Director, Clinical Pharmacology remote jobs - 208 jobs

**Job Description**The 2-year Physician Scientist Program provides pharmaceutical medicine training and opportunities to physicians completing residency or fellowship with the goal of recruiting new talent and contributing to the organization's inclusion objectives. The program provides in-depth exposure to clinical drug development with emphasis on key elements of clinical trial planning, execution, data analysis and reporting of clinical trial results. Physician Scientists will develop skills working with clinical and cross-functional teams as clinical programs progress toward regulatory approvals.Successful candidates will spend their first year in one of the following areas: (a) **Global Clinical Development:** Understand the role and methods of pharmaceutical research, participate in the writing of research protocols, conduct of clinical trials, safety monitoring, analysis of data and communication of study findings; (b) **Global Regulatory Affairs and Clinical Safety:** Focus on late-stage and lifecycle drug activities, understand key regulatory policies and the procedures for interacting with health agencies (e.g. FDA); understand key elements in pharmacovigilance, drug safety monitoring, signal detection and processing of adverse reports; (c) **Global Medical/Scientific Affairs:** Exposure to the management of a product asset prior to, during and after the launch phase (US and Global) including caveats on drug promotion. After a successful first year, the Physician Scientist will be equipped to assume a leading role in the team with additional responsibilities and interactions. The Physician Scientist also has the opportunity to do a second 1-year rotation in another area instead.**Required Education and Experience:*** Candidates must currently hold an MD degree and have completed residency or fellowship training in an accredited US medical program, preferably within the last 5 years.**Required Skills:**Clinical Development, Clinical Research, Clinical Sciences, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Communication, Drug Development, Drug Research, Ethical Standards, Good Clinical Practice (GCP), Medical Research, Medical Writing, Pharmaceutical Research, Pharmacy Regulation, Protocol Development, Regulatory Policies, Research Proposals, Scientific Consulting, Scientific Research**Preferred Skills:**Current Employees apply Current Contingent Workers apply**US and Puerto Rico Residents Only:**Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.**U.S. Hybrid Work Model**Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The salary range for this role is$190,800.00 - $300,300.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance**Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.**Employee Status:**Regular**Relocation:****VISA Sponsorship:****Travel Requirements:****Flexible Work Arrangements:**Hybrid**Shift:****Valid Driving License:****Hazardous Material(s):****Job Posting End Date:**01/30/2026**\*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.** #J-18808-Ljbffr

Job Details Position Type: Full Time Travel Percentage: Minimum of 2x/year to Boston area Job Category: Biotech The Opportunity: We are seeking highly engaged individuals to represent Praxis Precision Medicines in the role of Medical Science Liaison. In this field‑facing role you will provide a critical link to Health Care Providers, clinical trial sites and personnel, and both professional and patient organizations. You'll be responsible for building long‑term relationships with key stakeholders through targeted scientific exchanges and respond to unsolicited requests for information about the company's development programs and products. We are seeking to fill multiple positions for this role, which involves 50% to 75% travel. We offer flexibility on candidate location, including temporary out of region residency options for exceptional candidates who are a strong match for both the role and company. Primary Responsibilities Develops and/or delivers presentations to Healthcare Professionals (HCPs), Academic Institutions, payors, patient advocacy groups, and professional organizations. Represents the company in medical scientific congresses and conferences. Develops, organizes, and carries out Advisory Boards, Round Tables, Regional Medical Meetings, Symposia, as needed. Educate investigators and site staff on trial protocols, eligibility criteria and ensure that there is a thorough understanding of the investigational product being used in the study. Identify new trial sites and work with established sites to accelerate enrollment of subjects. Stays current on therapeutic areas of interest for the company and competing development programs. Supports adherence to relevant regulatory requirements and Company Policies and Standard Operation procedures (SOPs). Qualifications and Key Success Factors Experience managing the support of clinical development programs and/or commercialized products in Neurology, in particular Movement Disorders or Epilepsies. Advanced degree (e.g., PharmD, M.D. or Ph.D.) in a scientific discipline and 3 to 5+ years' experience in an MSL role. Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment. Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms. Highly organized and detail‑oriented with a passion to deliver quality results. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices. Compensation & Benefits At Praxis, we're proud to offer an exceptional benefits package that includes: 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans Bonus program structured to pay on a quarterly basis 401k plan with 100% match up to 6% of employee's contribution (Traditional & Roth) Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit Eligibility for equity awards and Employee Stock Purchase Plan (15% discount) To round out this world‑class total rewards package, we provide base salary compensation in the range of $155k to $170k annualized. Final salary range may be modified commensurate with job level, education, and experience. Company Overview Praxis Precision Medicines is a clinical‑stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency. #J-18808-Ljbffr

A leading automotive company is seeking a Senior Systems Data Scientist for their Autonomous Vehicle organization. This hybrid role involves developing data-driven methodologies to measure confidence in AV validation results, collaborating with cross-functional teams, and simplifying complex analytical methods. Candidates should have an advanced degree in data science or a related field, with at least 4 years of experience in data analytics, proficiency in Python and SQL, and strong communication skills. This position is pivotal for advancing AV technology. #J-18808-Ljbffr

A global biopharmaceutical company is seeking an Executive Medical Science Liaison in Seattle, WA to advance KOL partnerships in Respiratory therapeutic areas. The role involves engaging with healthcare professionals, delivering medical education, and supporting research initiatives. Candidates should have a graduate degree and extensive MSL experience, particularly in Asthma/COPD. The position offers a competitive salary and comprehensive benefits, emphasizing diversity, development, and sustainability. #J-18808-Ljbffr

