Associate director jobs in Knightdale, NC - 684 jobs

The Vice President of Strategic Analytics is a key member of the leadership team responsible for leading the development and communication of advanced analytics to support execution of strategic initiatives and sustainable growth. This role involves working closely with operations, growth, managed care, clinical, and finance leaders to support achievement of the company's objectives. Key Responsibilities Lead the planning and execution of enterprise wide analytics projects Establish KPIs and metrics to monitor the performance and impact of strategic initiatives across operations, growth, managed care, and clinical operations Support the implementation and management of the company's long-term strategic goals Analyze market trends, competitive landscape, and industry shifts to inform business strategy Partner with the finance team to create in-month forecasting In partnership with the growth team, develop frameworks for evaluating and prioritizing growth opportunities, including mergers, acquisitions, partnerships, and new MSA entry Analyze effectiveness of sales and marketing campaigns Support division presidents in driving same site revenue growth by providing insights to optimize strategies for higher acuity services Support clinical operations leadership with capacity and demand models, and analyses to optimize physician practice workflows Oversee managed care analytics to support contract negotiation and revenue forecasting Foster a culture of collaboration, innovation, and data-driven decision-making across the organization Required Education Bachelor's degree in business, statistics, mathematics, economics, health care management, or related field Master's degree preferred Required Experience Proven track record of at least 10 years in healthcare analytics Proven track record of building and leading teams, creating strategic plans, and operationalizing teams to meet business goals Demonstrated experience influencing cross-functionally Strong knowledge of healthcare trends, markets, and competitive dynamics Strong Tableau, Power BI, and SQL skills, and familiarity with data warehousing concepts in a Snowflake environment Key Competencies Exceptional analytical and problem-solving skills, with the ability to synthesize complex data into actionable strategies Strong leadership, communication, and interpersonal skills, capable of influencing and inspiring at all organizational levels Adept at managing change and navigating ambiguity in a fast-paced, dynamic environment Proficient in financial modeling, market research, and strategic planning tools

About Us Clayco is a full-service, turnkey real estate development, master planning, architecture, engineering, and construction firm that safely delivers clients across North America the highest quality solutions on time, on budget, and above and beyond expectations. With $7.6 billion in revenue for 2024, Clayco specializes in the "art and science of building," providing fast track, efficient solutions for industrial, commercial, institutional, and residential related building projects. The Role We Want You For As a Project Director, you will provide leadership on projects as the "single point of contact" for the owner, design department, the project staff, and assist through closeout within the Life Sciences/Biotech/Pharmaceuticals sector. Ensure quality and timely execution of design-build projects from design to completion and deliver the best solutions on projects valued anywhere from a $60 million to over $250 million. At Clayco, The Project Director will work with marketing, pre-construction services, business unit leaders, and mentoring Project Managers and Engineers and have overall responsibility for these projects. The Specifics of the Role Build client and subcontractor relationships. Team with Architects, Engineers, and Planners to create and manage a design schedule. Establish project forecasts and budgets. Manage costs. Accept full responsibility for project execution. Mentor and develop project management staff. Requirements Bachelor's Degree in Construction Management, Engineering, Architecture or related. 15-20 years of experience managing construction projects ($100+ million) ideally design-build. Demonstrated knowledge of construction principles, practices, and technology. Previous experience leading a successful project management team. Ability to walk a job site, climb ladders, and scale multi-floor scaffolding. Ability to lift objects of at least 50 lbs. Some Things You Should Know Our clients and projects are nationwide - Travel will be required. No other builder can offer the collaborative design-build approach that Clayco does. We work on creative, complex, award-winning, high-profile jobs. The pace is fast! This position is classified as a safety-sensitive role in accordance with applicable state and federal laws. Candidates selected for this position will be subject to a comprehensive background check, which includes mandatory drug testing. Why Clayco? 2024 Best Places to Work - Crain's Chicago Business, St. Louis Business Journal, Los Angeles Business Journal, and Phoenix Business Journal. 2024 ENR Midwest - Midwest Contractor (#1). 2024 ENR Top 100 Design-Build Firms - Design-Build Contractor (Top 5). 2024 ENR Top 100 Green Contractors - Green Contractor (Top 5). Benefits Discretionary Annual Bonus: Subject to company and individual performance. Comprehensive Benefits Package Including: Medical, dental and vision plans, 401k, generous PTO and paid company holidays, employee assistance program, flexible spending accounts, life insurance, disability coverage, learning & development programs and more! Compensation The salary range for this position considers a wide range of factors in making compensation decisions including but not limited to: Education, qualifications, skills, training, experience, certifications, internal equity, and location. Compensation decisions are dependent on the facts and circumstances of each case.

We are seeking a seasoned and strategic Executive Director of Internal Manufacturing to lead internal GMP manufacturing operations for pharmaceutical drug products. This role is critical to ensuring the consistent, compliant, and high-quality production of drug products in accordance with FDA and global regulatory standards. The ideal candidate brings deep expertise in GMP manufacturing, a strong commitment to operational excellence, and a proven ability to build and lead high-performing teams. Key Responsibilities Manufacturing Leadership Provide overall leadership and oversight of internal GMP drug product manufacturing operations, ensuring reliable, efficient, and compliant production. Quality & Compliance Uphold rigorous quality standards and ensure full compliance with FDA and global regulatory requirements. Partner closely with Quality Assurance and Regulatory Affairs to ensure alignment of CMC activities, regulatory readiness, and continuous improvement initiatives. Operational Excellence Drive continuous improvement initiatives across manufacturing processes, equipment utilization, and operational workflows to enhance productivity, efficiency, and cost effectiveness. Team Development & Leadership Recruit, mentor, and develop a high-performing manufacturing operations organization capable of meeting current and future production demands. Foster a strong performance-driven culture aligned with organizational values. Strategic Planning Develop and execute long-term manufacturing strategies aligned with corporate objectives, including capacity planning, technology enhancements, and operational risk mitigation. Cross-Functional Collaboration Collaborate closely with Supply Chain, External Manufacturing, Quality, R&D, and other cross-functional teams to support product launches, lifecycle management, and future pipeline needs. Budget & Resource Management Oversee departmental budgets, capital expenditures, and resource allocation to ensure manufacturing objectives and production targets are met. Qualifications Bachelor's degree in Engineering, Life Sciences, or a related discipline; advanced degree (MS, MBA, or PhD) preferred. Minimum of 20 years of experience in pharmaceutical manufacturing, including at least 5 years in a senior leadership role overseeing commercial manufacturing and complex drug product formulations. Deep expertise in GMP regulations and pharmaceutical manufacturing operations. Proven track record of successfully leading manufacturing organizations across multiple drug modalities. Strong strategic, analytical, and decision-making capabilities. Excellent leadership, communication, and stakeholder engagement skills.

