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  • Project Manager, Project Management Innovation Center of Excellence (PROMICE)

    Uwmsn University of Wisconsin Madison

    Remote job

    Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process. The UW Institute for Clinical and Translational Research (ICTR, *********************** helps researchers move their research findings from experimental settings into real world use in clinics and communities (‘translating' research into practice).We do this by supporting the career development of researchers through training and educational programs, and by providing a range of services that assist researchers with the development and delivery of their research projects, such as help with study design and data analysis, and guidance on partnering with communities to recruit study participants. We're recruiting an experienced Project Manager to join the ICTR Project Management Innovation Center of Excellence (PROMICE). PROMICE is a new office within ICTR Central Administration that supports multidisciplinary projects across ICTR, as well as collaborative research projects with our partners (UW Health, multiple schools and colleges within UW-Madison, and Marshfield Clinic Research Institute). This position will play a key role in leading large, cross-ICTR projects and initiatives, such as our upcoming CTSA grant renewal application. Reporting to the ICTR Administrative Director, the Project Manager will be responsible for: Helping teams define roles and responsibilities, deliverables, timelines and resources. Ensuring robust communication among project participants and proactive coordination and tracking of project activities. Creating and implementing effective project management tools, processes and standards. Producing dashboards, reports, and other communication products and tools for internal and external audiences. Facilitating data collection to inform program/project planning, reporting and evaluation. Initiating and documenting continuous improvement activities related to project management. Contributing to strategic visioning for PROMICE as we work to enhance and grow this new office. Educating researchers and leaders about the value and appropriate integration of project management into their activities. Contributing to scholarly work related to project management and translational research. ICTR Mission: We discover, translate & disseminate interventions to improve health & health care. To learn more about ICTR visit: ********************** This position may require some work to be performed in-person (3 days/week onsite required), onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location. Knowledge, Skills, Abilities: • Strong drive and ability to bring structure and clarity to complex projects. • Highly collaborative with a focus on customer service and solutions. • Exceptional organizational and time management skills. • Exceptional interpersonal skills including excellent verbal communication and attentive listening. Key Job Responsibilities: Creates a project plan, monitors progress and performance against the project plan, and identifies, resolves, or escalates risks and issues Facilitates the estimation of project costs, resources, and time required to complete the assigned phase of a project and monitors activities, negotiates for resources, and assigns tasks to ensure these targets are met. Follows established change control processes if targets can no longer be met Prepares regular reports to communicate the status of the project within and beyond the project team Manages the activities of outside contractors to ensure they are integrated into the project and that the organization receives satisfactory standards of service Sets priorities, allocates tasks, and collaborates with project staff to meet project targets and milestones Department: School of Medicine and Public Health, Insitute for Clinical and Translational Research (ICTR) Compensation: The expected salary range for this position is $90,000 up to $125,000 for highly experienced candidates. Actual pay within this range will depend on experience and qualifications. Required Qualifications: • Minimum of 2 years of professional experience in a project management role. • Demonstrated experience using cloud-based collaboration and project management tools, such as Asana, Smartsheet, Basecamp, or Teams. Preferred Qualifications: • Experience managing complex, multidisciplinary projects. • Experience supporting grant proposal development. • Experience in an academic setting. Education: Bachelor's Degree Preferred How to Apply: To apply for this position, please click on the "I am a current employee" button or "I am not a current employee" button under Apply Now. You will be prompted to upload the following documents. Cover Letter Resume Please note, there is only one attachment field. You must upload all of your documents in the attachment field. Applicants are to submit a cover letter and resume detailing their training and experience relating to the required and preferred qualifications referenced above. The application reviewers will be relying on written application materials to determine which qualified applicants will advance in the recruitment process. We will notify selected applicants to participate further in the selection process directly. References will be requested of final candidates. All applicants will be notified after the search is complete and a candidate has been selected. University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position you must provide proof of work authorization and eligibility to work. Contact Information: Kim McFarlane, ******************** HR Business Partner Institutional Statement on Diversity: Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. The University of Wisconsin-Madison is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, visit the Human Resources Workplace Poster website. To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you. Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment. The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7). The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.
    $90k-125k yearly Auto-Apply 10d ago
  • Director, Feasibility Lead

    Genmab

    Remote job

    At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Overview: The Director, Feasibility Lead, will drive the implementation of strategic, data-driven feasibility practices that optimize the design and delivery of clinical trials across Genmab's development portfolio. This role balances operational ownership of high-impact feasibility work with broader leadership responsibilities, such as evolving internal processes, mentoring team members, and contributing to cross-functional strategies. The Director will lead complex feasibility initiatives and serve as a senior subject matter expert across multiple programs and indications. In addition to executing feasibility assessments, they will support team development, thought leadership, and innovation in feasibility methodology, tooling, and stakeholder partnerships. Responsibilities/Tasks: Lead the end-to-end feasibility process for priority or complex development programs, including early indication assessments, country and site selection, patient recruitment forecasting, and operational risk analysis. Serve as a senior strategic partner to Development Operations (DevOps), Clinical Strategy and external partners to inform study design and operational delivery strategies. Shape feasibility approaches and standards by incorporating internal and external data sources, novel technologies, and evolving regulatory and business needs. Mentor and provide strategic guidance to Associate Directors and other feasibility team members; contribute to capability-building across the function. Drive cross-functional planning sessions related to feasibility strategy, scenario modeling, country allocation, PI identification and enrollment planning. Represent Strategic Feasibility in key governance and decision-making forums, effectively communicating insights, risks, and recommendations. Identify opportunities for continuous improvement and lead or support change initiatives at the intersection of process, technology, and data science. Partner with the Head of Strategic Feasibility on function-wide priorities such as resourcing, standards, and vendor strategy. Competencies and Attributes: Education: Minimum BS/BA required; advanced degree preferred. Language: Fluent in spoken and written English. Experience: 8-10+ years of experience in clinical drug development, including significant experience in feasibility within pharmaceutical, biotech, or CRO settings. Proven leadership of complex, global feasibility initiatives and ability to influence clinical development strategy. Track record of cross-functional leadership in matrixed environments. Experience mentoring or managing colleagues, even in an informal or project-based capacity. Proficiency in feasibility-related analytics, competitive intelligence, operational scenario planning, and stakeholder engagement. Attributes of a Successful Candidate: Strategic thinker who also executes with precision. Exceptional communication and facilitation skills, with a global mindset. Curious, solution-oriented, and collaborative by nature. Adept at working independently while balancing competing priorities. Embraces innovation and continuous improvement. Demonstrates self-awareness and supports team development through feedback and coaching. For US based candidates, the proposed salary band for this position is as follows: $183,040.00---$274,560.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com). Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
    $183k-274.6k yearly Auto-Apply 29d ago
  • Sr CRA - Oncology

    Syneos Health Clinical Lab

    Remote job

    Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close out Knowledge of local requirements for real world late phase study designs Chart abstraction activities and data collection As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff Identify and communicate out of scope activities to Lead CRA/Project Manager Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations Identify operational efficiencies and process improvements Develop country level informed consent forms Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared Participate in bid defense meetings Qualifications: Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected. Ability to manage required travel of up to 75% on a regular basis At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $80,600.00 - $145,000.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
    $80.6k-145k yearly Auto-Apply 6d ago
  • Toxicologist

