Director, metabolism jobs near me - 45 jobs

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one' to the future they've envisioned. POSITION SUMMARY: Day One Biopharmaceuticals is seeking a Director of Clinical Pharmacology to lead and drive early-stage clinical programs. This is a high-impact, hands-on role that requires deep scientific expertise, a rigorous understanding of antibody drug conjugates (ADC), and a proactive, solution-oriented mindset. This position reports to Vice President, Clinical Pharmacology. The successful candidate will serve as the Clinical Pharmacology Lead and subject matter expert (SME) for one or more ADC programs, playing a critical role in dose selection, optimization, and the integration of pharmacologic and clinical insights. This role is ideal for someone who thrives in the details- taking full ownership of data analysis and interpretation -and is motivated to make a meaningful impact on program direction and success. This is not a purely strategic leadership role; it requires active, hands-on involvement in all aspects of clinical pharmacology planning and execution. Success in this role depends on deep familiarity with program data, scientific rigor, and a clear understanding of clinical development priorities. In addition to technical excellence, the ideal candidate will bring a collaborative mindset, accountability, dependability and a strong commitment to high-quality work. The Clinical Pharmacology team and our cross-functional partners foster a culture rooted in trust, open communication, and mutual respect-where team members feel safe speaking up, sharing ideas, and working through challenges together. We take pride in what we do, enjoy our work, and find genuine satisfaction in contributing to the goal of helping patients. This is a team of highly skilled, collaborative, and committed individuals who consistently deliver results, support one another, and thrive in an environment where shared purpose and trust create a naturally positive and cohesive dynamic. This position has the potential to be fully remote with a preference for Boston or the San Francisco Bay Area. Occasional travel will be required for in-person meetings. ESSENTIAL DUTIES AND RESPONSIBILITIES: Serve as the Clin Pharm lead for one or more ADC programs within cross-functional team: Lead dose selection and optimization in support of early-stage clinical development and decision-making; you are expected to be SME on dose selection and optimization Provide clear and actionable recommendations to the cross-functional team by review, analysis, and interpretation of PK, PD, and exposure-response data; you are expected to be the primary expert on your data and prepared to discuss it confidently and accurately at any time Drive clinical pharmacology strategy and execution with direct accountability for data integrity and scientific interpretation Translate cross-functional questions into clear, actionable Clin Pharm objectives with defined scopes of work and timelines Author and maintain a comprehensive Clinical Pharmacology Plan, ensuring timely execution of deliverables Author or co-author, and critically review key program documents including Investigator's brochure, clinical trial protocols, study reports, and regulatory submission documents. Collaborate with Medical Affairs to support scientific communications, including abstracts, posters, and manuscripts for conferences and peer-reviewed publications Respond to clinical pharmacology-related inquiries from medical monitors, investigators, and cross-functional stakeholders Lead clinical pharmacology input and strategy for regulatory interactions, including written responses and meetings with Health Authority Oversee external vendors: monitor vendor performance to ensure alignment with scientific and operational expectations and provide timely, constructive feedback to support high-quality deliverables and effective collaboration May serve as a strategic leader for the clinical program: Identify and proactively resolve issues that may impact the programs execution (e.g., data quality or timelines) Influence program direction using integrated scientific, clinical, and business insights Provide leadership and mentorship to junior colleagues or contractors, including effective delegation, professional development, and performance support QUALIFICATIONS PhD, PharmD, or equivalent in pharmaceutical sciences, clinical pharmacology, pharmacokinetics, or related discipline. 10+ years of industry experience in clinical pharmacology, with a strong preference for hands-on experience in ADC program Proven ability to lead in a fast-paced, cross-functional, and collaborative environment. Strong written and verbal communication skills, with the ability to clearly convey complex scientific and clinical concepts to diverse audiences. Demonstrated strategic thinking coupled with strong attention to detail and operational execution The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. INTERVIEW INTEGRITY At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone. COMPENSATION AND BENEFITS The salary range for this position is $220,000-$240,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary. Please visit ********************************** to see our competitive benefits. DISCLAIMER Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. We are unable to sponsor or take over sponsorship of any applicant work visas at this time. Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical's internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.

