The Account Executive, Wellness will be responsible for growing Catalent's Consumer Healthcare business in their assigned region within the United States and Canada. Primary focus will be to develop and execute an account plan for strategic management of existing account base, as assigned, and continued growth in the nutritional dietary supplement industry, providing our customers with solutions and ultimately growing Catalent's portfolio of business. The Account Executive, Wellness role is ideally filled by a high energy, team player who is not afraid to roll up his or her sleeves, who thrives in a fast moving, lean, and entrepreneurial environment.
This is a field-based, remote role with travel required for business development related activities.
**The Role:**
+ **Account Management:**
+ Customer Relationships: Manage business relationships with assigned customers, including pricing, contract extensions/amendments, forecasting, periodic business review meetings, and addressing customer service-related issues.
+ Account Planning: Set account objectives and establish plans to achieve results. Ensure alignment with Catalent's Standards of Business Conduct.
+ Engage daily in activities that drive meeting or exceeding financial targets.
+ **Internal Coordination:**
+ Cross-Functional Collaboration: Work with internal teams across Catalent (Customer Service, Commercial Operations, Marketing, Legal, Finance, Project Management) to maintain effective communication with key internal stakeholders to ensure all account management activities are conducted in a coordinated, team-based fashion. Collaborate with other selling teams within Catalent to actively engage in cross-selling opportunities.
+ Internal Meetings: Plan and participate in regular internal business review meetings to present strategic plans and progress within the assigned territory.
+ **Opportunity Management:**
+ Sales Funnel Development: Develop and build the funnel to drive new business through prospecting, outreach, relationship building, and qualifying leads, captured in Salesforce with specific actions leading to successful closures.
+ Sales Process Management: Manage opportunities from start to finish, including tracking in Salesforce, defining scope, creating pricing strategies, handling customer credit, confirming confidentiality agreements, negotiating, and closing deals. Ensure thorough and timely handoff to internal project managers and product development teams.
+ **Customer Interaction:**
+ Consultative Approach: Employ a consultative approach with regular meetings for capabilities reviews, site visits, business updates, and innovation discussions. Prepare well for calls/visits with a clear agenda and meeting outcome goals. Must be natural and curious in front of customers to understand client needs and develop tailored, innovative solutions.
+ Communication and Presentations: Develop and deliver customer-facing presentations, leveraging existing resources to create a unique value proposition. Use formal and informal communication methods to assure a detail-oriented approach to follow up with rapid response and follow through to customer inquiries, opportunities, and issues.
+ **Market and Competitive Analysis:**
+ Market Intelligence: Gather and analyze competitive intelligence through trade shows, articles, newsletters, and customer feedback. Stay informed about market trends and new launches in collaboration with Catalent's Marketing Team.
+ Competitive Positioning: Use gathered intelligence to inform and enhance Catalent's competitive positioning in the industry.
+ **Administrative Responsibilities:**
+ Compliance and Reporting: Adhere to corporate responsibilities by staying current with internal training, tracking opportunities, submitting expense reports, managing time off, and complying with travel and gift policies. Ensure confidentiality and ethics standards are met.
+ Goal Setting and Career Development: Engage in annual goal setting, track progress, and drive career development activities with your director. Pursue continuous learning through feedback, mentorship, and professional development opportunities.
+ **Travel:**
+ Travel Requirements: Travel 25-50% to Catalent sites, customer sites, tradeshows, and industry events. A passport is required.
+ **Additional Duties:**
+ Other tasks and duties as assigned.
**The Candidate:**
+ A BS/BA degree is required.
+ Minimum 3 years in a business development role, with relevant experience in the outsourcing market (CMO, CRO, CSO) preferably in the nutritional dietary supplement space.
+ Excellent oral and written communication and presentation skills required.
+ Proven ability to organize and plan work, manage travel, and balance multiple priorities effectively required.
+ Ability to work effectively as a member of cross-functional teams required.
+ Strong computer skills required, including Microsoft Word, Excel, and PowerPoint.
+ Experience using Salesforce or similar customer relationship management tools preferred.
+ Must be willing and able to travel up to 50% to visit clients, attend tradeshows, participate in training, as well as meet with clients in Catalent's manufacturing facilities.
+ This position required to work from home is not eligible for relocation assistance.
**Pay:**
The annual pay range for this position in New Jersey is $91,500-$132,000
The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
**Why You Should Join Catalent:**
+ Join a high growth and fast paced organization with a people focused culture
+ Global exposure, defined career path and annual performance review and feedback process
+ Competitive Medical, Dental, Vision, Life Insurance, and 401K
+ 19 days PTO & 8 paid holidays
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (*********************************** to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
$91.5k-132k yearly 31d ago
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Project Leadership - Biotech (clinical trials) - Oncology - Home Based - (Future Needs)
Parexel 4.5
Columbus, OH jobs
The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve.
Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients.
**Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading global studies in a variety of therapeutics including Oncology (Hematology), Respiratory / General Medicine and Obesity/Endocrine**
Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations
Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director, and Project Director.
To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills.
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
**Parexel is hiring an FSP** **Consultant, Advanced Analytics: Meta-Analysis (HTA Statistician)** **to work remotely. Must be able to accommodated East Coast/CET hours. The ideal candidate will have key experience in** **NMA/Evidence Synthesis, Survival analysis, and HTA experience.**
**Location: US -** Remote |
**Employment Type:** Full-Time
**Job Purpose**
The Statistician, **Consultant, Advanced Analytics: Meta-Analysis,** contributes statistical capabilities and methodological leadership at all stages of projects, from planning to completion. The role involves working with junior team members to design, develop, and deliver client solutions across multiple projects-leveraging competencies in **statistical theory, data analysis and interpretation, regression analysis, systematic review, and evidence synthesis methodologies** .