Why Join Us? Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides - Helicons™ - capable of modulating intracellular proteins that are inaccessible to traditional drug modalities. Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead candidate, FOG-001, is the first direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in colorectal cancer, desmoid tumors, and a range of other Wnt/β-catenin-driven tumors. Parabilis is also advancing investigational degraders of ERG and ARON for the treatment of prostate cancer, as well as other preclinical programs. What's the opportunity? The Senior Director of Clinical Pharmacology & Pharmacometrics (CPP) provides scientific, functional, and operational leadership across assigned drug development programs. Reporting to the VP, Head of Clinical Pharmacology, this individual is responsible for designing and executing program-level clinical pharmacology and pharmacometric strategies, ensuring their integration into global development plans. The Senior Director works cross-functionally with Clinical Development, DMPK, Regulatory, and Biostatistics to optimize dose selection, study design, and quantitative decision-making from early to late development. Key Responsibilities Program Leadership and Strategy Lead the design and implementation of clinical pharmacology and pharmacometrics strategies for assigned programs, from early development through registration and lifecycle management. Integrate PK/PD modeling, exposure-response, and quantitative pharmacology to support data-driven decision-making and model-informed drug development (MIDD). Collaborate with the VP, Head of Clinical Pharmacology, to ensure alignment with the overall departmental and organizational strategy. Serve as the global CPP lead on cross-functional project teams, providing scientific guidance on study design, dose rationale, and risk-benefit assessment. Partner with Translational Medicine, Biomarker Sciences, and Biostatistics to incorporate quantitative and mechanistic insights into clinical development plans. Operational Excellence Oversee planning, conduct, and interpretation of clinical pharmacology studies (e.g., FIH, DDI, food effect, special population studies). Ensure timely and high-quality preparation of study protocols, analysis plans, and reports. Author and review clinical pharmacology sections of regulatory submissions (IND, CTA, NDA, BLA) and represent the function in interactions with global health authorities (FDA, EMA, PMDA, NMPA). Support cross-functional integration of modeling and simulation into global regulatory strategies and provide scientific input to agency queries. Modeling, Simulation & Innovation Apply and oversee population PK/PD, PBPK, exposure-response, and disease modeling approaches to support dose selection, trial design, and risk management. Promote the use of innovative modeling techniques, including AI/ML, Bayesian methods, and quantitative systems pharmacology. Drive implementation of new tools and processes that enhance the impact and efficiency of model-informed development. Leadership & Mentorship Provide scientific and functional leadership to clinical pharmacology and pharmacometrics team members working on assigned programs. Mentor and develop staff to foster scientific excellence, collaboration, and continuous learning. Contribute to departmental initiatives, best practice development, and knowledge sharing in partnership with the VP and other senior leaders. Represent Clinical Pharmacology in cross-functional governance discussions and external scientific forums. What you'll need to be successful: PhD, PharmD, MD, or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related quantitative discipline. 12+ years of experience in clinical pharmacology, pharmacometrics, or quantitative drug development in the biopharmaceutical industry. Demonstrated success in designing and leading clinical pharmacology strategies at the program or portfolio level. Strong understanding of regulatory expectations (FDA, EMA, PMDA, NMPA) for clinical pharmacology and modeling & simulation. Proficiency in modeling and data analysis tools (e.g., NONMEM, Monolix, Phoenix NLME, MATLAB, R). Proven ability to lead in matrixed environments, influence cross-functional teams, and drive decision-making. Experience with both small molecules and biologics; exposure to novel modalities (e.g., gene or cell therapies) preferred. Excellent communication, collaboration, and presentation skills. Demonstrated use of AI tools in your current role and responsibilities is required. Advanced or innovated use of AI is a strong plus. Core Values Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit. Growth-Minded. We're inventing a new class of medicines-one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable. In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options. Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact. All-In. We're All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history. The base salary range for this position is $250,000-300,000 per year, depending on experience, qualifications, and internal practices. Parabilis's total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees' overall well-being. As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law. 30 Acorn Park Drive | Cambridge, MA 02140 | ********************

The Role The role is positioned in the Clinical Pharmacology group, Clinical and Quantitative Pharmacology (CQP) function. This individual will bring strong technical and strategic expertise in clinical pharmacology, Model-Informed Drug Development (MIDD), representing CQP on program teams, and contributing significantly to advancing our exciting mRNA platform and therapeutic pipeline. This role will closely partner with CQP colleagues in Pharmacometrics and Quantitative Systems Pharmacology to determine and implement the overall CQP strategies across therapeutic areas, from preclinical development through lifecycle management. Success in this role requires close collaboration with Translational Medicine, Research (including Nonclinical Development), Clinical Development, Clinical Safety and Risk Management, Biometrics, and Regulatory functions to ensure integrated and innovative clinical pharmacology strategies are developed and executed to enable agile development of our exciting pipeline. At Moderna, we are pioneering the development of mRNA medicines to transform patients' lives. As part of our innovative team, you will play a key role in shaping the future of medicine while growing your career in a supportive, collaborative environment. Here's What You'll Do * Resonsible to develop a fit-for-purpose Clinical Pharmacology development plan, including dose selection and optimization, evaluation plan for special populations, PK/PD and immunogenicity assessment, and pediatric development. * Collaborate with program teams to develop dose selection strategy and support decision makings for first-in-human studies and IND submissions. * Represent CQP in a highly matrixed team setting to drive study execution and operational excellence toward product development goals. * Lead the development of CQP related sections in regulatory documents (e.g., clinical protocols, INDs, regulatory meeting briefing books, summary documents for BLAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions. * Lead/oversee the Clin Pharm data analysis, interpretation, and reporting to inform clinical implications and development decisions * Advocate and represent clinical pharmacology and MIDD strategies with internal and external stakeholders. * Mentor junior team members to contribute to the development of a high-performing Clinical Pharmacology team. * Leverage literature data and collaborate with external consultants, CRO partners and academic sites to problem solve and develop solutions to clinical pharmacology issues and grow organizational knowledge on mRNA platform Here's What You'll Need (Basic Qualifications) * PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 8-10 years of industry experience in clinical pharmacology * In depth knowledge of clinical pharmacology, PK/PD principles, modeling and simulation, ADME and quantitative translational sciences * Hands-on quantitative skills, modeling expertise and familiarity with clinical operations and translational sciences. * Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products * Drug development experience in oncology and rare diseases preferred; expertise in immune therapeutics and/or infectious diseases is a plus. Here's What You'll Bring to the Table (Preferred Qualifications) * Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred. * Demonstrated ability to work independently, lead functional initiatives, adapt quickly and collaborate effectively in a highly dynamic environment and influence cross-functional teams. * Proficient in using pharmacokinetic, modeling and data visualization software (e.g. Phoenix WinNonlin, R, Monolix, NONMEM, etc). * Outstanding verbal and written communication skills, with the ability to distill complex data for diverse audiences. * Drug development experience in oncology and rare diseases preferred; expertise in immune therapeutics and/or infectious diseases is a plus. * Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred. * Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidance on quantitative analysis * Ability to develop and deliver clear and concise presentations for both internal and external meetings * Candidate will be curious in exploring new paths for model informed drug development. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes * Strong publication record * Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams * Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential. * A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. * Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs * A holistic approach to well-being, with access to fitness, mindfulness, and mental health support * Family planning benefits, including fertility, adoption, and surrogacy support * Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown * Savings and investment opportunities to help you plan for the future * Location-specific perks and extras The salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NH1 *

Job DescriptionBenefits: 401(k) Bonus based on performance Dental insurance Health insurance Opportunity for advancement Paid time off Vision insurance Position Summary: The Director will apply advanced pharmacometric approaches to support drug development from late preclinical development through registration. This role is responsible for conducting population PK, PK/PD, and exposureresponse analyses, contributing to model-based drug development (MBDD), and preparing high-quality regulatory documentation. The ideal candidate is a hands-on modeler who can organize and model nonclinical and clinical PK, PD, efficacy and safety data. The Director will interact directly with clients and will provide quantitative input into study designs and dose selection, and ensure deliverables meet regulatory and client expectations. Key Responsibilities: Modeling & Analysis: Lead population PK, PK/PD, and exposureresponse/safety modeling using NONMEM, Monolix, R, or equivalent tools. Develop, validate, and execute modeling and simulation plans for clinical development. Conduct noncompartmental PK analyses (NCA) 2. Regulatory & Documentation: Contribute to nonclinical, clinical pharmacology, and pharmacometric sections of protocols, study reports, IBs, and regulatory submissions (IND, NDA, BLA, briefing documents). Provide quantitative justifications for dose/regimen selection and study designs in alignment with regulatory expectations. 3. Cross-Functional Collaboration Work with clients and bioanalytical scientists to deliver integrated CP outputs. Present results and recommendations to internal teams, clients, and (as appropriate) regulatory agencies 4. Leadership & Mentorship Mentor junior pharmacometricians and data analysts in NCA, modeling, and regulatory writing. Contribute to building internal best practices and SOPs in quantitative pharmacology. Qualifications & Educational Requirements: Ph.D. (preferred) or Pharm.D./M.D. in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacology, or related field. 5+ years of quantitative pharmacology and pharmacometrics experience in a CRO, pharmaceutical, or biotech environment. Demonstrated expertise in PopPK, PK/PD modeling & simulation, exposureresponse analysis, and MBDD. Proficiency with quantitative tools: NONMEM, Monolix, Phoenix WinNonlin/NLME, R, SAS. Understanding of regulatory expectations (ICH, FDA, EMA) for nonclinical, clinical pharmacology and pharmacometric analyses. Familiarity with regulatory requirements and expectations for quantitative analyses. Strong data interpretation, problem-solving, and scientific writing skills. Effective communicator, able to collaborate in cross-functional and client-facing settings. This is a remote position.

About Generate:Biomedicines Generate:Biomedicines is a new kind of therapeutics company - existing at the intersection of machine learning, biological engineering, and medicine - pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us! Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees. The Role: As Generate:Biomedicines advances multiple programs into late-stage development, we are seeking a Senior Director of Clinical Pharmacology and Pharmacometrics to lead strategy and execution across key Phase 2 and 3 studies. Reporting to the Head of Clinical Pharmacology, this leader will provide scientific and operational direction for pharmacokinetic (PK), pharmacodynamic (PD), and exposure-response strategies across our portfolio, with an emphasis on respiratory and immunology indications. This role will partner closely with Clinical Development, Biostatistics, Regulatory, and Translational Sciences to ensure high-quality clinical pharmacology deliverables that enable data-driven decisions and successful regulatory interactions. Here's how you will contribute: Serve as the clinical pharmacology and pharmacometrics lead on late-stage programs, driving PK/PD and exposure-response strategy from early clinical studies through pivotal trials and submissions. Design and oversee modeling and simulation plans to inform dose selection, trial design, and regulatory filings. Author and review key clinical pharmacology and pharmacometrics sections of INDs, BLAs, and related documents; participate in regulatory interactions as functional expert. Collaborate with cross-functional teams to integrate clinical pharmacology and pharmacometrics principles into clinical study designs, endpoints, and statistical approaches. Contribute to pediatric strategy development and submissions. Support the Head of Clinical Pharmacology in building scalable processes, standards, and systems that enable late-stage and global development. Leadership Responsibilities Set clear expectations for scientific rigor, data quality, and accountability. Foster an inclusive, high-performing team culture that emphasizes transparency, adaptability, and collaboration. Develop team members through mentorship, coaching, and stretch opportunities. Partner effectively across functions to ensure timely delivery of critical program milestones. The Ideal Candidate will have: 10-12+ years of experience in clinical pharmacology and pharmacometrics within biotech or pharma, including significant late-stage (Phase 2/3) and regulatory submission experience. Demonstrated success contributing to regulatory agency interactions (FDA, EMA, PMDA, or NMPA) on clinical pharmacology and pharmacometrics deliverables. Strong background in PK/PD modeling and simulation and demonstrated ability to translate quantitative findings into clinical strategy. Experience supporting respiratory or immunology indications preferred. Excellent communication skills, with the ability to present complex data to diverse audiences. Proven experience building effective cross-functional partnerships Education PhD, PharmD, or MD in clinical pharmacology, pharmaceutical sciences, or related field. Nice to Have (Optional) Prior experience in a fast-growing or first-to-market biotech environment. Familiarity with combination products or complex biologics. Working knowledge of bioanalytical methods and data review. Why Join Us? Join Generate:Biomedicines and play a key leadership role in shaping clinical pharmacology strategy as we enter late-stage development. You'll work alongside world-class scientists translating the power of generative biology into transformative therapies for patients worldwide. Equal Opportunity Employer Statement Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. Recruitment & Staffing Agencies : Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto. #LI-RT1 Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range$219,000-$329,000 USD

