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bi developer / data analyst Jobs in Boston

bi developer / data analyst

business strategy and data analyst Jobs in Boston

business strategy and data analyst

clinical scientist ii

clinical trials associate

data analyst ambulatory clinical operations

Dana-Farber Cancer Institute

<b>Job Ref:</b><br>
46675
<br><br>
<b>Location:</b><br>
450 Brookline Ave, Boston, MA 02215
<br><br>
<b>Category:</b><br>
IT/Informatics
<br><br>
<b>Employment Type:</b><br>
Full time
<br><br>
<b>Work Location:</b><br>
<b>Remote:</b> occasional time on campus
<br><br>
Overview
<br><br>
This role is remote with occasional time onsite. The selected candidate must live and work from one of the New England states (ME, NH, VT, MA, RI, CT)
<br><br>
The Ambulatory Clinical Operations (ACO) Data Analyst reports the the ACO Business Manger and is responsible for independently delivering high-quality data products and insights to support the department's operational and strategic goals. This role requires proficiency in data analysis, visualization, and reporting, as well as the ability to collaborate effectively with stakeholders and the Enterprise Data and Analytics (ED&A) team. The Analyst works on multiple projects simultaneously, ensuring deliverables are completed on time and meet business needs. This role involves gathering requirements, developing dashboards, and contributing to the creation of reusable analytic assets to support decision-making.
<br><br>
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
<br><br>
Responsibilities
<br><br>
Assist preparing detailed analysis to support cost and cost-effectiveness analysis.
<br>Handle complex, iterative and multi-part analyses and prepare summaries of important points
<br>Engage in problem solving and decision-making
<br>Assist in the development, implementation, and operation of systems and processes to support the activities and goals of the Department.
<br>Serve as a resource to other junior level staff within the Department (Interns, co-Ops)
<br>Immediately bring the attention of the Director issues, concerns and problems which may hinder achievement of deadlines and or/ accomplishments of responsibilities
<br>Perform other similar and related duties as required or directed
<br><br>
Qualifications
<br><br>
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
<br><br>
Bachelor's degree or equivalent in Computer Science, Mathematics, Accounting, Finance or related field
<br>Minimum of two to three years of related work experience in healthcare industry
<br>Must be able to function independently in a fast-paced environment while managing multiple priorities
<br>Must have superior interpersonal and communication skills to effectively work and communicate with all levels of internal and external staff
<br>Requires superior computer skills, i.e. MS Excel, Access, PowerPoint, Word and data mining techniques. Programming abilities and/or statistical software skills strongly desired.
<br>Extensive experience with Microsoft Excel and Access required. Competent with the rest of Microsoft Office suite (e.g. Word, PowerPoint, Outlook, Visio)
<br>Familiarity with databases (eg. SQL) using a variety of applications (Excel, MS Access, Microstrategy)
<br>Statistical skills (STATA and/or SAS) strongly desirable
<br>Programming knowledge desirable
<br>Comfortable learning new software tools
<br>Proven ability to document business requirements and ability to design and develop reporting
<br>Solid oral and written communication skills
<br>Must be able to function independently in a fast-paced environment while managing multiple priorities.
<br>Must be able to work with minimal direction and be very flexible to coordinate complex activities that are often subject to rapid or extensive changes
<br>Knowledge of health care delivery systems and cost containment strategies including medical management interventions and provider contracting methodologies desired
<br><br>
Pay Transparency Statement
<br><br>
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.
<br><br>
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA)
<br><br>
$74,800 - $87,100
<br><br>
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
<br><br>
EEOC Poster

