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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.

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary We are seeking a motivated Director, Clinical Pharmacology, to join our growing Clinical Development team. In this role, you will lead clinical pharmacology programs in immunology & inflammation, providing strategic planning for drug development activities in line with departmental strategies, goals, and objectives. You will have a seat at the table to influence, decide, and recommend key clinical pharmacology strategies across the drug development spectrum, ranging from first-in-human through approval. You will develop and help implement quantitative approaches to drug development programs. You will work in close collaboration with different functions, including preclinical toxicology, preclinical pharmacokinetics, translational medicine, clinical development, clinical operations, and regulatory affairs. The position requires strong communication skills to lead and present key Clinical Pharmacology information to teams, senior leaders, regulatory agencies, and external partners. Key Responsibilities Independently lead Clinical Pharmacology/PK/PD activities and provide scientific and strategic expertise to program teams, regulatory, and senior leaders to guide critical decisions and inform development plans Support pediatric development, including protocol development and dose selection. Develop and oversee implementation of clinical pharmacology studies from protocol development to final study reporting, in collaboration with cross-functional study team members, including Clinical Operations, Biometrics and Regulatory Affairs, as well as CRO partners Lead the analysis, interpretation, and reporting of clinical PK/PD data, author clinical study reports Develop and execute and/or oversee PK/PD modeling strategies to describe the relationship between drug exposure and response to support dose selection and overall development for clinical programs Provide clinical pharmacology timelines to program teams and negotiate with other functions on outcomes and deliverables to meet conflicting demands (time, cost, quality/performance) Lead authoring of clinical pharmacology sections of clinical and regulatory documents, including protocols investigator brochures, INDs, BLAs, and responses to regulatory agency comments Maintain a current understanding of PK and PD literature and methodology, as well as the scientific literature related to the emerging Apogee pipeline Ideal Candidate PhD or PharmD with relevant expertise in clinical pharmacology or pharmaceutical science is required 5+ years of direct industry experience in conducting clinical stage drug development Experienced in developing clinical pharmacology plans and authoring relevant sections of clinical and regulatory documents Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetic and pharmacodynamic principles, drug metabolism, bioanalysis, biopharmaceutics Experience in biologic drug development preferred, and/or immunology and inflammation (I&I) a plus Experience with late-stage development (Phase 2/3) preferred Fluency in model-informed drug development, with hands-on modeling and simulation experience highly preferred (e.g. NONMEM, R, Phoenix NLME, MATLAB, etc.) Experience working with external CROs Proficient in using common PK/PD modeling software (such as Phoenix WinNonlin, Prism, and other similar tools) Ability to work proactively and effectively, with exceptional creative problem-solving skills and self-motivation Ability to work in cross-functional teams within a highly dynamic environment Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless Up to 15-20% travel is required to company All Hands meetings and development team meetings The anticipated salary range for candidates for this role will be $230,000 to $260,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

About This Role As the Associate Scientific Director, Clinical Pharmacology you will serve as the clinical pharmacology lead on program and study teams, providing strategic leadership in the development and execution of clinical pharmacology plans for drug candidates. You will integrate knowledge of clinical and quantitative pharmacology to optimize and provide rationale for doses, dosage regimens, and study designs throughout the drug development lifecycle. What You'll Do Provide clinical pharmacology expertise to program and study teams throughout a molecule's lifecycle (discovery through development) Provide functional representation on development program and study teams Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical) Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results Serve as lead author and key contributor to clinical pharmacology sections of clinical and regulatory documents Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent You are a scientifically driven clinical pharmacologist with deep expertise in PK/PD modeling, quantitative pharmacology, and translational science. You bring hands-on experience leading clinical pharmacology strategy across early and late-stage development, applying Model-Informed Drug Development (MIDD) principles to optimize dose selection, study design, and regulatory strategy. You thrive in cross-functional settings, bridging science and strategy to advance innovative therapies for patients. Who you are: You are a scientifically driven clinical pharmacologist with deep expertise in PK/PD modeling, quantitative pharmacology, and translational science. You bring hands-on experience leading clinical pharmacology strategy across early and late-stage development, applying Model-Informed Drug Development (MIDD) principles to optimize dose selection, study design, and regulatory strategy. You thrive in cross-functional settings, bridging science and strategy to advance innovative therapies for patients. Qualifications PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD) Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles Experience designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology data Experience with use of PK/PD software packages such as Phoenix, R, SimCYP, NONMEM, Monolix, Adapt, MATLAB, SAS Excellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards #LTD-1 Job Level: Management Additional Information The base compensation range for this role is: $163,000.00-$225,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

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

can be based remotely (working from home) or at our headquarters in Stamford, CT. 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 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.

