Akebia Therapeutics jobs - 22 jobs

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary Reporting to the Vice President, FP&A, the Director, R&D & Technical Operations Finance will lead all aspects of financial management for the Research & Development and Tech Ops functions. This individual will partner with teams across those functions to drive operational and strategic decision-making key to Akebia's success. Duties & Responsibilities Responsible for all aspects of the R&D and Tech Ops budget & forecast, including leading the team through annual budget development and interim updates Provide guidance to the R&D and Tech Ops teams in financial planning and project financial management, including informing forecasts for clinical trials, cost of goods sold, and related working capital impacts Drive various analyses to support strategic & operational decision making for the Supply & Operations Planning process (S&OP) in collaboration with the Supply Chain team Lead departmental and cross-functional prioritization initiatives, as needed Lead the team responsible for R&D and Tech Ops planning to ensure understanding, communication, documentation, and reporting of ongoing and future project initiatives, including scope definition and changes, contract amendments, and change orders Ensure a culture where scope, provisions, vendor obligations and payment terms included in project work orders and contracts are understood and consistent with budgetary and accounting guidelines and methodologies Responsible for overseeing and reviewing the monthly accounting close process for the R&D and Tech Ops functions, working closely with accounting, functional business partners, and external vendors (including CROs and CMOs) to ensure appropriate expense recognition for clinical trials & other outsourced spend Support Company's Sarbanes-Oxley compliance efforts and ensure team's deliverables for quarterly and annual audits are met Develop an in-depth understanding of key collaborative agreements to help the team develop processes for tracking, complying with and reporting on financial provisions/deliverables in connection with all agreements Work closely with Alliance Management, Program Management, and Business Development to establish and foster relationships, communication, and reporting with strategic partners Drive long-range planning activities in partnership with Corporate Finance & business partners Define and anticipate risks and opportunities and propose solutions and plans of action to inform key decision makers, including the Leadership Team, CFO, and Executive Team Identify and enable opportunities for operational improvements and efficiencies Develop and manage a team of leading finance professionals Basic Qualifications Bachelor's degree required Minimum of 10 years' experience in finance and accounting functions Pharmaceutical / Biotechnology industry experience required Experience in Operational Finance, including business partnering with R&D and / or Technical Operations functions Preferred Qualifications Deep understanding of drug development process Strong written & verbal communication skills, including with Executive Leadership Significant experience with clinical trial accruals and execution Strong understanding of Cost of Goods Sold & Inventory accounting In depth understanding of US GAAP and financial statement reporting Excellent analytical, decision making, and organizational skills Thrives in a dynamic, fast-paced environment Experience with NetSuite ERP and Adaptive Planning EPM tools Compensation: Targeted Base: $199,712 - $246,703* *Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: ************** Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristics protected by applicable law.

Role Overview & Key Functions: As a Karyopharm, reporting to the Executive Director, GMP (Good Manufacturing Practice) Quality, you will positively impact patients' lives by: Assisting with Quality Unit (QU) efforts and activities within the organization and the Contract Service Providers, including the development and implementation of the programs. You will provide help to GMP Quality and Quality Management Systems teams, in support of the Annual GMP Quality Management Review (QMR), training program improvements, Veeva Vault processes and other ancillary quality activities. Responsibilities Participate in following activities to support GMP Quality Operations: * Assist GMP in data collection and report generation for Annual Quality Management Review (QMR). This project will require creation of excel lists, statistical analysis, and technical writing. This will give an individual overview of drug manufacturing and testing processes along with affiliated regulations and guidelines. * Assist in management of minor product quality investigations in Veeva Vault. This project will require individuals to learn and execute documentation for quality event investigations. * Develop Smartsheets and trackers for GMP Quality to better manage project deliverables and timelines. * Assist GMP Quality group in continuous improvement projects by participating in SOP revisions and process optimization. * Maintain deviation and change control lists and assist in notification of change controls to Karyopharm's global partners. * Provide communication support for training notifications and scheduling training for Karyopharm's business partners. * Assist Quality Management Systems team with revision of the training management program including updating training matrices, creating excel of GxP processes; training requirements and required training per functional team in support of Veeva configuration updates. * Support review of batch documentation and analytical data review received from CDMOs (Contract Drug Manufacturing Organizations) for various manufacturing and testing operations of Karyopharm's product. Qualifications * Enrolled into undergraduate or graduate programs in scientific disciplines with interest to learn highly regulated drug manufacturing process, analytical testing, and quality oversight. * Previous experience in Pharmaceutical or Biotech organizations is desired but not required * Good Oral and Written communication skills. * Highly proficient with MS Office tools. * Ability to learn and adapt with ambiguity of strengths. * Work in a team setting adopting collaborative and learning approach for achieving results. * Enthusiasm to learn new skills and Motivation towards career development. Candidate Profile & Requirements: * Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025 * Currently enrolled high school or college (bachelor's program) student * Student must be returning to school in the Fall Term. * Must have a minimum GPA of 3.0 * Must be highly organized and have the ability to work in independently and collaboratively as a team * Clear, concise verbal & written communication Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school. Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!