Clorox is the place that's committed to growth - for our people and our brands. Guided by our purpose and values, and with people at the center of everything we do, we believe every one of us can make a positive impact on consumers, communities, and teammates. Join our team. #CloroxIsThePlace Your role at Clorox: The Associate Director of Organizational Change and Transformation play a pivotal role in leading enterprise change and transformation initiatives across the enterprise. This role leads and partners with Business leaders, HR leaders and cross-functional teams to design and execute change and transformation that drives organizational effectiveness, intended culture, sustainable adoption of new ways of working, implements people-oriented strategies that ensure the successful execution of pivotal transformational initiatives. This strategic position will deliver and advise on a broad portfolio of change and transformation projects, with the goal of embedding change readiness as a core capability across the enterprise. In this role, you will: * Develop, lead and execute Organizational Change Management (OCM) plans, including stakeholder engagement, impact analysis, communications, and training. * Develop, lead and execute Organizational Design (OD) efforts that are anchored to strategy. * Ensure alignment across business units and functions for smooth adoption of change for transformation efforts. * Identify risks and develop mitigation strategies for change and transformation programs * Use analytics to measure effectiveness and validate outcomes of transformation efforts. * Partner with HRBPs and business leaders to assess people's impacts and create integrated support plans. * Lead portfolio planning and management of change and transformation initiatives, ensuring seamless integration into business operations and capacity management. * Provide actionable insights for continuous improvement. * Lead dynamically deployed resources across workstreams (change management, organizational development, project management). * Serve as a trusted advisor to senior leaders on change and organizational design and capability building. * Introduce innovative approaches to embed new behaviors and processes. * Champion agility and operational excellence in transformation efforts, ensuring projects are delivered efficiently and effectively, with a focus on meaningful outcomes. * Improve change capability across the organization to increase speed and impact of change, leaders lead change effectively. What we look for: * 10+ years in organizational change management, organizational design, HR strategy, or transformation leadership roles. * Bachelor's degree in business, majoring in HR, Organizational Development, or related field is preferred, equivalent experience will be considered. * Proven experience in key OCM and OD methodologies. #LI-HYBRID Workplace type: Hybrid- 3 Days in Office; 2 Days WFH Our values-based culture connects to our purpose and empowers people to be their best, professionally and personally. We serve a diverse consumer base which is why we believe teams that reflect our consumers bring fresh perspectives, drive innovation, and help us stay attuned to the world around us. That's why we foster an inclusive culture where every person can feel respected, valued, and fully able to participate, and ultimately able to thrive. Learn more. [U.S.]Additional Information: At Clorox, we champion people to be well and thrive, starting with our own people. To help make this possible, we offer comprehensive, competitive benefits that prioritize all aspects of wellbeing and provide flexibility for our teammates' unique needs. This includes robust health plans, a market-leading 401(k) program with a company match, flexible time off benefits (including half-day summer Fridays depending on location), inclusive fertility/adoption benefits, and more. We are committed to fair and equitable pay and are transparent with current and future teammates about our full salary ranges. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities, while also allowing for differentiation based on performance. Based on the breadth of our ranges, most new hires will start at Clorox in the first half of the applicable range. Your starting pay will depend on job-related factors, including relevant skills, knowledge, experience and location. The applicable salary range for every role in the U.S. is based on your work location and is aligned to one of three zones according to the cost of labor in your area. -Zone A: $153,700 - $309,000 -Zone B: $140,900 - $283,300 -Zone C: $128,100 - $257,500 All ranges are subject to change in the future. Your recruiter can share more about the specific salary range for your location during the hiring process. This job is also eligible for participation in Clorox's incentive plans, subject to the terms of the applicable plan documents and policies. Please apply directly to our job postings and do not submit your resume to any person via text message. Clorox does not conduct text-based interviews and encourages you to be cautious of anyone posing as a Clorox recruiter via unsolicited texts during these uncertain times. To all recruitment agencies: Clorox (and its brand families) does not accept agency resumes. Please do not forward resumes to Clorox employees, including any members of our leadership team. Clorox is not responsible for any fees related to unsolicited resumes.

**About Otsuka** We defy limitation, so that others can too. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. **Position Overview:** The Director of Field Strategy and Operations serves as the orchestrator of field strategy, ensuring that prioritization, stakeholder engagement, and execution are effectively aligned with brand strategy and enterprise objectives. This role provides leadership across multiple regions, enabling a holistic, enterprise-wide approach to field strategy and operational excellence. This role also partners closely with the Business Analysis team to ensure field teams have access to standardized dashboards and data-driven insights, supporting execution excellence and performance tracking. The Director will be the point of contacts for ad hoc analytics requests, ensuring field teams have the right data to make informed decisions, but will not be creating these reports themselves or with their team and will work with Business Analysis to ensure accurate measurement and proper data is used. **Key Responsibilities:** + **Strategic Prioritization & Field Execution:** Align field activities with marketing strategy, launch planning, and market access pull-through, ensuring execution efficiency. + **Execution Excellence & Field Performance Tracking:** Oversee Omnichannel efforts, account planning, and KPI tracking, ensuring insights from Field Analytics support execution. + **Strategic prioritization & orchestrating field execution: Analyzes current and future state of the business based on insights and trends, and** leads efforts to align field activities with high-priority initiatives such as marketing strategy, launch planning, and market access pull-through. + **Field Communication & Data-Driven Decision Support:** Act as the primary field communicator, ensuring clarity on CRM tools, performance insights, and operational priorities. + **Resource Allocation & Budget Optimization:** Optimize the distribution of budgets, speaker programs, and promotional resources, leveraging data-driven insights to maximize ROI. + **Team Development & Analytics Training:** Mentor team members on business reviews, reporting systems, and analytics interpretation, working with Business Analysis to enhance field intelligence capabilities. + **Compliance Management:** Must comply with all state and federal laws, regulations and guidelines including PhRMA Code on Interactions with Healthcare Professionals as well as complying with all OAPI standards and policies relating to all job activities. **Qualifications:** + Bachelor's degree required; MBA or advanced degree preferred. + Minimum of 10 years of pharmaceutical experience, with a strong understanding of sales force operations and execution. + Prior experience in field leadership roles such as first- or second-line leadership, regional operational and customer strategy roles or other field-based support roles required. + Established expertise in business analytics, business operations, sales support, and resource management within a commercial pharmaceutical organization. + Ability to focus on priorities and resolve operational issues effectively. + Excellent communication and collaboration skills, with the ability to work cross-functionally and drive execution efficiency. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $194,247.00 - Maximum $290,375.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka 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.

Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Canada - Ontario - Mississauga, UK - London - New Oxford Street, USA - Massachusetts - Waltham, USA - North Carolina - Durham At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D The Associate Director, Epidemiology will provide scientific leadership in disease epidemiology, leveraging real-world data (RWD), cutting-edge methods, and technology across medicine and vaccine development. The role aims to generate credible and actionable real-world evidence (RWE) to improve patient outcomes, aligning epidemiology programs with broader asset/disease strategies to deliver new medicines and vaccines efficiently and effectively. Join us to grow your skills, influence decisions that affect patients, and contribute to GSK's mission of uniting science, technology and talent to get ahead of disease together. Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: * Accountable for the epidemiology program for at least one asset or disease area, including proposing and negotiating program content and budget with matrix leaders. This includes developing a Global Epidemiology Plan and may include leading a cross-functional team. * Provide expert epidemiological insights to asset matrix teams (e.g., Clinical Development Team, Safety Review Team, Medicine/Vaccine Development Team). * Lead complex epidemiological studies and negotiate new partnerships with oversight from senior staff. * Identify new vendors, tools, and data sources to deliver innovative epidemiology solutions for assets or disease areas. * Contribute to strategic initiatives on the role of epidemiology at the departmental, CMO or R&D level. * Represent GSK in scientific interactions with internal governance bodies, external regulators, and at international conferences. * Plan and coordinate scientific dissemination of epidemiology data, including authoring regulatory documents, peer-reviewed publications, and presentations at national and international meetings. * Partner with external groups conducting epidemiological studies globally and manage external collaborations. Why You? Basic Qualifications: We are seeking professionals with the following required skills and qualifications to help us achieve our goals. * Master's degree in Epidemiology, Public Health, Biostatistics, or a related quantitative discipline. * Epidemiological experience and ability to influence key internal (matrix leaders) and external (e.g. regulators) stakeholders * Experience applying epidemiologic methods in pharmacoepidemiology, clinical development, or outcomes research. * Experience designing and delivering observational and database studies, including protocol development and analysis oversight. * Experience working in a matrix environment and influencing multidisciplinary teams. * Experience providing the delivery of increasingly complex epidemiological studies, including regulatory requirements. * Experience applying epidemiology methods and study design knowledge in execution of their work (e.g. post-approval studies) * Experience working with external regulatory requirements and scientific landscape around RWE Preferred Qualifications: If you have the following characteristics, it would be a plus. * Doctoral degree (PhD, ScD, DrPH) in Epidemiology, Public Health, Biostatistics, or a related quantitative discipline. One year or more in the pharmaceutical industry or equivalent experience in an academic or government setting Experience in the pharmaceutical or biotechnology industry supporting regulatory submissions or post-authorization commitments. * Track record using multiple real-world data sources (claims, electronic health records, registries) and familiarity with data linkage. * Experience with advanced quantitative methods such as propensity scores, target trial emulation, or causal inference approaches. * Familiarity with safety signal evaluation and background rate estimation for risk assessment. * Active participation in scientific networks or professional societies and a record of peer-reviewed publications. * Prior experience presenting to regulators, advisory boards or scientific conferences. * Highly proficient written, verbal, and listening skills Working Model This role is based in Upper Providence PA United States or London UK and is expected to be hybrid, with a mix of remote and 3 days a week on-site work. How to Apply If you are ready to help shape evidence that matters for patients and to grow in a collaborative, mission-driven environment, we want to hear from you. Please submit your resume and a brief cover letter that highlights your most relevant experience and what excites you about this role. We welcome applicants from all backgrounds. We value inclusion and strive to make our teams reflect the communities we serve. Join us and help get ahead of disease together. #LI-GSK * If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $149,325 to $248,875. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD129,000 to CAD179,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at ************************ where you can also request a call. Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************