The individual must have a **Master's or Doctoral Degree** in **Health Economics, Health Policy, Statistics, Biostatistics, Mathematics** , or other quantitative fields. Proficiency in **data analytics and statistical software/tools** such as **WinBUGS, R, Stata, Python, and SAS** is required.
**Key Accountabilities**
+ Provide expert input on the design of clinical development programs to ensure Access/HTA evidence needs are considered within global development and commercialization strategies.
+ Identify evidence gaps, possible data sources, and design and implement robust evidence-generation plans.
+ Ensure Access/HTA evidentiary activities are strategically aligned with other functions within Global Access and the wider organization (affiliates, Product Development, commercial, etc.).
+ Plan and conduct statistical analyses of clinical trials and other relevant data sources and develop supporting technical documentation for statistical analyses and economic models.
+ Interpret and communicate the findings of analyses and work closely with affiliates to incorporate global statistical and health economics input into their local reimbursement applications.
+ Lead or contribute to cross-functional teams within a matrix structure and actively contribute to the development of methodologies and continuous improvement within the Evidence Chapter.
+ Keep up to date with the changing Access/HTA landscape and academic research to ensure current access trends and methodologies are incorporated into evidentiary plans and build relationships with relevant external statistics, health economics, Access/HTA, and policy experts.
**Additional Responsibilities**
The Consultant is responsible for ensuring that all assigned projects are conducted efficiently and that **quality and client satisfaction** are maximized-ensuring project direction and deliverables meet objectives and client needs.
Consultants are expected to guide **Senior Associates and Associates** in their daily duties and flag any areas of acute training needs to their line managers. Supported by senior staff and Business Development partners, the Consultant is responsible for maintaining client relationships on their projects.
Candidates will be part of **multi-disciplinary research teams** and will provide statistical expertise and methodological leadership at all stages of projects from planning to completion. Duties may include:
+ Preparing network meta-analysis protocols
+ Reviewing data extracted from systematic literature reviews
+ Conducting feasibility assessments
+ Generating network diagrams
+ Critically assessing study heterogeneity
+ Conducting network meta-analysis
+ Assisting with interpretation and dissemination of findings
The candidate is also expected to support **thought leadership and innovation objectives** in advanced analytics, including but not limited to:
+ Pairwise meta-analysis
+ Mixed treatment comparison
+ Indirect treatment comparison
+ Network meta-analysis
+ Match-adjusted indirect treatment analysis
+ Meta-regression
+ Single-arm trial analysis
+ Simulated treatment comparison
+ Surrogate outcome assessment
**Skills & Qualifications**
+ **Master's or Doctoral-level degree** in applied statistics, health economics, or related quantitative fields.
+ Minimum of **3 years of hands-on experience** in the pharmaceutical industry, consultancy, Access/HTA/reimbursement agency, or academic institution (pharma affiliate experience is a plus).
+ In-depth knowledge of **Access and HTA** , clinical research and development methods, and international payer evidence requirements.
+ Skilled in research design and statistical methods, such as **Generalized Linear Models, Survival Analysis, Network Meta-Analysis, and Bayesian statistics** .
+ Proficient in **R** and **GitLab** (experience with SAS, Python, WinBUGS, JAGS, or other relevant statistical software is a plus).
+ Strong strategic, collaboration, and communication skills; excellent organization, planning, and prioritization abilities; ability to meet tight deadlines; and strong written and verbal communication skills in English.
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$61k-89k yearly est. 54d ago
Principal Real World Research Delivery Lead (RWRDL)
Parexel International 4.5
Remote
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Title: Principal Real World Research Delivery Lead (RWRDL)
Location: US - Remote
Are you ready to take on a challenge and accelerate your career? This is an excellent opportunity for a self-driven, autonomous leader eager for growth and progression. Parexel is seeking a Principal Real World Research Delivery Lead (RWRDL) to join our team and deliver innovative Real World Research (RWR) solutions for global clients.
This is a great opportunity to join our team as a senior leader driving Real World Research (RWR) solutions for global clients. In this role, you'll lead cross-functional teams, manage budgets and timelines, and serve as the primary client contact for innovative RWD projects.
We're looking for a strategic project leader with strong communication skills, adaptability, and a go-getter mindset. Experience in RWD/RWE, data privacy, and drug development is a plus.
Career Growth: Shape new services, mentor emerging leaders, and gain visibility in a lean PM model.
As a senior leader, you will:
Lead cross-functional teams and act as the primary client contact for complex RWR and RWD projects.
Oversee project proposals, budgets, timelines, and milestones while ensuring compliance with SOPs and data privacy standards.
Collaborate with multidisciplinary teams to design and implement RWR-enabled solutions.
Mentor junior team members and help shape new services in a lean PM model.
What We're Looking For:
Strong project leadership experience with proven ability to manage multiple projects and decentralized teams.
Excellent communication skills, adaptability, and a proactive, go-getter mindset.
Knowledge of RWD/RWE methodologies, data privacy, and drug development processes.
Ability to thrive in dynamic environments and lead independently.
Preferred Experience:
RWD/RWE expertise, commercial experience, and familiarity with late-phase clinical research.
Understanding of RWD platforms, project management systems, and GCP environments.
Education:
Bachelor's degree in a science or clinical-related field; Prince II or AMPM certification preferred.
Why Join Us?
Career progression and visibility in a growing RWD space.
Opportunity to develop new services and mentor emerging leaders.
Work on impactful projects that shape the future of clinical research.