    Zoetis 4.9company rating

    Remote job

    Zoetis Veterinary Medicine Research and Development (VMRD) seeks a skilled Toxicologist to join the Toxicology Group within Clinical Pharmacology and Safety Sciences based in Kalamazoo, MI. This challenging and dynamic role provides global toxicology and safety assessment support. The successful candidate will collaborate across VMRD and Global Manufacturing and Supply (GMS) to develop scientifically rigorous safety assessments supporting product safety across therapeutic areas, veterinary species, human health, and manufacturing processes. Responsibilities: Toxicological Assessment for Drug Products: Conduct safety assessments for formulation excipients, degradants, raw materials, and residual solvents in active pharmaceutical ingredients (APIs) and drug products Toxicological Assessment for Manufacturing: Qualify impurities in the manufacturing process of APIs and drug products; conduct safety assessments for extractables and leachables, cross-contamination of products in shared facilities, and establish cleaning limits. Occupational Safety: Develop Occupational Exposure Limits (OELs/ OEBs) following Zoetis processes and procedures. User and Worker Safety: Provide product user and worker safety support for project teams, including risk assessments, exposure scenario calculations, risk mitigation proposals, packaging recommendations and label language development. Safe Exposure Level Development: Establish Threshold of Toxicological Concern (TTC) and health-based exposure limits, including Permitted Daily Exposure (PDE), Acceptable Daily Intake (ADI), and Margin of Exposure (MoE). Health Hazard/ Medical Assessments: Support pharmacovigilance, product quality, and qualification of out-of-specification batches. Regulatory Support: Assist with REACH registration for API intermediates and raw materials, and address global regulatory queries related to the safety of registered products. Toxicology Data Analysis & Literature Review: Perform rigorous toxicology gap analysis, literature data mining, and critical evaluation of toxicological information to support product development and registration. Hazard Communication and Chemical Regulatory Compliance (Preferred): Experience in preparing Safety Data Sheets (SDS), classifying drug substances and process intermediates according to the Globally Harmonized System (GHS) and national requirements, and horizon scanning and monitoring of chemical regulations. Cross-Collaboration and Technical Leadership: Engage in multidisciplinary collaboration within R&D, and with Manufacturing, Product Quality, and Sustainability, to develop and integrate key knowledge areas and expertise into actionable business insights. Regulatory & Scientific Engagement: Support regulatory compliance, trade association participation, and involvement in professional organizations relevant to toxicology. Travel Requirement: This role involves up to 10% travel for collaborations, regulatory engagements, or conferences as needed. Minimum Qualifications Ph.D. (or equivalent) plus at least 2-3 years of experience in toxicology or closely related discipline is critical. Master's degree in toxicology or closely related discipline with 8 years of relevant experience shall be considered. Demonstrated experience in preparing regulatory-quality technical documents or toxicology dossiers, with strong technical writing skills (e.g., protocols, reports, journal articles) Experience in study design, implementation, and interpretation of studies evaluating in vivo and in vitro toxicity or similar experience. Highly organized with strong problem-solving skills, capable of performing rigorous scientific assessments. Ability to prioritize tasks, make informed decisions, and collaborate effectively in a global matrix environment. Excellent verbal and written communication skills in English. Proficiency in MS Office, and toxicology databases for literature research and data analysis Desirable Skills, Experience, and Attributes: Board certification in toxicology (e.g., DABT, ERT) and/or DVM. Knowledge of global regulatory requirements for toxicology risk assessment and documentation to support product safety and chemical registrations. Experience in preparing safety data sheets. The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors. Base Pay Range: $91,000 - $131,000 The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and other factors. Base Pay Range: $103,000 - $148,000 [This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.] We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $103k-148k yearly Auto-Apply 60d+ ago
  • Part Time- R Programmer / Biostatistician (Clinical Trial Simulation & Data Engineering) - Remote

    Penfield Search Partners

    Remote job

    Contact: Neisha Camacho/Terra Parsons - ************************* No 3rd party candidates Our client is seeking an experienced R Programmer / Biostatistician who can operate at the intersection of data engineering and biostatistics. This role requires someone who thrives in modern data environments - including PostgreSQL and Databricks - and understands how R fits into that ecosystem for analytics, simulation, and modeling. You'll be joining a collaborative team working on clinical trial simulations, study design, and data wrangling efforts. The ideal candidate combines hands-on programming ability with statistical acumen, helping to structure and streamline complex, messy back-end data to support analytical workflows. Key Responsibilities Build and run clinical trial simulations to support study design decisions. Perform advanced data wrangling, cleaning, and transformation in R and PostgreSQL. Work across modern data platforms (Databricks, PostgreSQL, etc.) to integrate, query, and prepare datasets. Develop reproducible, well-documented R code for modeling, analysis, and reporting. Leverage Seql (Posit's new AI-assisted R/Python tool) to accelerate analysis and automate code generation. Collaborate with biostatistics, data science, and engineering teams to optimize workflows and improve data accessibility. Support onboarding and integration of new team members into R-based and database environments. Required Skills & Experience Fluency in R for programming, data manipulation, and simulation. Strong SQL experience (preferably PostgreSQL) for querying and data integration. Proven experience with clinical trial simulations, adaptive/study design, or statistical modeling. Expertise in data wrangling and structuring messy datasets for analysis. Comfort working in modern data ecosystems (e.g., Databricks, cloud data warehouses, pipelines). Excellent documentation and communication skills, with a collaborative, problem-solving mindset. Nice to Have Familiarity with Seql (Posit's AI-assisted R/Python tool). Experience in biostatistics, clinical research, or pharma/biotech environments. Exposure to Bayesian simulation, Monte Carlo modeling, or reproducible R workflows (e.g., R Markdown, Quarto). Ideal Candidate Profile This role is perfect for someone who sits between a data engineer and a biostatistician - an independent problem solver who can connect analytical goals with the technical backbone needed to achieve them. You'll thrive if you're comfortable in R, fluent in SQL, and excited to explore emerging tools that make working with data faster, smarter, and more intuitive. $75-$100 hourly W2 / $85-$110 hourly 1099, commensurate with experience
    $64k-86k yearly est. Easy Apply 42d ago
  • Senior Director Medical Affairs, Movement Disorders

    Lundbeck 4.9company rating

    Remote job

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! **Remote Opportunity - Open to candidates anywhere in the United States** **SUMMARY:** The Senior Director and Head of Movement Disorders within US Medical Affairs will play a pivotal role reporting to the Vice President, Rare Neurology, US Medical Affairs. As a strategic partner and leader collaborating across research, development, and commercial functions, the Director ensures the alignment of Multiple System Atrophy (MSA) strategies with the needs of patients, healthcare professionals, payers and policy makers. This is an opportunity for a seasoned manager with rare neurology launch experience to lead a Medical Affairs team that delivers world-class engagement, practice-defining collaborations, and persuasive evidence. **ESSENTIAL FUNCTIONS:** + Represent Lundbeck as a credible and knowledgeable scientific leader in the field of Movement Disorders, collaborate as a peer with external stakeholders to drive scientific leadership, improvement in diagnosis and access to treatment + Develop plans to achieve ambitious business objectives; execute aligned medical strategies and tactics with urgency and measurable impact + Shape evidence generation efforts to differentiate and expand access to treatment, working closely with global colleagues to support the design, protocol review and execution of Phase IIIb/IV studies, manage investigator-initiated (IIT) proposals + Lead and plan national advisory boards to inform and shape medical strategy + Develop and communicate high-quality medical content, compelling scientific narratives, engaging congress and field materials + Provide constructive input to optimize global publication strategy and represent US needs and priorities + Identify and create new opportunities to drive value for external stakeholders + Serve as medical reviewer and internal subject matter expert for promotional and nonpromotional materials + Provide medical perspectives to internal stakeholders (Commercial, Market Access, Regulatory, Clinical Development, Pharmacovigilance etc.) ensuring clinical and scientific alignment with integrated plans + Drive an ambitious external engagement agenda by identifying, developing and maintaining strong networks with key external stakeholders including investigators, thought leaders and healthcare practitioners; foster productive partnerships, engage through scientific congresses, and scientific exchange + Partner closely with Field Medical on overall strategy for external engagement, insights gathering and reporting, and translate insights to action + Remain intimately aware and abreast of evolving disease area trends and competitor activities to continuously anticipate changes and assess impact to US and Global scientific and brand strategy **REQUIRED EDUCATION, EXPERIENCE, AND SKILLS:** + Doctoral Degree (PhD, PharmD, or MD.) + 8+ years of non-field-based Medical Affairs experience in the pharmaceutical or biotech industry, at least 3 years leading medical strategy in a for a rare asset + Managed full time direct reports for at least 3 years + Led the development and execution of integrated medical strategies within rare neurology and across broader rare disease therapeutic areas + Directed medical affairs strategy, launch planning, evidence generation, and scientific communication initiatives to advance medical and corporate objectives + Led high-quality advisory boards and roundtables in rare diseases, ensuring capture of relevant and actionable insights + Oversaw the design and delivery of Medical Education programs (CME and non-CME) to enhance disease understanding and clinical engagement + Provided strategic oversight for evidence generation efforts, including study design, registries, real-world evidence initiatives, and publication planning + Served as senior medical reviewer for promotional and non-promotional materials, ensuring alignment with compliance standards and scientific accuracy + Championed the collection, synthesis, and application of scientific and clinical insights to inform strategic decision-making and cross-functional alignment + Recognized for strong scientific acumen, critical thinking, and the ability to drive data-driven, patient-centered strategies + Built and led high-performing teams, fostering a culture of collaboration, accountability, and innovation in a dynamic, fast-paced environment + Partnered effectively across global and regional teams to ensure alignment between medical, commercial, and regulatory priorities + Upheld the highest ethical standards, integrity, and professionalism in representing the organization to both internal and external stakeholders **RARE DISEASE CAPABILITIES AND LEADERSHIP** + Recognized as an authentic, long-term leader within the rare disease community - fostering trust and collaboration with patient advocacy groups (PAGs), clinicians, and industry partners + Demonstrated track record of building strategic alliances with PAGs and patient families as research collaborators, ensuring patient perspectives shape scientific priorities + Trusted and respected voice within the rare disease ecosystem, known for transparency, empathy, and sustained community engagement + Deep expertise in rare disease best practices, including advocacy relations, policy and access strategy, , and patient support program development + Strategically guided innovative partnerships and thought-leadership initiatives with rare disease alliances and policy groups (e.g., Rare Disease Caucus, PFDD Consortium, FDA Rare Disease Center of Excellence) + Highly proactive and solutions-oriented, capable of driving organizational progress in ambiguous or unstructured settings + Brings a mission-driven mindset - combining scientific rigor with empathy, credibility, and purpose to inspire cross-functional and external collaboration + Maintains a broad and influential network within the rare disease ecosystem, effectively mobilizing partnerships and coalitions to accelerate shared goals **PREFERRED EDUCATION, EXPERIENCE, AND SKILLS:** + Strong Preference to be based in Deerfield, IL Office + 8+ years of non-field-based Medical Affairs industry experience in rare disease, experience preparing for and launching a rare neurology asset + 5+ years managing a team of full-time direct reports + Demonstrated managerial success of a US Medical Affairs team through launch + Movement disorder specialist with established relationships within the movement disorder KOL and advocacy communities + Direct accountability for creating and managing a real-world rare disease registry partnership with KEEs + Direct accountability for phase IIIb/IV study design and execution for a rare disease + Past responsibility for managing IIT process + FDA regulatory knowledge and direct exposure **TRAVEL:** + Willingness/ability to travel up to 35% domestically. Occasional international travel may be required. + If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $270,000 - $310,000 and eligibility for a 30% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on ourcareer site (***************************************************************************************************************** . Applications accepted on an ongoing basis.\#LI-LM1, #LI-Remote **Why Lundbeck** Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on theU.S. career site (***************************************************************************************************************** . _Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit theU.S. career site (*********************************************************************** ._ _Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates inE-Verify (****************************************************************************************************************************** ._ **About Lundbeck** At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real. **About Lundbeck** At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real.
    $270k-310k yearly 7d ago
  • Analytic Research Manager