**Compensation Data** This position offers a base salary typically between $220,000.00 and $350,000.00 USD. 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 (***************************************************************** . **Description** 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 several 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. The Group Lead, Medical Writing ExpMED, is accountable for the organizational set up, development, implementation, and oversight of a high-performing, innovative Medical Writing group for the early phase, and the development and oversight of an ExpMED Medical Writing excellence strategy (i.e., acceleration of clinical development timelines, use of AI, and creation of patient value while maintaining high quality) via strategic planning and execution of early clinical documents across all Therapeutic Areas. The Group Lead, Medical Writing ExpMED, in alignment with Head of ExpMed Clinical Operations (ExpMED CO) and ExpMED Leadership team, contributes to overall ExpMED strategy. The Group Lead provides leadership and guidance to a diverse team, creates an environment that inspires, motivates, and empowers colleagues, fosters a culture of continuous learning, knowledge sharing, improvement, innovation, accountability, and collaboration to accelerate clinical trial delivery and maximize value for investigational sites, patients, and the organization. **Duties & Responsibilities** - Develop and implement a global early phase Medical Writing excellence strategy that simplifies processes, sharpens focus, and accelerates clinical development across all Therapeutic Areas. - As part of the ExpMED Clinical Operations department, you will build and continuously enhance a high-performing and innovative global Medical Writing team. - Accountable for the creation and continuous refinement of a world-class ExpMED Medical Writing (MW) department to effectively deliver in the early phase. - Accountable for talent attraction, development retention, and succession planning within ExpMED (MW), in close alignment with HR. Group Lead MW in close alignment with other members of the ExpMED CO Leadership team, is responsible for functional talent development within ExpMED CO. - Accountable for the creation of an environment that inspires, motivates, and empowers colleagues within ExpMED MW to accelerate clinical development timelines and to create value for patients and the healthcare system. - Accountable that staff is well trained and qualified; supports staff in technical and personal skills development to support career progression. - Leads the communication of scientific programs and holistic evidence to key stakeholders, including investigators, regulators, payers, patients, and caregivers. - Oversees capacity planning, financial management, and the strategic deployment of internal and external (CRO) resources to support clinical program needs. - Provide oversight to constantly improve ExpMED MW processes and standards to prevent and/or remedy quality and/or compliance findings (in-house and/or CRO setting) to ensure early clinical execution excellence, in alignment with other Corporate functions. - Representation of Boehringer Ingelheim at external meetings and conferences to create value for Boehringer Ingelheim and external stakeholders. **Requirements** - Minimum of Bachelor's degree required; advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., Master's), strongly preferred. - 10+ years of professional experience in a scientific, clinical, and/or medical space. - Strong leadership skills with the ability to inspire and motivate to build a high-performing, innovative team. - Comprehensive understanding of drug development and reporting process required for study reports, submission documents, and data transparency deliverables across multiple providers. - Experience in (at least passion for) storytelling. - Knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements. - Demonstrated experience presenting to scientific and non-scientific audiences. - Experience managing multiple, complex projects, and a strong record of developing successful partnerships and meeting customer expectations in global settings. - Strategic mindset with the ability to drive innovation, digital transformation, and process integration across complex, global environments. - Expertise in globalizing functions to operate in a standardized fashion. - Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with colleagues and vendors. - Proactively identify gaps, emerging risks, and opportunities for improvement through ongoing analysis and benchmarking to maintain industry leading position - Encourages the adoption of new technologies, smart risk-taking, and a unified ExpMED CO identity that empowers teams and accelerates clinical development. - Demonstrated ability to build, lead, develop and maintain a high-performance, medical writing team. - **Remote*:** this position is considered remote based. **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.

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 - $246,000.00 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.

