senior clinical research scientist

Johnson & Johnson

<div>
 
 At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
 
 
 
 
 
 
 Job Function:
 
 Discovery &amp; Pre-Clinical/Clinical Development
 
 
 
 Job Sub Function:
 
 Clinical Development &amp; Research &ndash; Non-MD
 
 
 
 Job Category:
 
 Scientific/Technology
 
 
 
 All Job Posting Locations:
 
 Irvine, California, United States of America
 
 
 
 
 
 
 Job Description:
 
 
 
 Johnson and Johnson is currently seeking a
 
 Staff Clinical Research Scientist
 
 to support the scientific publication medical writing needs of the Electrophysiology business. This role is based in Irvine, CA and reports to the office on assigned days 2-3 times per week.
 
 
 At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
 
 
 
 
 
 The Staff Clinical Research Scientist will join the Clinical Science &amp; External Research (CSER) Team responsible for global evidence dissemination of scientific findings from clinical trials and registries sponsored by Johnson &amp; Johnson MedTech Electrophysiology. This associate will play a critical role in the creation and delivery of accurate, high-quality scientific content that communicates clinical and real-world data on the Company&rsquo;s Electrophysiology medical devices. This role is responsible for writing and managing manuscripts, abstracts, posters, and presentations that support peer-reviewed publications and congress activities. The ideal candidate will have strong scientific writing experience, deep familiarity with the cardiovascular and/or electrophysiology clinical landscapes, and a thorough understanding of publication standards, regulatory guidelines, and clinical study design.
 
 
 
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Develop and deliver high-quality scientific manuscripts, abstracts, posters, and podium presentations for publication in peer-reviewed journals and presentation at major cardiovascular and electrophysiology congresses
 </li>
 <li>
 Collaborate closely with internal cross-functional teams (Clinical, Biostatistics, Medical Affairs, Global Strategic Marketing, Health Economics and Market Access) and external physician authors to ensure accuracy, alignment, and scientific integrity
 </li>
 <li>
 Support the strategic publication plan for key products and studies, including first-in-human trials, pivotal studies, indication expansions, postmarket surveillances, and registries
 </li>
 <li>
 Analyze and interpret clinical data; effectively communicate data using well-structured tables and visually compelling figures
 </li>
 <li>
 Adhere to external guidelines and Company policies governing the ethical development of clinical data publications while continuing to look at innovation in publication and scientific communications
 </li>
 <li>
 Coordinate document review, incorporate feedback, obtain approvals, and ensure timely submissions
 </li>
 <li>
 Maintain awareness of emerging trends and competitors in cardiovascular and electrophysiology therapy spaces to inform content development
 </li>
 <li>
 Track publication metrics, congress submissions, and support database management using publication tools and systems
 </li>
 <li>
 Stays on top of current scientific data by participating in monthly literature review and sharing key insights with global teams
 </li>
 <li>
 Support congress planning, including participating in clinical booth activities and gathering of scientific evidence to be shared with company
 </li>
 <li>
 Engage with Clinical Science &amp; External Research associates and cross-functional teams to develop evidence dissemination materials tailored to various internal and external audiences (ie, field personnel, HCPs, investors)
 </li>
 </ul>
 
 
 
 
 
 Qualifications:
 
 
 
 
 Required:
 
 
 <ul>
 <li>
 Minimum of a Bachelor's Degree in Life Sciences, Physical Science, Nursing, Biological Science, or closely related field
 </li>
 <li>
 Minimum of 5+ years of direct involvement in scientific publications in a medical industry or related setting
 </li>
 <li>
 Excellent written and oral communication skills
 </li>
 <li>
 Strong project management skills to balance multiple projects
 </li>
 <li>
 Excellent interpersonal skills, with the ability to build relationships and collaborate effectively with key partners across different time zones
 </li>
 <li>
 Demonstrated adaptability in fast-paced, evolving environments
 </li>
 <li>
 Knowledge of Good Clinical Practice, Good Publication Practice, and ICMJE Standards
 </li>
 </ul>
 
 
 Preferred:
 