Digital.ai is the only AI-powered software delivery platform purpose-built for the enterprise, enabling the world's largest organizations to build, test, secure, and deliver high-quality software. By unifying AI-driven insights, automation, and security across the software development lifecycle, Digital.ai empowers enterprises to deliver innovation with confidence. Trusted by 5,000 global enterprises, Digital.ai is redefining how enterprises build better software in an AI-driven world. Additional information about Digital.ai can be found at digital.ai and on Twitter, LinkedIn, and YouTube. About the role We are seeking a dynamic leader to oversee our global Revenue Operations (RevOps) function, driving alignment and efficiency across Sales, Marketing, and Customer Success. As a strategic partner to the Chief Revenue Officer (CRO), you will anticipate pipeline risks, optimize closing rates, and deliver data-driven insights that accelerate growth. This role is pivotal in shaping forecasting, business planning, and operational excellence to elevate Digital.ai's go-to-market (GTM) organization from strong to exceptional. What you will do Lead and develop a high-performing RevOps team, fostering a culture of excellence and career growth. Partner with GTM leaders to align strategies across Sales, Marketing, Customer Success, and Partnerships, identifying opportunities for scalable growth. Drive accurate forecasting and business planning, ensuring credibility and alignment with Finance and executive leadership. Define and refine revenue performance metrics, forecasting models, and actionable insights. Design and implement scalable processes and systems to enhance efficiency across the revenue lifecycle. Oversee quota-setting for all revenue-generating roles. Optimize technology infrastructure to support business objectives and GTM effectiveness. Act as a trusted advisor to the CRO, providing strategic recommendations on growth and operational improvements. What you will bring Proven experience leading global RevOps in a high-growth environment Track record as a strategic advisor to senior leadership, influencing GTM strategy Exceptional leadership skills with the ability to build and inspire cross-functional teams Strong analytical and problem-solving capabilities; adept at turning complex data into actionable strategies AI-driven mindset: skilled in leveraging automation and analytics to improve forecasting and pipeline visibility Hands-on operator with the ability to balance tactical execution and long-term planning Deep expertise in CRM systems such as Salesforce, reporting, forecasting, and enablement tools Comprehensive understanding of operations across Sales, Marketing, Customer Success, and Partnerships Excellent communication and influencing skills to drive alignment among senior stakeholders Why Digital.ai? At Digital.ai, we're more than just a software company - we're a team of innovators, thinkers, and problem-solvers. By joining our sales organization, you'll be part of a dynamic, collaborative environment that encourages professional growth and values diverse perspectives. You'll work with some of the brightest minds in the industry, all while having the opportunity to shape the future of AI-enabled enterprise software development. Digital.ai also offers phenomenal benefits such as: Unlimited PTO in the US Comprehensive medical, dental, and vision plans Paid parental leave Unlimited access to continuous learning and professional development with TalentLMS Flexible working arrangements Opportunity to work with a diverse, globally distributed team If you're ready to take your sales career to the next level and make a real impact with a leading tech company, we want to hear from you. What's Next? If you're excited about this opportunity and believe you have the experience and drive to succeed, we'd love to connect. Apply today and let's talk about how you can join us in redefining digital transformation for enterprises across the globe. At Digital.ai, we believe in fostering a culture of pay transparency. We are committed to providing our employees with fair and competitive compensation. The current base salary range for this specific job is estimated to be $220,000 - 235,000. Please note that final compensation will be determined based on factors such as qualifications, experience, and internal equity. We value transparency and aim to create an inclusive and equitable workplace for all our employees. Certain positions at Digital.ai might also be eligible for additional compensation in the form of bonuses, or other employee benefits which are separate from the base salary and to be defined at offer stage. Digital.ai is firmly committed to merit-based hiring. We maintain compliance with US and International laws. We welcome everyone from all backgrounds, including age, race, color, gender, identity, gender expression, sex, pregnancy, national origin, ancestry, religion, physical or mental ability, medical condition, sexual orientation, marital status, citizenship status, protected military or veteran status, and believe that diversity is the foundation of innovation. For individuals with disabilities who would like to request accommodation, please advise us within your job application or cover letter. FRAUD PREVENTION ALERT: please note that Digital.ai does not use third party recruiters. In our efforts to protect you against impersonation please check the email address or if you are contacted by an unfamiliar/third party requesting please reach out directly to Digital.ai.

At Cumming Group, you will work on some of the world's most exciting projects in a dynamic environment where your success is measured by the impact you make. We are one of the fastest-growing project and cost management consultancies in the United States, as reflected in our top 10 rankings in ENR. With over 60 offices globally, an extremely diverse project portfolio, and double-digit year-over-year revenue growth, the opportunities to make your mark are limitless! In this role, you will be a member of our highly reputable cost management and estimating team. The cost team delivers solutions to clients in the areas of conceptual estimating, budget development, cost planning, feasibility studies, value management, economic forecasting, milestone reports, pre- and post-contract auditing, change order review and reconciliation, BIM 5D cost modeling, LEED cost analysis, life cycle costing, and more. We encourage you to research us to learn more about our outstanding reputation within this service line. We are currently hiring for an Associate Director, Project Controls to be based on-site in the Raleigh, NC area. In this role, you will have the opportunity to work on large-scale life science projects where you will be heavily involved in a variety of tasks ranging from cost controls, risk, and overall client management. Essential Duties & Responsibilities: Oversee a client account with significant growth potential or a portfolio of smaller clients as the point of contact. Perform Project Controls Services service offering including but not limited to capital planning, portfolio and project governance, front end planning, project funding, project set up, construction technology, procure to pay, project, cost & commercial managing, schedule control, risk management, project close-out. Engage in business development to defend, maintain and grow accounts being managed. Actively participate in resource management including talent acquisition, retention, development and usage. Lead the development of staff through supervision, training, coaching, and mentoring. Fee proposal development & management. Provide mentorship and training to team members in understanding methods of measurement, construction technology, contracts and delivery methods. Participate in industry events. Responsible for business management of the areas assigned including maintaining revenue and margins. Responsible for accounts receivables and projections. Leads cost controls efforts for projects with multi-phase structure and/or complex funding structure and requirements. In partnership with Director Project Controls, leads QA/QC reviews of junior controls peers. Plans and leads project controls "lessons learned" sessions post project closeout. Other duties as assigned. Attendance at work during normal business hours. Knowledge & Skills Required: Demonstrated technical competency in project controls service offering including but not limited to capital planning, portfolio and project governance, front end planning, project funding, project set up, construction technology, procure to pay, project, cost & commercial managing, schedule control, risk management, project close-out. Manage and monitor team members' activity in alignment with organizational goals. Delegate providing clear instructions and ongoing feedback. Monitor metrics and course correct as necessary while holding self and others accountable. Provide feedback to senior leaders and clearly communicate organizational direction to team members. Build relationships with key internal resources (peers, direct reports, & senior leaders). Create development opportunities and plan for direct reports and teams; provide ongoing feedback. Ability to begin to move from task focused to more business mentality. Demonstrate leadership traits and represent company values in a client facing capacity. Provide Value Engineering solutions to clients by identifying opportunities for savings and ensuring material substitutions are equal. Proven business development skills that have grown current market over the past year. Skilled in the use of ERP systems such as SAP, Oracle. Functionally proficient estimator across multiple divisions. Functionally proficient in scheduling including ability to work with Primavera and MS project. Functionally proficient in the contracts management of projects (Pre and post award). Functionally proficient in cost management of Projects. Functionally proficient in the use of analytical / reporting software such as power BI. Functionally Proficient in the use of project information management systems such as Procore or ACC build. Excellent verbal and written communication. Preferred Education and Experience: Education: BS in Construction Management, Engineering, QS, Architecture, or related field Experience: 10+ years exp in project controls Preferred Certification: MRICS, CPE, CCE, CEP, PMP, Six Sigma #LI-PJ1 Cumming Group is committed to providing Equal Employment Opportunity in its personnel policies and practices. It is Cumming Group's policy to recruit, hire, train and promote Team Members and applicants for employment without regard to race, color, creed, religion, age, sex, marital status, registered domestic partner status, genetic information, sexual preference, sexual orientation, gender (including gender expression and gender identity), pregnancy (including childbirth or related medical conditions, including breastfeeding), military service, national origin, ancestry, citizenship, physical disability, mental disability, veteran status or any other protected classification under federal, state, or local law. All such decisions are based on (1) individual merit, qualifications, and competence as they relate to the particular position, and (2) promotion of the principle of equal employment opportunity. All other terms and conditions of employment, such as compensation, benefits, transfers, layoff, return from layoff, training, education, and social and recreational programs, are administered without regard to the characteristics described above. To this end, Cumming Group complies with all provisions of Title VII of the Civil Rights Act of 1964 as amended, all of the rules, regulations and relevant orders of the Secretary of Labor, and all similar state and local laws. The salary range for this full-time role is $139,400.00-$195,133.36 per year. Ranges are determined based on the position, geography, client and industry experience and level, and represent a good faith effort to provide a fair and equitable salary. This range reflects base salary only, and not the total compensation package. Cumming Group reserves the right to pay more or less than the posted range, depending on a candidate's experience, skills, and qualifications, including client requirements. In addition to base salary, Cumming Group offers a comprehensive benefits package including: Medical Dental Insurance Vision Insurance 401(k) 401(k) Matching Paid Time Off Paid Holidays Short and long-term disability Employee Assistance Program