Data Analyst, Ambulatory Clinical Operations

Mass General Brigham

<div>Site: The General Hospital Corporation<br>
<p></p><br>
<p>Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.<br>
</p><p></p><br>
Nursing Director, Ambulatory Transplant
<br>
<br>
Lead a dynamic team in an innovative environment as the Nursing Director for the Ambulatory Transplant at MGH! Lead all aspects of clinical operations and patient care for our multifaceted clinics, such as adult and pediatric pre-/post-abdominal transplant, nephrology, thoracic transplant, dialysis access, laboratory, and infusion clinics. Collaborate with Medical, Surgical, and Administrative Directors and Managers for detailed and safe, operations. Your role will entail recruiting, onboarding, training, and mentoring nursing and clinical support staff. Additionally, you will collaborate with practice leadership to conduct performance evaluations, address performance concerns, and handle the termination of clinical support staff when vital. You will be instrumental in planning, evaluating, and implementing clinical and administrative functions, ensuring that all staff have vital proficiencies and provide impeccable patient care.
<br>
Support nursing staff as needed, recruit and retain clinic staff, monitor patient satisfaction, and coordinate care.
<br>
<br>
Skills and Experience
<br>
<ul><li>Minimum of 5 years of Transplant Nursing experience in an ambulatory care setting, preferred.
</li><li>Three years of management experience preferred.
</li><li>Proven track record to successfully supervise others.
</li><li>Highly motivated, independent, and capable of performing in a complex environment.
</li><li>Good sense of initiative and perseverance to carry tasks through to completion.
</li><li>Demonstrates forthrightness and integrity.
</li><li>Ability to identify issues/projects and initiate plans to address them, seeking direction when appropriate.
</li></ul>Ability to develop a common vision for diverse constituents, communicate effectively, sell ideas, and take ownership and responsibility for activities.
<br>
Baccalaureate and Master's degree required, with one in nursing.
<br>
<br>
Licensure, Certifications, or Registration
<br>
Current licensure as a registered nurse in the Commonwealth of Massachusetts.
<br>
Certified Clinical Transplant Coordinator (CCTC) certification or Certified Clinical Transplant Nurse (CCTN) is vital and required within 3 years of the date of employment.
<br>
<br>
If you are interested, join Mass General Brigham to advance in your career alongside a group that prioritizes outstanding performance, partnership, and personal development. Your contributions will leave a significant mark!
<br>
<br>
Full-time with the ability to work remotely one day a week after orientation.
<br>
<br>
Reasons to Choose MGH
<br>
1. The State&rsquo;s First Magnet Hospital
<br>
2. Opportunities for growth and development
<br>
3. Medical, Dental and Vision insurance
<br>
4. Tuition Reimbursement
<br>
5. Generous paid time off
<br>
6. Subsidized MBTA pass (50% discount)
<br>
7. Resources for childcare and emergency backup care
<br>
8. Hospital paid retirement plan and tax-sheltered annuity plan.
<br>
9. Employee &ldquo;Perks&rdquo; - enjoy discounts on tickets and passes for
<br>
everything from ski resorts to museums to sporting events.<br>
<p></p><br>
<p><b>Job Summary
</b></p>Responsible and accountable for the planning, organizing, directing, and evaluating nursing services of the nursing location. Also responsible for the management of all operational services for their location of responsibility. Working within federal, state, and regional regulations, we strive to meet the needs of our patients.
<br>
Does this position require Patient Care? Yes
<br>
Essential Functions Evaluate and supervise staff based on mutually agreed-upon goals in job descriptions.
<br>
Implements strategies to enhance retention and reduce turnover.
<br>
Promotes a safe and positive working environment.
<br>
Ensure that the RN supervisors/clinical care managers are aware of any updated policies and procedures.
<br>
Prepares departmental budget and operates department within budgetary guidelines.
<br>
Assign patients for day-to-day management to nursing coordinators and/or Nursing Supervisors/Managers.<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Qualifications
</b></p></div></div></div></div></div></div></div><div>Education
<br>
Master's Degree Nursing required or Bachelor's Degree Nursing required and Master's Degree Related Field of Study required
<br>
<br>
Can this role accept experience in lieu of a degree?
<br>
No
<br>
<br>
Licenses and Credentials
<br>
Registered Nurse [RN - State License] - Generic - HR Only required Advanced Cardiovascular Life Support [ACLS (AHA)] - American Heart Association (AHA) preferred Basic Life Support [BLS Certification] - Data Conversion - Various Issuers preferred
<br>
<br>
Experience
<br>
Nursing management 3-5 years required
<br>
<br>
Knowledge, Skills and Abilities
<br>
<ul><li>Proficient organizational and interpersonal skills.
</li><li>Must have excellent critical thinking and problem-solving skills.
</li><li>Proficient commitment to clinical excellence.
</li><li>Ability to remain calm in stressful situations.
</li><li>Adjusting actions in relation to others' actions.
</li><li>Knowledge of Regulatory Agency Regulations.<br>
</li></ul></div><p></p><br>
<div><div><div><div><div><div><div><p><b>Additional Job Details (if applicable)<br>
</b></p></div></div></div></div></div></div></div><p></p><br>
<div><div><div><div><div><div><div><p><b>Remote Type
</b></p></div></div></div></div></div></div></div>Onsite<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Work Location
</b></p></div></div></div></div></div></div></div>165 Cambridge Street<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Scheduled Weekly Hours
</b></p></div></div></div></div></div></div></div>40<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Employee Type
</b></p></div></div></div></div></div></div></div>Regular<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Work Shift
</b></p></div></div></div></div></div></div></div>Day (United States of America)<br>
<p></p><br>
<br>
<p><b>Pay Range
</b></p>$144,206.40 - $209,757.60/Annual<br>
<p></p><br>
<p><b>Grade
</b></p>9<br>
<p></p><br>
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>EEO Statement:
</b></p></div></div></div></div></div></div></div>The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran&rsquo;s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.<br>
<p></p><br>
<h2 class="jobSectionHeader"><b>Mass General Brigham Competency Framework
</b></h2><div><div><p>At Mass General Brigham, our competency framework defines what effective leadership &ldquo;looks like&rdquo; by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.</p></div></div></div>