Role Overview & Key Functions: If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That's why we've built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us - whether that's onsite, from home, or anywhere in between. Our summer intern program, which will run from May 25th - Aug 7th, allows students to gain real world work experience in a high energy, collaborative work culture. Role Overview & Key functions: We are seeking a motivated and detail-oriented Analytical Data Analyst Summer Intern to be part of our Analytical team. This internship offers hands-on experience in analytical data analysis, trending, and generating reports/dashboards to support business decision-making. This experience will enhance the Intern's career prospects in Analytical and related fields. * Transfer data between Smartsheet and excel worksheets/workbooks. Ensuring data integrity and correct formatting in the new destination file. * Develop complex spreadsheets including creating formulas, functions, PivotTables, Power Query, and data visualization tools to generate reports/dashboards for reporting metrics to be used for annual Quality Management Review (QMR) of XPOVIO products. * Improve filtering techniques for data queries. * Participate and collaborate in cross-functional meetings with Quality and Pharmaceutical Sciences to understand data requirements and deliver analytical support. * Perform administrative tasks related to documentation to standardize formats, ensuring version control and gap assessments for missing values or duplicates as needed. Candidate Profile & Qualifications * Enrolled in a full-time pharmaceutical science, or statistical degree program * Proficiency with Microsoft Office including Word, Excel, PowerPoint, and Teams * Proficiency with PowerBI, JMP or excel statistical add-on packages a plus * Strong organization skills with the ability to handle multiple projects simultaneously and effectively * Strong communication and time management skills capable of working independently and cross-functionally in a remote work environment * Familiar with data analytics and trending including excel for graphing and hyperlinking source documents * Analytical or quality control experience in small or large molecules or oral drug products a plus for exposure to different types of data * Interest in understanding FDA regulatory commitments in commercial programs * Familiar with cGMP, USP, FDA, and ICH requirements a plus * You have a strong interest in life sciences and are passionate about giving patients with cancer a chance to enjoy more of life's precious moments. * You feel a strong connection with our ICARE values (Innovation, Courage, Alignment & Accountability, Resilience, and Energy) * You demonstrate enthusiasm for learnin Candidate Profile & Requirements: * Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025 * Currently enrolled high school or college (bachelor's program) student * Student must be returning to school in the Fall Term. * Must have a minimum GPA of 3.0 * Must be highly organized and have the ability to work in independently and collaboratively as a team * Clear, concise verbal & written communication Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school. Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!