About This Role The Senior Director and Section Head of Clinical Pharmacology & Pharmacometrics leads a team of clinical pharmacologists providing scientific leadership and execution of clinical development plans from Phase 1-Phase 4 programs. This includes prediction and characterization of the pharmacokinetics, pharmacodynamics, efficacy of drug candidates into a Model-Informed Drug Development (MIDD) framework. This facilitates the generation of rationale for dose regimen selection, clinical study design, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered. The section head is focused on people leadership with accountability for Clinical Pharmacology resource internally and externally across programs and provides mentorship and career development guidance to staff. The section head collaborates with additional departmental leaders to ensure that the diverse Biogen portfolio has optimal leadership from clinical pharmacology and pharmacometrics What You'll Do Leads and manages high profile clinical pharmacology activities including training, CDP and study designs with R&D across drug modalities and Biogen disease areas Leads clinical pharmacology efforts in early and late stage (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results. Ability to represent clinical pharmacology function at governance (DPAC, RDGC, TRC) and external advisory boards Provides extensive regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents. Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent. Engages in cross-functional activities providing Clinical Pharmacology input and provides a source of Clinical Pharmacology expertise and advice to other functions across the Company. Participates in and provides Clinical Pharmacology perspective to cross-functional committees and activities. Maintains extensive scientific awareness and presence in Clinical Pharmacology, publishes multiple manuscripts and posters, presents at Scientific Conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large. Manages and/or mentors staff within the function and matrix leadership across projects. Develops expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serves as a reference source in these for his peers. Who You Are You have excellent knowledge of the principles of Clinical Pharmacology & Pharmacometrics. You are someone who demonstrates strong team work in a multidisciplinary environment who has the ability to manage and mentor junior scientist with strong leadership skills. Required Skills Ph.D., M.D./Ph.D., or Pharm.D. in Clinical Pharmacology, pharmacokinetics, or a related field 15+ years of direct industry experience in Clinical Pharmacology Demonstrated experience in leading teams and/or managing professional staff International recognized expert in Quantitative Clinical Pharmacology Solid experience in developing Clinical Pharmacology strategy, designing/implementing Clinical Pharmacology studies Strong knowledge of the drug development process and overall familiarity with the regulatory process. Direct experience in preparing regulatory submissions and responding to health authority questions. Extensive record of publications, presentations, invited lectures, and other scientific activities Active knowledge of advanced methods for Quantitative Pharmacology and PMx analyses Experience with use of PK/PD software packages such as -Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS #LI-TD1 Job Level: Management Additional Information The base compensation range for this role is: $242,000.00-$333,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Simulations Plus is a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry. Our biosimulation solutions integrate artificial intelligence/machine learning, physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. Leadership truly cares about maintaining a positive culture and employee well-being. We offer fully remote work, flexible schedules, and generous vacation policy along with affordable health coverage, stock options, annual bonuses, and more! The Director, Quantitative Clinical Pharmacology will lead multi-disciplinary project teams through the successful completion of client goals. This role will engage in activities ranging from consultations on study design through the development and evaluation of models, the performance of simulations, and the presentation of results. Department: Strategic Consulting Services/Clinical Pharmacology and Pharmacometrics Internal Grade: 16 Direct Reports: No Status: Exempt Location: Remote Job Responsibilities: * Lead and collaborate with multi-disciplinary teams to implement quantitative clinical pharmacology projects/programs and to provide clinical pharmacology and pharmacometric consultation to other company projects/programs * Support clinical pharmacology-related components of clinical study protocols, study conduct, data analysis, and report writing with the support of colleagues * Participate in regulatory interactions with health authorities * Support project teams by providing clinical pharmacology and pharmacometric consulting through advanced PBPK, population PK, PK/PD, and exposure-response modeling and simulation as well as for noncompartmental analyses, using GastroPlus, MONOLIXSuite (PKAnalix, MONOLIX, Simulx), NONMEM, R, or other tools * Apply advanced scientific knowledge and expertise to assigned programs and projects * Responsible for appropriateness of methods, integrity of data used for analysis, and accuracy of results * Ensure communication between the company and clients throughout project execution * Regularly engage with clients regarding the strategic approach, presentation of results, regulatory implications, and messaging of findings * Initiate and maintain positive, productive, and profitable client relationships * Prepare final technical reports, synopses, executive summaries, and other regulatory documents * Ensure the provision of advanced literature searches for project/program-related information * Provide sophisticated written interpretation of material and integrate research findings into project/program methodology and results * Share findings with internal and external project teams * Prepare abstracts, presentations, and publication-ready manuscripts * Provide mentoring and feedback to junior scientists * Engage in cross-divisional discussions of scientific strategy * Serve as an expert resource for the Business Development Team * Integrate knowledge of PBPK, population PK, and PK/PD to provide guidance regarding proposed approaches to addressing drug development and regulatory approval challenges * Stay current with pharmacometric and clinical pharmacology literature and project/program-related literature * Expand scientific expertise through attendance and presentation at international, national, and regional scientific conferences, client meetings, and government meetings * Develop and teach at GastroPlus, MONOLIX, and other workshops and courses * Other duties as assigned Qualifications: * 10+ years of applied clinical pharmacology experience * 8+ years of leading projects, programs, and scientists preferred * Previous supervision of junior clinical pharmacologists and pharmacometricians, fellows, and students preferred * Strong experience presenting scientific results to professional audiences * Extensive experience preparing, submitting, and receiving approval for publications in scientific journals * Population pharmacokinetic and pharmacokinetic/pharmacodynamic modeling and simulation experience * Non-compartmental and compartmental pharmacokinetics experience * Mechanistic physiologically based pharmacokinetic modeling and simulation experience * Excellent communication, presentation, and leadership skills * Relationship-building skills with the ability to work closely with project leaders and team members * Strong organization skills and ability to handle multiple tasks simultaneously * Work well handling tight deadlines * Great critical-thinking and problem-solving skills * Some travel required for meetings, conferences, and events Education: * PharmD, PhD, or masters in pharmacokinetics, clinical pharmacology, or related field * Advanced clinical pharmacology related training preferred Find out more about how amazing it is to work at Simulations Plus by visiting ************************************** and apply today!