Nurse Director Transplant - MGH

Crescentia

<p><b>*** No visa sponsorships supported</b></p><p><b>** Signing Bonus : Negotiable </b></p><p><b>.</b></p><p><b>POSITION SUMMARY:</b></p><p><b>Clinical Investigator, Gastrointestinal Oncology</b></p><p>Boston University/Boston Medical Center</p><p>The Section of Hematology and Medical Oncology at Boston University Chobanian &amp; Avedisian School of Medicine and Boston Medical Center is seeking a medical oncologist to join its program in Gastrointestinal Oncology. This rapidly expanding multi-disciplinary program is focused on providing exceptional clinical care and performing high-impact research in gastrointestinal malignancies. The ideal candidate will have strong clinical expertise as well as an interest in clinical/translational research. Opportunities within the program include participation and leadership in clinical trials and collaborations with both internal and external laboratory-based investigators pursuing a range of basic and translational research projects. The successful candidate will also engage in teaching students, residents, and fellows in ambulatory and inpatient settings.</p><p>Qualified candidates will have an MD, MD/PhD, or DO and be BE/BC in Medical Oncology. Candidates must be licensed or eligible for a medical license in the state of Massachusetts. Academic rank will be based on qualifications and experience.</p><p><b>Must Haves </b></p><ul><li>MD, MD/PhD, or DO</li><li>BE/BC in Medical Oncology</li><li>Candidates must be licensed or eligible for a medical license in the state of Massachusetts</li></ul><p>Job Type: Full-time</p><p>Pay: $291,000.00 - $320,000.00 per year</p><p>Application Question(s):</p><ul><li>PLEASE SHARE YOUR E-MAIL ADDRESS AND CURRENT ZIP CODE</li><li>DO YOU HAVE MD, MD/PHD, OR DO ?  PLEASE COMMENT</li><li>ARE YOU  HAVE BE/BC IN MEDICAL ONCOLOGY? PLEASE COMMENT</li><li>ARE YOU  LICENSED OR  ARE YOU ELIGIBLE FOR A MEDICAL LICENSE IN THE STATE OF MASSACHUSETTS?  PLEASE COMMENT</li><li>ADDITIONAL INFORMATION YOU WOULD LIKE THE EMPLOYER TO KNOW ?</li></ul><p>Work Location: In person</p>