 
 <ul>
 <li>
 PhD/MD/PharmD with industry/academic research experience
 </li>
 <li>
 8+ years of scientific writing experience in a medical industry or related setting
 </li>
 <li>
 3+ years of experience in cardiovascular and/or electrophysiology therapeutic areas
 </li>
 <li>
 Familiarity with publication management platforms and reference software
 </li>
 <li>
 ISMPP CMPP&trade; or AMWA MWC&reg; credentials
 </li>
 <li>
 Knowledge of electrophysiology procedures and terminology
 </li>
 </ul>
 
 
 Other:
 
 
 <ul>
 <li>
 May require up to 10% travel
 </li>
 </ul>
 
 
 
 
 Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
 
 
 
 
 
 Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (
 
 ra-employeehealthsup@its.jnj.com
 
 ) or contact AskGS to be directed to your accommodation resource.
 
 
 
 
 
 
 The anticipated base pay range for this position is :
 
 
 
 
 
 $105K - $169,050
 
 
 
 
 Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company&rsquo;s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company&rsquo;s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation &ndash;120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington &ndash;56 hours per calendar year Holiday pay, including Floating Holidays &ndash;13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave &ndash; 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave &ndash; 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave &ndash; 10 days Volunteer Leave &ndash; 4 days Military Spouse Time-Off &ndash; 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
 
</div>

Staff Clinical Research Scientist

Alameda Health System

<div><div><div><div>SUMMARY: The AHD Senior Clinical Lab Scientist performs medical laboratory tests, procedures, experiments and analyses to provide data for diagnosis, treatment and prevention of disease. Performs related duties as required.
DUTIES &amp; ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification.
1. Conducts chemical analyses of body fluids such as blood, urine, spinal fluid, and other, to determine presence of normal and abnormal components according to laboratory protocols.
2. Performs quality control studies, calibrations and validations to ensure accuracy of clinical data. Follows procedures/protocols when results/controls are out of established/acceptable limits. Analyzes test results and enters findings in the laboratory computer system. Interprets age and sex specific data.
3. Performs phlebotomies as required, at least ten (10) venipunctures per hour, with 100% accuracy regarding patient ID and correct specimen requirements. Performs phlebotomies on patients of all ages. Assists with phlebotomy training when necessary.
4. Visits off-site locations to collect samples from patients as needed.
5. Performs routine preventative maintenance on assigned instruments and equipment according to established schedule and procedures. Troubleshoots, resolves, and documents in the appropriate logs any repairs, replacement, malfunctions or technical problems, and maintenance needed on any laboratory instrumentation. Maintains appropriate levels of supplies/reagents and maintains equipment/instrumentation in operational condition. Troubleshoots and works with on-line technical support to identify and resolve instrumentation problems. Maintains work area in a clean and safe manner.
6. Prioritizes and organizes work during busy periods of laboratory operations and coordinates multiple, concurrent testing.
7. Trains new employees in hospital and laboratory policies, procedures and operations.
8. Greets customers with full attention and courtesy. Answers telephone, admits/registers patients and orders tests. Interacts with other patient care departments of the hospital to provide optimal patient care.
9. Maintains technical knowledge in all areas of the clinical laboratory by keeping current in clinical developments and requirements, attending departmental meetings and maintaining awareness of hospital policies and procedures.
10. May direct activities of phlebotomists or laboratory clerical personnel. May be responsible for the day-to-day supervision and oversight of the laboratory.
MINIMUM QUALIFICATIONS: Education: Bachelor's degree (B.S./M.A.) from a four-year college or university or three to five years previous related experience and/or training, or an equivalent combination of education and experience. Required Licenses/Certifications: Current California Clinical Laboratory Scientist License. 

