkeep of exam and treatment rooms, and performing basic skills such as vital signs and point of care testing. In addition, the Certified Medical Assistant will administer intramuscular injections, immunizations, small volume nebulizer treatment, over-the-counter medications under the direction of a Physician. The individual who holds this position exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures, including complying with all Rush University Medical Group Customer Service Standards.
**Other information:**
**Required Job Qualifications:**
- High school diploma/GED required.
- Clinical Medical Assistant Certification by AAMA, AMT, NCCT, NAHP, AAH, or NHA required (includes principles and techniques of injections and medication administration) required upon hire.
- Graduates of a Rush Medical Assistant Apprenticeship program are required to obtain Clinical Medical Assistant Certification by AAMA, AMT, NCCT, NAHP, AAH, or NHA required within six months of hire.
- Current CPR certification required upon start date.
- Computer skills.
- Excellent communication and interpersonal skills.
- Excellent customer service skills.
- Excellent organizational skills.
**Preferred Job Qualifications:**
- One year clinical experience.
- Phlebotomy experience.
- Epic Ambulatory experience.
**Responsibilities:**
1. Coordinates and maintains organized patient flow.
2. Performs patient intake: vital signs, height and weight, reason for visit, interim history, allergies, medication lists, and other interventions as required.
3. Prepares patient for exam based on reason for visit.
4. Prepares and supports patient and assists provider with procedures.
5. Reviews appointment schedules and ensures all patient charts are available for the visit.
6. Reviews patient charts and ensures that all ancillary reports and required paperwork are available to the provider at the time of visit.
7. Performs basic lab and testing procedures according to standards.
8. Performs phlebotomy and EKGs.
9. Administers immunizations as ordered by Physician.
10. Administers RUMG approved intramuscular or subcutaneous medications after competency has been assessed, verified and documented.
11. Performs nebulizer treatments in the clinic setting after competency has been assessed, verified and documented.
12. Performs Tuberculin skin testing upon the order of the Physician.
13. Demonstrates appropriate population specific techniques with patients.
14. Documents administration of over-the-counter medications and/or other medications in Epic per policy or protocol.
15. Cleans, prepares and stocks exam rooms, treatment rooms, and workstations.
16. Calls patients regarding test results and medical instruction under the direction of a Physician.
17. Calls in medication refills under the direction of a Physician or protocol.
18. Documents patient care information in the outpatient medical record according to standards.
19. Assists with scheduling of patient tests, procedures, and follow-up appointments.
20. Assists in the care, cleaning, and sterilization of equipment and instruments.
21. Maintains the inventory of medical and linen supplies.
22. Maintains quality control for equipment.
23. Provides cross coverage to other clinical areas as assigned.
24. Participates in quality improvement projects.
25. Maintains compliance with The Joint Commission (TJC) standards and other regulatory bodies.
26. May have Unit specific duties as needed.
Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
**Position** Medical Assistant - Community Testing
**Location** US:IL:Chicago
**Req ID** 21954
Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: Community Testing
**Work Type:** Full Time (Total FTE between 0.9 and 1.0)
**Shift:** Shift 1
**Work Schedule:** 8 Hr (8:00:00 AM - 4:00:00 PM) _This position will occasionally be asked to support community events outside of these hours._
Rush offers exceptional rewards and benefits learn more at our Rush benefits page ( on Bonus:** $3,000
**Pay Range:** $9.50 - 29.73 per hour
Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush's anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.
**Summary:**
The Medical Assistant is responsible for assisting Physicians, Mid-Level Practitioners, and Registered Nurses with the evaluation, management, and treatment of patients in an ambulatory care setting. The Medical Assistant assumes responsibility for maintaining patient flow, the upkeep of exam and treatment rooms, and performing basic skills such as vital signs and point of care testing. In addition, the Certified Medical Assistant will administer intramuscular injections, immunizations, small volume nebulizer treatment, over-the-counter medications under the direction of a Physician. The individual who holds this position exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures, including complying with all Rush University Medical Group Customer Service Standards.
**Other information:**
**Required Job Qualifications:**
- High school diploma/GED required.
- Clinical Medical Assistant Certification by AAMA, AMT, NCCT, NAHP, AAH, or NHA required (includes principles and techniques of injections and medication administration) required upon hire.