    Strideinc

    Remote job

    ESSENTIAL FUNCTIONS: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. · Design and conduct high-quality, large-scale quantitative, qualitative, and mixed methods research including study design, data collection, organization, statistical modeling, and reporting related to academic performance and implementation of Stride products and services. Provide quality assurance at all phases of the research process; · Employ advanced statistical analysis to answer questions posed by internal and external stakeholders; · Extract data from multiple sources and assemble tables using pre-determined common identifiers. Scrub, parse and sort data based on internal rules, best practices, industry standards, corporate policies and research specifications; · Prepare deliverables including detailed research reports and PowerPoint presentations that provide high-level overviews of methodology (design and analysis), major conclusions, constraints or cautions, and actionable next steps; Submit final research reports to public evidence repositories, as needed. · Align research methods and reports to ESSA Tiers of Evidence and in accordance with What Works Clearinghouse Procedures and Standards, as requested. Work with third-party researchers to validate internal studies; · Manage and mentor a small team of researchers, ensuring high-quality outputs and adherence to research standards; Provide guidance on study design, data analysis, and reporting; · Propose meaningful project ideas. Develop insightful research proposals based on collaboration with internal stakeholders and senior leadership; Foster a collaborative and growth-oriented research environment. · Coordinate team efforts to align with organizational priorities and timelines. Track and report on research activities, progress, and outcomes. · Develop and implement processes and instruments to collect data; Collect data routinely and independently as requested to monitor and report on implementation of specific initiatives; Supervisory Responsibilities: This position has no formal supervisory responsibilities. MINIMUM REQUIRED QUALIFICATIONS: · Ph.D. in education research, statistics, applied social sciences, research methods or a related field AND · Three (3) years of experience with a wide range of research projects, statistical methods and assessment strategies related to mining data to understand process improvement in the education market, both quantitative and qualitative and team leadership OR · Equivalent combination of education and experience Certificates and Licenses: None required. OTHER REQUIRED QUALIFICATIONS: · Advanced computer skills, particularly with statistical programming languages or software, such as R, SPSS, or STATA, and Microsoft Office Suite (Outlook, Word, Excel, PowerPoint) · Experience in the field of K-12 academic research pertaining to school effectiveness and student achievement · Demonstrated expertise in research or evaluation methodology, design, and analysis, including advanced quantitative and mixed methods. Applicants should be familiar with various forms of regression analysis (e.g. multiple regression, logistic regression, mixed effect modeling) and matching methods. · Demonstrated expertise with ESSA Tiers of Evidence and What Works Clearinghouse Procedures and Standards · Demonstrated success in working collaboratively with other professional staff · Proven experience leading and managing research teams, including setting goals, assigning tasks, and monitoring progress. · Demonstrated ability to mentor and develop junior researchers, fostering a collaborative and growth-oriented team culture. · Strong project management skills with the ability to prioritize multiple initiatives and meet deadlines. · Excellent verbal and written communication skills · Strong organizational skills and ability to prioritize tasks · Ability to pass required background check DESIRED QUALIFICATIONS: · Awareness of current trends and directions in K-12 research, assessment, standards and compliancy/regulations · Experience with producing materials for public review · Experience using qualitative data analysis software WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. · This is a home-based position Compensation & Benefits: Stride, Inc. considers a person's education, experience, and qualifications, as well as the position's work location, expected quality and quantity of work, required travel (if any), external market and internal value when determining a new employee's salary level. Salaries will differ based on these factors, the position's level and expected contribution, and the employee's benefits elections. Offers will typically be in the bottom half of the range. We anticipate the salary range to be $76,079.25 to $125,000.00 per year. The upper end of this range is not likely to be offered, as an individual's compensation can vary based on several factors. These factors include, but are not limited to, geographic location, experience, training, education, and local market conditions. Eligible employees may receive a bonus. Stride offers a robust benefits package for eligible employees that can include health benefits, retirement contributions, and paid time off. The above job is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. All employment is “at-will” as governed by the law of the state where the employee works. It is further understood that the “at-will” nature of employment is one aspect of employment that cannot be changed except in writing and signed by an authorized officer. Job Type Regular The above job is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. All employment is “at-will” as governed by the law of the state where the employee works. It is further understood that the “at-will” nature of employment is one aspect of employment that cannot be changed except in writing and signed by an authorized officer. If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you can request the appropriate accommodation by contacting *********************. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Stride, Inc. is an equal opportunity employer. Applicants receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, or any other basis prohibited by federal, state, or local law. Stride, Inc. complies with all legally required affirmative action obligations. Applicants will not be discriminated against because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
    $76.1k-125k yearly Auto-Apply 8d ago
  • Insights Analyst - Remote, PST/MST Preferred

    Escalent 4.4company rating

    Remote job

    Who We Are Escalent is an award-winning data analytics and advisory firm that helps clients understand human and market behaviors to navigate disruption. As catalysts of progress for more than 40 years, our strategies guide the world s leading brands. We accelerate growth by creating a seamless flow between primary, secondary, syndicated, and internal business data, providing consulting and advisory services from insights through implementation. Based on a profound understanding of what drives human beings and markets, we identify actions that build brands, enhance customer experiences, inspire product innovation and boost business productivity. We listen, learn, question, discover, innovate, and deliver for each other and our clients to make the world work better for people. Why Escalent? Once you join our team you will have the opportunity to... Access experts across industries for maximum learning opportunities including Weekly Knowledge Sharing Sessions, LinkedIn Learning, and more. Gain exposure to a rich variety of research techniques from knowledgeable professionals. Enjoy a remote first/hybrid work environment with a flexible schedule. Obtain insights into the needs and challenges of your clients to learn how the world s leading brands use research. Experience peace of mind working for a company with a commitment to conducting research ethically. Build lasting relationships with fun colleagues in a culture that values each person. Role Overview This is a role where you could design and deliver research for well-known brands you would recognize. This is not an entry-level position. You should have at least 1 - 3 years of work experience to qualify. Our industry groups have a diverse set of clients offering you the chance to work on projects ranging from large quant studies that are fielded internationally, or smaller highly custom studies that may include a mix of qualitative and quantitative methodologies to manage. Across our teams, we have great people, great work, and clients that treat us like an extension of their team. In addition, we have internal experts to help you learn and grow analytically, plus navigate the nuances of our clients' business or industry. Responsibilities Participate in study design meetings with project team and/or clients. Execute research projects using a variety of research methodologies Demonstrate understanding of survey sampling concepts, their impact, and use. Draft questionnaires using our preferred questionnaire writing processes. Format surveys and prepare for programming. Monitor the quality of the data and discard non-qualified respondents (set and apply strike criteria). Execute phases of the analysis plan with guidance from experienced team members. Analyze research results and create graphical displays to convey the implications of the data. Create reports that include effective graphs, tables, summaries, and narratives. Qualifications Must have a Bachelor degree in a related field. Minimum 1 year of prior Market Research experience (as Intern or entry-level market research role). Must demonstrate knowledge of basic statistics, research procedures, and survey methodology. Proficiency in SPSS required. Experience with data mapping, troubleshooting data that doesn t make sense, weighting data, etc. Must have effective communication skills, both verbal and written. Must show strong organizational skills, time management and attention to detail abilities. Works well on multiple projects simultaneously and under pressure. Must be proficient in MS Office (Word, Excel, and PowerPoint). Benefits and Culture Medical, Dental, and Vision Insurance - Large carriers on a national level (domestic partner coverage included) 401k with Company Match No vesting period; bi-weekly contributions Flexible PTO - Feel no guilt in taking off a minimum of 3 weeks of real vacation time Paid Parental Leave 12 Paid Company Holidays Hybrid/Virtual Work - Virtual-first workforce with employees in most states Salary range for this role is $65,000 - $75,000 Explore our Careers and Culture page to learn more about the people behind the brand: **************************************** Equal Opportunity Employer: All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
    $65k-75k yearly 31d ago
  • Instructor