Who You'll Work With In our Salesforce business, we help our clients bring the most impactful customer experiences to life and we do that in a way that makes our clients the hero of their transformation story. We are passionate about and dedicated to building a diverse and inclusive team, recognizing that diverse team members who are celebrated for bringing their authentic selves to their work build solutions that reach more diverse populations in innovative and impactful ways. Our team is comprised of customer strategy experts, Salesforce-certified experts across all Salesforce capabilities, industry experts, organizational and cultural change consultants, and project delivery leaders. As the 3rd largest Salesforce partner globally and in North America, we are committed to growing and developing our Salesforce talent, offering continued growth opportunities, and exposing our people to meaningful work that aligns to their personal and professional goals. Job Title: Director, Financial Services Cloud - Salesforce As a Director in our Global Salesforce Financial Services Cloud capability practice, you'll lead and drive sales pursuits, expand our Financial Services Cloud and Financial Services footprint through exceptional client delivery, and develop and cultivate client relationships within the Financial Services industry, and its sub verticals. This is an exciting opportunity for a results-driven leader with client management, sales, and client delivery experience working with financial services customers. This role requires deep industry expertise and the ability to interface with senior level client executives. With this deep expertise comes the ability to help clients think strategically about their investments in the Salesforce platform and the required services to implement. The ideal candidate has experience leading and driving complex Financial Services Cloud pursuits and has a passion for both sales and delivery. In this role, you will focus on supporting sales pursuits, providing subject matter leadership, client management, client delivery, and leading the Salesforce account strategy in partnership with regional market leadership for an account and/or set of accounts. Responsibilities: Support sales pursuits; serve as a global leader that encourages Pursuit Excellence throughout the deal cycle. * Supports sales pursuits and sales process in partnership with local market leadership and global industry and capability leaders * Proactively engages capability leadership; partners with go to market leaders, regional leaders to help solution the engagement approach and scope for our clients * Determines sales strategy inclusive of win themes in partnership with regional market sales leadership * Manage an overall team utilization target of 76% * Supports development of proposal and statement of work * Drives decision making on deal structure in partnership with sales solution leads * Ensures deal due diligence (staffing, financials, legal, risk management, contract approval gates) * Work closely with Slalom's Talent Acquisition team to attract the best Salesforce talent in the market * Identifies pursuit close plans, identifies blockers and risks, and escalates any issues impacting pursuit progress * Actively participates in driving pursuits to closure and supports contracting process in partnership with regional and local sales leadership Business development: Focuses on increasing our Financial Services Cloud footprint across Banking, Insurance and Wealth and Asset Management accounts * Responsible for $15-20M+ annually within the Financial Services Cloud Capability * Proactively thinks beyond the project and product to continue to expand our engagements with our clients * Serves as a bridge between pursuit and delivery teams; focuses on identifying opportunities to expand our footprint on accounts to bring more to our customers in partnership with Salesforce and other capabilities * Leverages relationships across the ecosystem to nurture leads, opportunities, and existing partnerships Client Engagement Management: Builds and cultivates relationships with senior clients (project sponsor, director level and above) * Shares industry and product thought leadership in partnership with Slalom Industry and Salesforce Industry Capability leadership * Identifies opportunities for Slalom to continue to help our clients achieve business objectives * Partners with in-market Accountable Executives and Client Partners to ensure customer success and satisfaction, using Slalom's "Customer Love" survey criteria Delivery & Delivery Excellence: Exceptional client delivery; responsible for ≥60% individual utilization delivering industry specific solutions and offerings * Engages as part of client project teams ranging from 2-15+ consultants, and brings industry perspective and expertise to the overall project engagement * Keeps a pulse on industry trends through client engagement and delivery and provides feedback and insights to industry leadership to inform our solution program * Provides oversight and project delivery governance best practices, and oversees project delivery quality Industry & Platform Expertise: * 10+ years' experience in the Financial Services industry * 10+ years' consulting experience * 3+ years' leading Financial Services Cloud programs * Maintains awareness of industry best practices (working with Industry leaders) * Broad understanding of Salesforce and the Financial Services ecosystem and offerings (working with Capability leaders) Qualifications: * Minimum 3-5 years of account/delivery management experience * Experience working with banking customers and experience in a large consulting environment * 3-5 years' experience selling and delivering within the Salesforce Financial Services ecosystem * Previous sales and consulting experience, as well as experience working in an account leadership and/or customer success role * Prior experience meeting and exceeding sales targets of a similar size * Skilled at leading teams through complex technology solution sales * Passionate about financial services, and technology * Proven track record in selling through exceptional client delivery * Experienced in building relationships with customers (director level and above) * Able to partner with clients to understand their organizational needs and recommend solutions that add value to their business * Strong customer service and interpersonal skills * Budget and project management experience * Excellent verbal and written communication skills * Able to travel up to 30% About Us Slalom is a fiercely human business and technology consulting company that leads with outcomes to bring more value, in all ways, always. From strategy through delivery, our agile teams across 52 offices in 12 countries collaborate with clients to bring powerful customer experiences, innovative ways of working, and new products and services to life. We are trusted by leaders across the Global 1000, many successful enterprise and mid-market companies, and 500+ public sector organizations to improve operations, drive growth, and create value. At Slalom, we believe that together, we can move faster, dream bigger, and build better tomorrows for all. Compensation and Benefits Slalom prides itself on helping team members thrive in their work and life. As a result, Slalom is proud to invest in benefits that include meaningful time off and paid holidays, parental leave, 401(k) with a match, a range of choices for highly subsidized health, dental, & vision coverage, adoption and fertility assistance, and short/long-term disability. We also offer yearly $350 reimbursement account for any well-being-related expenses, as well as discounted home, auto, and pet insurance. Slalom is committed to fair and equitable compensation practices. For this role, we are hiring at the following levels and targeted base pay salary ranges: East Bay, San Francisco, Silicon Valley: Director: $249,000-$307,000 San Diego, Los Angeles, Orange County, Seattle, Boston, Houston, New Jersey, New York City, Washington DC, Westchester: Director: $228,000-$281,000 All other locations: Director: $209,000-$258,000 In addition, individuals may be eligible for an annual discretionary bonus. Actual compensation will depend upon an individual's skills, experience, qualifications, location, and other relevant factors. The salary pay range is subject to change and may be modified at any time. We will accept applicants until January 30, 2026, or until the position is filled. We are committed to pay transparency and compliance with applicable laws. If you have questions or concerns about the pay range or other compensation information in this posting, please contact us at: ********************. EEO and Accommodations Slalom is an equal opportunity employer and is committed to attracting, developing and retaining highly qualified talent who empower our innovative teams through unique perspectives and experiences. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veterans' status, or any other characteristic protected by federal, state, or local laws. Slalom will also consider qualified applications with criminal histories, consistent with legal requirements. Slalom welcomes and encourages applications from individuals with disabilities. Reasonable accommodations are available for candidates during all aspects of the selection process. Please advise the talent acquisition team or contact ****************************** if you require accommodations during the interview process.