- Graduates of a Rush Medical Assistant Apprenticeship program are required to obtain Clinical Medical Assistant Certification by AAMA, AMT, NCCT, NAHP, AAH, or NHA required within six months of hire.
- Current CPR certification required upon start date.
- Computer skills.
- Excellent communication and interpersonal skills.
- Excellent customer service skills.
- Excellent organizational skills.
**Preferred Job Qualifications:**
- One year clinical experience.
- Phlebotomy experience.
- Epic Ambulatory experience.
**Responsibilities:**
1. Coordinates and maintains organized patient flow.
2. Performs patient intake: vital signs, height and weight, reason for visit, interim history, allergies, medication lists, and other interventions as required.
3. Prepares patient for exam based on reason for visit.
4. Prepares and supports patient and assists provider with procedures.
5. Reviews appointment schedules and ensures all patient charts are available for the visit.
6. Reviews patient charts and ensures that all ancillary reports and required paperwork are available to the provider at the time of visit.
7. Performs basic lab and testing procedures according to standards.
8. Performs phlebotomy and EKGs.
9. Administers immunizations as ordered by Physician.
10. Administers RUMG approved intramuscular or subcutaneous medications after competency has been assessed, verified and documented.
11. Performs nebulizer treatments in the clinic setting after competency has been assessed, verified and documented.
12. Performs Tuberculin skin testing upon the order of the Physician.
13. Demonstrates appropriate population specific techniques with patients.
14. Documents administration of over-the-counter medications and/or other medications in Epic per policy or protocol.
15. Cleans, prepares and stocks exam rooms, treatment rooms, and workstations.
16. Calls patients regarding test results and medical instruction under the direction of a Physician.
17. Calls in medication refills under the direction of a Physician or protocol.
18. Documents patient care information in the outpatient medical record according to standards.
19. Assists with scheduling of patient tests, procedures, and follow-up appointments.
20. Assists in the care, cleaning, and sterilization of equipment and instruments.
21. Maintains the inventory of medical and linen supplies.
22. Maintains quality control for equipment.
23. Provides cross coverage to other clinical areas as assigned.
24. Participates in quality improvement projects.
25. Maintains compliance with The Joint Commission (TJC) standards and other regulatory bodies.
26. May have Unit specific duties as needed.
Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
**Position** Medical Assistant - Community Testing
**Location** US:IL:Chicago
**Req ID** 21954
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0
Associate Medical Director - Genetic Testing UM
60684 Chicago, Illinois
Elevance Health
Posted 4 days ago
Job Viewed
Job Description
**Clinical Operations Associate Medical Director**
**Carelon Medical Benefit Management**
**Genetic Testing Utilization Management/Review**
**Virtual:** This role enables associates to work virtually full-time, with the exception of required in-person training sessions, providing maximum flexibility and autonomy. This approach promotes productivity, supports work-life integration, and ensures essential face-to-face onboarding and skill development. Alternate locations may be considered if candidates reside within a commuting distance from an office.
**_Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law._**
_A proud member of the Elevance Health family of companies, Carelon Medical Benefits Management, formerly AIM Specialty Health, is a benefit-management leader in Illinois. Our platform delivers significant cost-of-care savings across an expanding set of clinical domains, including radiology, cardiology and oncology._
The **Clinical Operations Associate Medical Director** is responsible for supporting the medical management staff ensuring timely and consistent medical decisions to members and providers.
**How you will make an impact:**
+ Ensures timely completion of clinical case reviews for their board certified specialty.
+ Makes physician to physician calls to gather medical appropriate information in order to make medical necessity determinations for services requested.
+ Makes medical necessity determinations for grievance and appeals appropriate for their specialty.
+ Ensures consistent use of medical policies when making medical necessity decisions.
+ Brings to their supervisors attention, any case review decisions that require Medical Director review or policy interpretation.
**Minimum Requirements:**
+ Requires MD or DO and Board certification approved by one of the following certifying boards is required, where applicable to duties being performed, American Board of Medical Specialties (ABMS) or American Osteopathic Association (AOA).
+ Must possess an active unrestricted medical license to practice medicine or a health profession.
**Preferred Skills, Capabities, and Expereinces:**
+ Board certified in Internal Medicine or Family Medicine preferred.
For candidates working in person or virtually in the below location(s), the salary* range for this specific position is $188,051 to $282,088.