    University of Colorado 4.2company rating

    Remote job

    University of Colorado Anschutz Medical Campus Department\: Colorado Center for Translational Science Institute Job Title\: Instructor #\: 00765186 - Requisition #\:34151 Job Summary: The Instructor position will develop and teach the Clinical Science Graduate Program's Clinical Outcomes and Applications (CLSC 7202) graduate course starting in Fall 2024 to Masters and PhD level students. This course provides an overview of the field of major issues in outcomes research, and we will provide a deeper dive into select topics. Outcomes research uses a wide variety of research designs to expand understanding of how to measure outcomes of health care. The course is designed to provide students with both theory and application through case studies and in-class activities. Topics to be included are introduction to course, introduction to patient reported outcome measures (PROMs) & other objective measures, study design, data sources, introduction to conceptual models, diversity, equity, inclusion and justice (DEIJ), qualitative methods/stakeholder engagement, mixed methods, dissemination & implementation (research to implementation gap), and research into policy. Class activities will involve hands-on experiences to support learning and developing approaches to address conducting outcomes research. The instructor will commit approximately 15 hours of preparation time for course and same hours for teaching, during this time instructor will have contact and coordinate with co-faculty instructors. Work Location: Remote - this role is eligible to work remotely, but the employee must be in the United States. This course will be presented in both an asynchronous and synchronous format. Synchronous: Mondays from 4\:00 pm to 5\:30 PM. During this time, we will be on ZOOM, students engage in small group activities, class discussions, and student presentations. Asynchronous\: Students will be required (except for the first class and some guest lectures) to review PPT slides/recorded lecture prior to class (approximately 45-60 minutes). Why Join Us: The Clinical Science Graduate Program is a key element of workforce develop in the Colorado Clinical and Translational Sciences Institute (CCTSI) and graduate program at the University of Colorado| Anschutz Medical Campus (AMC). The CCTSI is a biomedical research institute at CU Anschutz Medical Campus. As an instructor in the Clinical Science Graduate Program you will preparing future clinical and translational sciences researchers to understand and apply ethical and regulatory frameworks, guidelines and requirements and the role of Ethics regrading research. Diversity and Equity: The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment. Qualifications: Minimum Qualifications: Applicants must meet minimum qualifications at the time of hire. Graduate degree in clinical science More than 3 years of experience conducting clinical and translational research in humans Previous teaching experience Preferred Qualifications: Completion of ethics and responsible conduct of research coursework Familiarity/previous experience conducting research with industry Familiarity/previous experience conducting research with multiple sites, PIs, and IRBs Familiarity/previous experience conducting clinical and translational research using a range of approaches and study designs Knowledge, Skills and Abilities: Familiarity with Canvas Superior communication and organizational skills Knowledge and abilities to teach the NIH requirements for ethics and responsible conduct of research in humans for investigators How to Apply: For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position 2. Curriculum vitae / Resume 3. Three professional references including name, address, phone number (mobile number if appropriate), and email address Applications are accepted electronically ONLY at ********************** Questions should be directed to\: Galit Mankin *************************** or Lisa Cicutto, *************************** Screening of Applications Begins: Immediately and continues until July 18, 2024. Anticipated Pay Range: The starting salary range ( or hiring range ) for this position has been established as HIRING RANGE: $2,083 for single instructor teaching course of 2 credits. The above salary range ( or hiring range ) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position is not eligible for overtime compensation unless it is non-exempt. ADA Statement: The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at ****************************** . Background Check Statement: The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees. Vaccination Statement: CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.
    $2.1k monthly Auto-Apply 60d+ ago
  • US Director, Health Economics & Outcomes Research

    Bridgebio 4.2company rating

    Remote job

    Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. What You'll Do BridgeBio is looking for a US Director, Health Economics & Outcomes Research, to join our strong and growing team. This position will report to the Sr. Director of US Value & Health Economics. The role will focus on the conception and execution of innovative strategies to ensure patients access and commercialization of BridgeBio therapies in the US. The ideal candidate should be prepared to work in a fast-paced environment and must be demonstrate cross functional collaboration across Market Access, Medical Affairs, Commercial and Clinical Development among other functions. Additionally, the candidate is responsible for supporting field engagements with payers and population health decision makers to demonstrate the value of BridgeBio therapies. #LI-TC1 Responsibilities Execute on the HEOR plan by designing, developing, and completing HEOR-led studies that support commercialization strategies and demonstrate value to key stakeholders Lead development of AMCP Dossiers, Budget Impact Models and other economic tools to support the commercialization of BridgeBio therapies Collaborate with KOLs on study design and authorship to execute HEOR studies and build relationships with Centers of Excellence Support US field team with engagement with payers and population health decision makers to demonstrate the value of BridgeBio therapies to inform decisions on utilization Partner with Clinical Development, Evidence Generation and Statistics colleagues on the design and execution of HEOR studies including real world evidence for BridgeBio therapies Conduct HEOR advisory boards and market research as needed to understand evolving evidence requirements for payers and IDNs in assigned therapeutic areas Collaborate with Head of HEOR and Market Access colleagues in ICER assessments and responses related to assigned therapeutic areas Where You'll Work This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office. Who You Are A Master's Degree in a relevant discipline (e.g., health economics, health services research, medicine, pharmacy, public health, psychometrics, epidemiology, and decision sciences) required 8+ years of relevant experience with an emphasis on the pharmaceutical/medical device industry and/or managed care experience; 6+ years of experience in health economics and outcomes research Demonstrated understanding of the US and payer policy with a comprehensive understanding of the US healthcare systems and reimbursement processes, and public policy decision-making Outstanding communication and presentation skills with the ability to present at the executive level and with external thought leaders with the capability to examine and project appropriate details Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a small, fast-moving, and entrepreneurial environment Primarily domestic travel required, expected to be 20-30% of the time Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits: Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with $2,500 award for hired referrals Health & Wellbeing: Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend 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, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$229,430-$260,220 USD
    $82k-124k yearly est. Auto-Apply 8d ago
  • REGULATORY TOXICOLOGY CONSULTANT (SENIOR-LEVEL)