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: As a Director, Clinical Scientist at Spyre Therapeutics, you will play a key role in designing, executing, and interpreting clinical trials that support development of our novel antibody-based therapies. You will collaborate across functions (clinical operations, regulatory, translational science, biomarker teams) to ensure robust study designs, high-quality data generation and efficient progression of programs. You will bring scientific and operational expertise and act as a bridge between internal teams, external investigators and CRO partners. Key Responsibilities: Lead/Contribute to study design and amendments in collaboration with internal and external stakeholders. Collaborate with Clinical Development, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation. Collaborate with clinical operations, data management and CRO to develop and implement the overall data quality plan and lead internal medical data review and safety trend analysis on one or more studies/programs. Work closely with translational science to integrate mechanistic biomarkers, PK/PD modelling, patient stratification, and exploratory endpoints. Provide scientific oversight and decision-making support during trial execution: site selection, study start-up, monitoring of key trial metrics, risk-based quality oversight and study close-out. Interpret clinical data (safety, efficacy, biomarker, PK/PD) and present findings internally and externally (investigators, scientific meetings, publications). Write and/or review abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinate further reviews with internal partners and stakeholders. Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes Collaborate with regulatory affairs to ensure study designs meet regulatory standards (e.g., FDA/ICH, GCP) and support regulatory submissions and interactions. Develop and maintain clinical trial documentation (protocols, clinical study reports, investigator brochures, informed-consent forms, etc.). Monitor the competitive and scientific landscape in therapeutics space and contribute to strategic positioning of Spyre's pipeline programs. Additional duties as assigned. Ideal Candidate: PhD, MD, PharmD or equivalent in life sciences, clinical pharmacology, immunology or related discipline is preferred; alternatively, MSc plus significant industry experience. 5+ years of clinical development experience in the biotech/pharma industry, ideally with at least 2 years in immunology, gastroenterology/IBD or immune-mediated disease area. Demonstrated experience designing and executing clinical trials IBD or other I&I therapeutic area. Strong understanding of clinical biomarkers, PK/PD modelling, patient stratification and immunologic endpoints. Familiarity with regulatory requirements (FDA/ICH guidelines, GCP) and Good Clinical Practice. Proven ability to work cross-functionally in a matrix organization (clinical operations, translational science, regulatory, QA). Excellent written and verbal communication skills, presentation and interpersonal skills; ability to influence diverse stakeholders. Comfortable working in a fast-paced, dynamic environment with ambiguity, and willing to wear multiple hats. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $215,000 to $230,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for: preventing blindness through vision-saving medications delivering best-in-class proprietary pharmaceutical technologies transforming ocular drug delivery We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This position is reporting to the VP, Clinical Development and is remote. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio. Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs. Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans. Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials. Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required. Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program. Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation. Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations. Assist with study milestones and study metrics in collaboration with clinical operations. Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines. Qualifications Primary skills and knowledge required include, but are not limited to the following: A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required. Experience in ophthalmology and familiarity with drug/device combination products Experience with all phases of clinical drug development including regulatory submissions Ability to survey and interpret scientific literature related to the assigned portfolio of products Strong communication, organizational and interpersonal skills are required. Successful work experience in a matrix team environment with cross functional teams is required. Independent decision-making and analytical skills are required. Level of Education Required: Advanced degree in life science/clinical/medical field, PhD or PharmD Number of Years of Experience in the Function and in the Industry: Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level Minimum of 10 years of clinical development/research and R&D experience preferred at Director Level Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Remote Min USD $154,500.00/Yr. Max USD $249,947.00/Yr.