Role Overview & Key Functions: As a Karyopharm, reporting to the Executive Director, GMP (Good Manufacturing Practice) Quality, you will positively impact patients' lives by: Assisting with Quality Unit (QU) efforts and activities within the organization and the Contract Service Providers, including the development and implementation of the programs. You will provide help to GMP Quality and Quality Management Systems teams, in support of the Annual GMP Quality Management Review (QMR), training program improvements, Veeva Vault processes and other ancillary quality activities. Responsibilities Participate in following activities to support GMP Quality Operations: Assist GMP in data collection and report generation for Annual Quality Management Review (QMR). This project will require creation of excel lists, statistical analysis, and technical writing. This will give an individual overview of drug manufacturing and testing processes along with affiliated regulations and guidelines. Assist in management of minor product quality investigations in Veeva Vault. This project will require individuals to learn and execute documentation for quality event investigations. Develop Smartsheets and trackers for GMP Quality to better manage project deliverables and timelines. Assist GMP Quality group in continuous improvement projects by participating in SOP revisions and process optimization. Maintain deviation and change control lists and assist in notification of change controls to Karyopharm's global partners. Provide communication support for training notifications and scheduling training for Karyopharm's business partners. Assist Quality Management Systems team with revision of the training management program including updating training matrices, creating excel of GxP processes; training requirements and required training per functional team in support of Veeva configuration updates. Support review of batch documentation and analytical data review received from CDMOs (Contract Drug Manufacturing Organizations) for various manufacturing and testing operations of Karyopharm's product. Qualifications Enrolled into undergraduate or graduate programs in scientific disciplines with interest to learn highly regulated drug manufacturing process, analytical testing, and quality oversight. Previous experience in Pharmaceutical or Biotech organizations is desired but not Good Oral and Written communication skills. Highly proficient with MS Office tools. Ability to learn and adapt with ambiguity of strengths. Work in a team setting adopting collaborative and learning approach for achieving results. Enthusiasm to learn new skills and Motivation towards career development. Candidate Profile & Requirements: Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025 Currently enrolled high school or college (bachelor's program) student Student must be returning to school in the Fall Term. Must have a minimum GPA of 3.0 Must be highly organized and have the ability to work in independently and collaboratively as a team Clear, concise verbal & written communication Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school. Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!

Role Overview & Key Functions: If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That's why we've built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us - whether that's onsite, from home, or anywhere in between. Our summer intern program, which will run from May 25th - Aug 7th, allows students to gain real world work experience in a high energy, collaborative work culture. A summer internship in Clinical Pharmacology at Karyopharm is an exciting opportunity to apply the knowledge you have gained in the field, think strategically, learn and evaluate new tools to advance decision-making. Karyopharm is seeking applications for a Clinical Pharmacology Summer internship. Responsibilities * Learn from scientific mentors to navigate the field of drug development, pharmacometrics and clinical pharmacology * Develop pharmacometrics models that characterize drug exposure and response (efficacy and safety) relationship * Develop approaches to assess and improve model identifiability and evaluate new tools for pharmacometrics analysis * Build code repository for data visualizations, projections and simulations * Collaborate with data scientists, clinical scientists to provide solutions Qualifications * MS or PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or other suitable post-graduate qualification * Candidate demonstrates a breadth of experience in the field of clinical pharmacology/pharmacometrics * Strong quantitative skills and expertise in population modeling, exposure response analysis * Exposure to tools such as Phoenix WinNonlin, R, Pumas, NONMEM etc. * Motivation to learn Candidate Profile & Requirements: * Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025 * Must have a minimum GPA of 3.0 * Must be highly organized and have the ability to work in independently and collaboratively as a team * Clear, concise verbal & written communication Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school. Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!

Role Overview & Key Functions: If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That's why we've built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us - whether that's onsite, from home, or anywhere in between. Our summer intern program, which will run from May 25th - Aug 7th, allows students to gain real world work experience in a high energy, collaborative work culture. The clinical development team is searching for a candidate that is bound for a career in medicine. This internship will be focused on publishing results from completed and ongoing clinical trials. The internship will also interface with the translational medicine, pharmacology, pharmacovigilance, and regulatory teams as documents and health agency submissions undergo collaborative generation. The offered experience is an ideal way to gain familiarity of the steps of drug development in the context of delivering the best care for cancer patients. This internship serves as experience for those candidates interested in a career in clinical development or for future clinicians who want to understand the biopharmaceutical industry in depth. A sample of tasks involved include: Role Overview & Key functions: * Assist in the preparation, review, and submission of manuscripts to medical journals, conferences, and other forums. * Review the medical portions of regulatory documents to ensure accurate description of the efficacy and safety of regimens in clinical trials * Conduct research on the treatment landscape of the cancer of interest * Participate in cross-functional meetings and collaborate with departments such as Clinical Operations, Clinical Development, Quality, Pharmaceutical Sciences, etc Candidate profile & Qualifications * Currently pursuing a college degree with intention to go on to medical school or are actively in medical training. * Strong analytical skills and attention to detail. * Excellent written and verbal communication skills. * Ability to work independently and collaboratively in a fast-paced environment. * Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) as well as reference software, such as Endnote or Zotero. * A working knowledge of physiology, statistics, and molecular biology. * Ability to work independently and collaboratively in a fast-paced environment. * You feel a strong connection with our ICARE values (Innovation, Courage, Alignment & Accountability, Resilience, and Energy) * You demonstrate enthusiasm for learning and a commitment to career development Candidate Profile & Requirements: * Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025 * Currently enrolled high school or college (bachelor's program) student * Student must be returning to school in the Fall Term. * Must have a minimum GPA of 3.0 * Must be highly organized and have the ability to work in independently and collaboratively as a team * Clear, concise verbal & written communication Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school. Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary Reporting to the Sr. Director, Drug Substance, the Principal Scientist of Drug Substance will primarily provide technical leadership for late-stage product development, process optimization, and manufacturing to support Phase 3 and registration activities for Akebia's praliciguat program. The Principal Scientist will be responsible for the identification of critical process parameters, process scale-up and technical transfers, and the oversight of contract drug substance manufacturing sites relating to the program. The Principal Scientist will ensure timely delivery of drug substance supplies for research, non-clinical and clinical activities, provide support to internal and external deviation/investigation, change controls, and authoring and/or review of protocols, reports and relevant sections of IND/IMPD and NDA/MAA Essential Functions & Duties Provide technical and tactical leadership for the phase-appropriate execution of drug substance strategies to support the development, optimization, scale-up, and manufacturing of praliciguat drug substance. Lead Praliciguat CMC drug substance Project Team. Provide oversight of project milestones, drive activities with additional project team members, as required, manage timelines, contracts, invoices and be both responsible and accountable for project deliverables. Assist functional and senior CMC leadership to develop risk-based strategies with respect to process development and commercial activities that include but are not limited to route scouting, registration, validation and clinical/commercial manufacturing. Assist in the identification and characterization of process impurities. Provide the technical rationale for impurity structures and routes of formation. Author/review and approve technical protocols, reports, and batch records. Oversee and manage activities at contract manufacturing organizations (CMOs); ensure timely production of drug substance inventory, ensuring robust compliance with Akebia processes, procedures, and regulatory requirements. Use statistical tools to develop process understanding, analyze data to establish critical process parameters and in-process controls, and identify process improvements. Foster a collaborative team environment that contributes to cross-functional problem solving and decision-making. Support regulatory submissions by writing and reviewing drug substance-related sections. Up to 25% of time allocated to domestic travel, as required. Some international travel may be required. Skills & Experience Required Skills: Bachelor's, Master's, or Ph.D. Degree in Organic Chemistry, Biochemistry, Chemical Engineering or a related discipline 10+ years of relevant experience Experience in small molecule chemical process development, technology transfer and oversight of activities at external partners. Direct experience in managing activities at contract development and manufacturing organizations. Advanced writing skills required. Includes the ability to draft protocols, technical reports, impact assessments, process justification reports, policies and procedures. Ability to review and approve clinical/commercial batch records and extract relevant data for analysis and trending. Experience with review and approval of commercial process validation related documentation: validation plan, manufacturing stage specific protocols, validation reports. Experience with the use of statistical tools preferred. Experience in performing activities supporting registration and validation including but not limited to: Impurities fate/purge assessments. Identification and setting of critical process parameters and in process controls. Identification of additional key process parameters to be monitored. Writing/Reviewing/approving protocols and reports. Manufacturing oversight. Ability and desire to work in a fast-paced, start-up environment. Effective time management skills. Sound judgment and commitment to ethical conduct. Working knowledge of relevant ICH guidelines, GMPs and global regulatory requirements. Strong collaboration, team-building skills and communication skills required. Compensation: Targeted Base: $153,362 - $189,447* *Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: **************