Clinical Investigator, Gastrointestinal Oncology - Boston__-MA

Guidelight Health

<div><div><p>Guidelight Health is a cutting-edge behavioral healthcare company dedicated to transforming lives through high-quality PHP (Partial Hospitalization Program) and IOP (Intensive Outpatient Program) services. As a newly launched organization, we are on a mission to redefine the behavioral health industry by delivering exceptional care, utilizing state-of-the-art facilities, and prioritizing the well-being of those we serve. At Guidelight Health, we are building a team of passionate, forward-thinking professionals who are eager to be part of this exciting journey to reshape mental health care. Join us in making a lasting impact!</p></div><p><b>
Description:</b></p>
<p><b>
Title:</b> Financial Planning &amp; Analysis Analyst</p>
<p><b>
Reports to:</b> Senior Vice President, Finance</p>
<p><b>
Department/Location:</b> Finance &amp; Accounting - Remote</p>
<p><b>
FLSA Status: Exempt</b></p>
<p><b>
Role Summary:</b></p>
<p>
We are seeking a highly motivated Financial Planning &amp; Analysis (FP&amp;A) Analyst with 3-5 years of progressive experience in healthcare finance, ideally in outpatient clinic or multi-site healthcare operations. The FP&amp;A Analyst will play a critical role in driving data-informed decision-making by supporting forecasting, budgeting, variance analysis, and operational performance reporting. This position partners closely with clinic leadership, operations, and corporate finance to ensure financial sustainability and growth in a patient-centered care environment.</p>
<p><b>
Role Responsibilities:</b></p>
<ul>
<li>Budgeting &amp; Forecasting
<ul><li>Assist in the preparation of annual operating budgets and quarterly forecasts for outpatient clinic operations.</li>
<li>Develop financial models to support scenario planning, new clinic openings, and service line expansions.</li>
</ul></li><li>Financial Reporting &amp; Analysis
<ul><li>Prepare and analyze monthly financial statements, including variance analysis against budget and prior periods.</li>
<li>Track key performance indicators (KPIs) related to clinic operations such as patient volumes, revenue per visit, staffing ratios, and operating margins.</li>
<li>Present actionable insights to clinic and executive leadership.</li>
</ul></li><li>Operational Support
<ul><li>Partner with operations leaders to monitor productivity, staffing efficiency, and resource utilization.</li>
<li>Support revenue cycle analysis, payer-mix reviews, and reimbursement trend monitoring.</li>
</ul></li><li>Strategic Projects
<ul><li>Contribute to business cases for new clinics, capital investments, and payer contract negotiations.</li>
<li>Conduct ad-hoc analyses for leadership to evaluate opportunities, risks, and cost-saving initiatives.</li>
</ul>
</li></ul><p><b>Required </b><b>Qualifications</b><b>:</b></p>
<ul>
<li>Education &amp; Experience
<ul><li>Bachelor's degree in finance, Accounting, Economics, or a related field (Master's or MBA preferred).</li>
<li>3&ndash;5 years of experience in FP&amp;A, corporate finance, or healthcare financial operations, with preference for outpatient or multi-site healthcare organizations</li>
<li>Strong understanding of healthcare reimbursement, payer mix, and clinic operational drivers.</li>
</ul></li><li>Skills &amp; Competencies
<ul><li>Advanced proficiency in Excel, financial modeling, and data visualization (experience with Power BI, Tableau, or similar tools preferred).</li>
<li>Strong analytical and problem-solving skills with the ability to translate data into actionable insights.</li>
<li>Excellent communication and presentation skills to interact effectively with both financial and non-financial stakeholders.</li>
<li>Detail-oriented with strong organizational and time-management skills.</li></ul></li></ul></div>

FP&A Analyst

Xenon Pharmaceuticals Inc.