Job TitleClinical Scientist (Denver, CO local) Job Description Clinical Scientist (Denver, CO local) The Clinical Scientist will support both IGTS and CT Clinical Science Partnerships by leveraging your clinical and technical expertise to drive innovation, research collaborations, and evidence generation. Your work will focus on advancing minimally invasive and diagnostic procedures, with primary support provided to local Denver area sites. Your role: Identify new customer needs and drive collaborative innovation with clinical and research partners to enhance diagnosis, treatment, and care methods, supporting both CT and IGTS businesses. Lead and contribute to the development of clinical prototypes, strategic innovation roadmaps, and overall business strategy for the CT and IGTS teams. Collaborate with clinical experts, execute feasibility studies, and engage in research collaborations to demonstrate the value of new technologies. Maintain and expand a network of Key Opinion Leaders (KOLs) and stakeholders to support ideation, feasibility studies, and the adoption of novel clinical solutions. Stay current on clinical, regulatory, and market trends, and communicate clinical strategy and value propositions to internal and external audiences. You're the right fit if: You've acquired 2+ years of experience interacting with clinical partners and clinical research, and have strong expertise in clinical investigations, especially in a hospital setting. Your skills include a strong clinical background, preferably in Angiography, CT, or similar imagining modality; knowledge of image-guided interventional procedures and innovations across cardiology, radiology, and/or surgery; and excellent interpersonal skills to work cross-functionally with other key internal and external stakeholders. You have an MD/PhD in biomedical sciences/engineering, or a related discipline. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You're a self-learner, customer-oriented, and enthusiastic about exploring new technologies and solutions with a demonstrated ability to multi-task and transition from micro-to macro level focus. Ability to travel to hospitals and medical congresses as needed. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is a field-based role with an onsite presence expected at the University of Denver and other local locations as needed. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in CO is $101,250 to $162,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Denver, CO. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Clinical Scientist will be working within a multi-disciplinary team focusing on a Clinical Development Program. This individual will provide clinical expertise and scientific insights to help elaborate a protocol for phase 1 - 3 studies then monitor, track, and analyze subjects' data in these studies. The incumbent will collaborate with all the groups involved in Clinical Development e.g., Clinical Pharmacology (CP), Clinical Operations, Medical Writing, Biometrics, Pharmacovigilance, Regulatory Affairs, HEOR and Medical Affairs. Essential Job Functions and Responsibilities: These may include but are not limited to: Conduct data analyses before and during clinical studies to support medical decision making, create presentation slides, and prepare for development division discussion meetings. Perform high quality clinical data review to identify events of special interest from data within the EDC system for further investigations. Collaborate with biometrics and pharmacovigilance to review periodic data listings (e.g. adverse events, protocol deviations, concomitant medications) to discussion with clinical team. Perform regular trend analysis in ongoing clinical trials. Lead periodic Medical Review meetings. Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings. Contribute to the development of relevant sections of regulatory documents such as protocols, amendments to protocols, informed consent forms, briefing books, safety updates, responses to Health Authorities questions. Contribute to the development of study documents such as feasibility questionnaires, study plans, electronic Case Report Forms (eCRFs), eCRF guidelines and other essential trial specific documents. Collaborate in cross-functional meetings (with internal stakeholders and/or external consultants) to develop clinical development plans. Support Clinical Operations, CROs, and site staff on study protocol related questions Support preparation for safety review committees, DSMBs/DMC incl. data review and development of presentations Collaborate with Medical Affairs and Patient Advocacy to support effective working relationships with key investigators, key opinion leaders and patient advocates. Participate in research site identification and relationship building with CROs in this space. Track progress, take notes and plan meetings for the protocol discussion group (Biometrics and Clinical Research, plus ad hoc functions). Other duties as assigned. Education and Experience: Required: MD, Ph.D., Pharm. D., MPH (Master of Public Health), MSN or RN with 8 years of industry related experience with a minimum of 2 years clinical research experience in clinical development within a biopharmaceutical company. Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Practical knowledge of the day-to-day medical monitoring of clinical trials required (e.g., review of safety parameters, etc.). Great analytical skills and a passion for “search and find” among complex data generated in clinical studies. Collaborative, effective writing skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization. Ability to thrive and flourish in a fast-paced, dynamic, entrepreneurial small company environment; ability to prioritize and parallel process multiple workstreams, comfortable “changing gears” and remaining flexible, as well as making definitive decisions. Ability to inspire and earn respect from the leadership team, colleagues, and staff. Respectful of the ideas and experience of all members of the Crinetics team Ethical, with the highest standards of integrity recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders. Desire to develop personal and communication skills through several complex tasks and challenges. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. The Anticipated Base Salary Range: In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary Range The salary range for this position is: $144,000 - $180,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

SummaryAs the Clinical Scientist - Interventional, you will be responsible for working daily in close partnership with Interventional key clinical partners as well as global and local GE HealthCare colleagues. You will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionEssential Responsibilities: Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership Support adoption of new technology or clinical applications through advocacy and evidence Participate in customer presentations regarding use of Interventional products for institution research purposes Closely connected with GEHC global modality clinical and research and development teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns Grow technology leadership mindshare through joint scientific presentations and publications Lead and represent the global modality technical, scientific and product expertise in the US and Canada to support local clinical teams and best-in-class customer experience on new products Study new technology concepts and leverage expertise to move initiatives forward Qualifications/Requirements: PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field Preferred 1+ year(s) of experience in Interventional healthcare industry or clinical research Knowledge of Interventional procedures, anatomies, clinical practice Knowledge of Interventional products including IGS product line and Advantage Windows applications Excellent customer relationship management and collaboration skills Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. Able to individually lead complex projects with autonomy, rigor, drive & competence Ability to travel ( Desired Characteristics: 5 + years experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) Demonstrated record of innovation and development. History of publications, clinical/non-clinical experiments, knowledge in statistics Programming / Image processing experience Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: Yes