PAY RANGE: $66.32/HR - $82.08/HR
The pay range for this position reflects the base pay scale for the role at Alameda Health System. Final compensation will be determined based on several factors, including but not limited to a candidate&rsquo;s experience, education, skills, licenses and certifications, departmental equity, applicable collective bargaining agreements, and the operational needs of the organization. Alameda Health System also offers eligible positions a generous comprehensive benefits program.</div> 

</div>
</div> 
Location: Alameda Health System &middot; AHD Laboratory 
Schedule: Part Time, Night</div>

AHD Senior Clinical Laboratory Scientist

Merck

<div>Job Description
The Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
Specifically, The Clinical Director May Be Responsible For:<ul><li>
Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.</li><li>
Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline</li><li>
Developing clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these clinical development strategies</li><li>
Monitoring and managing the conduct of ongoing or new clinical trials for investigational drugs</li><li>
Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and</li><li>
Participation in internal and joint internal/external research project teams relevant to the development of new compounds</li></ul>
The Clinical Director may:<ul><li>
Supervise the activities of Clinical Scientists in the execution of clinical studies.</li><li>
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects</li><li>
Assist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.</li></ul>
The Clinical Director is responsible for maintaining a strong scientific fund of knowledge by:<ul><li>
Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies</li><li>
Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational drugs in Immunology</li><li>
Establishing collaborative relationships with external experts in Rheumatology diseases, particularly those whose research focus and expertise can inform and assist the evaluation of the company's investigational drugs</li><li>
Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.</li></ul>
To accomplish these goals, the Clinical Director may:<ul><li>
Author detailed development documents, presentations, budgets, and position papers for internal and external audiences</li><li>
Facilitate collaborations with external researchers around the world</li><li>
Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.</li></ul>
Education<ul><li>
M.D., D.O., M.D./PhD, or D.O./PhD</li></ul> 
Required education and experience<ul><li>
Minimum of 5 years of clinical and/or development experience (academia, clinical medicine, and/or corporate clinical development).</li><li>
Demonstrated record of scientific scholarship and achievement</li><li>
Prior experience in design and execution of phase 2 or 3 clinical trials in rheumatologic diseases is preferred</li><li>
Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment.</li></ul>
Required Skills:
Allergy and Immunology, Clinical Development, Clinical Immunology, Clinical Investigations, Clinical Medicine, Clinical Research, Clinical Trial Planning, Clinical Trials, Clinical Trial Support, Cross-Functional Teamwork, Immunogenicity Assays, Intellectual Curiosity, New Technology Integration, Pulmonology, Respiratory Treatments, Scientific Consulting, Strategic Planning
Preferred Skills: 
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another&rsquo;s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as &ldquo;remote&rdquo;.
The salary range for this role is
$250,800.00 - $394,800.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee&rsquo;s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles&rsquo; Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully 
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
11/21/2025<ul><li>A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. 
</li></ul> 
Requisition ID:R373533</div>

Principal Scientist, Clinical Research, Immunology

Calico Life Sciences

<div>Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives.

Calico&rsquo;s highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

We are looking for an outstanding and innovative senior scientist to join our team to derive transformative biological insights from preclinical imaging studies. A key responsibility of the role is the development and implementation of new magnetic resonance imaging (MRI) methods as well as utilizing imaging methods to plan and execute imaging studies in rodents to derive quantitative biomarkers for basic research and translational development. These projects will be conducted in collaboration with translational and research scientists, machine learning engineers and data scientists in a dynamic collaborative environment. Calico provides a stimulating working environment focused on fundamental discovery research and a commitment to translate scientific advances to realize their therapeutic potential.