    Scilucent

    Remote job

    SciLucent, Inc. (******************* a partially employee-owned Northern Virginia-based scientific consulting firm is dedicated to providing innovative solutions in all aspects of drug development. We are committed to helping our clients navigate the complexities of the pharmaceutical industry to achieve their goals. We are seeking an experienced Regulatory Toxicologist to join our multidisciplinary consulting team as an Associate Principal or Principal Consultant, depending on level of knowledge, skills, and experience. This senior role within the Nonclinical Safety & Development team requires a professional capable of operating with a high degree of independence across the services we offer. The successful candidate will be expected to lead nonclinical strategy development and client engagements, design and oversee studies, provide regulatory and scientific guidance and authoring, and represent SciLucent as a subject-matter expert in the development and execution of programs for drugs, biologics, devices, and combination products across multiple therapeutic areas. Essential Duties and Responsibilities: * The candidate will devise and execute moderately complex to complex integrated nonclinical development strategies to support the development activities of drugs, biologics, devices, and combination products. * Act as a trusted advisor to drug development clients, providing strategic support on nonclinical strategies and activities * Advise, guide, and design integrated national and international nonclinical drug development strategies for our clients * Provide oversight and management of program outsourcing activities * Review, analyze, and interpret complex scientific data, and effectively communicate data interpretation to project teams, clients, and regulatory agencies * Author and/or critically review nonclinical submission packages for scientific content and quality * Act as nonclinical representative for Agency interactions and meetings * Conduct scientific assessments (e.g., gap analysis, safety assessments) * Assist in the preparation of proposals and presentations tailored to client needs and business development goals Job Requirements: * Advanced degree (PhD or MS) in toxicology or a related and relevant scientific field * 7 or more years' experience working in nonclinical development, toxicology, and/or veterinary medicine in the pharmaceutical, biotechnology, life sciences consulting and/or contract service industries * Prior experience and knowledge in working with Contract Research Organizations (CRO) including general study design and conduct, study monitoring, technical and scientific aspects of study execution including common routes of administration and species * Must possess current knowledge and expertise in regulated drug development processes * Excellent track record of successfully authoring quality nonclinical regulatory documents * Knowledgeable in regulatory guidance documents, precedents and GLP regulations * Excellent communication skills and ability to effectively address scientific and regulatory questions under pressure * Strong sense of teamwork and demonstrated experience working with project teams, clients and regulatory personnel * Must be detail-oriented, with an ability to think critically and innovatively * Demonstrated track record of managing multiple projects and client accounts simultaneously, preferably in a consultancy setting * Ability to synthesize complex technical information and present it clearly to diverse audiences. * Must have a client service minded attitude and be able to travel This is a remote position working from your home location with travel as needed for client and business needs. We are a small company and at this time are unable to sponsor candidates for employment. Our most valuable resource is our people. We hire intelligent, creative, passionate professionals with a strong desire to learn. At its core - collaboration, camaraderie, growth, and collective hard work without egos - our culture is one that encourages, supports, and celebrates our colleagues! We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development. Additionally, we offer the following benefits: medical, dental, vision, FSAs, HSA, EAP, Life insurance, disability insurance, 401K with company contribution, ESOP, Holidays, and PTO. The annual base salary for this position ranges from $85,000 - $175,000 depending on qualifications and experience. Any offered salary is based on internal equity, internal salary ranges, market data/ranges, applicant's skills and prior relevant experience, certain degrees, and certifications. Please send a cover letter and curriculum vitae or resume to [email protected]. Applications without a cover letter will not be reviewed. SciLucent is an equal opportunity employer. We thank all applicants for their interest and effort in applying for our open position; while all applicants will be considered, only candidates selected for interviews will be contacted.
    $85k-175k yearly 60d ago
  • Postdoctoral Fellow - Genomic Medicine

    Md Anderson Cancer Center

    Remote job

    The Wang Laboratory at MD Anderson Cancer Center is a computational biology research lab. We apply innovative bioinformatics approaches to dissect the tumor 'ecosystem', deeply profile tumor cells and cells of the tumor microenvironment as well as tumor-immune-stroma crosstalk at single-cell resolution and in the spatial context. The lab's key focus areas include: 1) Transition from premalignant lesions to invasive cancer; 2) Evolution of metastasis from a localized tumor; 3) Dynamic response to anti-cancer therapies and the development of therapeutic resistance. Leveraging cutting-edge single-cell and spatial multi-omics technologies, cellular imaging, and innovative bioinformatics tools and computational frameworks, we aim to harness the potential of big data to fight cancer. Our overarching goal is to advance our understanding of the cellular & molecular cues underlying early tumorigenesis, disease progression, and the development of therapy resistance and translate our novel discoveries into improved patient care. We are seeking multiple talented and highly motivated Postdoctoral Fellows with a strong background in bioinformatics and a passion for exploring the heterogeneity and evolution of tumor cells and tumor microenvironment using the state-of-the-art single cell and spatial multi-omics approaches. *LEARNING OBJECTIVES* Gain skills in single cell, spatial omics, and imaging data analysis, immunogenomics, immune-informatics, and cancer-specific bioinformatics. Develop expertise in study design, data analysis, data interpretation, presentation, manuscript and grant writing All duties and responsibilities are carried out in compliance with institutional policies, ethical research standards, and applicable federal and state regulations. *ELIGIBILITY REQUIREMENTS* Individuals with a PhD degree in computational biology, bioinformatics, data science or a related field are encouraged to apply. A strong computational background, proficiency in R and at least one additional scripting language (e.g., Python) and knowledge in biostatistics are required. Experience working with single cell and spatial omics data analysis and high-performance computing environment (Unix/Linux) is highly preferred. A good understanding of cancer biology, immunology, cell biology, and molecular biology is also preferred. Proven track record of publications, excellent spoken and written communication skills are required *ADDITIONAL APPLICATION INFORMATION* Interested applicants should send a Cover Letter specifying past research experience/skills/accomplishments, a Curriculum Vitae and the contact information of three (3) Referees to Dr. Linghua Wang at ********************** with the subject line entitled "Postdoctoral Fellow - Application - Applicant's Name". *POSITION INFORMATION* Offsite work arrangements are subject to approval and may be modified or revoked at any time based on business needs, performance considerations, or regulatory requirements. This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment. It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. ************************************************************************************************ *FACULTY MENTOR* Dr. Linghua Wang
    $34k-51k yearly est. Easy Apply 60d+ ago
  • Senior SQL and Power BI Developer

    TPI Global (Formerly Tech Providers, Inc.

    Remote job

    Role: Senior SQL and Power BI Developer Duration: 12+ months contract Note: Please note that although the position is 100% remote, the live scan will be conducted onsite at our Downey HQ location. This position is for developing Power BI dashboards with advanced DAX, data modeling, and performance tuning and a strong SQL expertise in PL/SQL and T/SQL for building and optimizing database solutions. Position Description: A Senior Programmer is responsible for leading and/or working on the most complex IT applications design, documentation, development, modification, testing, installation, implementation and support of new or existing applications software. This classification may also plan, install, configure, test, implement and manage a systems environment in support of an organization's IT architecture and business needs. Common organizational or functional industry position titles for programmers include but are not limited to programmer analyst, applications developer, software engineer, software developer, software quality assurance specialist, systems programmer, systems software programmer, database administrators, computer systems analysts, systems engineer, systems software engineer. The Senior Programmer, in development of applications software, is responsible for analyzing and refining systems requirements;translating systems requirements into applications prototypes;planning and designing systems architecture;writing, debugging and maintaining code;determining and designing applications architecture;determining output media/formats;designing user interfaces;working with customers to test applications;assuring software and systems quality and functionality;integrating hardware and software components;writing and maintaining program documentation;evaluating new applications software technologies;and/or ensuring the rigorous application of information security/information assurance policies, principles and practices to the delivery of application software services. The Senior Programmer, in development of operating systems, is responsible for analyzing systems requirements in response to business requirements, risks and costs;evaluating, selecting, verifying and validating the systems software environment;evaluating, selecting and installing compilers, assemblers and utilities;integrating hardware and software components within the systems environment;monitoring and fine-tuning performance of the systems environment;evaluating new systems engineering technologies and their effect on the operating environment;and/or ensuring that information security/information assurance policies, principles and practices are an integral element of the operating environment. Skills Required: The Senior Programmer will possess knowledge and experience in applications software development principles and methods sufficient to participate in the design, development, testing and implementation of new or modified applications software;operating systems installation and configuration procedures;organization's operational environment;software design principles, methods and approaches;principles, methods and procedures for designing, developing, optimizing and integrating new and/or reusable systems components;pertinent government regulations;infrastructure requirements, such as bandwidth and server sizing;database management principles and methodologies, including data structures, data modeling, data warehousing and transaction processing;functionality and operability of the current operating environment;systems engineering concepts and factors such as structured design, supportability, survivability, reliability, scalability and maintainability;optimization concepts and methods;establish and maintain cooperative working relationships with those contacted in the course of the work;and speak and write effectively and prepare effective reports. Possess advanced knowledge of SQL, encompassing intricate query optimization techniques, nuanced data manipulation strategies, and a keen ability for fine-tuning database performance. Proficiency extends to crafting queries that operate efficiently even with large datasets, ensuring optimal processing times and minimal resource usage. Demonstrate expertise in working with diverse and popular database management systems such as Oracle, MySQL, SQL Server, and Azure SQL. Proficiency includes database administration, schema design, and the seamless execution of operations across various platforms, showcasing adaptability and proficiency in different environments. 3. Exhibit a strong understanding and extensive experience in Oracle PL/SQL programming. This expertise encompasses the development and optimization of intricate stored procedures, triggers, and functions. Proficiency in PL/SQL ensures the seamless execution of complex tasks, enhancing database functionality and performance. Showcase the ability to design efficient data models that facilitate optimal storage and retrieval of information. Proficiency in creating robust data structures ensures streamlined access to relevant data, enhancing overall database efficiency and reducing query complexity. Demonstrate a comprehensive understanding of Extract, Transform, Load (ETL) processes and tools and scripting languages like Python, Perl, or Shell scripting for automating and data manipulation. Proficiency in integrating data from diverse sources into the database showcases the ability to harmonize disparate datasets, ensuring data consistency, accuracy, and reliability. Exhibit a strong ability to optimize both database queries and underlying structures. Proficiency in query optimization techniques and structural refinements enhances database performance and responsiveness. Skills in identifying and rectifying bottlenecks contribute to streamlined operations. Possess knowledge of data warehousing concepts and tools, enabling effective management of vast volumes of data. Expertise in data warehousing ensures efficient storage, retrieval, and analysis of large datasets, supporting the organization's data-driven decision-making processes. Display proficiency with Power BI, including crafting insightful visualizations and reports that translate raw data into valuable, actionable insights. Demonstrate proficiency in utilizing version control systems like Git to effectively manage and track changes in database scripts and queries. Expertise in version control ensures systematic tracking of modifications, enabling collaboration, maintaining code integrity, and facilitating seamless integration of changes into the database systems. Experience Required: This classification must have a minimum of seven (7) years of experience in electronic data processing systems study, design, and programming. At least four (4) years of that experience must have been in a lead capacity. 4 years of experience in the past 7 years writing complex SQL queries, optimizing database performance, and ensuring data integrity across various database management systems, including Oracle, MySQL, SQL Server, and Azure SQL. 3 years of experience in the past 4 years working with advanced skills in Oracle PL/SQL or similar procedural languages, adept at developing efficient stored procedures, triggers, and functions for seamless database operations. 3 years of experience in the past 4 years working with designing and optimizing database schemas, ensuring scalability, data normalization, and efficient indexing for high-performance transactional systems. 3 years of experience in the past 4 years working with developing intricate reports and visualizations using tools such as Cognos, Power BI, or Crystal Reports, transforming raw data into meaningful insights for diverse stakeholders. 3 years of experience in the past 4 years working with Implementing robust ETL processes, integrating data from diverse sources into data warehouses flawlessly, ensuring accuracy, consistency, and reliability of data for analytical purposes. 3 years of experience in the past 4 years working with Providing technical leadership to junior developers, conduct thorough code reviews, offer mentorship, and foster a collaborative environment within the team. 2 years of experience in the past 4 years working with communicating complex technical concepts clearly to both technical and non-technical stakeholders, ensuring a shared understanding of database solutions and their alignment with business objectives. 3 years of experience in the past 4 years working with complex database issues, debugging code, and optimizing queries for peak performance. 2 years of experience building Power BI reports. 2 years of experience in the past 4 years maintaining comprehensive documentation of database schemas, stored procedures, and ETL processes, ensuring knowledge accessibility and smooth transfer within the team. Education Required: This classification requires the possession of a bachelor's degree in an IT-related or Engineering field. Additional qualifying experience may be substituted for the required education on a year-for-year basis. Bachelors in computer science, data analytics, or a related field.
    $84k-111k yearly est. 8d ago
  • Sr Manager Biostatistics