If you're ambitious, adaptable, and ready to make a difference, apply today and lead the way in Real World Research!
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
$113k-163k yearly est. Auto-Apply 29d ago
Medical Director - Ophthalmology
Parexel International 4.5
Remote
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability.
Parexel is looking for a Medical Director with a very strong background in Ophthalmology to join our Global Medical Sciences team.
The role is remotely based in the US.
The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians.
Primary activities will focus on Medical Monitoring Delivery & PV Support. The medical monitor will independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician).
Medical Expertise and experience in Ophthalmology is essential to the medical monitor role and will be manifested in high quality consultation on protocol development or drug development programs, medical review of various documents, collaboration on internal therapeutic area meetings, training module development, white papers, slide sets, publications etc.
Client Relationship Building & Engagement, including soliciting and addressing client feedback and suggestions regarding medical study-related activities, are core skills required of the medical monitor.
Business Development: the medical monitor will provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings.
Skills
Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
Client-focused approach to work
Excellent time management skills
Excellent verbal and written medical communication skills
Excellent standard of written and spoken English
A flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Willingness to work in a matrix environment and to value the importance of teamwork.
Knowledge And Experience
Experience in clinical medicine (general or specialist qualifications) with Fellowship or specialty training in Ophthalmology, which is expected to be kept up to date.
A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred
Clinical practice experience
Good knowledge of the drug development process including drug safety, preferred
Experience in Pharmaceutical Medicine, preferred
Experience leading, mentoring and managing individuals/ a team, preferred
Education
US Board certified in Ophthalmology
Experience as a Physician in Industry or as a clinical trial investigator is required
Previous CRO experience is strongly preferred
Medically qualified in an acknowledged medical school with completion of at least basic training in clinical medicine (residency, internship)
The ability to travel 15% domestically or internationally is required.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
$188k-271k yearly est. Auto-Apply 4d ago
Corporate Counsel - Labor & Employment (REMOTE)
Charles River Laboratories 4.3
Wilmington, MA jobs
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
**Job Summary**
We are seeking an experienced individual for our Corporate Counsel - Labor & Employment position within our Legal Department.
Working with other members of the legal labor and employment team, provide analysis and counsel to management and HR on global labor and employment issues including recruitment and hiring, discipline, reorganizations, training, company policies, employee handbooks, compensation and benefits issues, etc. Draft, negotiate and review documents relating to executive employment, as well as general HR-related contracts including separation agreements. Develop and recommend company policy and position on worldwide labor and employment issues to ensure company compliance with local, state and federal regulations related to employment (Affirmative Action, ADA, FLSA, FMLA, EEOC, MCAD, NLRB, USERRA etc.) and related regulations in other jurisdictions where employees are situated. Handle employment -related litigation, mediations, hearings (EEOC, etc.), and arbitrations. Anticipate and guard against labor and employment legal risks facing the company. Provide general legal support, when appropriate.
**Position is remote and will require occasional domestic and international travel.
Essential Duties and Responsibilities
+ Provide analysis and counsel on labor and employment issues globally. Key areas include recruitment and hiring, discipline, reorganizations, training, company policies, employee handbooks, compensation and benefits issues.
+ Assist with legal compliance initiatives (policies, trainings, processes, etc.) related to employment and labor areas for the global workforce, as well as in other areas requested from time-to-time, and otherwise provide support generally to members of the legal compliance function.
+ Draft, negotiate and review documents related to senior executive employment and compensation, including benefits plan documents (including ERISA, COBRA and 409A issues), change-in-control agreements, and employment offer letters.
+ Draft, negotiate and review both routine and complex HR-related contracts including separation agreements.
+ Prepare and conduct training for HR and business partners on labor and employment issues and best practices.
+ Provide counsel on employment disputes, including EEOC, NLRB, MCAD and other discrimination complaints.
+ Recommend, advise and enforce company policy and position on worldwide labor and employment issues to ensure company compliance with local, state and federal regulations related to employment (Affirmative Action, ADA, FLSA, FMLA, EEOC, MCAD, USERRA etc.) and related regulations in other jurisdictions where employees are situated.
+ Manage outside counsel on employment litigation matters.
+ Review employment, labor and benefit issues as part of our acquisitions and divestiture teams, and provide related advice, counsel and risk assessments during the evaluation process.
+ As requested, serve as Legal Department representative on acquisition integration processes.
+ As requested, serve as Legal Department representative on Policy Management Committee.
+ Provide legal counsel on issues arising from actual or anticipated employment-related lawsuits.
+ Assist in the development and recommendation of company policy and position on employment-related legal issues.
+ Monitor and analyze changes to employment-related laws and regulations to ensure continued company compliance. Proactively advise management on changes which may affect the business and recommend actionable guidance.
+ Establish a strong partnership with HR and business teams, providing practical and sound labor and employment advice.
+ Provide backup legal support for general corporate legal issues as required.
+ Perform all other related duties as assigned. (Note: Position may be requested in the future to also serve as principal counsel to one or more businesses or functions, including coordinating the delivery of legal services to the businesses/functions and collaborating and establishing strong relationships with their respective leadership teams.)
**Job Qualifications**
+ Education: Bachelor's degree (B.A./B.S.) and Juris Doctor or equivalent from an accredited law school.
+ Experience: Five or more years of related experience, preferably in a combination of a law firm and corporate setting.
+ An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
+ Certification/Licensure: Current license in any US State Bar as an attorney qualified to practice law.
+ Other: Knowledge of labor/employment-related statutes and regulations. Strong interpersonal and communication skills.