Responsibilities:
<ul>
<li>Design and execute preclinical imaging studies for basic research and drug development</li>
<li>Lead collaborative studies and closely work with multidisciplinary project teams</li>
<li>Implement, optimize, and validate new MRI methods</li>
<li>Implement and utilize image processing/analysis pipelines to generate quantitative readouts from in-vivo imaging data</li>
<li>Develop, characterize and validate image-based biomarkers of diseases and aging processes</li>
<li>Communicate scientific findings internally and externally</li>
</ul>
Position Requirements:
<ul>
<li>Ph.D. degree in Physics, Biomedical Engineering, Computer Science or related field with at least 5 years of related work or postdoctoral experience</li>
<li>Highly experienced in animal MRI on Bruker MRI systems, good understanding of MRI methods and protocol development</li>
<li>Strong skills in advanced image analysis and programming (MATLAB, Python, R)</li>
<li>Experience in rodent handling and procedures</li>
<li>Self-motivated with a &ldquo;can-do&rdquo; attitude</li>
<li>Flexible, able to respond quickly to shifting priorities</li>
<li>Strong communication and presentation skills</li>
<li>Highly organized and able to solve complex problems independently</li>
<li>Ability to work collaboratively with multidisciplinary teams</li>
<li>Must be willing to work onsite 5 days a week</li>
</ul>
Nice to Have:
<ul>
<li>Research experience in neurodegenerative disorders and rodent brain imaging</li>
<li>Familiarity with cardiovascular imaging methods and disease models</li>
<li>Experience with ML-based image processing</li>
<li>Experience with pulse sequence programming using ParaVision</li>
<li>Experience with statistical analysis of longitudinal data</li>
<li>Experience with additional preclinical imaging modalities (uCT, ultrasound, BLI/fluorescence imaging)</li>
<li>A good understanding of the clinical validity of in vivo models</li>
<li>Experience with genetic and pharmacological approaches to modulate pathways of interest</li>
</ul>
The estimated base salary range for this role is $166,000 - $191,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.</div>

Senior Scientist, Preclinical Magnetic Resonance Imaging

Regeneron

<div>We are seeking a Senior Manager to join our Clinical Sciences team within Regeneron Genetics Medicine. Qualified scientist with training in the pharmaceutical/biotechnology sector, or academic or clinical setting. You will work closely with supervisor and other members of the cross-functional team, contributes to early development and clinical experimentation for projects for discovery phase through Proof of Concept (POC). 
As a Senior Manager, a typical day may include the following: 
 
- Supports the cross-functional study team on the following activities, including but not limited to:
- Contributes to the writing of sections of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments.
- Assists with identifying key internal and external collaborators/advisors, organizes consultations with global subject matter experts
- Represents the clinical ECD&amp;ES function on clinical study teams, contributing medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables
- Works alongside Clinical Trial Manager to provide day-to-day clinical input to the study team
- Drafts portions of the clinical sections in regulatory and clinical documents such as: regulatory agency briefing books, IND/IMPD submissions, investigator&rsquo;s brochure, informed consent forms, IRB/IEC submissions, clinical study reports, abstracts/manuscripts for publication, etc.
- Reviews study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc
- Trains and support study team and CRO personnel regarding clinical aspects of trial
- Assist with medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
- Organizes steering committees, advisory boards, and data safety monitoring boards as required
- Identifies program, trial or data risks, creates and implements mitigation strategies
- Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
- Provides background literature searches in support of:
- Early clinical strategy in terms of indication selection, study rationale, scientific/clinical endpoints
- POC-enabling human studies, First-In-Human (FIH) studies, clinical experimental studies as per clinical strategy 
This role may be for you if: 
 
- Effective communications (verbal &amp; written) and presentation skills are essential
- Must be able to work productively in a fast-paced collaborative environment
- Demonstrated/potential for critical thinking skills and sound decision-making 
To be considered for this role, you must have a Bachelor&rsquo;s degree. Ph.D., PharmD. or Master&rsquo;s degree in biomedical subject. Additionally, we are seeking 8 years of clinical research/development experience
<div><div><div><div><div><div><div>Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries&rsquo; specific benefits, please speak to your recruiter.
 
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron&rsquo;s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron&rsquo;s on-site policy and expectations for your role and your location. 
 
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
</div></div></div></div></div></div></div>$150,500.00 - $245,500.00</div>

Senior Manager, Clinical Scientist, Genetics Medicine

Department of General Services

<div><div><div><div><div><div><div>Are you a Scientist with interest in quality assurance, biochemistry, chemistry, and molecular biology testing?

Come join DGS as a Senior Scientist in our Newborn Screening Group!