<b>Who We Are:</b><br>
<b>Xenon Pharmaceuticals (NASDAQ:</b> XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.
<br><br>
<b>What We Do:</b><br>
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In August 2025, we announced the completement of patient recruitment in our Phase 3 X-TOLE2 study and topline data are anticipated in early 2026. We also have multiple Phase 3 azetukalner clinical trials in major depressive disorder (MDD) and bipolar depression (BPD) underway, based on topline data from our Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates, and have recently initiated Phase 1 studies for our follow-on Kv7 channel opener, XEN1120, and our lead Nav1.7 development candidate, XEN1701, in pain. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.
<br><br>
<b>About the Role:</b><br>
We are seeking an Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist) to join our Pharmacovigilance and Safety team. The incumbent is responsible for safety surveillance and development of aggregate safety reports in compliance with global drug safety regulations and departmental procedures. As such, the role is part of a team that performs high quality and timely scientific analysis of safety data, applies critical thinking skills and synthesizes data findings into clear, concise, and evidence-based statements. In this role the individual will be collaborating with safety physicians and risk management team to perform safety surveillance activities through proactive signal detection, ongoing benefit-risk analyses, and safety monitoring/reporting activities for all Xenon’s clinical assets and future marketed products. The individual will author safety documents, reviews safety sections of other documents, for Xenon products throughout the product lifecycle from First-in-Human (FIH) to post-marketing, performs QC, and, when necessary, assists in responding to information requests from Health Authorities for Xenon products. This individual will participate in cross-functional Safety Risk Management Team (SRMT) meetings and collaborate with colleagues in Clinical Development, Trial Operations, Clinical Pharmacology, Biostatistics & Programming, Regulatory, Medical Affairs, non-clinical safety lead, QA and Legal departments.
<br>This position reports to the Senior Director, Pharmacovigilance and Drug Safety and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. For Boston based candidates, this role is a hybrid position, requiring a minimum of 2 days per week in the office. The level of the position will be commensurate with the candidate’s education and industry experience.
<br><br>
<b>RESPONSIBILITIES:</b><br>
<ul>
<li>Lead the proactive signal detection activities, support the ongoing benefit-risk analyses, and safety monitoring/reporting activities for Xenon products across all stages of development.</li>
<li>Lead and manage Aggregate Safety Reports (e.g., IND/NDA Annual Reports, PADER, DSUR, PSUR, PBRER, ad-hoc regulatory responses, etc.) for Xenon products throughout product lifecycle from FIH to post-marketing in compliance with global safety regulations and guidelines and provide training within DSPV and cross-functionally.</li>
<li>Author Aggregate Safety Reports while working in collaboration with the cross functional teams (i.e. Non-clinical, Clinical Development, Trial Operations, Regulatory, Biostatistics, and Clinical Data Management) to compile safety information.</li>
<li>Support and review safety-related documents for Xenon products throughout product lifecycle from FIH to post-marketing such as Safety Assessment Reports, product labeling, risk management/risk mitigation-related documents, and responses to ad-hoc information requests by Health Authorities and internal stakeholders.</li>
<li>Review safety concerns escalated from internal and external stakeholders, including competent regulatory authorities, and support safety team to develop safety related responses.</li>
<li>Maintain continuous monitoring/updating of safety profiles for assigned investigational and marketed products. Collaborates with physicians and risk management team in ongoing risk/benefit assessment.</li>
<li>Performs careful review of all serious events of interests and expedited individual case safety reports ensuring that the knowledge gained from these individual reports contribute to a higher degree of interpretation, consistency, and quality of the analysis at the aggregate level. Reviews and provides input to Analysis of Similar Events (AoSE), as needed.</li>
<li>Review and communicate trending, signaling, and other safety-related issues originating from any source for the purposes of detecting and reviewing safety signals (e.g., change in frequency, nature, or severity of a safety-related issue) in a timely manner.</li>
<li>Participates and contributes to cross-functional SRMT meetings for signal management, risk management detection, and benefit-risk assessment for Xenon products.</li>
<li>Review potential issues and safety signals and contribute to the SRMT and Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic / aggregate safety data review.</li>
<li>Author the safety signal assessment reports in collaboration with Safety Physicians.</li>
<li>Support the risk management team in the development of risk management strategies and activities.</li>
<li>Review SMP and provide input to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), SAPs, DSMB charters, and other relevant documents.</li>
<li>Write and maintain relevant SOPs and procedures in compliance with global regulations and guidelines.</li>
<li>Support inspections by participating in audit preparedness activities and providing requested information.</li>
<li>Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.</li>
<li>Other duties as assigned.</li>
</ul>
<b>QUALIFICATIONS:</b><br>
<ul>
<li>Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 8+ years (AD)/ 9+ years (Dir) of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments.</li>
<li>Associate Director will have a minimum of bachelor’s degree with a minimum of 8+ years management experience in a pharma or biotech environment.</li>
<li>Director will have a minimum of bachelor’s degree with a minimum of 10+ years management experience in a pharma or biotech environment Master’s degree preferred.</li>
<li>Ability to lead cross-functional team through all activities in the full clinical study life cycle.</li>
<li>A good understanding of all phases of the drug development process between DSPV, Clinical, Regulatory Affairs, and other functional areas. Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities.</li>
<li>Experience authoring safety signal assessment report, DSUR, PADER, PBRER, and contributing to safety and risk management sections of other regulatory safety reports (RMP, RSIs).</li>
<li>Skilled in signal detection process and managing safety information from clinical development and post-marketing sources.</li>
<li>Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management.</li>
<li>Knowledge of drug development process, pharmacovigilance databases and MedDRA coding.</li>
<li>Understanding of clinical disease state and implications of treatment.</li>
<li>At ease with data handling and visualization, statistics, and technical writing skills.</li>
<li>Experience with use of safety databases, preferably Argus Safety Database and signal detection tools.</li>
<li>Strategic critical thinking skills with focus on data integrity and high-quality outputs.</li>
<li>Excellent verbal and written communication skills with ability to communicate effectively by writing clearly and concisely, and strong presentation skills.</li>
<li>Time management skills with ability to prioritize to meet required deadlines.</li>
<li>Ability to multitask and prioritize under tight deadlines while providing attention to detail and high-quality work in a dynamic environment.</li>
<li>Ability to be flexible, adapt to change, work independently, as well as experience working in a highly collaborative matrix environment.</li>
<li>Ability to work both independently and as part of a multidisciplinary team that is results-oriented.</li>
<li>Strong interpersonal skills and ability to foster strong collaborative relationships with internal and external team members.</li>
</ul>
The base salary range for this role is $168,000 - $242,275 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
<br><br>
Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
<br>Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
<br>As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.
<br><b>US positions only:</b> Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.
<br>To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