Compensation Data
The pay range for this position is $180K - $210K USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
**About Corporate Functions**
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
**About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
**Equal Employment Opportunity**
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit ***************
231226
$180k-210k yearly Easy Apply 54d ago
Clinical Study Physician - Oncology - FSP
Parexel 4.5
Madison, WI jobs
**Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed** External Job Description The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team.
**Trial Start-Up**
+ Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates.
+ Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct.
+ Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP.
+ Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs.
+ Contribution to the timely preparation of medically relevant core trial documents and timely milestones.
+ Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, "Information for CRF completion" (ICC), Data Review Plan (e.g.,propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts.
+ Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan.
+ Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
+ Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs.
+ Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans.
+ Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff.
**Trial Conduct**
+ Ongoing medical review with transparent documentation of the activity, related findings and resolutions.
+ Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues.
+ Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems.
+ Proactively address/ communicate clinical quality issues in a collaborative environment.
+ Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols
+ Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list.
+ Building network with experts and active contribution to site engagement.
+ Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM.
+ Medical review of and contribution to the content of Trial Newsletters
+ Contribution to the scientific publication of trial data, if applicable
**Leadership**
+ Management of medical activities related to one or more clinical trials
+ Cross functional planning, execution, and analysis of a clinical program
+ Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes
**Compliance with Parexel standards**
+ Comply with required training curriculum
+ Complete timesheets accurately and timely as required
+ Submit expense reports as required
+ Update CV as required
+ Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements
**Skills:**
+ Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
+ Proficiency in written and spoken English and (local language)
+ Excellent interpersonal, active listening and influencing skills
+ Pronounced analytical skills and systematic and well-structured working style.
+ Pronounced presentation and training skills
+ Capability to work proactively and with team spirit in an international environment
+ Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment
**Knowledge and Experience** **:**
+ Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities
+ Understanding of relevant regulations and guidance including ICH-GCP.
+ Experienced with data visualization systems and IT systems.
**Education:**
+ Physician MD, ideally with medical thesis, trained in a clinical setting
+ Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred.
\#LI-LG4
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$120k-164k yearly est. 3d ago
Client Development Representative - RMS (REMOTE)
Charles River Laboratories 4.3
Wilmington, MA jobs
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
**Job Summary**
The Client Development Representative works in collaboration with the Research Models & Services (RMS) sales partners, customer service, and technical services teams. The role is responsible for gathering market intelligence, prospecting new leads and companies within the assigned Sales Team for RMS. Initially, the position will focus on internal collaboration with the opportunity to transition to more client-facing activities.
This is a remote-based position. Territory is the Mid-Atlantic. Must be able to work East Coast hours.
Key Responsibilities
* Maintain a cooperative relationship with the assigned sales team to optimize conversion from qualified opportunities and contacts.
* Work closely with cross-functional stakeholders including marketing, product management, project management, and operations within the assigned Sales Team.
* Perform extensive datamining using internal and external tools to identify new prospects, emerging biotechs, funding trends, and research focus areas.
* Gather data on market trends, competitive products, and analyze competitor activity.
* Gain knowledge of customer study needs and applications of Charles River products and services while continuously gathering account intelligence and identifying new sales opportunities through data-driven insights.
* Plan, develop, implement, and optimize sales opportunity campaigns.
* Collaborate with the extended selling team to position Charles River products and services for market growth or share takeaway.
* Maintain CRM database (Salesforce) with updates to sales campaigns, leads, and customer intelligence data.
* Assist with special projects and perform other duties as assigned.
* Position does not require customer-facing travel, but participation in sales meetings may be required.
**Job Qualifications**
* Bachelor's degree in a science or technical field required. Animal Science, Veterinary Tech, Biology, Genetics, Molecular Biology, strongly preferred.
* 1-3 years of successful sales experience with a technical life science or research related field preferred. AALAS Certifications a plus.
* An equivalent combination of education and experience may be accepted as a satisfactory substitute.
* Demonstrated ability to quickly grasp and master highly technical concepts and articulate them well to others.
* Outstanding listening, verbal, presentation, and written communication skills.
* Strong interpersonal skills with the ability to communicate effectively with a wide range of customer personality types. Ability to work well with highly educated research scientist customers.
* Strong ability to identify customer needs and solutions using Charles River products and services.
* Proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint)
* Experience working with Salesforce or a similar CRM database a plus.
* Strong business sense, instinct, and personal drive.
* Team goal oriented with a focus on achieving team sales performance metrics through personal contribution and teamwork
**Compensation Data**
The pay range for this position is $21.59/hr. - $31.99/hr. USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
**About Corporate Functions**
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
**About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
**Equal Employment Opportunity**
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit ***************
231736
$21.6-32 hourly Easy Apply 5d ago
Data Management Lead
Parexel International 4.5
Remote
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Job Title: Data Management Lead (Medical Affairs) - Oncology
Location: Fully Remote (US based) Must be able to accommodate West Coast hours.
About Us: At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you!
Who You Are:
Required:
BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience.
7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology
Strong project management experience
Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required).
Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity.
Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing.
Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques.
Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.
Ownership and accountability relative to key accountabilities in the job description.
Ability to travel as required.
Written and oral fluency in English.
Preferred:
Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI).
Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau).
Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming.
BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions.
What you will be doing:
Responsibilities will include:
Develop risk management strategies and proactively manage timel What ines to ensure successful oversight and delivery of studies and projects.
Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones.
Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models.
Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data.
Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results.
Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis.
Cross-functional Data Management Leadership:
Manage and coordinate the integration and utilization of all ancillary systems.
Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan.
Review and analyze metrics to derive meaningful summaries of study health and trends.
Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators.
Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs.
Project Financial and Resource Management:
Ensure appropriate project-level resourcing of staff and staff assignments.
Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand.
Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope.