Title: Senior Scientist (Newborn Screening) &ndash; CL538

State Role Title: Scientist II

Hiring Range: $69,000 - $83,000

Pay Band: 5

Agency: Department of General Services

Location: Richmond, VA

Agency Website: www.dgs.virginia.gov

Recruitment Type: General Public &ndash; G

DGS is seeking a Senior Scientist for our Newborn Screening Laboratory at the Division of Consolidated Laboratory Services (DCLS). This position serves as a Senior Scientist. This position oversees quality assurance (QA) efforts for the NBS Group and the performance of filter paper blood spot analysis for a variety of genetic disorders as required by the Code of Virginia.

Virginia&rsquo;s Newborn Screening Program is a partnership between DCLS and the Virginia Department of Health to screen each baby born in Virginia for certain rare yet serious metabolic and genetic disorders. Babies with these disorders may look healthy at birth but can suffer devastating consequences, even death, if the disorder goes untreated. The Newborn Screening Group works with various platforms including mass spectrometry, electrophoresis, microfluidics, automated immunoassays, and molecular techniques including polymerase chain reaction (PCR) and sequencing.

As a member of the Newborn Screening laboratory team, this Senior Scientist will support customer service efforts, oversee quality assurance efforts, review analytical results, write, review and update SOPs, train staff, act as a technical specialist and prioritize, schedule and coordinate testing performed by other staff members, as needed. This position will also participate in product evaluations, method analysis, and maintain competency according to the agency accreditation requirements. These duties are performed independently with minimal supervision from the Group Manager.

Job duties include, but are not limited to:
<ul>
<li>Independently performs moderate and highly complex testing accurately.</li>
<li>Support the DCLS Quality Management System to ensure the accuracy and integrity of DCLS laboratory test results.</li>
<li>Maintains, troubleshoots, monitors repair services for and documents instrument, equipment, method problems, and service requests.</li>
<li>Monitors and maintains a current inventory of testing supplies and materials.</li>
</ul><ul><li>In addition, some weekend and holiday work as well as on-call coverage is required.</li>
</ul>
We&rsquo;ve got great benefits!

DGS offers excellent health benefits at affordable pricing, pre-tax spending accounts, paid life insurance, paid Short- and Long-Term Disability benefits, paid holidays, vacation, and other leave benefits, wellness programs, and a state retirement plan with options for tax-deferred retirement savings including employer matching. Additionally, supplemental bus passes, ride share, or parking are available and DGS is a qualifying employer for the Public Service Loan Forgiveness Program.

Minimum Requirements
<ul>
<li>Candidate must meet the requirements for technical supervisor in a high complexity testing laboratory as defined by 42 CFR 493.1449.
</li><li>Candidate must demonstrate significant knowledge and experience in clinical laboratory testing.</li>
<li>Experience training staff.</li>
<li>Ability to communicate effectively and work in a team environment.</li>
<li>Experience operating and troubleshooting laboratory instrumentation.</li>
<li>Demonstrated ability to apply safe laboratory practices.</li>
<li>Experience with QA and QC procedures and ability to document and interpret QC data.</li>
<li>Ability to work a set schedule for Monday through Friday, with some weekend and holiday work as well as on-call coverage.</li>
</ul>
Sponsorship will not be provided for this position now or in the future. Confirmation of eligibility to work will be required at time of hire.

The selected candidate must also pass a fingerprint-based criminal background check.

Additional Considerations
<ul>
<li>Knowledge and experience with high complexity, high volume clinical laboratory testing using automated laboratory equipment.</li>
<li>Experience with Laboratory Information Management Systems (LIMS).</li>
<li>Work-related experience serving as a team leader with the ability to prioritize, schedule and coordinate laboratory testing of others.</li>
<li>Work-related experience with mass spectrometry, including LC-MS/MS.</li>
<li>Work-related experience with immunoassays, molecular biology assays, enzyme activity assays, and/or HPLC.</li>
<li>Experience leading quality assurance and quality improvement initiatives.</li>
<li>Experience preparing for CLIA audits.</li>
</ul>
Special Instructions

The online state application must contain all required information and fully respond to questions to be considered for this job opportunity. Please be sure that all of your relevant qualifications and considerations are specifically addressed in your submitted application.