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

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 $265,000-$320,000 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 | ********************

**Apply to join Lockwood's Scientific Director Freelancer Community for both immediate and future assignments** About Lockwood: Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies to address their objectives through medical communications. Our clients count on us to challenge their assumptions and help them creatively navigate around obstacles. From strategy through execution, we focus on accuracy, transparency, and scientific value to create programs that are evidence-based, clinically relevant, and contribute to the development of our clients' brands. Over a third of our staff hold advanced scientific or medical degrees, and most work from where they live. Because our flexible structure provides better work-life balance, we attract the best talent, facilitate their best work, and as a result, are more responsive to our clients, wherever and whenever they do business. Summary: In this role, the Freelance Scientific Director is responsible for the planning, development, and oversight of scientific content for an assigned account or accounts across various therapeutic areas addressing different target audiences. Responsibilities: Responsibilities include working with the Group Scientific Director to provide clients with strategic medical communication recommendations that support the achievement of brand goals, independently leading execution of content development activities, supervising Associate Scientific Directors, and liaising with other in-house or freelance staff to manage writing and other content-related tasks such as conducting background research, data-checking, and reference annotation. Education: An advanced degree in science (ie. PhD, PharmD, or MD) is required. CMPP preferred. Professional Skills and Requirements: Candidates must have 5 or more years of relevant job experience with medical publications, including manuscripts, posters, abstracts, podium presentations, scientific platforms, and publication extenders. This role requires demonstrated organizational, analytical, and interpersonal communication skills, as well as the ability to analyze and interpret scientific data, multitask, work independently, and manage projects within tight deadlines. Experience with established professional medical editorial processes (ie. AMA style) and ethical guideline working knowledge (ie. ICMJE, GPP2022) is also required.

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.

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 us as a Scientific Director/Senior Scientific Director. This position falls within our wider Medical Strategy and Communications division, which serves our clients by mobilizing our scientific knowledge to interpret data and create compelling narratives to guide their medical communications strategy in the context of the current therapeutic landscape and through regulatory challenges. The Scientific Director/Senior Scientific Director will serve as a leader in our Scientific Services department and oversee the development of high-quality deliverables aligned with strategic objectives for Medical Affairs/Publications accounts. This role will serve as a valued and strategic partner to clients, lead a team of medical writers, and ensure timely and efficient delivery of projects. Oncology experience is highly desired. Qualifications * PhD, PharmD, or MD required * Minimum of 5+ years' experience in a medical communications agency setting, preferably in oncology * 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 * Generous amount of paid time off annually + 10 paid holidays * Flexible spending accounts for health and dependent care * Employee Assistance Program * Paid short-term and long-term disability coverage

About Us We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology - enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation - enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit ****************** and follow us on LinkedIn. About the Role As the Associate Director, Medical Writing, you will support the development of high-quality clinical and regulatory documents that support our drug development programs. Reporting to our Senior Director, Medical Writing, you will bring scientific expertise, and the ability to thrive in a dynamic start-up environment. Day to day you will lead critical clinical and regulatory documents from start to finish by working closely with Clinical Development, Regulatory Affairs, Biostatistics, and other stakeholders. You will support cross-functional teams to ensure data presentation and messaging is clear and consistent across documents in addition to ensuring timely and compliant document delivery. You must have experience with leading the development of clinical and regulatory documents in collaboration with cross-functional teams in order to be successful in this role. This is an exciting opportunity to be a critical part of drug development and regulatory submissions at a growing organization with an expanding pipeline. This is a fully remote position, with opportunities to travel and meet with teams as needed. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely. Key Responsibilities Author, review, and manage clinical and regulatory documents including: Clinical Study Protocols and Amendments Investigator Brochures Clinical Study Reports (CSRs) Regulatory submission documents (e.g., INDs, NDAs, MAAs) Collaborate with internal teams and external vendors to manage timelines and deliverables. Provide input on document planning and regulatory submissions. Ensure documents comply with ICH guidelines, regulatory requirements, and company standards. Develop and maintain templates, style guides, and best practices for medical writing. Mentor junior writers and contribute to building the medical writing function. Experience Advanced degree in life sciences (PhD, PharmD, or MS preferred). 8+ years of medical writing experience in the biotech/pharmaceutical industry, including regulatory submissions. Strong knowledge of ICH, FDA, and EMA guidelines. Excellent writing, editing, and project management skills. Ability to work independently in a fast-paced, start-up environment. Ability to work collaboratively and coordinate the efforts to resolve comments with team members Flexible and able to adapt to changing deadlines and priorities High attention to detail Experience with StartingPoint templates, PleaseReview, and Microsoft Project is a plus.