Locations:
Illinois
In addition to your salary, Elevance Health offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The salary offered for this specific position is based on a number of legitimate, non-discriminatory factors set by the Company. The Company is fully committed to ensuring equal pay opportunities for equal work regardless of gender, race, or any other category protected by federal, state, and local pay equity laws _._
* The salary range is the range Elevance Health in good faith believes is the range of possible compensation for this role at the time of this posting. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Even within the range, the actual compensation will vary depending on the above factors as well as market/business considerations. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health.
Who We Are
Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve.
How We Work
At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.
Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process.
The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws.
Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact for assistance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.
**Carelon Medical Benefit Management**
**Genetic Testing Utilization Management/Review**
**Virtual:** This role enables associates to work virtually full-time, with the exception of required in-person training sessions, providing maximum flexibility and autonomy. This approach promotes productivity, supports work-life integration, and ensures essential face-to-face onboarding and skill development. Alternate locations may be considered if candidates reside within a commuting distance from an office.
**_Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law._**
_A proud member of the Elevance Health family of companies, Carelon Medical Benefits Management, formerly AIM Specialty Health, is a benefit-management leader in Illinois. Our platform delivers significant cost-of-care savings across an expanding set of clinical domains, including radiology, cardiology and oncology._
The **Clinical Operations Associate Medical Director** is responsible for supporting the medical management staff ensuring timely and consistent medical decisions to members and providers.
**How you will make an impact:**
+ Ensures timely completion of clinical case reviews for their board certified specialty.
+ Makes physician to physician calls to gather medical appropriate information in order to make medical necessity determinations for services requested.
+ Makes medical necessity determinations for grievance and appeals appropriate for their specialty.
+ Ensures consistent use of medical policies when making medical necessity decisions.
+ Brings to their supervisors attention, any case review decisions that require Medical Director review or policy interpretation.
**Minimum Requirements:**
+ Requires MD or DO and Board certification approved by one of the following certifying boards is required, where applicable to duties being performed, American Board of Medical Specialties (ABMS) or American Osteopathic Association (AOA).
+ Must possess an active unrestricted medical license to practice medicine or a health profession.
**Preferred Skills, Capabities, and Expereinces:**
+ Board certified in Internal Medicine or Family Medicine preferred.
For candidates working in person or virtually in the below location(s), the salary* range for this specific position is $188,051 to $282,088.
Locations:
Illinois
In addition to your salary, Elevance Health offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The salary offered for this specific position is based on a number of legitimate, non-discriminatory factors set by the Company. The Company is fully committed to ensuring equal pay opportunities for equal work regardless of gender, race, or any other category protected by federal, state, and local pay equity laws _._
* The salary range is the range Elevance Health in good faith believes is the range of possible compensation for this role at the time of this posting. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Even within the range, the actual compensation will vary depending on the above factors as well as market/business considerations. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health.
Who We Are
Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve.
How We Work
At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.
Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process.
The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws.
Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact for assistance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.
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1
Lead Automotive Diagnostics Engineer
60611 Chicago, Illinois
$120000 Annually
WhatJobs Direct
Posted 2 days ago
Job Viewed
Job Description
Our client, a premier automotive manufacturer known for its innovation and quality, is seeking a Lead Automotive Diagnostics Engineer to join their cutting-edge R&D facility in Chicago, Illinois, US . This is an on-site position, crucial for hands-on development and close collaboration with vehicle testing and manufacturing teams. You will be responsible for developing, implementing, and validating advanced diagnostic systems and tools for next-generation vehicles. This role requires a deep understanding of automotive electronic systems, embedded software, and diagnostic protocols. Your expertise will be vital in ensuring the reliability, performance, and maintainability of our vehicles throughout their lifecycle, from initial design to production and field service.
Key Responsibilities:
Key Responsibilities:
- Lead the design and development of diagnostic software and hardware for automotive electronic control units (ECUs).
- Define diagnostic requirements and specifications based on vehicle architecture and regulatory standards.
- Develop and implement diagnostic test procedures and validation methodologies.
- Work closely with software development teams to integrate diagnostic functionalities into vehicle firmware.
- Analyze diagnostic data to identify root causes of system failures and recommend corrective actions.
- Collaborate with vehicle integration and testing teams to ensure diagnostic systems function correctly under various operating conditions.
- Develop and maintain diagnostic tools and software used by manufacturing, service, and R&D departments.