Online applications should be submitted via jobs.virginia.gov.

Fax, e-mail, or mail applications will not be accepted. For assistance or computer access, please visit your local Virginia Employment Office or contact our office jobs@dgs.virginia.gov or 804-786-3910.

You will be provided with confirmation of receipt when your application has been successfully submitted. Applications will continue to be accepted until a suitable pool of candidates is received, but this position may be closed at any time after NOVEMBER 18, 2025. Please refer to the &ldquo;Your Application&rdquo; page in your account to check the status of your application for this position. Applicants in need of accommodation during the application and/or interview process may contact DGS at 804-786-3910 for assistance.

Sponsorship will not be provided for this position now or in the future. Confirmation of eligibility to work will be required at time of hire. DGS will record information from each new employee&rsquo;s Form I-9 (Employment Eligibility Verification) into the Federal E-Verify system to confirm identity and work authorization.

The selected candidate must pass a fingerprint-based criminal background check.

Blood-borne pathogen training will be provided by the employer. In order to comply with OSHA blood-borne pathogen requirements, DCLS offers the Hepatitis B vaccine.

DCLS employees are designated as essential personnel. This designation requires DCLS employees to report to the workplace or at an assigned remote location during state authorized closings or delays (i.e., weather-related closures/delays, holidays, etc.), unless otherwise instructed by management.

Due to the critical nature of the work performed by the Division of Consolidated Laboratory Services (DCLS) and the requirements and responsibilities placed upon DCLS by the Drug Free Workplace Act, Federal Select Agent Program, and DHRM Policy 1.05 Alcohol and other Drugs, it is the policy of DCLS to maintain a workplace that is free from the harmful effects of alcohol or other drugs. The unlawful or unauthorized use of drugs by DCLS employees while at work adversely impacts DCLS&rsquo;s ability to perform high quality analytical testing services and support for local, state and federal agencies that serve to protect the health, safety and security of the public. As such, DCLS strictly prohibits the manufacture, distribution, dispensation, possession or use of alcohol, marijuana, or other drugs, prohibits employees from possessing or using alcohol, marijuana or any controlled substances (including, but not limited to prescription drugs) while in state owned vehicles, in the workplace or on DCLS premises, or when performing official work duties.

Applicants that indicate they have preferential hiring rights in the form of a yellow form or blue card must submit these to our office prior to the closing of the posting, in accordance with DHRM policy 1.30. Please note that only current and former employees of the Commonwealth of Virginia that will be or have been laid off are eligible for preferential hiring rights.

The Virginia Department of General Services is an equal opportunity employer and a proud Virginia Values Veterans (V3) Certified employer. Individuals from minoritized groups, individuals with disabilities, veterans, and individuals with AmeriCorps, Peace Corps, and other national service experience are encouraged to apply.

In support of the Commonwealth&rsquo;s commitment to inclusion, we are encouraging individuals with disabilities to apply through the Commonwealth Alternative Hiring Process. To be considered for this opportunity, applicants will need to provide their AHP Letter (formerly COD) provided by the Department for Aging &amp; Rehabilitative Services (DARS), or the Department for the Blind &amp; Vision Impaired (DBVI). Service-Connected Veterans are encouraged to answer Veteran status questions and submit their disability documentation, if applicable, to DARS/DBVI to get their AHP Letter. Requesting an AHP Letter can be found at AHP Letter or by calling DARS at 800-552-5019.

Note: Applicants who received a Certificate of Disability from DARS or DBVI dated April 1, 2022- February 29, 2024, can still use that COD as applicable documentation for the Alternative Hiring Process.

Contact Information

Name: DGS Human Resources

Phone: 804-786-3910

Email: jobs@dgs.virginia.gov 
</div></div></div></div></div><div><div><div>Each agency within the Commonwealth of Virginia is dedicated to recruiting, supporting, and maintaining a competent and diverse work force. Equal Opportunity Employer</div></div></div></div></div><div></div>

Senior Scientist (Newborn Screening) - CL538

Arrowhead Pharmaceuticals

<div>
 Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead&rsquo;s RNAi-based therapeutics leverage this natural pathway of gene silencing.
 