Who we are Teva is a global pharmaceutical leader. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. At Teva, we strive to deliver quality medicines to patients around the world with integrity and ethical business practices. Our culture is about not only what we do, but how we do it. We innovate to create value for patients, our partners in the healthcare system and our stakeholders. We constantly look for original and better ways to excel, creating solutions for current and future unmet needs. Join us on our journey of pivot to strategic growth: To make an impact, innovate, and work on diverse portfolio of products within a promising pipeline centered around our core therapeutic areas To help make healthcare accessible to more patients, as part of a highly global diverse matrixed R&D team, To improve health and enable people to live better, healthier lives. The opportunity As a Director, in Global Regulatory Medical Writing (GRMW), you will primarily work in a therapeutic area specific role as a leader and SME representing GRMW in matrixed stakeholder R&D program teams. This role provides a significant level of oversight and SME guidance to internal medical writing team and cross-functional matrixed project teams in the strategic planning, scope determination, and development of clinical and regulatory documents used in drug development and product registrations. In this role you will offer clear guidance, leadership, accountability for the preparation of quality, fit-for-use clinical regulatory documents for various regulatory and reporting purposes in an E2E business model. As per business needs, you may write and edit clinical regulatory documents, including submission summaries and other complex documents. How you'll spend your day Manage a team of direct reports; oversee contingent workers and/or vendors; provide training to others; strategically analyze needs to manage resources and take accountability for resource allocation for therapeutic specific business needs with support from the department head Oversee/provide guidance and accountable for all document types prepared by medical writers, review documents internally within medical writing function before stakeholder engagement, may write and edit clinical regulatory documents (all types) as per business needs Ensure that documents are fit-for-purpose, contain clear and consistent medical/scientific messaging that are accurate and complete, adhere to applicable regulatory guidelines, ICH guidance, and Teva standards Lead/contribute to the preparation/revision of document templates Participate in the recruiting/hiring process, development of direct reports including identifying learning/training opportunities, performance assessment and reviews Responsible for tracking/providing team metrics and establish key performance indicators Your experience and qualifications PhD or PharmD in life sciences (or other related field) with a minimum of 8 years of experience; Master's degree in life sciences (or other related field) with minimum of 10 years of experience Expert in all document types. Oversees/mentors for all document types at therapeutic area or functional level. Guides/oversees medical writers; considered a proficient manager with regulatory medical writing expertise. Considered an internal expert in all aspects of regulatory medical writing and clinical drug development. Influences and potentially leads creation of regulatory medical writing processes and standards. Serves as subject matter expert for the Medical Writing function. Knowledge of global regulations and guidelines for document submissions, and experienced in leading regulatory global submissions Excellent written and oral communication skills Team player, dynamic, engaged, and agile to drive business needs and execute departmental vision at Teva Primary accountability is delivering high quality documents that are fit-for-use and within timelines with medical writing colleagues Represents MW in program teams providing leadership and guidance as an SME Addresses business/program/project level issues; makes independent decisions using past experience and current situation to drive solutions and mitigate risks Persuades and inspires team to take action; coaches and mentors' junior medical writers and team as applicable to build MW SME presence, has expert negotiation skills Contributes to content preparation for departmental initiatives, participates in process development, and improvement cross-functionally with direction from department head Leads development of process, and preparation/revision of SOPs and guidance documents with department head and medical writing LT team Forecasts and maintains budget as per business needs and direction from department head Role location This is a remote opportunity and can be based anywhere in the United States. Enjoy a more rewarding choice We offer a competitive benefits package, including: • Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. • Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. • Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays. • Life and Disability Protection: Company paid Life and Disability insurance. • Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. Reports To Head of Global Regulatory Medical Writing Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Important notice to Employment Agencies - Please Read Carefully Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies 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.