- Stay current with automotive industry trends, diagnostic technologies (e.g., UDS, OBD-II), and relevant standards.
- Mentor junior engineers and contribute to the team's technical growth and knowledge sharing.
- Troubleshoot and resolve complex diagnostic issues reported from production or field testing.
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2
Senior Automotive Diagnostics Technician
60601 Chicago, Illinois
$70000 Annually
WhatJobs Direct
Posted 2 days ago
Job Viewed
Job Description
Our client, a leading automotive service center in the bustling city of **Chicago, Illinois**, is seeking a highly skilled and experienced Senior Automotive Diagnostics Technician. This is a hands-on role responsible for diagnosing and repairing complex mechanical and electrical issues in a wide range of vehicles, utilizing advanced diagnostic tools and equipment. The ideal candidate possesses exceptional problem-solving skills, a deep understanding of automotive systems, and a commitment to delivering high-quality service.
Responsibilities:
Responsibilities:
- Perform in-depth diagnostics on vehicle engines, transmissions, braking systems, suspension, electrical systems, and other components using state-of-the-art diagnostic equipment.
- Interpret diagnostic data, technical service bulletins (TSBs), and repair manuals to accurately identify root causes of vehicle malfunctions.
- Conduct comprehensive inspections and recommend necessary repairs or maintenance.
- Perform complex repairs and replacements of automotive parts and systems according to manufacturer specifications.
- Effectively communicate diagnostic findings and proposed repair solutions to service advisors and customers in a clear and understandable manner.
- Maintain accurate and detailed repair orders, documenting all work performed.
- Stay up-to-date with the latest automotive technologies, diagnostic procedures, and repair techniques.
- Adhere to all safety regulations and maintain a clean and organized work environment.
- Mentor and provide technical guidance to junior technicians.
- Perform routine maintenance services, including oil changes, tire rotations, and filter replacements.
- Ensure customer satisfaction by delivering efficient and reliable service.
- Operate and maintain shop equipment and tools properly.
- ASE Master Certified Technician with specialized certifications in areas such as Engine Performance, Brakes, Suspension & Steering, and Electrical/Electronic Systems.
- Minimum of 6 years of experience as an automotive technician, with a strong emphasis on diagnostics.
- Proficiency in using advanced diagnostic software and equipment (e.g., scan tools, oscilloscopes, multimeters).
- In-depth knowledge of internal combustion engines, hybrid and electric vehicle systems, and automotive electronics.
- Strong mechanical aptitude and problem-solving abilities.
- Excellent attention to detail and ability to follow complex instructions.
- Good communication and interpersonal skills.
- Ability to work effectively in a team environment and manage time efficiently.
- Valid driver's license and a clean driving record.
- Commitment to continuous learning and professional development.
- Experience with European or Asian makes is a plus.
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3
Global Precision Medicine Lead, Companion Diagnostics
60065 Northbrook, Illinois
Astellas Pharma
Posted 1 day ago
Job Viewed
Job Description
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The Global Precision Medicine Lead role is responsible for the development and execution of biomarker and diagnostic strategies across drug development programs to develop tailored therapies that drive improved patient outcomes. The primary responsibility of a Global Precision Medicine Lead is to bring companion diagnostics through development to approval in collaboration with external diagnostic partners for Oncology and/or Gene Therapy. The role requires strong knowledge and experience in applied biomarker research and companion diagnostics development together with strong personal drive to deliver innovative solutions.
**Essential Job Responsibilities:**
+ Participates in the development and execution of precision medicine and diagnostic strategies for early and late-stage clinical development programs in oncology and other therapeutic areas.
+ Contributes to the design of clinical studies that incorporate patient stratification, enrichment and biomarker testing including contribution to the relevant sections of study and regulatory documentation.
+ Enhances drug success in early development through the implementation of precision medicine strategies to define the relationship between biomarkers and drug efficacy and safety.
+ Facilitates biomarker testing of patient samples and interprets biomarker data from clinical studies to inform precision medicine and diagnostic strategies and generate data to support health authority submissions.
+ Leads the evaluation and selection of diagnostic technologies and external diagnostic partners to support drug development programs.
+ Leads the integration of companion diagnostic studies with drug clinical studies from development to approval through close collaboration with cross-functional teams and external diagnostic partners and vendors.