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary The VP of Regulatory Affairs will lead, create and drive the regulatory strategy for life cycle management activities for Vafseo, Auryxia and early development programs and ensure that there is a sound regulatory foundation for the successful advancement of the products through development and ultimately well positioned for rapid global regulatory approval. The VP, Regulatory Affairs will further strengthen the management team, serving as a highly visible, credible regulatory lead, and bring strong leadership to the development organization. Reporting to the Head of Research and Development/Chief Medical Officer, this individual will lead the Regulatory team which covers five main areas, Regulatory Strategy, Regulatory CMC, Regulatory Operations, Regulatory Intelligence, and Regulatory Labeling and Advertising and Promotion. This person will be a member of the Research and Development Leadership team and accountable for delivering Regulatory Strategy and Operational excellence, that is aligned with Akebia's overall corporate objectives. Essential Functions and Duties Formulate and oversee implementation of regulatory strategy and activities needed to secure approval of Akebia's products. Manage coordination, preparation and timely submission of regulatory documents (e.g., INDs, MAAs, NDAs). Author, review and critique documents that will be included in regulatory applications and interactions Foster strong relationships and advocacy with FDA and international regulatory authorities as well as ensuring strong coordination and collaboration across internal functional and stakeholders Maintain expert knowledge of, and familiarity with, FDA/EMA regulations and ICH guidelines. Provide clear and valid regulatory guidance and direction to other departments and project teams. Represent regulatory strategy at project team meetings and provide regulatory support for projects which may include clinical, preclinical, CMC and marketing issues. Develop and maintain relationships with external vendors and health care regulatory authorities. Manage all activities pertaining to interactions with FDA, and other health care regulatory authorities, and communicate outcomes to senior management. Supervise team members and consultants to the Regulatory Affairs department. Develop and implement standard operating procedures and common work practices within the team. Host FDA/third party regulatory audits and ensure follow up on findings/observations issued Provide guidance to business development regarding critical evaluation of potential opportunities in support of strategic partnering and licensing activities Skills & Experience 10+ years of progressively responsible experience in drug development and regulatory affairs in the biotechnology or pharmaceutical industry. The position also requires a minimum of 3 years of leadership experience in a regulatory affairs management role. Minimum BS degree in a scientific discipline, preferably life sciences or pharmacy; regulatory certification (RAC) a plus. An advanced degree in the biological sciences (MD, PhD, or PharmD) is desirable. Demonstrated knowledge in the regulatory aspects of clinical development, including protocol development, data collection and analysis, preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA), and prosecution of NDAs through review to a final decision by health care regulatory authorities, specifically including FDA and EMA. Knowledge and management of the regulatory aspects of drug manufacturing, quality assurance, and GCP and GMP compliance is a strong plus. Demonstrated expert knowledge of the regulations and practices of FDA, EMA, and other major health care regulatory authorities Proficient in the delivery and conduct of all Regulatory Affairs activities including, but not limited to: submissions, publishing, review, and oversight Demonstrated experience in negotiating with and presenting to regulatory agencies such as FDA. Prior experience of NDAs and MAAs and gaining global regulatory approvals is desirable. Strong consulting and analytical skills and the ability to understand, balance, and articulate both tactical and strategic issues and solutions Demonstrated management expertise, including the leadership and professional development of the Regulatory team. A hands-on leader who leads by example as well as willingness to roll-up sleeves and draft sections for regulatory submissions. Demonstrated ability to work independently with exceptional organization and attention to detail. Excellent oral and written communication and presentation skills. Ability to work well under pressure and adhere to deadlines Compensation: Targeted Base: $307,913 - $380,363* *Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: ************** Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristics protected by applicable law.

Role Overview & Key Functions: The Sr Director, Clinical Research Scientist position serves a key role within the Clinical Development R&D team. The Sr Director, CRS works closely with the assigned study team(s) and medical director(s) to support the activities associated with one or more clinical studies. This position collaborates with clinical team members as well as with functions outside of clinical to provide high quality and timely deliverables. Reporting to our Senior Vice President, Clinical Development, you will positively impact patients' when you: * Support assigned study level activities for one or more clinical studies. * Develop thorough understanding of assigned protocol and protocol requirements * Support study activities as applicable: * Liaison between medical monitor, clinical operations, and CRO * Participate in the protocol development process; including writing, reviewing, adjudication/resolution of cross functional comments, ensuring high quality final document * Lead the medical data review process during ongoing study, including individual patient review for purposes of data cleaning, and aggregate data review for safety and protocol conduct purposes * Participate in the creation of and the review of clinical study reports (CSRs) * Contribute to the creation of and the review of Regulatory Documents (e.g., IB, Briefing Books, and regulatory submission documents) in collaboration with medical writers with minimal to moderate supervision * Review/Edit Master Informed Consent Forms (ICF); * Active contributor to study committee (e.g., DMC) activities such as charters, meetings, presentation preparation * Active contributor to Investigator Meeting and Site Initiation Visit presentations * Active contributor to