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!

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. argenx is a clinical-stage biopharmaceutical company creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates - tailored from discovery through development to address patient needs. For the expansion of our team, argenx is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department. This individual will contribute to and execute the overall strategy for all medical writing processes to according argenx medical writing standards standards and corporate objectives. Roles and Responsibilities: Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs, briefing documents for scientific advice, specialty regulatory documents like PIPs, ODDs, aggregate reports, RFIs, and other documents required for drug development Engages relevant SMEs and document owners to develop content that is well-organized, consistent, accurate, and appropriate for a regulatory audience Responsible for inspection-readiness of medical writing activities Facilitates standardization of documents using document templates, lexicons, and argenx style guide to ensure the quality and consistency of documents across programs Manage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents Collaborates with project teams, including program leader, clinical study managers, biostatisticians, and medical directors, to ensure project deadlines are met Responsible for inspection-readiness of medical writing activities Responsible for medical writers assigned to support the medical writing activities for a particular project Executes corporate objectives, goals, measures, and strategies and begins to inform the development of them Capable of working on multiple deliverables simultaneously Desired Skills and Experience: Bachelor's degree in a scientific or clinical discipline or related field required; PhD preferred Minimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered Native/bilingual or fluent American English proficiency Solution-focused eCTD Module 5 and Module 2 writing experience for global MAAs Basic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission Knowledgeable in the regulatory guidances developed for documents authored by medical writing Ability to proofread documents for compliance with internal and external guidance documents Ability to approach issues from various perspectives and accurately summarize data to provide conclusions Ability to work precisely according to procedures and regulations Excellent written and verbal communication skills Ability to prioritize and multi-task successfully in a fast-paced environment Ability to work autonomously, as well as collaboratively in a team Excellent time management skills and a proven ability to work on multiple projects at any given time Must be proficient in MS Office Familiarity with Veeva Vault and Please Review preferred Familiarity with pharmacovigilance documents preferred ** Strong preference for individuals located on the East Coast** #LI-Remote For applicants in the United States: The annual base salary hiring range for this position is $164,000.00 - $225,500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks. This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. At argenx, all applicants are welcomed in an inclusive environment. They will receive equal 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 applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com . If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at **************** . Only inquiries related to an accommodation request will receive a response.

At the American Cancer Society, we're working to end cancer as we know it, for everyone. Our employees and 1.3 million volunteers are raising the bar every single day. We are a culture comprised of diverse backgrounds and experience, to better serve our communities. The people who work at the American Cancer Society focus their diverse talents on our lifesaving mission. It is a calling. And the people who answer it are fulfilled. Develop and manage a portfolio of grant opportunities across the continuum of Cancer Research. The portfolio may include projects in cancer drug discovery, the genetics and genomics of tumor models, and translational science leading to clinical or implementation research. The Director will represent the Research Department as liaison to Division staff, and provide expert information, education and communication about cancer and the American Cancer Society's Research and Training Program to a variety of constituents. This role will strategically coordinate with other ACS departments, and external agencies regarding extramural research and training activities and provide regular communications regarding research outcomes of their portfolio. *This is remote position* ESSENTIAL FUNCTIONS: Program and Strategic Development (20%) The Senior Scientific Director will lead the design and execution of research strategies and initiatives that advance mission-critical cancer research priorities. This includes overseeing research programs, guiding a team with a defined scope and resources needs, creating frameworks and impact measures, managing risk and contingency planning, and ensuring timelines align with departmental goals. Program Oversight (15%) Manage Requests for Applications (RFAs) related to Program, as necessary. Lead or participate in the development or presentation of conference programs or sessions that support existing grant programs or specific areas of research and training or provide opportunities for ACS funded researchers to meet, interact and collaborate. Act as a scientific and organizational resource