Associate Director/Director, Pharmacovigilance and Drug Safety (Safety Scientist)

Monte Rosa Therapeutics

<div>Overview:
<div>
We are seeking an energetic and highly motivated individual to join our Clinical Operations team. This position reports to the Head of Clinical Operations and is an opportunity to significantly contribute to the growth and development of a top-tier Biotech company. The CTA position is focused on providing support associated with the planning, start-up, maintenance, and closeout of clinical trials. The ideal candidate will be proactive and detail oriented with a desire to be involved in all aspects of clinical trial execution.
</div>Responsibilities:
<ul><li>Assist with audit of central files
</li><li>Assist with the preparation of required study documentation and performs literature searches.
</li><li>Assist with dissemination of information to the project team members (including meeting minutes and action items)
</li><li>Distributes regular clinical project updates.
</li><li>Tracks clinical study center supplies and coordinate re-supply with Clinical Operations personnel and external vendors</li><li>
Assist the Director, Clinical Operations with tracking of financial documents.
</li><li>Assist with creation of presentations of clinical research study information.</li><li>
Assist with the preparation of training materials for investigational sites, in[1]house personnel, and new hires.
</li><li>Performs set up of new project files and maintains current project central files.
</li><li>Perform periodic reviews of the clinical study files for accuracy and completeness and resolves any deficiencies with general supervision.
</li><li>Responsible for tracking studies, patient information, timelines, payment schedules as well as central files and regulatory documents with general supervision.
</li><li>Provides assistance in the design, layout and creation of slide presentations.</li></ul>
Qualifications:
<ul><li>BS (with 2+ years), or MS (with 1+ year) experience in a clinical department (in a pharmaceutical, biotech or CRO environment) performing project coordination activities and maintenance of Central Files
</li><li>Basic understanding of regulatory issues related to Phase I-IV clinical research.
</li><li>Demonstrates excellent communication, interpersonal and organizational skills. Knowledge of project management tools and practices.
</li><li>Comprehensive knowledge of Microsoft Word, Excel, and PowerPoint
</li><li>Basic knowledge and understanding of GCP and ICH guidelines.
</li><li>Experience working with eTMFs strongly preferred</li></ul></div>

Clinical Trials Associate

Katalyst Healthcares & Life Sciences Inc

<p><b>Responsibilities:</b></p><ul><li>Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. Attends congress and reviews literature to develop and augment expertise in therapeutic area</li></ul><ul><li>Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and help identify and evaluate business development opportunities.</li></ul><ul><li>Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).</li></ul><ul><li>Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to program. Engage opinion leader interactions to build pipeline awareness and foster research collaborations.</li></ul><ul><li>Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.</li></ul><ul><li>Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.</li></ul><ul><li>Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.</li></ul><ul><li>Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and may participate in meetings.</li></ul><p><b>Requirements:</b></p><ul><li>Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, PharmD) preferred. Ability to provide input and direction to clinical research with appropriate supervision</li></ul><ul><li>Strong desire to collaborate in a cross-functional setting.</li></ul><ul><li>Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.</li></ul><ul><li>Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols</li></ul><p>Job Type: Contract</p><p>Pay: $35.00 - $43.00 per hour</p><p>Work Location: In person</p>

Clinical Scientist II

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