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

The Virology (HIV) Regional Medical Scientific Director is a credentialed (i.e., MD, PhD, DNP, or PharmD) therapeutic and disease area expert who engages in both scientific exchange and research support, when requested, with external scientific leaders and investigators in the medical and scientific community. This MSL-type role provides Scientific Leaders (SLs) balanced, factual, scientific information about non-product areas of interest to our Company and responds to scientific questions from SLs, including questions about our Company's products and data. Virology RMSDs are responsible for facilitating and developing peer-level relationships with scientific leaders in the external medical/scientific community including those investigators who have potential interest in participating in our Company's research studies. Virology RMSDs provide support for data generation activities including our Company's sponsored trials and our Company's Independent Investigator Study Programs as prioritized and requested by Research and Development (R&D) leadership. Virology RMSDs reports to the Regional RMSD Team Leader - within US Medical Affairs, Global Clinical Development, Research and Development (R&D). Location details: This role covers KS, MO, IA, ND, SD, & NE. Candidates must reside within the territory, with a strong preference for the St. Louis or Kansas City areas. Travel up to 50% within the territory. Primary Activities: Identify, establish and manage collaborative professional relationships with national, regional and clinical practice scientific leaders (SLs) and investigators to identify and address scientific needs and to ensure access to medical and scientific information on areas of therapeutic interest and our Company's data or products Conduct peer-level scientific discussions and maintain a reliable presence to ensure SLs have a Research and Development (R&D)/ Medical Affairs contact within our Company Engage in proactive non-product discussions regarding scientific issues (e.g., disease states, diagnosis, epidemiology, unmet medical need, and population health, etc) that are intended to enhance scientific discussions or inform/guide Research and Development (R&D)/ GMA and Human Health (HH) strategy or Research and Development (R&D) research programs Facilitate appropriate scientific exchange of information with SLs, including integration of scientific knowledge with actionable insights to inform Research and Development (R&D) and Human Health (HH) strategies Communicate external stakeholder opinions, insights and feedback on new data, clinical trends and the evolving vaccine landscape to Medical Affairs HQ teams to enhance scientific understanding and inform internal Research and Development (R&D) strategies Represent Research and Development (R&D) at scientific meetings and congresses and contribute to Research and Development (R&D) debriefs, insight discussions and post-congress reports Develop and execute territory plans in alignment with global Virology strategy Support data generation activities when requested by Research and Development (R&D) leadership, including our Company's Investigator Study Program (MISP), by acting as the primary liaison to investigators interested in developing and performing investigator-initiated research When requested by Research and Development (R&D) leadership, work to identify potential investigators for consideration of participation in phase IIIV clinical development programs and provide scientific support for Research and Development (R&D) sponsored trials as needed Provide in-depth scientific support to Health Systems teams within USMA Demonstrate and maintain in-depth knowledge of the assigned disease and therapeutic area(s) through educational efforts, including attendance at relevant conferences, scientific workshops and review of key journals • Fully comply with all company policies and applicable laws, regulations, and ethical standards Education Minimum Requirement: An advanced degree (MD, PhD, DNP or PharmD), that is relevant to Virology and requirements of the position. Experience- Minimum Requirements: A minimum of 3 years prior experience in the biotech/pharmaceutical or healthcare environment A minimum of 3 years of clinical and/or research experience (beyond that obtained in the terminal degree program) in Virology/HIV (or related therapeutic area, e.g. infectious diseases, immunology, preventative medicine) Demonstrated scientific excellence in either Virology or the related therapeutic area. Excellent interpersonal, communication, networking and presentation skills Ability to travel up to 50% of the time overnights and reside in the coverage region Skills Required: Deep therapeutic competency; abreast of trends and new information Virology Ability to network and partner with important external customers, including scientific leaders, investigators, clinical practice leaders and academic affiliated institutions, including treatment guideline members (as permitted) The ability to consolidate and understand complex data sets, plan and/or execute data analyses, summarize or synthesize data and objectively interpret results Knowledge of national and society treatment guidelines, clinical research processes, FDA regulations, and OIG, HIPAA and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its external stakeholder environment Must be able to organize, prioritize, and work effectively in a constantly changing environment Preferred capabilities: Recognition for scientific excellence in Virology as demonstrated by sustained contributions to Virology via strong clinical, academic and/or translational/basic science research experience in Virology. Experience in both clinical Virology and owner of independent research and publication in Virology is highly desirable (i.e., experience in late stage clinical research as an investigator or key study personnel conducting outcomes research, company sponsored trials, or investigator-initiated trials). 5+ years of prior pharmaceutical industry experience (MSL or other clinical, medical or research related position) in Virology Prior working experience within the coverage region and established relationships with Virology stakeholders Demonstrable effective leadership skills (by example and through accomplishments), and the ability to step forward to handle challenges within scope of authority Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel) Headquarters located in Upper Gwynedd, PA; however, the position will work remotely; candidate should reside within the coverage region. #eligiblefor ERP Required Skills: Clinical Research, Clinical Trials, HIV AIDS, Infectious Disease, Medical Affairs, Pharmaceutical Medical Affairs, Professional Networking, Scientific Communications, Stakeholder Management, Stakeholder Relationship Management, Strategic Thinking, Virology Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $187,000.00 - $294,400.00 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 employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 01/11/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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.