for the Extramural Council, Chief Scientific Officer, Senior Vice President for Extramural Research. Peer Review (50%) The Senior Scientific Director will oversee all functions of the Career Growth and Research Program, including managing 3-4 peer review committees. Responsibilities include recruiting qualified volunteer scientists and health professionals, advising on Council member selection, coordinate and reporting outcomes of biannual Peer Review Committee (PRC) meetings, maintain communication with applicants and providing funding recommendations to the Council. Program Communication and Dissemination (15%) The Senior Scientific Director will communicate grant policies and procedures to researchers and institutional officials, while managing the programs' grant portfolio. This is achieved through establishing and maintaining relationships with the grantees, advising on project modifications, monitoring progress, and highlighting high-impact discoveries. Additionally, the incumbent will synthesize and communicate scientific information about cancer for internal and external constituents, e.g., the public, the media, and donors. EXPERIENCE/QUALIFICATIONS: Minimum Degree Required: Doctorate MD and/or PhD or equivalent combination of education and experience in relevant areas required. Preferred Degree: Doctorate Years of experience: Previous experience in scientific or program management including Assistant, Associate, or Full Professor academic level or equivalent in public or private research institutions is required. Significant experience in performing peer review, establishing and leading peer review committees. KNOWLEDGE, SKILLS, AND ABILITY: Strategic Leadership & Problem-Solving - Synthesizes complex information, anticipates future research possibilities, and develops scientific breakthrough strategies. Stakeholder & Relationship Management - Balances diverse stakeholder needs and builds strong internal and external networks. Team Building & Engagement - Creates high-performing, motivated teams and fosters a collaborative environment. Accountability & Trust - Holds self and others accountable while instilling confidence through integrity and authenticity. Scientific Expertise & Communication - Deep knowledge of preclinical/translational cancer research; strong written, verbal, and presentation skills; ability to engage lay audiences. Operational & Technical Skills - Experienced in program development, project management, nonprofit operations; proficient in Microsoft Office and adaptable to proprietary systems. TRAVEL REQUIREMENTS: Regular travel required PHYSICAL REQUIREMENTS: Work is normally performed in a standard office environment No or limited physical effort required No or little exposure to physical risk The starting rate is $160,100 to $200,000. The final candidate's relevant experience/skills will be considered before an offer is extended. Actual starting pay will vary based on non-discriminatory factors including, but not limited to, geographic location, experience, skills, specialty, and education. ACS provides staff a generous paid time off policy; medical, dental, retirement benefits, wellness programs, and professional development programs to enhance staff skills. Further details on our benefits can be found on our careers site at: jobs.cancer.org/benefits. We are a proud equal opportunity employer.

Support the early Oncology clinical drug research and development process by providing strategic planning and execution, including clinical trial design and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to clinical projects like actual trial data, registries and real-world data bases. Represent biostatistics and coordinate the inputs from programing and data management at a substance/asset level regarding data science related aspects. Collaborate with cross-functional teams to design, evaluate, and optimize clinical trial strategies and development scenarios. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Lead and oversee designing, transforming, analyzing and reporting complex early Oncology clinical trials or projects with established BI experience . + Lead and oversee for designing, transforming, analyzing and reporting of other data from research and development like registries and real-world data bases with respect to a specific use case or project/asset. + Develop and implement fit-for-purpose statistical designs and Go/NoGo decision frameworks through simulations and scenario planning to ensure high-quality evidence generation. + Keep abreast of data science within and outside BI. Apply advanced statistical methodologies and turn derived insights into new data science approaches for early Oncology clinical development. + Support fostering innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models. + Present compelling validated stories regarding complex data science aspects to Biostatistics colleagues and other professionals within and outside of BI. + If applicable, supports the clinical drug development process up to the level of substance/assets. + Guide and/or lead other colleagues, internal and external customer and external providers on data science related tasks. + Coordinate cross-functional working with programming and data management. + Be a team player and contribute to cross-functional collaborations. + Supports regulatory interactions by ensuring statistical rigor in evidence strategies. + Participate in cross-functional BI internal working-groups and drive/plan relevant data science aspects. Participate in external working groups. + Liaise with late phase Oncology Biostatistics and Data Science team to leverage synergies and share knowledge. **SR AD:** In