TITLE (Oracle title) CHIEF FACILITIES AND OPERATIONS OFFICER WORKING TITLE Chief Facilities and Operations Officer SCHOOL/DEPARTMENT Facilities and Operations PAY GRADE Contract as established by Superintendent/Board of Education FLSA STATUS Exempt ELIGIBILITY FOR EMPLOYMENT CONTRACT Yes WORK WEEK SCHEDULE Monday-Friday (occasional evenings and weekends) Position is not available for a hybrid telework workweek POSITION PURPOSE: Provides leadership to the Facilities Design and Construction, Maintenance and Operations, Child Nutrition Services (CNS), and Transportation Departments. Leads and ensures execution of the Wake County Public School System's (WCPSS) multi-year capital building program. Implements comprehensive business plans and yearly operating budgets to manage each department and insure fiscal accountability. Meets educational facility needs of each school and department through active communication with principals and administrators. Creates and monitors program metrics, administers contracts, and maintains fiscal accountability. MINIMUM QUALIFICATIONS: KNOWLEDGE, SKILLS, AND ABILITIES (KSAs) Comprehensive in-depth knowledge and understanding of the principles, practices, and procedures of public school system policies and federal, state, and local regulatory requirements; Considerable knowledge of design and construction terms and processes; Considerable knowledge of Occupational Safety and Health Administration (OSHA) regulations and procedures; Comprehensive knowledge of Microsoft Office, specifically Word, Excel, Access, and PowerPoint; Google Apps; Skills in effective leadership of adults, including coaching, evaluation, and team building among a variety of stakeholders; Ability to communicate clearly and concisely both in oral and written form using a variety of communication techniques and tools to ensure the appropriate flow of information, collaborative efforts, and feedback; ability to convey complex information to a variety of audiences; excellent public speaking and presentation skills; Ability to maintain professional and emotional control under Reflects appropriate response to situations, while maintaining a professional and personal demeanor; Ability to establish and maintain effective working relationships with school officials, school administrators, teachers, support staff, vendors, contractors, and other community groups. EDUCATION, TRAINING, AND EXPERIENCE Bachelor's degree in engineering, building construction, construction engineering, business management, architecture, or a related field; AND Ten years of experience in facilities management, design, construction, or related areas; AND Demonstrated successful leadership and managerial experience; AND Experience preparing and presenting technical and management information to diverse audiences; AND Experience speaking with CERTIFICATION AND LICENSE REQUIREMENTS Must hold and maintain a valid motor vehicle operator's license according to the State of North Carolina requirements. PREFERRED QUALIFICATIONS: Master's degree in engineering, construction management, architecture, business, financial management, public administration, or related field; Registration as a professional engineer or architect in North Carolina, or qualification to attain registration within one year of employment. ESSENTIAL DUTIES AND RESPONSIBILITIES: Oversees the management of assigned operational functions to ensure that planning methodologies, organizational structures, and accountability measures are in place to give stakeholders the best service possible within the resources Provides leadership in promoting childhood nutrition, in support of student Provides leadership in assuring accountability and sound stewardship of capital and operating fund Provides leadership in promoting and providing high quality learning environments for all students, in support of student Provides leadership in transporting students safely to and from school Directs execution of the capital improvement program for construction of new schools, renovation of existing schools, and other capital projects. Directs the engineering, designing, construction and maintenance of new and existing building and facilities; supervises compliance with engineering specifications and state regulations. Oversees the planning, design, bidding and award, construction administration, completion, and accounting for all Serves as an advocate for supplier and contractor diversity in each department; supports efforts to employ Historically Underutilized Business enterprises. Oversees the management of school capital programs, to ensure that planning methodologies, organizational structures, resources (including bond elections), and accountability measures are in place so that all new schools and rehabilitation projects are completed on time and within budget. Administers contracts for planning, design, construction, and construction Coordinates and supervises work performed by outside engineering, architectural and construction firms. Accounts for capital improvement program funds and department's operating Prepares and controls annual departmental operation budgets and assists with capital needs budget. Implements safety programs for all Ensures adherence to good safety procedures. Represents WCPSS at public meetings; serves as district liaison to local government agencies; represents WCPSS before meetings of Board of Commissioners, municipal boards, and other organizations. Participates in development of long-range facilities plans and student assignment Serves as a member of the Superintendent's Leadership Team to actively participate in division-wide planning, implementation, and evaluation; helps to shape and drive initiatives across the organization; engages in short- and long- term planning with the senior directors of supervised departments (child nutrition services, transportation, facility design and construction, and maintenance and operations). Maintains a process for continuous improvement of departmental procedures and Supervises staff selection, placement, development, training, and performance management to meet department's and Superintendent's annual performance goals. Utilizes program management software programs to support capital building program with graphical, fiscal, and project data, which is posted for public information. Develops and maintains design and construction contracts, contract terms, change order resolutions, claims avoidance and claim resolutions. Keeps informed of federal and state regulations and verifies that all departmental activities are in compliance; follows Federal and State laws, as well as School Board policies. Performs other related duties as WORK ENVIRONMENT/PHYSICAL REQUIREMENTS This job operates in a professional office environment and has a noise level of mostly low to moderate. This role routinely uses standard office equipment such as computers, scanners, and copiers. The position, at times, must be able to come into direct contact with school system staff and staff members of external funding agencies, and the community. Work is considered light physical work, requiring the exertion of up to ten pounds of force. The work frequently requires activities involving driving automotive equipment as visits to construction sites, schools, and administrative offices around Wake County are required for this position. EFFECTIVE DATE: 6/2025 DISCLAIMER: The above statements are intended to describe the general purpose and responsibilities assigned to this position. They are not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and skills required by the employees assigned to this position. This description may be revised by HR and approved at any time.

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: * Advance innovative science by pushing boundaries. * Bring transformative therapeutics to patients in need. * Provide an environment for employees to reach their fullest potential. Our values: * Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. * Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. * Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. * Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. * Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. Position Summary The Associate Director Pathology serves as the lead for Translational Medicine Safety (anatomic and clinical pathology & toxicology) of multiple drug candidates of AskBio's pipeline and reports to the Sr. Director, Pathology. This individual will act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies to ensure high-quality toxicology and pathology assessments. The AD, Pathology will provide comprehensive support for nonclinical studies, including primary histopathology and pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions (IND, CTA, NDA, briefing books, Investigator Brochures, etc.). Additionally, they will frequently interact with internal and external colleagues to ensure timely and accurate dissemination of findings. The successful candidate will demonstrate excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams. Job Responsibilities * Serve as the lead for Translational Medicine (anatomic and clinical pathology & toxicology), shaping the strategy and execution of nonclinical safety assessments * Provide comprehensive support for nonclinical studies, including but not limited to pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions * Act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies and communicate effectively with CRO pathologists to discuss findings, address questions, and reach the pathology conclusions to ensure high-quality toxicology and pathology assessments * Manage and provide scientific leadership to the internal staff and work closely with Discovery, Product Development, Clinical Development, and Regulatory to integrate nonclinical safety findings into overall program strategy and goals * Advise and direct the preparation of Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.) * Represent Translational Medicine on discovery and development-IPT and EPT program teams * Oversees and drives the preparation of SOPs as needed to guide functional activities and ensures adherence to all Toxicology and Pathology SOPs * Maintain current knowledge of regulatory guidance, industry standards and recommendations * Participates in selecting, developing and evaluating personnel to ensure efficient operation within the histopathology group * Other pathology and translational medicine-related tasks as assigned Minimum Requirements * PhD or DVM with 8+ years of post-graduate experience in a pharmaceutical, biotech or academic organization * Board certification by the American College or European College of Veterinary Pathologists (ACVP or ECVP certification) in Anatomic Pathology * Previous experience working on programs that integrate pathological results to drive clinical development * Experience with LIMS, digital/computational pathology platforms to characterize features from H&E and IHC images * Expert knowledge in nonclinical safety assessment in drug development of small molecules, biologics, and peptides. Knowledge in gene therapy is plus * Proven project management skills with the ability to manage multiple projects and priorities simultaneously * Excellent communication skills (both oral and written) and collaboration skills with the ability to work effectively in a fast paced cross-functional team environment * Deep understanding of regulatory requirements for nonclinical safety assessments, including experience with FDA, EMA, and other global health authorities * Experience in responding to regulatory questions including discussion documents for various Health Authorities in support of discovery and development programs AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at ************** or sending us an email at ******************. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.