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

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 -

As a Senior Manager, Principal Scientist at CAI, you will play an integral part of the machine learning team, which consists of mathematicians, data scientists, psychometricians, linguists, and software engineers. Our team focuses on natural language applications in educational measurement, with key foci in the automated scoring of student responses for both summative and interim assessments, automated feedback for formative assessments, and automated alerting of disturbing content in student responses. Our team uses state-of-the-art deep learning tools and models different modalities (e.g., speech, text) and is responsible for both prototyping and deploying engines and models. This position will lead a team of scientists on data design and analytic efforts for our suite of products, work closely with internal and external stakeholders to ensure we meet their needs, present at planning and technical advisory meetings, write technical reports and contribute to our growing body of research by publishing, and contribute to enhancements of existing products or to new products. This position will work closely with the other leads in the machine learning team on developing new applications for automated scoring methods. Job Responsibilities: Support CAI's innovation in natural language applications in support of our mission to improve educational outcomes for our students and educators. This includes automated scoring in large scale assessment programs (for writing, speech and other areas of educational measurement), detection of crisis alert content in student writing and the use of ML for feedback in student writing. Support CAI's emerging product portfolio for products that employ state of the art machine learning methods that provide solutions to real world problems in K-12, higher education and other related domains. Contributes to R&D agenda and sets priorities for the automated scoring team Drive and provide mentorship to a team of Scientists Design and implement studies to obtain, score, model, and examine results for any of CAI's current natural language applications, including automated scoring, crisis alert detection, and feedback. Pursue applied research to actively publish and represent CAI's leadership in this area Present at planning and technical advisory committee meetings Job Requirements: Ph.D. in psychometrics/measurement, NLP, or statistics or related computational field 10+ years professional experience in k-12 assessment 8+ years working with teams of software developers, NLP scientists, and data scientist Experience in working with client-facing work, including presentations Established publication record in NLP applications in k-12 assessment Why Work With Us? When you work with Cambium Assessment, you'll be helping to design and build inspiring solutions that make a real impact on the online testing industry, as well as the educators and students we support. Our ground breaking work includes: Advanced computer-adaptive algorithms Mobile support of user interfaces Learning management systems with social media features Universally accessible user interfaces Machine scorable items In the 2024 school year, we delivered more than 126 million online tests, and successfully supported peak testing volumes exceeding 1.5 million simultaneous test takers. We have the most advanced features of any online testing system, and we continue to push boundaries to improve student performance measurement and enabling educators with actionable insights to drive better overall educational outcomes for our students. To learn more about our organization and the exciting work we do, visit ************************** Remote First Work Environment Our Remote First approach gives employees the flexibility and trust they need to effectively balance work with life. It creates a culture in which all employees are valued and where success is measured in results. It allows us to work collaboratively, inclusively and for greater positive impact, regardless of our individual locations. If you will be working remotely, either occasionally or on a permanent basis, you must have a reliable internet connection through a cable or fiber-optic broadband service with minimum speeds of 10 Mbps download and 5 Mbps upload. The successful candidate will be expected to actively participate in video-based interviews during the recruiting process and ongoing virtual meetings with their camera on, as part of their role. As part of our Remote-First benefits, Cambium offers reimbursement to help cover the cost of setting up your home or remote office. An Equal Opportunity Employer We are dedicated to fostering a culture that celebrates unique backgrounds, ideas, and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, age, religion, sex (including pregnancy, gender, gender identity/expression, or sexual orientation), national origin, protected veteran status, disability, or genetic information (including family medical history). We will provide reasonable accommodations for qualified individuals with disabilities. You may request an accommodation during the recruiting process with your Talent Acquisition team member.