addition to what is listed above, you will also be responsible for the following: + Subject Matter Expert (SME) / Process Lead for designing, transforming, analyzing and reporting complex early Oncology clinical trials or projects, that represent new challenges and for which project and therapeutic knowledge is not given. + Subject Matter Expert (SME) / Process Lead for designing as well as transforming, analyzing and reporting of other data that represent new challenges from research and development like registries and real-world databases. + Identify trends in data science within and outside BI. + Lead cross-functional BI internal working-groups and drive/plan relevant data science aspects. + Foster innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models. + If applicable, supports the clinical drug development process up to the level of Therapeutic Area/assets. **Requirements** **AD Requirements:** + Bachelor of Science with a minimum of **seven (7) years** ; Or Master of Science with **six (6) years** of experience OR Doctoral Degree (PhD) with **three (3) years,** all must befrom an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.). Experience can be from within the pharmaceutical industry, CROs, regulatory authorities or academic institutions. + Working experience might be partially compensated by broad and deep topic-specific knowledge. + Broad knowledge and advanced experience in software languages relevant for business needs and understanding of clinical trial development process required. + Advanced project lead experience required. + Understanding and applying key of principles of data science. + In-depth understanding of advanced statistical concepts related to Data Science. + Demonstrated broad knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex clinical trials, in projects with established BI experience or data from other sources in clinical research and development. + Thorough knowledge of statistical methodology, design of clinical trials or clinical experiments, basic medical terminology and on processing clinical trial information. + Advanced working knowledge of broad variety of aspects of relevant software languages. + Abilitiy to lead and facitlitate meetings as well as develop and deliver trainings related to data science. + Language skills: English: fluent (Read/Write/Speak).Know, understand, and implement: + International regulations and guidelines for good clinical and statistical practice from all ICH regions, + The various international guidelines on clinical development, including statistical methodology, for TA-related disease areas, and + BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan). **SR AD Requirements:** + Bachelor of Science with a minimum of **ten (10) years** ; Or Master of Science with **ten (10) years** of experience OR Doctoral Degree (PhD) with **six (6) years,** all must befrom an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.). Experience can be from within the pharmaceutical industry, CROs, regulatory authorities or academic institutions. In addition to what is listed above, the following is required: + Demonstrated comprehensive knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex situations that represent new challenges and for which project and therapeutic knowledge is not given. + Excellent knowledge of statistical methodology, design of clinical trials or clinical experiments, basic medical terminology and on processing clinical trial information. + Advanced understanding of cutting-edge statistical concepts related to Data Science. + Comprehensive working knowledge of broad variety of aspects of relevant software languages. **Desired Skills, Experience and Abilities** + Basic medical understanding of Oncology disease areas, including familiarity with clinical endpoints, RECIST criteria, cancer-related terminology, and therapeutic strategies. + Familiarity with Oncology translational endpoints (e.g., exploratory or early surrogate markers) and statistical modeling for translational research. **Compensation:** This position, AD, Principal Clinical Data Scientist, offers a base salary typically between $140,000.00 and $222,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (***************************************************************** **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact you will make in this role: Principle Responsibilities: (essential job duties and responsibilities) Utilizes scientific and clinical expertise, along with advanced writing and analytical skills, to research, develop, edit, format, and proofread medical and scientific publications in English. Produces a variety of medical/scientific documents-including abstracts, posters, and manuscripts-in compliance with relevant journal and conference requirements. Reports to the Medical Information and Publications Manager and may provide training or supervision to junior writers or contractors as needed. Participates or leads publication panel planning meetings, contributing expertise and insights. Works independently or collaboratively as part of a project team to accomplish assigned writing projects. Demonstrates initiative in identifying and resolving challenges throughout the publication process. Maintains comprehensive understanding of all Solventum product literature. Effectively manages and prioritizes multiple projects to ensure timely completion of tasks. Assists with special writing projects as assigned. Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: Bachelor's degree, with 7-10 years of experience in medical and scientific publications research and authorship. Proficient in Microsoft Office applications, including Word, Excel, Access, and PowerPoint, or equivalent PC programs. Experience in the design, development, and authorship of publication panels. Demonstrated expertise in medical and scientific writing principles and practices. Additional qualifications that could help you succeed even further in this role include: Master's or PhD degree in Science or related field Knowledge of Solventum products Advanced writing, critical thinking, and analytical abilities. Exceptional communication and presentation skills. Strong organizational skills and attention to detail, with the ability to work independently and collaboratively within a team environment. Proven ability to interact effectively with employees and external business partners while maintaining a positive, service-oriented approach. Demonstrated capacity to handle confidential information with discretion and exercise sound business judgment. Work location: Remote Travel: May include some [domestic/international] travel Relocation Assistance: May be authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Supporting Your Well-being Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Applicable to US Applicants Only:The expected compensation range for this position is $137,439 - $167,981, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: *************************************************************************************** of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. 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Job Description The Senior Director of Product Development & Management is responsible for leading the strategy, execution, and lifecycle management of cross-functional products in medical cost containment. This role ensures alignment with CERIS' annual strategic objectives while addressing evolving industry needs. The Senior Director serves as a subject matter expert within their vertical segments, possessing relational, tactical and technical expertise in payment integrity across the industry. The leader in this role is accountable for driving product growth, with a focus on enhancing revenue generation and elevating client satisfaction. This is a remote position. ESSENTIAL FUNCTIONS & RESPONSIBILITIES: Develop next generation services supporting strategic initiatives with prepayment and post payment solutions Grow product relationships throughout CERIS/CorVel, including but not limited to, corporate marketing, IT, regional offices, external clients, and all AE and AM staff CERIS/CorVel wide Functions as a subject matter expert (SME) in product development processes, product/solution areas, competitor offerings, and customer needs Plan, develop, define requirements, produce cost benefit analysis, and launch project within scheduled and committed time frames Builds external alliances with customers and industry experts to discuss industry information & trends Lead in the integration of complex business factors and implement long-term strategic LOB or market segment objectives; Shapes products to enhance client values and experience Drive product integrity as part of the collaboration of the Sr. leadership team and all other CERIS departments Interfaces with key leadership and functional experts providing insight and advice on business process improvement approaches to strategic business challenges Provide mentoring, coaching, and leadership across all levels at CERIS; presses for continuous improvement in a “learn and do” approach Produces content for training AE and AM teams including market differentiation, benchmarking, ETC Manages multiple projects, priority setting, and committed schedules Available to travel up to 25% for customer onsite visits and events KNOWLEDGE & SKILLS: Strong interpersonal skills, complex problem-solving skills, drive for concrete results, be innovative Must be well spoken and able to present product/topics at events without verbal crutches Excels in building product business plans with forecasting and maturation plan Superb attention to detail and ability to deliver results in a fast paced and dynamic environment Strong analytical and modeling ability and distilling data into actionable results Comfortable with ambiguity and in working in a cross functional role Technology industry experience considered a plus but not required EDUCATION & EXPERIENCE: Bachelor's degree or higher from an accredited college or university is preferred 10+ years of relevant experience or equivalent combination of educations and work experience PAY RANGE: CorVel uses a market based approach to pay and our salary ranges may vary depending on your location. Pay rates are established taking into account the following factors: federal, state, and local minimum wage requirements, the geographic location differential, job-related skills, experience, qualifications, internal employee equity, and market conditions. Our ranges may be modified at any time. For leveled roles (I, II, III, Senior, Lead, etc.) new hires may be slotted into a different level, either up or down, based on assessment during interview process taking into consideration experience, qualifications, and overall fit for the role. The level may impact the salary range and these adjustments would be clarified during the offer process. Pay Range: $144,126 - $187,198 A list of our benefit offerings can be found on our CorVel website: CorVel Careers | Opportunities in Risk Management In general, our opportunities will be posted for up to 1 year from date of posting, or until we have selected candidate(s) to fulfill the opening, whichever comes first. ABOUT CERiS: CERiS, a division of CorVel Corporation, a certified Great Place to Work Company, offers incremental value, experience, and