Description :Is Kymanox the right fit for you? You want to make a difference and have an impact… You enjoy having an influence in your day-to-day work… You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow… You wake up every day and do what you do … because patients deserve better. If this sounds like you, you've come to the right place. The Kymanox Product Development & Commercialization team is seeking an experienced Associate Director with a strong technical and/or operations background in the pharmaceutical (combination product), biotechnology or medical device industries. Responsibilities: Provides senior technical leadership to external-facing Kymanox project teams with accountability for project strategy, execution, success, and client satisfaction. Plans and ensures execution of combination product development activities. Delegates and monitors quality and progress of work, providing technical support and direction to project teams and managers. Support sales calls and preparation of proposals by demonstrating knowledge and confidence in scoping activities. Identifies and supports internal business initiatives to improve Kymanox processes and practices. Collaboratively evaluates future business needs to derive and implement strategies to meet those needs. Provides mentorship and development opportunities to junior resources, as part of cross-functional projects or as direct reports. Functional management and leadership of direct reports within team. Responsible for team performance reviews and evaluations, mentoring and coaching, resource management, goal setting, time tracking and reporting. Ensures conformance to both Kymanox and external compliance standards. Performs technical and quality review of source documents. Directly supports and provides subject matter expertise. Job Description: Leverages expertise in technical leadership and cross-functional management to advance, de-risk, and deliver successful outcomes for clients' medical device and combination product development programs. Basic responsibilities include: Representing Kymanox to clients as a subject matter expert and thought leader. Providing technical leadership and direction to internal and external project teams. Contributing to internal business improvement projects. Maintaining conformance to internal and client quality management systems. Adhering to regulatory standards and promoting a positive compliance culture. Providing mentorship to junior staff. Projects may include any of the following technical areas: Evaluate client technical documentation and strategy to provide clear, actionable recommendations for product design, development, and commercialization activities. Conduct competitive landscape assessments and market analyses for delivery devices, contract organizations, and novel technologies. Prepare detailed project plans, schedules, and overall development strategy. Management of technically complex, multi-year development programs. Oversee the creation of technical documentation supporting design controls, manufacturing processes, and regulatory submissions. Lead the preparation of risk management file documentation. Oversee phase-appropriate client testing activities, including combination product and medical device design verification and human factors testing. Direct design verification and the associated test method development and validation activities. Contract Manufacturing Organization (CMO) evaluation, due diligence, and selection on behalf of clients. Serve as an independent reviewer for client design review meetings throughout the product development process. Process development, improvement, troubleshooting, and design transfer. Provide technical support for regulatory submission preparation and review. Educational Background: The ideal candidate will have an advanced degree in natural sciences (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution. Industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required. Experience: Minimum 15 years' experience in product development and/or manufacturing in the pharmaceutical (combination product), biotechnology, diagnostic, and/or medical device sectors is required. Direct experience with multiple device types is desirable. Leadership of complex, multi-disciplinary development programs, pharmaceutical (combination product) development, in vitro diagnostic development, clinical development, or electromechanical systems development is desirable. Experience working at startup companies or small biotech/pharma/med device companies and familiarity with government and private sector funding mechanisms is highly favorable. Experience working in professional services is favorable. Management of direct reports is not in scope of this role at the time of hire. However, organizational growth may allow for the role to expand to managerial responsibility of 1-5 direct reports. Successful candidates for this position will be experienced in leading and mentoring junior staff. Desired Aptitude and Skill Set: Executes high-profile activities with minimal supervision, drawing on a versatile and adaptable technical skill set Skilled in strategic planning and translating strategy into actionable processes Operates effectively within multiple client quality systems and product development frameworks concurrently Demonstrated ability identifying and implementing operational improvements Experienced with complex device systems, including software medical devices Highly detail-orientated and organized Strong professional presence with excellent presentation skills Confident in providing feedback and influencing internal and external stakeholders Collaborates effectively with remote team members and direct reports Self-motivated and inspires others to achieve goals Proactively identifies and resolves issues before they escalate Demonstrates both managerial (i.e., “do things right”) and leadership (i.e., “do the right thing”) skills Excellent verbal and written communication skills in English Innovative and creative mindset with a focus on continuous improvement Seasoned soft skills - high emotional intelligence (EQ) and strong team player Expert-level statistical analysis of development and production data, strong preference for experience in reliability Experience working with device software and cybersecurity risk assessments Technologically savvy, comfortable with modern IT tools and productivity software Thrives in fast-paced, dynamic, and growth-oriented environments Experienced engaging subject matter experts and effectively leveraging their input Understands and values, quality and regulatory compliance Uncompromising honesty and integrity Travel: Travel may be necessary to support client work. If the candidate is not local to Kymanox headquarters in RTP, North Carolina, periodic visits (e.g.: 2 to 4 visits per year) are required. Career Development: The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization. Compensation: Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process - as well as market conditions. Eligible for incentive program after 6 months of outstanding work. Benefits: Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits. About Kymanox:Join Kymanox - a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today's biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox's service offerings and the life science industry as a whole. Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey. To learn more about our company, please visit our website: Life Science Solutions | Kymanox Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility. Company: Veloxis Pharmaceuticals, Inc. Job Description: The Associate Director, Regulatory Affairs - Advertising & Promotion leads and manages regulatory oversight of promotional activities for the Company's expanded healthcare product portfolio. The incumbent plays a critical role in ensuring compliance with FDA regulations, mitigating risk, accelerating time-to-market, and providing regulatory strategy to cross-functional teams. Summary of Key Responsibilities Leads regulatory review of all promotional materials across media types (print, digital, social broadcast) for the Company's products. Serves as the regulatory representative on the Company's Promotional Review Committee (PRC/SRC/MRC), providing regulatory guidance and ensuring alignment with internal and external compliance standards. Ensures that promotional content complies with FDA regulations (including 21 CFS 202.1), FTC, PhRMA Code, and applicable global regulations, as necessary. Manages submission of promotional materials to the FDA (Form 2253) and manages FDA advisory comment requests, as appropriate. Provides strategic input during early campaign concept and copy development to streamline the review and approval process. Monitors evolving regulatory guidance and enforcement trends; applies relevant updates to internal review processes and training materials. Collaborates with Legal, Medical Affairs, and marketing departments to ensure consistent interpretation and implementation of regulatory standards. Assists in developing and maintaining SOPs and training programs related to promotional review activities. Participates in audits, inspections, and risk assessments related to promotional activities, and ensures appropriate documentation and response. Identifies and implements process improvements to increase the efficiency and effectiveness of the ad/promo review function. Required Qualifications and Skills Bachelor's degree in a scientific discipline required; advanced degree (PharmD, JD, MBA, or equivalent), preferred Minimum of 7 years of regulatory affairs experience, including significant exposure to promotional review of prescription drug and/or biologic products Deep understanding of FDA advertising and promotion regulations and guidance Proven ability to interpret and apply regulatory guidance in a practical, risk-managed manner Experience serving on PRC/SRC/MRC teams and working cross-functionally with Commercial, Medical, and Legal stakeholders Strong interpersonal, organizational, and communication skills Ability to manage multiple priorities and deliver under tight timelines in a dynamic environment Travel Requirements: Approximately 10% #LI-AS1 #Hybrid As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. Position Summary The Associate Director Pathology serves as the lead for Translational Medicine Safety (anatomic and clinical pathology & toxicology) of multiple drug candidates of AskBio's pipeline and reports to the Sr. Director, Pathology. This individual will act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies to ensure high-quality toxicology and pathology assessments. The AD, Pathology will provide comprehensive support for nonclinical studies, including primary histopathology and pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions (IND, CTA, NDA, briefing books, Investigator Brochures, etc.). Additionally, they will frequently interact with internal and external colleagues to ensure timely and accurate dissemination of findings. The successful candidate will demonstrate excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams. Job Responsibilities Serve as the lead for Translational Medicine (anatomic and clinical pathology & toxicology), shaping the strategy and execution of nonclinical safety assessments Provide comprehensive support for nonclinical studies, including but not limited to pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions Act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies and communicate effectively with CRO pathologists to discuss findings, address questions, and reach the pathology conclusions to ensure high-quality toxicology and pathology assessments Manage and provide scientific leadership to the internal staff and work closely with Discovery, Product Development, Clinical Development, and Regulatory to integrate nonclinical safety findings into overall program strategy and goals Advise and direct the preparation of Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.) Represent Translational Medicine on discovery and development-IPT and EPT program teams Oversees and drives the preparation of SOPs as needed to guide functional activities and ensures adherence to all Toxicology and Pathology SOPs Maintain current knowledge of regulatory guidance, industry standards and recommendations Participates in selecting, developing and evaluating personnel to ensure efficient operation within the histopathology group Other pathology and translational medicine-related tasks as assigned Minimum Requirements PhD or DVM with 8+ years of post-graduate experience in a pharmaceutical, biotech or academic organization Board certification by the American College or European College of Veterinary Pathologists (ACVP or ECVP certification) in Anatomic Pathology Previous experience working on programs that integrate pathological results to drive clinical development Experience with LIMS, digital/computational pathology platforms to characterize features from H&E and IHC images Expert knowledge in nonclinical safety assessment in drug development of small molecules, biologics, and peptides. Knowledge in gene therapy is plus Proven project management skills with the ability to manage multiple projects and priorities simultaneously Excellent communication skills (both oral and written) and collaboration skills with the ability to work effectively in a fast paced cross-functional team environment Deep understanding of regulatory requirements for nonclinical safety assessments, including experience with FDA, EMA, and other global health authorities Experience in responding to regulatory questions including discussion documents for various Health Authorities in support of discovery and development programs AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at ************** or sending us an email at ******************. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.