+ Ensures compliance with regulatory requirements for diagnostic tests and precision medicine approaches implemented in clinical studies.
+ Represents development as a subject matter expert on cross-functional diagnostic core teams for late-stage assets to drive successful diagnostic launches.
+ Supports publication of data from precision medicine research studies.
**Qualifications Required:**
+ Advanced science degree (PhD, PharmD or MD) in a relevant scientific field.
+ At least 5 years relevant experience and proven track record in the application of biomarkers and precision medicine in drug development at a biotech/pharmaceutical company.
+ Solid understanding of clinical development strategies, clinical study design and companion diagnostic development is required.
+ Experience in leading the implementation and interpretation of biomarker /diagnostic testing in clinical studies is required.
+ Experience working in cross functional matrixed work environments is essential.
+ Excellent communication, project management and leadership skills.
**Preferred:**
+ Experience in the registration of companion diagnostics and pharmaceuticals is preferred.
+ Strong knowledge of the process and global regulations for companion diagnostic development, approval and launch.
**Salary Range**
$150K - $195K (NOTE: Final salary could be more or less, based on experience)
**Working Environment:**
+ At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ RRSP match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
#LI-SS
Category Precision Medicine and Diagnostics
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The Global Precision Medicine Lead role is responsible for the development and execution of biomarker and diagnostic strategies across drug development programs to develop tailored therapies that drive improved patient outcomes. The primary responsibility of a Global Precision Medicine Lead is to bring companion diagnostics through development to approval in collaboration with external diagnostic partners for Oncology and/or Gene Therapy. The role requires strong knowledge and experience in applied biomarker research and companion diagnostics development together with strong personal drive to deliver innovative solutions.
**Essential Job Responsibilities:**
+ Participates in the development and execution of precision medicine and diagnostic strategies for early and late-stage clinical development programs in oncology and other therapeutic areas.
+ Contributes to the design of clinical studies that incorporate patient stratification, enrichment and biomarker testing including contribution to the relevant sections of study and regulatory documentation.
+ Enhances drug success in early development through the implementation of precision medicine strategies to define the relationship between biomarkers and drug efficacy and safety.
+ Facilitates biomarker testing of patient samples and interprets biomarker data from clinical studies to inform precision medicine and diagnostic strategies and generate data to support health authority submissions.
+ Leads the evaluation and selection of diagnostic technologies and external diagnostic partners to support drug development programs.
+ Leads the integration of companion diagnostic studies with drug clinical studies from development to approval through close collaboration with cross-functional teams and external diagnostic partners and vendors.
+ Ensures compliance with regulatory requirements for diagnostic tests and precision medicine approaches implemented in clinical studies.
+ Represents development as a subject matter expert on cross-functional diagnostic core teams for late-stage assets to drive successful diagnostic launches.
+ Supports publication of data from precision medicine research studies.
**Qualifications Required:**
+ Advanced science degree (PhD, PharmD or MD) in a relevant scientific field.
+ At least 5 years relevant experience and proven track record in the application of biomarkers and precision medicine in drug development at a biotech/pharmaceutical company.
+ Solid understanding of clinical development strategies, clinical study design and companion diagnostic development is required.
+ Experience in leading the implementation and interpretation of biomarker /diagnostic testing in clinical studies is required.
+ Experience working in cross functional matrixed work environments is essential.
+ Excellent communication, project management and leadership skills.
**Preferred:**
+ Experience in the registration of companion diagnostics and pharmaceuticals is preferred.
+ Strong knowledge of the process and global regulations for companion diagnostic development, approval and launch.
**Salary Range**
$150K - $195K (NOTE: Final salary could be more or less, based on experience)
**Working Environment:**
+ At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ RRSP match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
#LI-SS
Category Precision Medicine and Diagnostics
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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4
Senior Principal, Regulatory Affairs - Companion Diagnostics
60047 Lake Zurich, Illinois
Danaher Corporation
Posted 4 days ago
Job Viewed
Job Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology?
At Leica Biosystems, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business Syste m ( which makes everything possible.
The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and submissions to support product commercialization in multiple regions (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA) and will mentor the organization in these key activities. The Senior Principal Regulatory Affairs will work with Biopharma partners to develop and deploy CDx regulatory strategies. In this role you, will work with BioPharma partners on key projects, engaging with global regulatory agencies, and steering regulatory strategy for new product development and strategic initiatives. By guiding regulatory activities, this role ensures smooth global commercialization and compliance, driving innovation and excellence in the Biopharma sector.