a sincere dedication to our valued partners. Through our clinical expertise and cost containment solutions, we are committed to accuracy and transparency in healthcare payments. We are a stable and growing company with a strong, supportive culture along with plenty of career advancement opportunities. We embrace our core values of Accountability, Commitment, Excellence, Integrity and Teamwork (ACE-IT!). A comprehensive benefits package is available for full-time regular employees and includes Medical (HDHP) w/Pharmacy, Dental, Vision, Long Term Disability, Health Savings Account, Flexible Spending Account Options, Life Insurance, Accident Insurance, Critical Illness Insurance, Pre-paid Legal Insurance, Parking and Transit FSA accounts, 401K, ROTH 401K, and paid time off. CorVel is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable. #LI-Remote

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Essential Functions Serve as medical writing lead and subject matter expert on multiple concurrent complex writing assignments. Work closely with in-function and cross-functional team(s) on document strategies. Lead the day-to-day activities of the medical writers to include training new team members, coaching employees and monitoring performance. Participate in hiring new team members as needed. Contribute to the development of medical writing strategies and provide input on regulatory submission strategies. Draft, edit, and finalize development of regulatory documents (protocols, IBs, CSRs) for FDA submission. Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents. Develop, implement and adhere to the Scientific Communications Standard Operating Procedures (SOPs) to ensure that publication activities are aligned with strategic initiatives and industry best practices. Partner cross-functionally on teams to develop and implement regulatory documents and strategic publication plans for regulatory submissions and scientific manuscripts. Identify, propose and implement solutions to resolve issues and questions arising during the writing process, including resolution or escalation as needed. Guide scientific content development for regulatory documents and scientific publications. Assist with the development and implementation of strategic publication plans for creating, coordinating, and tracking scientific publication materials (manuscripts, abstracts, posters, and slide presentations) as needed. Lead project team meetings and document review meetings. Provide direction and solutions to cross-functional teams on expectations for document content. Ensure quality, consistency, alignment, and compliance of regulatory documents and publications inclusive of performing quality checks of clinical and nonclinical documents. Ensure documents are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines. Perform ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's Degree in a science-related field with 10+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or Masters' Degree in a science-related field with 8+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or PhD in a science-related field with 6+ years of relevant industry experience in medical writing in the healthcare industry or academia required Demonstrated experience in guiding medical writing efforts for clinical development of one or more investigational products required. Demonstrated expertise in writing and editing regulatory documents (clinical study protocols, IBs, CSRs) is required Experience in NDA/BLA submissions and writing CSRs, IBs, clinical study protocols and other documents for global regulatory submissions is required. Experience and strong scientific background in oncology, immunotherapy, or related field is required Prior experience in the biopharmaceutical industry preferred Knowledge, Skills, & Abilities Understanding good publication practices and guidelines, ie, ICMJE, GPP3, etc. Proficient knowledge of AMA style guidelines. Extensive knowledge of FDA, EMA, and ICH guidelines. Deep understanding and knowledge of the drug development process Ability to manage multiple projects and priorities simultaneously, meet deadlines, and adjust to shifting priorities in a fast-paced environment. Established proficiency with principles of clinical research and expertise in the interpretation and presentation of clinical data and other complex information. Ability to work cross-functionally and lead teams. Excellent written and verbal communication skills, with the ability to articulate complex technical information clearly and compellingly. Disciplinary expertise in oncology, immunology, and/or infectious disease. Strong critical and logical thinking skills with the ability to analyze problems, identify alternative solutions, and implement recommendations for resolution. Ability to work independently and collaboratively: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates. Working Environment / Physical Environment This position works onsite or remote based on the employee's geographic location. Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. Lift and carry materials weighing up to 20 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $138,000 (entry-level qualifications) to $152,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $145,500 (entry-level qualifications) to $160,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Job Title:Associate Principal Data Scientist (Remote) Requisition ID:R025545Job Description:Your Role Within Our KingdomWe 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 ThrillsMinimum 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.

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 -