Company Initiatives:
Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole.
Support other functions by providing meaningful feedback on initiatives.
Ensure Parexel-requested information entered into management systems is accurate and regularly updated.
Training:
Maintain training compliance as per job roles assigned, including on-the-job training.
Deliver project-specific training to internal Data Management teams.
Address training needs based on identified development goals.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve.
Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients.
**Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading global studies in a variety of therapeutics including Oncology (Hematology), Respiratory / General Medicine and Obesity/Endocrine**
Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations
Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director, and Project Director.
To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills.
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel!
We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership.
As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities.
This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence
cross‑functional teams in a fast‑changing environment.
Key Responsibilities:
Documentation & Compliance
• Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements.
• Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes).
• Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals.
Regulatory Submissions
• Review, prepare, and submit dossiers; negotiate with HAs to secure approvals.
• Provide local input for change control and post-approval requirements.
• Collaborate with global functions to obtain documentation aligned with local requirements.
Audit & Inspection Support
• Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure.
• Provide local expertise and responses to inspection queries.
Cross-Functional Collaboration
• Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes.
• Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies.
Strategic Leadership
• Lead regulatory strategies for product launches and integrations at the affiliate level.
• Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships.
• Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation.
Education
• Bachelor's degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent.
• Advanced degree (Master's or PhD) preferred in law, legal affairs, or natural sciences.
• Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus.
Experience
• 3-5+ years of local regulatory knowledge and experience in a health authority-facing role.
• Demonstrated previous life cycle management experience is required.
• Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes.
• Proven expertise in managing regulatory submissions, timelines, and cross-functional teams.
• Strong project management and leadership skills.
• Experience influencing Commercial Operations stakeholders and driving business-critical decisions.
• Demonstrated ability to adapt and succeed in rapidly changing environments.
#LI-LB1
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
$67k-95k yearly est. Auto-Apply 33d ago
Principal Scientific Advisor (REMOTE)
Charles River Laboratories 4.3
Wilmington, MA jobs
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
**Job Summary**
We are seeking an experienced nonclinical drug development professional to serve as a Principal Scientific Advisor within our Discovery and Safety Assessment business units.
The Scientific Advisory Services team is hiring an experienced professional with expertise in establishing effective scientific and regulatory strategies to advance new medicines through the various stages of the development process. This position provides opportunity for independent scientific guidance and leadership roles within project teams and functional areas across the organization, with an emphasis on providing innovative advice on nonclinical (pharmacology and toxicology) drug development programs across a broad spectrum of drug modalities.
This individual will work closely with current and potential clients and internal Charles River functional groups to design robust and scientifically sound nonclinical drug development programs. The person may act as the scientific leader for cross-functional teams for integrated discovery and safety programs. When appropriate, the individual may perform gap analyses, support due diligence procedures, and perform scientific review of discovery and/or safety assessment data or reports. This role provides for recognition throughout the company as a subject matter expert in one or more therapeutic area(s) or class(es) of therapeutic products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in determining the appropriate discovery and nonclinical safety assessment strategy for complex and novel products, including advanced medicinal products. There will be opportunities to support department leadership regarding strategy and recruitment. More broadly, one will work closely with Business Development, Client Services, Account Management, Marketing, and Operations by ensuring that clients' business and scientific needs are understood and efficiently addressed.
Scientific Advisory Services team members are located throughout the US and Europe and work virtually from their home offices and/or within Charles River discovery/safety assessment sites. This position offers a stimulating and dynamic work environment, flexibility in work schedule, and opportunities for professional development and leadership growth.
This position will mainly support potential clients generally located in the Eastern Time Zone.
Position is remote. Can work from US or Europe.
**Job Qualifications**
The following are minimum requirements related to the Principal Scientific Advisor position.
+ Education: Master's degree or PhD in relevant discipline (toxicology, pharmacology, biology, immunology, etc.).
+ Experience:
+ Minimum 15 years' experience in pharmaceutical/biotech sector, nonclinical contract research or consulting including at least 10 years nonclinical drug development experience.
+ Must have direct experience in regulated toxicology and drug development.
+ Prior experience in program management and/or Pharm/Tox Program Leadership is considered useful.
+ Certification/Licensure: DABT, DACVP or European Registered Toxicologist preferred.
+ Other:
+ Applied understanding of regulatory requirements for the conduct of nonclinical safety assessment studies including Testing Facility SOPs and the Good Laboratory Practices (GLPs).
+ Deep understanding of relevant regulatory guidance documents is essential.
+ Demonstrated leadership skills in support of intra- and interdepartmental initiatives, client/external interactions, and business development.
+ Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, etc. and standard laboratory calculations.
Compensation Data
The pay range for this position is $200K - $225K USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
**About Corporate Functions**
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
**About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
**Equal Employment Opportunity**
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit ***************
231309
$200k-225k yearly Easy Apply 55d ago
Investigator Financial Analyst II
Parexel International 4.5
Remote
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do.
Job Title:
Investigator Financial Analyst II
Job Introduction:
At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to patients. We are seeking an Investigator Financial Analyst II to join our team. As an Investigator Financial Analyst, you'll be joining a fast-paced, driven environment that's helping to make life-changing differences to patients by steering the investigator budget management for crucial projects. Through the collaboration and diversity of the Investigator Payment Division the Investigator Financial Analyst is provided with opportunities to excel and discover where your skills can take you.
Who we are looking for:
Curious individuals interested in understanding investigator budget economic drivers. Who are detailed-oriented while assisting in translating the clinical conduct into a financial impact and proactively advising the project leader and the project financial analyst on how to influence critical budget and cash flow levers to prevent negative impact project financials.