Opportunity for Secondment to AskBio We're pleased to share an exciting secondment opportunity at AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement. This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio's mission: to advance gene therapy and change the lives of patients around the world. If you're interested in exploring this opportunity, we encourage you to: Speak with your direct manager to discuss your interest and alignment with your development goals. Apply directly using the link provided in the posting. We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. Position Summary The Associate Director Pathology serves as the lead for Translational Medicine Safety (anatomic and clinical pathology & toxicology) of multiple drug candidates of AskBio's pipeline and reports to the Sr. Director, Pathology. This individual will act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies to ensure high-quality toxicology and pathology assessments. The AD, Pathology will provide comprehensive support for nonclinical studies, including primary histopathology and pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions (IND, CTA, NDA, briefing books, Investigator Brochures, etc.). Additionally, they will frequently interact with internal and external colleagues to ensure timely and accurate dissemination of findings. The successful candidate will demonstrate excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams. Job Responsibilities Serve as the lead for Translational Medicine (anatomic and clinical pathology & toxicology), shaping the strategy and execution of nonclinical safety assessments Provide comprehensive support for nonclinical studies, including but not limited to pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions Act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies and communicate effectively with CRO pathologists to discuss findings, address questions, and reach the pathology conclusions to ensure high-quality toxicology and pathology assessments Manage and provide scientific leadership to the internal staff and work closely with Discovery, Product Development, Clinical Development, and Regulatory to integrate nonclinical safety findings into overall program strategy and goals Advise and direct the preparation of Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.) Represent Translational Medicine on discovery and development-IPT and EPT program teams Oversees and drives the preparation of SOPs as needed to guide functional activities and ensures adherence to all Toxicology and Pathology SOPs Maintain current knowledge of regulatory guidance, industry standards and recommendations Participates in selecting, developing and evaluating personnel to ensure efficient operation within the histopathology group Other pathology and translational medicine-related tasks as assigned Minimum Requirements PhD or DVM with 8+ years of post-graduate experience in a pharmaceutical, biotech or academic organization Board certification by the American College or European College of Veterinary Pathologists (ACVP or ECVP certification) in Anatomic Pathology Previous experience working on programs that integrate pathological results to drive clinical development Experience with LIMS, digital/computational pathology platforms to characterize features from H&E and IHC images Expert knowledge in nonclinical safety assessment in drug development of small molecules, biologics, and peptides. Knowledge in gene therapy is plus Proven project management skills with the ability to manage multiple projects and priorities simultaneously Excellent communication skills (both oral and written) and collaboration skills with the ability to work effectively in a fast paced cross-functional team environment Deep understanding of regulatory requirements for nonclinical safety assessments, including experience with FDA, EMA, and other global health authorities Experience in responding to regulatory questions including discussion documents for various Health Authorities in support of discovery and development programs AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at ************** or sending us an email at *****************.

Kincell Bio engineers cells into therapies . With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance. For more information, please visit our website at ******************* Kincell is seeking a highly motivated Associate Director, Quality Assurance who will be a key contributor to a dynamic and collaborative Quality Assurance team. The Associate Director - Quality Control Lab will provide strategic, technical, and operational leadership for analytical quality control supporting cell therapy manufacturing. This role oversees development, validation, qualification, and routine execution of assays required for release, stability, in-process, and characterization testing of cell-based products. The Assoc. Director Quality Control must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives. The successful candidate will lead a high-performing QC analytical team, ensure regulatory and cGMP compliance, partner cross-functionally to support tech transfers and method lifecycle management, and drive continuous improvement to enable robust and phase-appropriate QC operations. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc. Provide scientific and managerial leadership for QC functions supporting clinical and commercial cell therapy programs. Build, mentor, and manage a team of scientists and analysts; establish strong technical capability in cell-based, molecular, analytical, microbiological, and immunological methods. Along with Analytical Development, develop long-term QC strategy including method lifecycle management, assay robustness, and future-state technologies. Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives. Oversee daily operations of the QC Lab to ensure safe, efficient, and compliant execution of testing activities. Ensure availability, qualification, and maintenance of QC equipment, reference standards, critical reagents, and controlled documents. Own and approve investigations, deviations, CAPAs, OOS/OOT results, change controls, and method performance reviews. Ensure adequate oversight and technical excellence for investigations and complaints. Lead qualification, validation, transfer, and ongoing monitoring of analytical methods for cell therapy release and stability testing. Collaborate with Analytical Development, Process Development, MS&T, and external partners on method transfer, trending, and troubleshooting. Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal, external, and regulatory agency audits. Ensure QC operations comply with FDA, EMA, ICH, USP, and other applicable regulatory guidelines for cell and gene therapy products. Work closely with Manufacturing, QA, Supply Chain, and MS&T to support lot disposition, process changes, and lifecycle initiatives. Provide scientific expertise on analytical trends and product quality attributes; contribute to control strategy and risk assessments. Define strategic direction and provide oversight for the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio. Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas. Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites. Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization. Other duties as assigned. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Bachelor's Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field 8+ of experience in Quality Control in a pharmaceutical manufacturing environment. A minimum of 3 years of management in a Quality Control laboratory Direct involvement in tech transfer, method lifecycle management, and phase-appropriate analytical strategy Strong experience in QC analytical testing of cell therapy, gene therapy, or biologics; CAR-T experience preferred Previous experience in contract development and manufacturing organizations preferred Proven ability to navigate regulatory expectations for ATMPs, including assay validation and method lifecycle management Responsible for maintaining a safe work environment Ability to influence and lead diverse groups Influences complex regulatory, business, or technical issues within the site and function Experience in statistics Technical leadership, administrative and organizational skills Strong leadership and team-building skills; ability to develop talent and foster a culture of scientific excellence Builds relationships with internal and external customers and partners Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional Demonstrated Project Management skills and ability to coordinate complex projects Strong analytical and quantitative problem-solving skills Ability to communicate and influence effectively across functional groups and stakeholders Strategic thinking and ability to balance short-term needs with long-term business evolution Enthusiasm for changes, team spirit and flexibility Demonstrated ability to learn & apply technical/scientific knowledge Management Responsibilities: Hire, recruit, coach, and train employees within the Quality Control group Continuously assess and ensure the appropriate Quality Control structure is in place to support growth. Identify gaps and ensure the proper hiring and development of employees with the support of Human Resources. Set expectations, provide feedback and coaching, and take necessary action to ensure appropriate performance and goal attainment. Physical Demands Adjusting or moving objects weighing up to 25lbs Travel Requirements Minimal travel (up to 5%) will be expected in this position. Location This is a site-based position in Durham, NC, and it will require some non-standard working hours, including early morning or late evening. #LI-Onsite. Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.