This position reports to the Director, Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote.
In this role, you will have the opportunity to:
+ Lead regulatory strategy and execution for external partnerships and product lifecycle management, ensuring compliance with global requirements and state-of-the-art standards.
+ Maintain regulatory intelligence and execute regulatory plans, and ensure internal procedures are updated to reflect evolving US and international regulations.
+ Assess the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products
+ Develop and manage regulatory submissions (e.g., 510(k), PMA, EU Technical Files, STED), including documentation, timelines, and agency interactions to secure product approvals.
+ Collaborate cross-functionally and globally with Clinical Affairs, R&D, QA, and Business Development to align regulatory plans with, and provide inputs and updates to, business and clinical goals.
+ Provide device-specific regulatory insight/guidance during CDx / Pharma partner cross-functional meetings.
The essential requirements of the job include :
+ Bachelor's, Master's, or PhD in a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. Further regions are a bonus but not a core requirement.
+ Extensive experience working with cross functional teams developing companion diagnostics and devices. Substantial experience developing and executing regulatory strategies for high-complexity diagnostic products, including 510(k) and PMA submissions.
+ Proven track record supporting new product development and complex clinical trials, including IDE approvals and EU Performance Study Application submissions .
+ Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required
+ Good understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel ~ 25%
It would be a plus if you also possess previous experience in:
+ Applying advanced regulatory expertise to support the global development and commercialization of complex, high-risk products, with a focus on both immediate challenges and long-term strategic outcomes.
+ Leading cross-functional teams in a matrixed environment, ensuring timely decision-making, issue resolution, and alignment across global and culturally diverse stakeholders.
+ Experience with drug development and drug regulatory procedures.
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
The salary range for this role is $200k - $240k. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.
This job is also eligible for bonus/incentive pay.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law
At Leica Biosystems, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.
#LI-LCS
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or .
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology?
At Leica Biosystems, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business Syste m ( which makes everything possible.
The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and submissions to support product commercialization in multiple regions (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA) and will mentor the organization in these key activities. The Senior Principal Regulatory Affairs will work with Biopharma partners to develop and deploy CDx regulatory strategies. In this role you, will work with BioPharma partners on key projects, engaging with global regulatory agencies, and steering regulatory strategy for new product development and strategic initiatives. By guiding regulatory activities, this role ensures smooth global commercialization and compliance, driving innovation and excellence in the Biopharma sector.
This position reports to the Director, Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote.
In this role, you will have the opportunity to:
+ Lead regulatory strategy and execution for external partnerships and product lifecycle management, ensuring compliance with global requirements and state-of-the-art standards.
+ Maintain regulatory intelligence and execute regulatory plans, and ensure internal procedures are updated to reflect evolving US and international regulations.
+ Assess the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products
+ Develop and manage regulatory submissions (e.g., 510(k), PMA, EU Technical Files, STED), including documentation, timelines, and agency interactions to secure product approvals.
+ Collaborate cross-functionally and globally with Clinical Affairs, R&D, QA, and Business Development to align regulatory plans with, and provide inputs and updates to, business and clinical goals.
+ Provide device-specific regulatory insight/guidance during CDx / Pharma partner cross-functional meetings.
The essential requirements of the job include :
+ Bachelor's, Master's, or PhD in a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. Further regions are a bonus but not a core requirement.
+ Extensive experience working with cross functional teams developing companion diagnostics and devices. Substantial experience developing and executing regulatory strategies for high-complexity diagnostic products, including 510(k) and PMA submissions.
+ Proven track record supporting new product development and complex clinical trials, including IDE approvals and EU Performance Study Application submissions .
+ Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required
+ Good understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel ~ 25%
It would be a plus if you also possess previous experience in:
+ Applying advanced regulatory expertise to support the global development and commercialization of complex, high-risk products, with a focus on both immediate challenges and long-term strategic outcomes.
+ Leading cross-functional teams in a matrixed environment, ensuring timely decision-making, issue resolution, and alignment across global and culturally diverse stakeholders.
+ Experience with drug development and drug regulatory procedures.
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
The salary range for this role is $200k - $240k. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.
This job is also eligible for bonus/incentive pay.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law
At Leica Biosystems, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.
#LI-LCS
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or .
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