What you'll do:
Lead the monthly investigator payment forecast cycle and support project analysis requirements, including a review of accruals, costs incurred, contracts signed, and patients enrolled.
Collaborate with clients, clinical team members, and other members of the organization to gather information and/or explain the financial impact of the observed clinical conduct.
Manage all required variance analyses for the set of projects, with insight and identify risks in the project forecast and to the budget.
Present updates on financial status of investigator payments for assigned projects and create information in response to client financial reporting needs for assigned projects in the area of project reporting, forecasting, or transactional details for the projects within the portfolio.
Why join us:
Be part of groundbreaking projects that are pushing the boundaries of the industry.
Experience a collaborative and inclusive work environment that highly appreciates your expertise.
Unlock your full potential with professional growth and development opportunities.
Enjoy work life balance and flexible working hours.
Parexel US Benefits:
Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Full list of benefits available here: ***********************************
About Parexel International:
At Parexel we embrace flexibility and understand that in today's fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you're exposed to a world of experiences and open doors.
If this job does not sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
$82k-135k yearly est. Auto-Apply 14d ago
Director, Business Intelligence and Strategy (REMOTE)
Charles River Laboratories 4.3
Wilmington, MA jobs
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
**Job Summary**
Charles River Laboratories is seeking a Director of Business Intelligence to lead the development and execution of our global market, competitor, and customer insights strategy. This leader will serve as a trusted advisor to senior executives and business units by transforming data into actionable intelligence that guides decision-making, shapes strategy, and accelerates growth. The Director will oversee a team of analysts and data professionals, build best-in-class BI capabilities, and ensure that insights directly inform commercial, operational, and investment strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Leadership & Strategy
* Define and lead the global business intelligence function and strategy, ensuring alignment with Charles River's strategic priorities.
* Partner with executive leadership, business units, strategic marketing, global technology, and other functional teams to translate data-driven insights into clear business strategies and initiatives.
* Build and manage a high-performing team of BI analysts, fostering a culture of curiosity, rigor, and customer-centricity.
Market Intelligence
* Direct comprehensive analysis of the global life science research, biotech, and pharmaceutical markets, including growth trends, emerging technologies, and therapeutic pipelines.
* Provide forward-looking insights into market opportunities, risks, and unmet customer needs.
* Develop market models and forecasting tools to support strategic planning and investments.
Competitor Intelligence
* Establish a robust competitor monitoring program, covering key players by business unit and geo, new entrants, M&A activity, pricing strategies, and service/product innovations.
* Synthesize competitor data into concise, actionable intelligence for executives and commercial teams.
* Support scenario planning and 'war gaming' exercises to anticipate competitor moves and guide proactive strategy.
Customer Intelligence
* Lead advanced analysis of customer data, including segmentation, behavior, satisfaction, and share of wallet.
* Partner with commercial teams to identify growth opportunities, improve customer retention, and guide go-to-market strategies.
* Ensure customer voice and feedback are integrated into business and service/product decisions.
Data & Analytics
* Oversee the design and deployment of BI tools, dashboards, and reporting systems, in partnership with Global Technology, to make insights accessible across the organization.
* Champion the use of advanced analytics, data visualization, and predictive modeling to improve strategic foresight.
* Drive data governance, quality, and integration across multiple internal and external data sources.
**Job Qualifications**
* Bachelor's degree in Business, Economics, Data Analytics, or Life Sciences required; MBA or advanced degree preferred.
* 10+ years of progressive experience in business intelligence, market research, consulting, or corporate strategy, ideally within life sciences, healthcare, or related industries.
* Proven track record leading BI or insights teams with direct impact on corporate strategy and growth.
* Exceptional analytical, critical thinking, and problem-solving skills with the ability to synthesize complex data into executive-ready insights.
* Strong leadership and people management experience, with the ability to inspire and develop talent.
* Excellent communication and presentation skills; adept at influencing senior executives and cross-functional stakeholders.
* Deep understanding of life sciences/biopharma market dynamics, customer decision drivers, and competitive landscape.
* Proficiency with BI platforms (Power BI, Tableau, Qlik, etc.), advanced Excel, and statistical/analytics tools (e.g., Python, R, SAS, SQL).
Compensation Data
The pay range for this position is $175K - $200K USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
**About Corporate Functions**
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
**About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
**Equal Employment Opportunity**
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit ***************
230898
$175k-200k yearly Easy Apply 6d ago
Regulatory CMC Project Manager
Parexel International 4.5
Remote
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you!
Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented Regulatory CMC Project Manager to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department.
Key Responsibilities:
Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions.
Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements.
Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed.
Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards.
Health Authority Engagement: Support the preparation of materials for health authority engagements
Qualifications:
Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management).
3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls).
Strong project management skills with a track record of managing complex projects and meeting deadlines.
Excellent organizational and communication skills.
Excellent time management abilities
Proficient in Microsoft Office Suite
Proven experience with project management software ie. Smartsheet
Strong communication and interpersonal skills
Ability to work collaboratively in a fast-paced, dynamic environment.
Additional Requirements:
Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
$78k-119k yearly est. Auto-Apply 13d ago
Clinical Laboratory Study Manager - FSP
Parexel International 4.5
Remote
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine. Will work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Additional responsibilities include overall project management in alignment with the core business strategy.