Are you a passionate individual that thrives when building scientific content designed to improve patient outcomes? Do you get excited when reviewing the most current research and can you interpret the science into action? We are proud to say that this is our core purpose. Are you a team player - eager to partner with clients, editors, and scientific directors to get the job done? Then this dynamic role in medical communications is for you. Our interactive and dedicated team is committed to excellence and success. At Precision AQ - Medical Communications, we translate the science of medicine into high-level strategy, tactical communication, and flawless execution. With a track record of long-tenured relationships with major pharmaceutical companies and leading biotech firms, we hold a leadership position in the delivery of strategic scientific and medical communication and training solutions for our clients. Position Summary The Senior Scientific Director (SrSD) is a senior leadership role responsible for overseeing scientific content development, leading and mentoring teams, and ensuring strategic alignment with client objectives. The SrSD drives quality, innovation, and operational excellence across projects, and serves as a key scientific and strategic resource for both internal teams and clients. Key Responsibilities Scientific Content Leadership Oversee and ensure the development of high-quality, evidence-based, and client-centric scientific content. Review content for flow, accuracy, consistency, and strategic alignment. Lead and direct project development, including strategic planning and tactical execution. Maintain current knowledge of therapeutic areas, competitor products, and industry trends; share insights with teams. Team Management & Mentorship Lead, mentor, and coach Scientific Directors, Associate Scientific Directors, and Medical Writers; “train the trainer” for skill development. Champion team adherence to department and company processes and SOPs. Provide onboarding and ongoing training for new hires and team members. Track team utilization, distribute work, and coordinate resource sharing. Foster engagement, morale, and a collaborative, inspired team mentality. Recognize outstanding work and facilitate team-building activities. Strategic & Operational Excellence Partner with cross-functional leadership to ensure consistency, efficiency, and profitability. Lead cross-team resource planning and long-term team planning (resourcing, PTO coverage, project timing). Review budgets and timelines; provide actionable feedback to program/accounts. Ensure projects remain on track and within budget; proactively address utilization concerns. Assist in developing and refining department-wide content development processes. Client Management & Communication Model professionalism and client-facing etiquette for the team. Lead content discussions with clients and faculty; anticipate client needs and provide strategic support. Ensure all feedback from clients, KOLs, MLR, and authors is implemented thoroughly and accurately. Support account and program teams in drafting project briefs and promoting account growth. Professional Development & Growth Identify goals for self and direct reports; monitor and adjust as needed. Use professional development guides to track progress and facilitate career growth. Participate in department/companywide initiatives and champion positive change management. Qualifications Advanced degree in life sciences (PhD, PharmD, MD, or equivalent). 5+ years of experience in a medical communications or other healthcare agency. Demonstrated expertise in scientific content development, team leadership, and client management. Impeccable written and verbal communication skills; mastery of AMA style and client guidelines. Proficiency in Microsoft Word, PowerPoint, Excel, Teams, OneNote, Outlook, Adobe Acrobat, EndNote, and other systems as needed. Proven ability to manage complex projects, budgets, and timelines. #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$101,300-$152,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner that brings together strategy, evidence, engagement, and technology, we were designed to engineer breakthrough value to tackle our clients' toughest challenges by revolutionizing how value is generated, demonstrated, and communicated. Responsibilities / Position overview We are seeking an advanced degree life sciences professional to join our Medical Communications team and serve as the Scientific Director/Associate Scientific Director. This position falls within our wider Medical Strategy and Communications practice. We focus on strengthening the bridge between clinical and commercial, drawing from our foundation of scientific knowledge, regulatory expertise, and industry experience. The Scientific Director/Associate Scientific Director will oversee the development of technically accurate and high-quality deliverables for Publications/Medical Affairs accounts. This role will serve as a strategic partner to clients and ensure projects and deliverables are on time and within budget. The Scientific Director/Associate Scientific Director will also direct the editorial component of projects, lead a team of medical writers, and ensure the accuracy, quality, and content of all written material. Qualifications PhD, PharmD, or MD required Minimum of 4-5+ years' medical writing experience in an agency or pharmaceutical company setting CMPP preferred, but not required Benefits We offer our employees a comprehensive benefits package that focuses on what matters to you - health and well-being, personal finances, professional development, and a healthy work/life balance: Competitive salary plus bonus scheme Medical, dental, and vision insurance options 401(k) plan with employer match Flexible paid time off program + 10 paid holidays Flexible spending accounts for health and dependent care Health savings account option with employer contribution Employee Assistance Program Paid short-term and long-term disability coverage Company-paid life insurance coverage at 1.5x annual salary Paid parental leave and more

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Purpose and Role Lilly is seeking an individual with expertise in early clinical development, including clinical pharmacology, to join a passionate team with a robust, industry-leading pipeline. The ideal candidate will have expertise in diabetes, obesity, cardiovascular, renal or endocrinology drug development with demonstrated learning agility, a problem-solving mindset, and the willingness to develop knowledge and skills in new areas. The Clinical Research Physician (CRP) will be the clinician to progress multiple early clinical assets into first-in-human studies or support their further development through the conduct of clinical pharmacology and mechanistic studies. Through the application of scientific and medical training, the CRP participates in the following: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, grant submissions and contracts, contracts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders. The CRP is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. In addition, the CRP works with the basic research scientists to plan pre-clinical studies, develop biomarker plans, and serves as a scientific and medical resource for study teams, departments, and others as needed. Basic Qualifications Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.). Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see PLA: Medical Licensing Information and Medical Education | MBC Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer. Additional Skills/Preferences At least two (2) years of pharmaceutical industry experience, or similar, that provides adequate background relevant to clinical trial design and conduct of Phase 1 and Phase 2 studies (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator/site management). Pharmaceutical company experience preferable. Clinical and/or research experience in endocrinology, diabetes, obesity, cardiovascular, or renal research preferable. Experience in Clinical Pharmacology preferable. Additional scientific training or degree (M.S., Ph.D.) preferable. Fluent in English; both written and verbal communications. Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills. Demonstrated ability to influence others (both within teams and a matrix environment) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team (approximately 10-15%). Core Job Responsibilities The primary responsibilities of the CRP are generally related to early phase clinical studies and late phase biopharmaceutical submission studies. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission. Support preparation for first-in-human dosing studies including biomarker plans. Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharmaceutical plan to support submission. Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies. Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug disease response models. Contribute, as an integral member of the Exploratory Medicine and Pharmacology team, to global Phase 1 and 2 clinical studies as well as submission planning activities. Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development. Work with Brand Team/Business Unit colleagues to provide appropriate market differentiation and regulatory support in the biopharmaceutical submission plan. Clinical Research/Trial Execution and Support Design and oversee implementation of all clinical pharmacology studies (e.g., single/multiple ascending dose, bioavailability, bioequivalence, drug-drug-interaction, food effect, renal impairment, hepatic impairment, mechanistic studies). Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups/special populations. Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research. Design and oversee implementation methods for development and biomarker qualification studies. Design, create, and provide oversight for protocol development. Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements. Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements. Participate in investigator identification and selection, in conjunction with the clinical pharmacology sourcing group. Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate communication of risk to study subjects. Provide oversight ensuring that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Serve as resource to clinical trial managers, clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with global patient safety policies and procedures. Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety. Provide appropriate oversight and partnership with Third Party Organizations to ensure successful study execution. Scientific Data Dissemination/Exchange Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers. Address the unsolicited scientific questions and information needs of external health care professionals according to guidelines above. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Partner with NPP (New Product Planning) and scientific communications staff on publication strategy and process. Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and other external agencies. Publish results of research projects as appropriate. Consider, review, or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications for clinical pharmacology-biopharmaceutical trials. Provide clinical reports for local and international regulatory purposes. Regulatory Support Activities Support and assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response. People Management and Development: Develop and retain a scientifically excellent, innovation-minded, highly capable workforce with strong exploratory medicine experience. Build an organizational culture that fosters inclusion and innovation, continual improvement, and with an external understanding and awareness. Develop an organizational talent base that demonstrates judgment-based risk taking and decision making. Business customer support (pre and post launch support) Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, New Product Planning, and business development. Understand the scientific information needs of all Development customers (business unit, payers, patients, health care providers). Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts. Support business-to-business and business-to-government activities as medical expert. Contribute actively on an ongoing basis to the strategic planning for the brand. Become familiar with market archetypes and potential influence on the medical interventions for the product. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $198,000 - $389,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Your Role Within Our Kingdom We are seeking an Associate Principal Data Scientist-a highly experienced and technically deep individual contributor who leads through influence, owns high-impact initiatives, and drives scientific excellence across experimentation and modeling. (This position is open to remote work.) Responsibilities: * Lead the design and execution of large-scale data science initiatives, shaping the roadmap for experimentation and modeling across teams. * Apply advanced statistical, optimization, and machine learning techniques (e.g., time-series, regression/classification, recommendation engines, reinforcement learning, and gen AI) to drive system understanding and develop data-powered solutions across the organization. * Own design and evaluation of experimentation for optimization systems. * Provide technical direction, mentor senior data scientists, and set high standards for scientific rigor, communication, and reproducibility. * Partner cross-functionally with Product, Engineering, and Game Studios to frame ambiguous problems, scope solutions, and influence strategy. * Champion innovation by evaluating new methodologies and tools, and by raising the bar for scalable, interpretable, and actionable data science. Skills to Create Thrills Minimum Qualifications: * Master's degree or PhD in a quantitative field (e.g., Statistics, Mathematics, Computer Science, Economics, Engineering, Operations Research). * 14+ years of industry experience (or equivalent post-graduate experience) in data science, experimentation, statistical modeling, and machine learning, including work with large-scale systems. * Proficient in Python and SQL; familiarity with big data tools (e.g., Spark, Hive) and cloud computing platforms (e.g., GCP, AWS). * Strong systems thinking-able to zoom out and define strategy while also diving deep into code and analysis. * Excellent communication and collaboration skills, with demonstrated experience partnering across Product, Engineering and Business teams. * Demonstrated experience mentoring, influencing, and elevating the technical bar across a data science organization. * Relevant experience with one or more advertising solutions (i.e. Real-Time Bidding, Ad Exchange, etc.) Bonus Points * Prior work with mobile gaming studios or player behavior modeling. * Experience in developing or maintaining experimentation platforms. * Familiarity with modern data orchestration and versioning (e.g., Airflow, dbt, MLflow). We love hearing from anyone who is enthusiastic about changing the games industry. Not sure you meet all qualifications? Let us decide! Research shows that women, veterans, and members of other under-represented groups tend to not apply to jobs when they think they may not meet every qualification, when, in fact, they often do! We are committed to creating a diverse and inclusive environment and strongly encourage you to apply. We are committed to working with and providing reasonable assistance to individuals with physical and mental disabilities. If you are a disabled individual requiring an accommodation to apply for an open position, please email your request to accommodationrequests@activisionblizzard.com. General employment questions cannot be accepted or processed here. Thank you for your interest. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, gender identity, age, marital status, veteran status, or disability status, among other characteristics. Rewards We provide a suite of benefits that promote physical, emotional and financial well-being for 'Every World' - we've got our employees covered! Subject to eligibility requirements, the Company offers comprehensive benefits including: * Medical, dental, vision, health savings account or health reimbursement account, healthcare spending accounts, dependent care spending accounts, life and AD&D insurance, disability insurance; * 401(k) with Company match, tuition reimbursement, charitable donation matching; * Paid holidays and vacation, paid sick time, floating holidays, compassion and bereavement leaves, parental leave; * Mental health & wellbeing programs, fitness programs, free and discounted games, and a variety of other voluntary benefit programs like supplemental life & disability, legal service, ID protection, rental insurance, and others; * If the Company requires that you move geographic locations for the job, then you may also be eligible for relocation assistance. Eligibility to participate in these benefits may vary for part time and temporary full-time employees and interns with the Company. You can learn more by visiting *************************************** In the U.S., the standard base pay range for this role is $143,060.00 - $264,846.00 Annual. These values reflect the expected base pay range of new hires across all U.S. locations. Ultimately, your specific range and offer will be based on several factors, including relevant experience, performance, and work location. Your Talent Professional can share this role's range details for your local geography during the hiring process. In addition to a competitive base pay, employees in this role may be eligible for incentive compensation. Incentive compensation is not guaranteed. While we strive to provide competitive offers to successful candidates, new hire compensation is negotiable.