    Dexcom 4.7company rating

    Remote job

    The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. About the Company: Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes. Meet the team: The Sr Manager Biostatistics will lead a team of biostatisticians supporting all phases of clinical development, from feasibility to pivotal and post-market studies. This role provides strategic statistical guidance, ensures high-quality deliverables, and drives cross-functional collaboration to support regulatory submissions and scientific publications. We have a fast-paced environment and are looking for dynamic people that want to work on an amazing life-changing technology. Where you come in: Lead a team of biostatisticians, managing performance, resource planning, prioritization and timelines. Direct statistical design, analysis, and reporting for feasibility, pivotal, post-market, and RWE clinical studies. Provide strategic guidance on study design, protocol development, CRF review, endpoint selection, statistical analysis methods, and definition of acceptance criteria. Lead or oversee the development and execution of Statistical Analysis Plans (SAPs), ensuring data integrity and analytical rigor. Guide statistical contributions to regulatory submissions (e.g., IDEs, PMAs, 510(k)s) and represent Biostatistics in interactions with regulatory agencies. Support scientific publications through data analysis and interpretation for abstracts, posters, and manuscripts. Collaborate with cross-functional teams including Data Management, Clinical, R&D, Regulatory Affairs, and Medical Affairs. Identify and implement innovative statistical methodologies to address complex study challenges. Ensure adherence to internal standards, regulatory requirements, and industry best practices. Communicate project status, risks, and scope changes to leadership. Provide statistical consultation across departments and perform other duties as assigned. What makes you successful: Experience managing biostatistics teams and operations. Strategic thinker with strong decision-making skills. Proficient in statistical methods and programming; expertise in advanced techniques preferred. Capable of independent work and team leadership with minimal oversight. Strong SAS programming skills; R experience is a plus. Excellent communication and collaboration skills. What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required 0 - 5% Experience and Education M.S. in Biostatistics, Statistics, Data Science, or related field with 10+ years of experience; Ph.D. preferred. Minimum 2 years of team management or supervisory experience. Industry experience in pharmaceutical, medical devices, or biotechnology highly desirable. #LI-Remote Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $156,400.00 - $260,600.00
    $156.4k-260.6k yearly Auto-Apply 45d ago
  • Sr. R&D Procurement Specialist

    Grns

    Remote job

    We're so happy you're here! Thank you for checking our job out and we hope to have the chance to meet you in our interview process! About the role We're looking for an Sr. R&D Procurement Specialist to fuel Grüns' innovation pipeline by finding, vetting, and delivering the very best ingredients - fast. This role sits at the intersection of science and sourcing, combining a curiosity for what's next in nutrition with the rigor to evaluate ingredient efficacy, quality, and feasibility. You'll uncover novel and proven actives, build supplier partnerships, and critically assess clinical evidence (especially for branded ingredients) to ensure our formulations are both effective and defensible. This role collaborates closely with R&D, Product Development, Quality, Regulatory, and Operations, and reports directly to our Sr. Manager, R&D within the Product organization. This is a remote HQ role - we operate in a fully remote, high-trust environment and meet bi-annually for energizing in-person offsites. Occasional travel to suppliers, audits, and industry events (e.g., SupplySide, NPEW) is expected. In this role, you will: Source & Scout Proactively identify ingredients (botanicals, minerals, vitamins, fibers, functional actives, flavors, excipients) with a focus on clinically supported, label-friendly, and gummy-compatible options. Build and maintain a competitive inventory of ingredients, capturing efficacy claims, standardization markers, and differentiation potential. Evaluate the Science Critically assess clinical and preclinical data for candidate ingredients, evaluating study design, endpoints, dosage, and reliability. Summarize findings in clear, decision-ready briefs for Product and Brand to support innovation and claims. Qualify & Negotiate with Suppliers Lead supplier due diligence, including quality questionnaires, certifications (GFSI), audit coordination, CoA review, and method validation (e.g., HPLC, ICP-MS). Review contaminant, micro, and allergen specs, and negotiate MOQ, lead times, and sample delivery for pilot and scale-up trials. Enable Fast Formulation Partner with R&D to maintain a living ingredient portfolio considering cost, stability, sensory impact, and manufacturability. Support formulation timelines through proactive communication and data organization. Operationalize & De-risk Build supply resiliency through multi-tier sourcing and vendor diversification. Collaborate with QA to ensure ingredient qualification, traceability, and acceptance criteria are met. Cross-Functional Collaboration Work with R&D on trials and V2 improvements, Ops on PO timing and inventory planning, and Brand on credible ingredient storytelling. Support CX with ingredient FAQs and claims accuracy. We're looking for someone who: 2-4 years of experience in ingredient sourcing, procurement, or ingredient science within CPG, nutraceuticals, or food-tech (gummy experience a plus). Hands-on experience with supplier qualification, audits, and sustainability questionnaires, and experience negotiating commercial terms. A Bachelor's degree in Food Science, Nutrition, Chemistry, Biology, or a related field. Strong understanding of clinical research methods (RCTs, meta-analyses, confidence intervals, power, bias, validity). Fluency in quality and analytical fundamentals - CoA review, potency/purity testing, stability, and shelf-life considerations. Excellent communication skills - able to translate scientific and technical detail into actionable insights for diverse teams. Approach to the role: Scientifically curious: constantly learning and scanning the market for new, validated ingredients. Operationally sharp: builds structure, documentation, and repeatable systems for scale. Cross-functional collaborator: aligns science, product, and operations seamlessly. Quality-driven: never compromises on data integrity or sourcing standards. Strategic communicator: translates complex data into clear, confident recommendations. At Grüns, we're committed to providing a competitive total compensation package - grounded in market data that considers our size, stage, and industry. For this role, the base salary range is $80,000-$100,000, depending on experience. Beyond base salary, we offer competitive equity packages and a comprehensive set of benefits designed to support your well-being, growth, and balance. A bit about us... At Grüns, we believe that foundational nutrition should be simple and convenient for everyone. We're dedicated to bringing comprehensive and real nutrition to you through our gummies, formulated from 60 nutrient-dense and whole-food ingredients. Simply enjoy a grab-and-go snack pack of gummies daily whenever fits best in your schedule and wherever life takes you. Like you, we were disappointed. There's an infinite number of “nutrition” companies, all focused on what's best for them - not what's best for you. Hundreds of products to sell you on, low-quality ingredients, and small nutrient doses. We've seen it all. So we decided it was time to fix it. No more choking on and popping pills like a pharmacy. No more clean-up and disgust from gross powders. And no more cobbling together handfuls to dozens of supplements. Grüns is comprehensive nutrition, made convenient and delicious. What we care about... Autonomy: Only the best work at Grüns. We're all confident, independent leaders. We are proactive. We find opportunities for improvement. Don't ask; just do. When our actions impact other areas of the organization, we communicate with those functional leaders to ensure connectivity. Growth: We love to take on new challenges, learn new things, and express interest in new functions. “I've never done this before” is not an excuse; it's an opportunity. Community: We care deeply about each other. We're good humans and provide support wherever we can. We care, not just professionally but personally as well. Compensation & Perks: For every role, we aim to have highly competitive compensation and opportunity for impact and career growth. Everyone at Grüns works hard, but we believe in wellness and balance too. We have super strong benefits coverage -- for you and your family, generous PTO, free Grüns subscriptions, and a few more perks centered around health and well-being that we can't wait to tell you about!
    $80k-100k yearly Auto-Apply 29d ago
  • Senior Project Toxicologist / Scientific Lead