 
 Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
 
 
 Arrowhead&rsquo;s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI &amp; San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
 
 
 
 The Position
 
 
 
 The Senior Medical Scientist, Drug Safety will provide operational and scientific support in managing the development, implementation and oversight of Arrowhead investigational products with engaging in, but not limited to: support safety governance and surveillance procedures including safety reporting processes, advanced safety analytics, expedited and periodic aggregate reports ensuring compliance with internal standard operating procedures, FDA and global safety reporting requirements. They will conduct trend recognition, signal detection, and assist in overseeing relationships with vendors and business partners to ensure the highest quality of safety data is collected, reviewed and analyzed which fulfill all safety reporting requirements are met in the required timelines.
 
 
 This role will collaborate with Drug Safety Operations, Safety Scientists, medical monitors, clinical operations, QA, Data Management and regulatory colleagues in the set-up of and support of clinical development programs and/or post-marketed products to ensure safety oversight.
 
 
 This role is based fulltime onsite 5 days a week in San Diego, CA.
 
 
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Safety Science Responsibilities
 </li>
 <ul>
 <li>
 Review potential safety observations, safety signals and contribute to the Safety Review Committee and Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic, aggregate safety data reviews, and provide recommendations for review and approval by the Executive Safety Committee
 </li>
 <li>
 Prepare periodic aggregate safety reports including PSUR, DSUR, FDA IND Annual Report etc.
 </li>
 <li>
 Performs routine signal detection, identifies and evaluate safety signals
 </li>
 <li>
 Continually stay up to date on relevant regulations associated with the above activities
 </li>
 <li>
 Develop and update of Safety Surveillance Plans for assigned products
 </li>
 <li>
 Supports the preparation and maintenance of safety sections of the Clinical Protocols, Clinical Study Reports, Company Core Data Sheet, Investigators Brochure and Risk Management Plan
 </li>
 <li>
 Assist in quality assurance activities, including deviation reports
 </li>
 <li>
 Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure effective reconciliation process
 </li>
 <li>
 Assist with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities
 </li>
 <li>
 Support activities associated with launching a filing for the BLA/NDA or global marketing
 </li>
 </ul>
 <li>
 Medical Review Responsibilities
 </li>
 <ul>
 <li>
 Perform Medical Review on SAE/SUSAR if applicable
 </li>
 <li>
 Conduct active case follow-up, including written and verbal follow-up with clinical operations, clinical investigators and sites if applicable
 
 </li>
 </ul>
 </ul>
 
 Requirements:
 
 
 
 <ul>
 <li>
 Medical Degree: MD/DO
 </li>
 <li>
 8 years in the pharmaceutical industry or CRO
 </li>
 <li>
 5 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience
 </li>
 <li>
 Experience in Signal Detection and Safety Data Analytics
 </li>
 <li>
 Strong safety science experience to utilize data analysis and visualization platforms and tools by applying advanced scientific algorithms and methods and translating the strategic vision of safety science into risk mitigation strategies and data visualization insights
 </li>
 <li>
 Strong working knowledge of FDA and international adverse event reporting regulations {ICH, EMA GPV, GCP etc.) and the ability to interpret and apply applicable regulations
 </li>
 <li>
 Strong working knowledge of ARGUS case management and processing; experience in using ARGUS or other safety databases; experience with MedDRA/WHODrug for coding AEs, medical history, and concomitant medications
 </li>
 <li>
 Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs)
 </li>
 <li>
 Strong interpersonal skills with the ability to professionally interact with cross functional team members
 
 
 </li>
 </ul>
 California pay range
 
 
 $195,000&mdash;$220,000 USD
 
 
 Arrowhead provides competitive salaries and an excellent benefit package.
 
 
 All applicants must have authorization to work in the US for a company.
 
 
 California Applicant Privacy Policy
</div>

Senior Medical Scientist, Drug Safety

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