Operations Management
Study Team Support
Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders, such as working with Informed Consent Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing
Operational Support of Sample Analysis (including exploratory analysis)
Establishment, oversight, planning, and integration of all issues related to collection, processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations
Liaises with Precision Medicine Strategy Leads and other scientists by assessing vendors, forecasting sample operational costs, timelines and reviewing invoices to ensure alignment with budget plans
Data Acquisition and Management
Works closely with data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials
Human Sample Management Flow and Compliance
Provides guidance to clinical teams and clinical sites regarding collection, storage, and shipping of samples acquired in the course of clinical trials or other human sample acquisition projects
Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF
Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed
Compliance with Parexel Standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery
Skills:
• Excellent written and verbal communication skills
• Resolve problems spontaneously and possess strong project management and organizational skills
• Work independently and proactively while still contributing to group initiatives and goals
• Good interpersonal skills and ability to work with many different groups/teams
• Microsoft applications
Knowledge and Experience:
6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. We are seeking a professional with working knowledge of clinical trials and clinical databases. Laboratory sample management experience is a plus.
Education:
Bachelor's degree in a life science, nursing qualification or other relevant experience required.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
$80k-106k yearly est. Auto-Apply 7d ago
Account Executive, Wellness
Catalent 4.4
New York, NY jobs
The Account Executive, Wellness will be responsible for growing Catalent's Consumer Healthcare business in their assigned region within the United States and Canada. Primary focus will be to develop and execute an account plan for strategic management of existing account base, as assigned, and continued growth in the nutritional dietary supplement industry, providing our customers with solutions and ultimately growing Catalent's portfolio of business. The Account Executive, Wellness role is ideally filled by a high energy, team player who is not afraid to roll up his or her sleeves, who thrives in a fast moving, lean, and entrepreneurial environment.
This is a field-based, remote role with travel required for business development related activities.
The Role:
Account Management:
Customer Relationships: Manage business relationships with assigned customers, including pricing, contract extensions/amendments, forecasting, periodic business review meetings, and addressing customer service-related issues.
Account Planning: Set account objectives and establish plans to achieve results. Ensure alignment with Catalent's Standards of Business Conduct.
Engage daily in activities that drive meeting or exceeding financial targets.
Internal Coordination:
Cross-Functional Collaboration: Work with internal teams across Catalent (Customer Service, Commercial Operations, Marketing, Legal, Finance, Project Management) to maintain effective communication with key internal stakeholders to ensure all account management activities are conducted in a coordinated, team-based fashion. Collaborate with other selling teams within Catalent to actively engage in cross-selling opportunities.
Internal Meetings: Plan and participate in regular internal business review meetings to present strategic plans and progress within the assigned territory.
Opportunity Management:
Sales Funnel Development: Develop and build the funnel to drive new business through prospecting, outreach, relationship building, and qualifying leads, captured in Salesforce with specific actions leading to successful closures.
Sales Process Management: Manage opportunities from start to finish, including tracking in Salesforce, defining scope, creating pricing strategies, handling customer credit, confirming confidentiality agreements, negotiating, and closing deals. Ensure thorough and timely handoff to internal project managers and product development teams.
Customer Interaction:
Consultative Approach: Employ a consultative approach with regular meetings for capabilities reviews, site visits, business updates, and innovation discussions. Prepare well for calls/visits with a clear agenda and meeting outcome goals. Must be natural and curious in front of customers to understand client needs and develop tailored, innovative solutions.
Communication and Presentations: Develop and deliver customer-facing presentations, leveraging existing resources to create a unique value proposition. Use formal and informal communication methods to assure a detail-oriented approach to follow up with rapid response and follow through to customer inquiries, opportunities, and issues.
Market and Competitive Analysis:
Market Intelligence: Gather and analyze competitive intelligence through trade shows, articles, newsletters, and customer feedback. Stay informed about market trends and new launches in collaboration with Catalent's Marketing Team.
Competitive Positioning: Use gathered intelligence to inform and enhance Catalent's competitive positioning in the industry.
Administrative Responsibilities:
Compliance and Reporting: Adhere to corporate responsibilities by staying current with internal training, tracking opportunities, submitting expense reports, managing time off, and complying with travel and gift policies. Ensure confidentiality and ethics standards are met.
Goal Setting and Career Development: Engage in annual goal setting, track progress, and drive career development activities with your director. Pursue continuous learning through feedback, mentorship, and professional development opportunities.
Travel:
Travel Requirements: Travel 25-50% to Catalent sites, customer sites, tradeshows, and industry events. A passport is required.
Additional Duties:
Other tasks and duties as assigned.
The Candidate:
A BS/BA degree is required.
Minimum 3 years in a business development role, with relevant experience in the outsourcing market (CMO, CRO, CSO) preferably in the nutritional dietary supplement space.
Excellent oral and written communication and presentation skills required.
Proven ability to organize and plan work, manage travel, and balance multiple priorities effectively required.
Ability to work effectively as a member of cross-functional teams required.
Strong computer skills required, including Microsoft Word, Excel, and PowerPoint.
Experience using Salesforce or similar customer relationship management tools preferred.
Must be willing and able to travel up to 50% to visit clients, attend tradeshows, participate in training, as well as meet with clients in Catalent's manufacturing facilities.
This position required to work from home is not eligible for relocation assistance.
Pay:
The annual pay range for this position in New Jersey is $91,500-$132,000
The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why You Should Join Catalent:
Join a high growth and fast paced organization with a people focused culture
Global exposure, defined career path and annual performance review and feedback process
Competitive Medical, Dental, Vision, Life Insurance, and 401K
19 days PTO & 8 paid holidays
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
$91.5k-132k yearly Auto-Apply 11d ago
Clinical Study Physician - Oncology - FSP
Parexel International 4.5
Remote
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! Oncology experience needed
External Job Description
The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team.
Trial Start-Up
Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates.
Contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct.
Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP.
Responsible for providing medical input into the definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs.