    Zoetis 4.9company rating

    Remote job

    Zoetis Veterinary Medicine Research and Development (VMRD) is seeking a highly accomplished Sr. Project Toxicologist to join the Toxicology group within Clinical Pharmacology and Safety Sciences in Kalamazoo, MI. This senior scientific role provides technical strategy, regulatory expertise, and project toxicology leadership in toxicology, ensuring the human food safety and user safety of our innovative veterinary medicines and established products. The responsibilities include: Scientific Leadership: Serve as a senior subject matter expert and individual contributor, representing Toxicology on cross-functional project teams. Lead program-level toxicology strategy for product development, ensuring scientific approaches and safety assessments are aligned with global standards from discovery through post-approval. Portfolio Impact: Apply cross-program toxicology and risk assessment expertise to anticipate safety challenges and provide project-level safety risk-based assessments. Contribute toxicology input that supports portfolio decision-making across therapeutic areas and development stages, with safety risks clearly articulated and considered in governance reviews, risk/benefit assessments, and senior leadership discussions on program prioritization. Regulatory Submissions and Engagement: Prepare and defend technical dossiers and submissions to global health authorities, including establishing key safety thresholds (e.g., PoD, ADI, PDE, MRL, TTC, etc.). Lead interactions with regulators and address complex safety questions through meetings, written responses, and position papers. Nonclinical Safety Assessment: Independently design, oversee, and interpret toxicology programs, integrating data into comprehensive safety packages. Ensure compliance with international guidance, with emphasis on human food safety and user safety assessments. Mutagenic Impurities Assessment: Lead the evaluation of mutagenic and genotoxic impurities in accordance with global regulatory guidance (e.g., ICH M7, VICH). Design and interpret studies, assess risk, and provide regulatory justifications to ensure compliance and product safety. Innovative Approaches & 3Rs: Champion the use of New Approach Methodologies (NAMs), next-generation risk assessment tools, and weight-of-evidence frameworks. Apply waiver approaches where scientifically justified and promote 3Rs principles to advance ethical, efficient, and innovative toxicology strategies. Cross-Disciplinary Collaboration: Partner with Discovery and Computational Toxicology, Pathology, PKPD, Human Food Safety Residue, Microbial Safety, Target Animal Safety, Occupational Toxicology, Chemistry, Environmental Safety, Global Regulatory Affairs, and other disciplines to elucidate toxicology findings of concern for research and development programs. External Influence: Represent Zoetis in scientific forums and industry consortia, including VICH and industry associations. Contribute to the development of regulatory guidance, publish peer-reviewed research, and present findings at both internal and external scientific meetings. Regulatory Intelligence: Monitor evolving trends in human and veterinary pharmaceutical and chemical regulation, proactively assessing implications for Zoetis' products, testing requirements, and manufacturing. Travel Requirement: This role involves up to 10% travel for collaborations, regulatory engagements, or conferences as needed. Minimum Skills: PhD (or equivalent) in toxicology or a closely related discipline (e.g., pathology, pharmacology, physiology, medicinal chemistry). At least 10 years of experience as a Project toxicologist in nonclinical safety assessment in veterinary or human health, spanning both small molecules and biologics/large molecules. Experience in developing regulatory strategy for drug development, including innovative study designs, and the ability to interpret, integrate, and apply toxicology data for veterinary and human safety assessment. Advanced expertise in safety risk assessment and interpretation of toxicological findings from in vivo, in vitro, in silico, and non-animal methodologies, applying weight-of-evidence approaches to support regulatory decision-making. Demonstrated expertise across multiple toxicology work streams, such as systemic in vivo toxicity in rodents and non-rodents (general toxicology and specialty areas including neurotoxicity, immunotoxicology, and cardiovascular safety). Working knowledge of global regulatory requirements and expectations (e.g., VICH, FDA, EMA, USDA etc.), with direct experience preparing submissions and engaging with health authorities. Highly organized with strong problem-solving skills, able to prioritize effectively, make informed decisions, and collaborate in a matrix environment. Strong interpersonal skills, with the ability to build lasting relationships and influence without direct authority and provide scientific leadership in project teams and cross-functional settings. Excellence in technical writing and scientific communication (regulatory documents, protocols, reports, journal articles, dossiers, etc.). Desirable skills, experience, and attributes: DVM is highly valued. Board certification (DABT) is strongly preferred. Experience conducting human food safety and user safety risk assessments. Experience applying innovative approaches (e.g., NAMs, next-generation risk assessment tools, 3Rs strategies, waiver approaches) in toxicology assessments. Demonstrated ability to influence the external environment (e.g., regulators, policymakers, industry consortia, scientific organizations). Experience contributing to or shaping regulatory guidance through participation in working groups (e.g., VICH, ICH, etc.). Direct experience in the industry or CRO, particularly in conducting and reporting GLP repeat-dose (including chronic) toxicology studies. The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors. Base Pay Range: $137,000 - $197,000 The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and other factors. Base Pay Range: $155,000 - $223,000 [This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.] We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $155k-223k yearly Auto-Apply 60d+ ago
  • Senior Epidemiologist

    Tempus Ai 4.8company rating

    Remote job

    Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. The Outcomes Research team at Tempus partners with external life science partners to provide best-in-class data, analysis, and methodological guidance to Tempus's real-world data offering. We are seeking a highly motivated and capable epidemiologist with extensive experience and interest in the design and analysis of pharmacoepidemiological studies to join our team. Responsibilities: Contribute to the design and execution of RWE studies by developing protocols, crafting statistical analysis plans, and creating analysis deliverables such as table shells, leveraging Tempus's data to support external Pharma Medical Affairs, HEOR, and RWE team objectives. Lead independent analysis of Tempus data for Pharma RWE studies, involving extensive coding, comprehension of Tempus molecular and clinical data, acquisition of oncology-specific clinical insights, derivation of real-world endpoints using time-to-event methodology, and staying abreast of current NCCN guidelines and the evolving oncology landscape within a retrospective database. Present insights from RWE studies to external Pharma epidemiologists and medical liaisons through formal presentations, providing strategic recommendations. Communicate research findings effectively, interpreting results and drawing appropriate inferences based on study design/statistical methods, while also evaluating study limitations. Collaborate with internal product, engineering, oncology, bioinformatics, and clinical abstraction teams to continually enhance Tempus data quality and feature builds for retrospective analysis. Work with translational research and computational biologists to analyze Tempus sequencing data within RWE studies. Stay updated on methodological advancements in real-world studies, oncology guidelines, and ongoing clinical trials. Demonstrate proficiency in various types of RWD and their suitability for analysis, distinguishing between retrospective RWD, clinical trials, and other prospective observational study designs, and articulating their advantages and limitations. Ensure compliance with all relevant regulations and company procedures. Required Experience: Masters or Phd Degree in epidemiology, biostatistics, health economics or a related discipline and 5+ years of post-grad experience Experience in conducting observational retrospective analyses in oncology including a published track record. Computational skills using R and SQL, especially relevant statistical tools and packages Ideal candidates will possess: Prior involvement in oncology Phase II-IV clinical trials or proven expertise in analyzing RWD studies, including utilization of claims, EHR, or registry data. Demonstrated experience interfacing with clients or in a consulting capacity, showcasing adeptness in presenting results to stakeholders. Proficiency in navigating large, complex problems within a fast-paced environment. Meticulous attention to detail coupled with a commitment to delivering analytics of the highest quality and punctuality. A collaborative mindset, coupled with a genuine eagerness to learn and a steadfast dedication to maintaining integrity in all endeavors. Direct involvement in assisting with the preparation of regulatory submissions to the FDA or EMA Proficiency in machine learning techniques, with a nuanced understanding of the strengths and limitations of various approaches, particularly regarding predictive and prognostic algorithms in medical research. Familiarity with cancer genetics, immunology, or molecular biology. CHI: $100,00 - $160,000 USD NYC/SF: $115,000-$175,000 USD The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
    $45k-88k yearly est. Auto-Apply 7d ago
  • Director, Statistical Innovation