We are seeking the Associate Director for Translational Research (AD TR) at the UNC Lineberger Comprehensive Cancer Center. This individual will hold a primary faculty appointment within the School of Medicine, with a secondary administrative appointment as the AD TR. Appointment and rank in an academic department will be determined by the applicant's qualifications. This is a senior-level faculty rank, and the selected candidate will be a faculty member who conducts outstanding basic and translational cancer research. The AD TR shall be an established independent investigator with interdisciplinary translational research in innovative biology with immediate clinical relevance and application, significant publications, and extramural grant funding. Responsibilities include: mentorship of graduate students, postdoctoral fellows, and junior faculty members; serve as a member of the Lineberger Senior Leadership team; foster close working relationships with Program Leaders and Shared Resource Directors; participate in team science initiatives. Administrative duties include: upon request, perform reviews of grant applications and investigator-initiated clinical trials originating from the Center to ensure translational project opportunities are embedded into each, as appropriate; attend and actively participate in LCCC research program meetings to foster programmatic content that is inclusive of translational science concepts; at the direction of the Cancer Center Director, represent the program during NCI site visits and annual External Advisory Board meetings; work collaboratively with fellow Associate Directors to co-create a scientific community at Lineberger reflective of all components of an NCI -designated comprehensive cancer center. UNC Lineberger Comprehensive Cancer Center ( LCCC ) is one of the largest research organizations in the UNC system. UNC Lineberger is the only public NCI -designated comprehensive cancer center within the State of North Carolina and supports 425 members, 605 staff, nine research programs, and 32 shared resources. UNC Lineberger has been rated an exceptional NCI center in the last three CCSG cycles (2010,2015,2020) making it eligible to extend the current cycle to 2027. LCCC is the center of cancer research at UNC -Chapel Hill and beyond. LCCC focuses on a mission to propel cancer research for the state of North Carolina, the nation, and the globe to improve patient outcomes. As a large matrix cancer center, they are physically located in the center of the medical campus in the UNC Lineberger building, a 79,000 square foot building dedicated exclusively to cancer research. It is flanked by Marsico Hall (completed in 2015) and the Mary Ellen Jones Building (completed in 2021), where LCCC has additional wet and dry research facilities. LCCC has more than 170,000 square feet of dedicated research across the campus. Patients are seen in Basnight Cancer Hospital completed in 2009. The faculty are representative of the broad scope and depth of LCCC's cancer research enterprise. Forty-eight departments are represented across the campus, including those in the Schools of Medicine, Pharmacy, Nursing, Public Health, Dentistry, Journalism, Social Work, and the College of Arts and Sciences. Preferred Qualifications, Competencies, And Experience Excellent communication, interpersonal and organizational skills. Relevant NCI cancer center program leadership experience.

Job DescriptionDescription: Therapy Smarts, Inc. is looking to hire a dedicated and innovative Board Certified Behavior Analyst (BCBA) or Qualified Behavior Analyst (QBA) to join our growing team in a full-time capacity. Our mission: Turning challenges into triumphs, one child at a time. Requirements: Qualities that fit this opportunity Minimum of 3 years of experience in the field of ABA, including comprehensive intervention development and implementation for children and adolescents, required 2 years with BT or RBT supervisory experience required. Experienced in training, mentoring, and supporting a team in an intensive treatment environment is preferred Self-motivated, not afraid of hard work Takes initiative Problem-solver Efficient and dedicated to getting things done Positive perspective Excellent time management and organizational skills Collaborative team player Essential Job Functions Build and design a comprehensive ABA and parent training program for young children and adolescents. Help oversee clinic operations to ensure efficacy and efficiency of all aspects of service delivery. Foster a positive team culture and support agency culture/morale. Supervise and mentor the Autism Service Team, including establishing performance expectations, developing supervision plans, conducting performance evaluations, and monitoring program progress and productivity. Collaborate with other team members. Setting Our state-of-the-art Sensory Clinic Headstart centers Benefits that set us apart - Exceptional earnings potential! One of the best you will find. Competitive compensation with monthly incentive bonuses PTO (Paid Time Off) Paid federal holidays Up to 5 days off during the end-of-year shutdown Continuing education reimbursement License Dues Reimbursement Company iPad Health, Vision, and dental insurance for full-time employees Health Savings Account and Flexible Spending Account Voluntary Life Insurance, Long Term Disability, and Short Term Disability 401K to full-time employees Mileage reimbursement Yearly performance BONUS Referral BONUS Electronic subscription to the Latest Therapy Material Resources Fun, multi-disciplinary setting with supervision and mentorship programs Opportunity for growth within the company - Leadership and management opportunities open to all Additional Benefits Office staff for intake, billing, and support, meaning you only have to treat and complete your documentation! Report templates for easy report writing Web-based, electronic documentation system Take the next steps to a new opportunity and a new career. Let Therapy Smarts inspire you to work hard, succeed, and create miracles for our clients, together. Working as a therapist for Therapy Smarts is not another job; it is a meaningful career. Interested candidates should email Luis at hr.coordinator@therapysmarts.net or apply online.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities JOB SUMMARY Provides leadership, direction, and management to FSP 360 functional teams. Provides training, consultation and oversees quality related to operating activities of assigned staff to ensure project deliverables are met. May liaise with other departments or business units to optimize resources as well as to establish harmonized clinical operations practices, processes, and tools. Contributes to operational initiatives. Acts as an SME where country/region/functional knowledge is key. May act as a regional operational lead. JOB RESPONSIBILITIES Overall, the role will be responsible for three primary performance areas: Customer Delivery and Success * Develops and fosters strong, collaborative relationships with customers and escalates more serious issues as required. Solicits feedback from customer PoC (s) for continuous improvement of service delivery and to strengthen customer relationships. * Responsible for delivery and compliance with agreed-upon KPIs, as well as analyzing performance and quality metrics to assure BU achievement of regional productivity and compliance metrics; develops and executes mitigation and remediation plans for non-compliance as needed. Expected to address improvement initiatives as identified. * Responsible for managing headcount and reviewing workloads for all staff in the reporting chain. Oversees resource availability for assigned staff, country, or region, ensuring projects are adequately staffed and staffing needs are promptly identified. Resolves potential resourcing conflicts to facilitate mutually beneficial resolutions. Collaborates with local Talent Acquisition (TA) teams and identifies future customer resourcing needs. * Proactively communicates and manages customer issues through assigned escalation channels. * Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCPs. Ensures all staff follow the required training and complete the required documentation. Provides regular compliance updates to management accordingly. * Conducts oversight visits as required for Clinical Research Associates. * Responsible for all system updates, and compliance with systems and relevant procedure and practices applicable to the customer and Syneos Health processes. Business Impact * Responsible for partnering with internal and external stakeholders to drive and oversee customer growth strategies. May provide support to facilitate new project awards during the proposals and Bid Defense process, providing expert functional guidance where required. May participate in marketing activities, customer presentations and proposal development. * Responsible for knowledge sharing across the business unit to disseminate best practices and lessons learned in support of the overall FSP 360 operating model. Makes informed and data-driven decisions that result in positive impact on overall business unit performance. * Responsible for delivering BU revenue targets by supporting the assessment of overall program customer delivery and the development of program/regional staff plan. * May serve as a Company representative at professional meetings or seminars. People Leadership * Responsible for active management of team members' performance through the established Syneos Health process; at an individual contributor level (M23+) and manager level. Act as a local SME for people related queries. * Verifies that team members adhere to training guidelines, maintain their training records and individual and corporate training needs are identified and addressed. * Provides administrative oversight (for example, HR processes, timecards, expense reports). * Supports team members' professional development through coaching, providing opportunities to increase knowledge and skill levels, and by delegating tasks commensurate with skill level. * Proactively works to ensure team members' engagement, retention and turnover rates remain within expected levels. * Demonstrates commitment to diversity, equity, and inclusion through continuous development of all staff, modeling inclusive behaviors and proactively managing bias. QUALIFICATION REQUIREMENTS (please indicate if 'preferred') * Bachelor's degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required. * Knowledge of GCP/ICH guidelines and other applicable regulatory requirement. * Excellent communication, presentation, interpersonal skills; both written and spoken, with an ability to inform, influence, convince, and persuade. * Strong time management, technical and organizational skills. Ability to work independently and within a team environment. * Creative problem solver who is self-motivated, flexible, open to change, collaborative, and possesses a customer-centric mindset. * Demonstrate strong leadership skills, including ability to set direction, mentor and motivate others to achieve departmental goals. * Demonstrate understanding of the workflow process, roles, and responsibilities of multiple functional areas. * Ability to travel as necessary; up to 25%. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Provides leadership, direction, and management to FSP 360 functional teams. Provides training, consultation and oversees quality related to operating activities of assigned staff to ensure project deliverables are met. May liaise with other departments or business units to optimize resources as well as to establish harmonized clinical operations practices, processes, and tools. Contributes to operational initiatives. Acts as an SME where country/region/functional knowledge is key. May act as a regional operational lead.