Contribution to the timely preparation of medically relevant core trial documents and timely milestones.
Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, “Information for CRF completion” (ICC), Data Review Plan (e.g., propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts.
Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan.
Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs.
Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans.
Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff.
Trial Conduct
Ongoing medical review with transparent documentation of the activity, related findings and resolutions.
Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues.
Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data medical oversight by using advanced technologies and systems.
Proactively address/ communicate clinical quality issues in a collaborative environment.
Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols
Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list.
Building network with experts and active contribution to site engagement.
Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM.
Medical review of and contribution to the content of Trial Newsletters
Contribution to the scientific publication of trial data, if applicable
Leadership
Management of medical activities related to one or more clinical trials
Cross functional planning, execution, and analysis of a clinical program
Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes
Compliance with Parexel standards
Comply with required training curriculum
Complete timesheets accurately and timely as required
Submit expense reports as required
Update CV as required
Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
Proficiency in written and spoken English and (local language)
Excellent interpersonal, active listening and influencing skills
Pronounced analytical skills and systematic and well-structured working style.
Pronounced presentation and training skills
Capability to work proactively and with team spirit in an international environment
Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment
Knowledge and Experience:
Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities
Understanding of relevant regulations and guidance including ICH-GCP.
Experienced with data visualization systems and IT systems.
Education:
Physician MD, ideally with medical thesis, trained in a clinical setting
Minimum of 4 years of active clinical experience; specialization in internal medicine or general practice preferred.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
$112k-172k yearly est. Auto-Apply 5d ago
Project Leadership - Biotech (Clinical Trials) - Obesity / Diabetes - Home Based (Future Needs)
Parexel 4.5
Nashville, TN jobs
The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve.
Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients.
**Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading obesity global studies.**
Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations
Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior role of Senior Project Leader.
To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills.
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is hiring an FSP Consultant, Advanced Analytics: Meta-Analysis (HTA Statistician) to work remotely. Must be able to accommodated East Coast/CET hours. The ideal candidate will have key experience in NMA/Evidence Synthesis, Survival analysis, and HTA experience.
Location: US - Remote |
Employment Type: Full-Time
Job Purpose
The Statistician, Consultant, Advanced Analytics: Meta-Analysis, contributes statistical capabilities and methodological leadership at all stages of projects, from planning to completion. The role involves working with junior team members to design, develop, and deliver client solutions across multiple projects-leveraging competencies in statistical theory, data analysis and interpretation, regression analysis, systematic review, and evidence synthesis methodologies.
The individual must have a Master's or Doctoral Degree in Health Economics, Health Policy, Statistics, Biostatistics, Mathematics, or other quantitative fields. Proficiency in data analytics and statistical software/tools such as WinBUGS, R, Stata, Python, and SAS is required.
Key Accountabilities
Provide expert input on the design of clinical development programs to ensure Access/HTA evidence needs are considered within global development and commercialization strategies.
Identify evidence gaps, possible data sources, and design and implement robust evidence-generation plans.
Ensure Access/HTA evidentiary activities are strategically aligned with other functions within Global Access and the wider organization (affiliates, Product Development, commercial, etc.).
Plan and conduct statistical analyses of clinical trials and other relevant data sources and develop supporting technical documentation for statistical analyses and economic models.
Interpret and communicate the findings of analyses and work closely with affiliates to incorporate global statistical and health economics input into their local reimbursement applications.
Lead or contribute to cross-functional teams within a matrix structure and actively contribute to the development of methodologies and continuous improvement within the Evidence Chapter.
Keep up to date with the changing Access/HTA landscape and academic research to ensure current access trends and methodologies are incorporated into evidentiary plans and build relationships with relevant external statistics, health economics, Access/HTA, and policy experts.
Additional Responsibilities
The Consultant is responsible for ensuring that all assigned projects are conducted efficiently and that quality and client satisfaction are maximized-ensuring project direction and deliverables meet objectives and client needs.
Consultants are expected to guide Senior Associates and Associates in their daily duties and flag any areas of acute training needs to their line managers. Supported by senior staff and Business Development partners, the Consultant is responsible for maintaining client relationships on their projects.
Candidates will be part of multi-disciplinary research teams and will provide statistical expertise and methodological leadership at all stages of projects from planning to completion. Duties may include:
Preparing network meta-analysis protocols
Reviewing data extracted from systematic literature reviews
Conducting feasibility assessments
Generating network diagrams
Critically assessing study heterogeneity
Conducting network meta-analysis
Assisting with interpretation and dissemination of findings
The candidate is also expected to support thought leadership and innovation objectives in advanced analytics, including but not limited to:
Pairwise meta-analysis
Mixed treatment comparison
Indirect treatment comparison
Network meta-analysis
Match-adjusted indirect treatment analysis
Meta-regression
Single-arm trial analysis
Simulated treatment comparison
Surrogate outcome assessment
Skills & Qualifications
Master's or Doctoral-level degree in applied statistics, health economics, or related quantitative fields.
Minimum of 3 years of hands-on experience in the pharmaceutical industry, consultancy, Access/HTA/reimbursement agency, or academic institution (pharma affiliate experience is a plus).
In-depth knowledge of Access and HTA, clinical research and development methods, and international payer evidence requirements.
Skilled in research design and statistical methods, such as Generalized Linear Models, Survival Analysis, Network Meta-Analysis, and Bayesian statistics.
Proficient in R and GitLab (experience with SAS, Python, WinBUGS, JAGS, or other relevant statistical software is a plus).
Strong strategic, collaboration, and communication skills; excellent organization, planning, and prioritization abilities; ability to meet tight deadlines; and strong written and verbal communication skills in English.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.