    Amgen 4.8company rating

    Remote job

    Career CategoryResearchJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director, Statistical Innovation (DSI) What you will do Let's do this! Let's change the world. In this vital role you will critical expertise and leadership in the design and planning of innovative development programs and clinical trials. Responsibilities: Guides Product Strategy and Study Design Promotes innovative design options and fit-for-purpose analysis approaches that address appropriate clinical questions in protocol / program design and balance speed, quality, and cost Provides advisory input in the development of the Global Statistical Strategic Plan (GSSP) to align study design and statistical approaches with product strategy and Evidence Generation Plan (EGP) Reviews key phase 2 and 3 protocols and provides input during the TA TRC review Provides Technical Expertise Provides technical expertise to GSL and EGT on innovative study designs and advanced analytical methods Provides design options and simulation specifications to the Simulation and Modeling team and develops and approves the simulation plan and results Interprets and communicates modeling and simulation results to inform and guide the selection of optimal trial designs Provides guidance and training to the Simulation and Modeling biostatisticians. Builds Cross-functional Network Develops positive relationships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA ‘team' approach when interacting with product teams Forms relationships with counterparts in EGTs to help drive the importance of Design consultation throughout the end-to-end clinical development process Establishes relationships with TA TRC members to ensure alignment in development strategies Promotes the advancement of innovative designs and analysis methods Builds professional network with external peers in innovative designs and analysis methods Promotes awareness of innovative designs and analysis methods by coordinating and providing internal training sessions What we expect of you We are all different, yet we all use our unique contributions to serve patients. The director we seek has these qualifications. Basic Qualifications: Doctorate degree and 4 years of Biostatistics/Statistical experience Or Master's degree and 8 years of Biostatistics/Statistical experience Or Bachelor's degree and 10 years of Biostatistics/Statistical experience Preferred Qualifications: 10 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, implementation, analysis and reporting Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc. Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research Proven experience with both conventional and innovative trial designs (including adaptive and/or Bayesian) in different phases of drug development Expertise in advanced statistical analysis methods, modeling and simulation Knowledge of multiple disease areas and related regulatory guidelines Experience in leading regulatory and/or reimbursement submissions Strive for innovation and quick adaptation to new industry trends Well recognized statistical and strategic leadership among statisticians and cross-functional teams External visibility in biostatistics profession (e.g., through industry committees/forums, links to academia) Scientific research/publications in one or more areas of statistical science Strong technical and effective communication skills Managerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resources What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 217,725.00 USD - 246,888.00 USD
    $99k-135k yearly est. Auto-Apply 22d ago
  • Pharma Physician Development Program (Associate Director)

    Astellas Pharma 4.9company rating

    Remote job

    Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Pharma Physician Development Program is a premier two-year rotational program designed to equip high-potential clinicians with critical insights into the pharmaceutical industry while fostering business acumen, leadership skills, and scientific expertise. Through three diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain hands-on exposure to key functions that drive product innovation and patient impact. Throughout the program, participants will receive in-depth training on the Product Development Lifecycle, develop essential leadership abilities, and gain valuable knowledge and experience working with cross functional teams to support Product Life Cycle Management. This experience is supported by mentorship and networking opportunities that create lasting foundations for career success in the pharmaceutical industry. Responsibilities and Accountabilities: Participants will contribute to Astellas programs across three key functional areas and gain a 360 degree view of drug development. This will require participation in 3 specialized rotations: Clinical Development (12 months) Collaborate as part of the leadership of the clinical team to support the definition of the clinical hypothesis, the clinical development plan (CDP) including Life Cycle Management (LCM) and execution of clinical programs. Engage in clinical study design, preparation of essential clinical documents (e.g., Investigator Brochure, Protocols, Clinical Study Reports), and global health authority interactions. Participate in medical monitoring, clinical safety and efficacy data review, and evidence generation strategy creation based on stage of product development. Support clinical and program risk assessment and mitigation planning Work cross-functionally on study-level activities (including operational readiness and execution required to deliver trials within timelines and budgets), stakeholder collaborations within matrix-based Asset Maximization teams to support efficient and timely decision making at governance discussions. Medical Affairs (6 months) Support the development and execution of regional growth strategies, planning the MA strategy aligned with LCM nd alignment of Global Brand Strategies. Identify medical data gaps based on SWOT analyses lead Medical Affairs scientific initiatives, participate in Medical Legal Review (MLR) and support internal training programs for field teams (e.g., MSLs and Sales Reps ). Drive the design and execution of clinical and Real-World Evidence (RWE) studies, as well as HEOR initiatives for data generation advisory boards and external engagement for strategic insight collection, publication and congress planning, medical communications and medical education programs. Embed agile ways of working while fostering collaboration across commercial and Medical teams. Pharmacovigilance (6 months) Develop hands-on experience in safety monitoring and risk management throughout the drug lifecycle. Develop an understanding of global pharmacovigilance regulations by engaging in activities such as signal management, aggregate reporting, and causality assessment in individual case safety reporting. Develop an understanding of optimizing the benefit-risk profile of a product by participating in Safety Management Teams, Benefit Risk Teams and engaging in risk management planning and product label discussions. Collaborate with teams on inspection readiness, QMS reviews and CAPAs. Learn the fundamentals of relevant databases (e.g., LSLMV), dictionaries (e.g. MedDRA) and their use in both pre- and post-marketing safety surveillance. Throughout the Program Participants will benefit from additional developmental opportunities, including: Business Acumen Training: Gain specialized knowledge of Astellas' business processes, operational frameworks, and market dynamics. Product Development Lifecycle Training: Develop a comprehensive understanding of the pharmaceutical innovation process, from concept to commercialization. Leadership Skill Development: Build core leadership capabilities through mentorship, direct industry exposure, and structured training programs. Cross-Functional Insights: Connect with and learn about relevant functions, including commercial, regulatory, and clinical teams, while engaging in collaborative decision-making processes. Why Join the Program? This program offers: Mentorship: Receive guidance from experienced leaders across scientific, clinical, and business disciplines. Leadership Development: Participate in curated experiences designed to build strategic leadership skills for success in the pharmaceutical industry. Pharmaceutical Insight: Gain immersive exposure to Clinical Development, Medical Affairs, and Pharmacovigilance. Cross-Functional Networking: Engage with professionals across global and diverse teams, fostering collaboration and networking opportunities. Embark on a transformative journey into the pharmaceutical industry that will position you as a future leader in clinical, medical, and scientific innovation.
    $73k-119k yearly est. 2d ago
  • 1042-Senior Real-World Evidence (RWE) Analyst / Programmer-REMOTE-FTE

    Clinchoice

    Remote job

    ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Real-World Evidence (RWE) Analyst/Programmer on a permanent basis. Join our team: you can be part of making a difference in people's lives and experience a fulfilling and rewarding career! Main Job Tasks and Responsibilities: Design and execute statistical programming to support real-world evidence studies. Work with observational datasets such as claims, EHR, and registries. Apply appropriate statistical methodologies (e.g., propensity score matching, regression modeling, survival analysis). Develop, validate, and maintain reusable SAS and R macros or functions. Collaborate with epidemiologists, statisticians, and HEOR experts on study design and data interpretation. Contribute to protocol development, statistical analysis plans (SAPs), and final reports or publications. Ensure compliance with data governance, privacy (e.g., HIPAA), and company policies Requirements: Bachelor's or Master's degree in Biostatistics, Statistics, Epidemiology, Computer Science, or a related field. 5+ years of experience in statistical programming within life sciences, with at least 3 years in RWE or observational research. Strong programming experience in SAS and R. Hands-on experience with real-world data sources (e.g., MarketScan, Optum, Flatiron, IQVIA, Cerner). Strong knowledge of epidemiologic and statistical methods used in observational research. Experience with regression models, survival analysis, propensity score techniques, etc. Ability to interpret results and generate insights that are meaningful to cross-functional teams. Excellent communication skills and ability to work independently. Preferred Qualifications Familiarity with clinical trial data and integration with RWD. Knowledge of data visualization in R (ggplot2, Shiny, etc.). Experience working in pharma/biotech or CRO setting. Understanding of FDA and EMA guidelines on RWE. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-#TT1 #LI-Remote #Senior #FTE
    $83k-108k yearly est. Auto-Apply 60d+ ago

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