activities related to data generation and validation, including CRF creation, clinical data review, data cleaning, communication as needed to resolve data queries, contribute to development of data review plans, support medical director and pharmacovigilance physicians in data review (generation of reports, action plans, trend identification), etc.) * Provides mentoring to more junior clinical researcher scientists as needed based upon past experience and prior understanding of roles and responsibilities. * Collaborate with study team members (Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality data output * Participate in operational excellence projects as appropriate and audit readiness activities Candidate Profile & Requirements: * Degree in Life Sciences (advanced degree preferred) * 12 years of pharmaceutical clinical research experience including prior experience in pharma/biotech. * Prior experience supporting and participating in regulatory inspection activities. * Prior experience supporting regulatory submissions including NDA, sNDA or equivalent (outside the US/FDA). * Comprehensive knowledge of oncology drug development with some direct experience required * Proficient knowledge of GCP/ICH, study design, statistics, clinical operations within the oncology therapeutic space. * Excellent verbal, written, communication and interpersonal skills. Must be able to effectively communicate and collaborate across functions and job levels. * Proficient knowledge and skills to support program specific data review, trend identification, data interpretation * Proficient in Medical Terminology and medical writing skills * Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism) * Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), or similar data reporting tools Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That's why we've built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us - whether that's onsite, from home, or anywhere in between. What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission. Check out our Culture Video! What We Offer: In addition to our exciting, supportive, and intellectually challenging global workspaces(s), team members enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills. * A culture of employee engagement, diversity, and inclusion * Competitive salary, bonus, and generous equity offerings (RSU's at time of offer and annual awards) - we are partners in prosperity! * Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement. * Wellness Program with a monthly stipend. * Generous PTO and Holidays - we encourage you to recharge and spend time with family and friends. * Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs) * Cell phone allowance

Nortiva Bio, Inc., a subsidiary of Innoviva, Inc., is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. The company's proprietary LYNX drug delivery platform represents a major advancement in oral drug delivery, enabling the creation of medicines designed to last a week or longer in a single oral dose. Our near-term focus is on advancing clinical programs in therapeutic areas where weekly or monthly doses would improve adherence and health outcomes. Summary of Position: The Senior Director of Financial Planning and Analysis (FP&A) is responsible for leading the financial strategy and analytics for Nortiva Bio, Inc. In this high-visibility, hands-on role, this individual will serve as a strategic thought partner to the executive team, shaping our financial roadmap, driving operational financial excellence, and delivering clear, data-driven insights to drive informed decisions across the organization. The Senior Director will be critical in driving financial planning, budgeting, forecasting, and analysis to support our corporate goals and objectives. Responsibilities: * Lead the FP&A function, providing strategic financial insights that drive decision-making across programs and overall business operations. * Drive all FP&A activities including budgeting/forecasting, long-range planning, scenario modeling and financial analysis for strategic initiatives * Conduct timely analysis of monthly budget-to-actuals including variance analyses, generation and reporting of results * Serve as a strategic partner to executives and cross-functional leaders, translating complex financial data into clear, actionable insights that inform high-impact decisions * Deliver dashboards, reports, and presentations that clearly communicate the story behind the numbers and support decision-making. * Prepare detailed reports and presentations for senior management and the board. * Identify financial risks and opportunities and develop strategies to mitigate risks while supporting business growth * Partner with Legal to manage the purchasing process. * Support ad-hoc strategic initiatives as capabilities are demonstrated and opportunities arise; potential initiatives include but are not limited to: business development analyses, partner support, portfolio prioritization, and financing strategies * Continuously improve of FP&A processes, with the goal of improving efficiency while maintaining flexibility to adapt to future business needs Experience & Education: * Bachelor's degree in Finance, Accounting, Business Administration, or related field; MBA or relevant advanced degree preferred. * 10 plus years of experience in financial planning and analysis, with significant experience in the biotechnology or pharmaceutical industry Skills and Abilities: * Proven track record of strategic financial leadership and a deep understanding of clinical-stage operations, R&D budgeting and resource allocation * Experience supporting R&D functions and/or programs in a cross-functional environment * Proficiency with Excel in order to conduct complex analysis that will support key decisions * Knowledge of fundamental accounting principles * Strong analytical and financial modeling skills, with the ability to translate complex data into actionable business insights. * Excellent communication and presentation skills, with a demonstrated ability to influence stakeholders and and convey financial information clearly across all levels of the organization * Proficiency in financial planning tools and ERP systems; experience with business intelligence software is a plus. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Nortiva Bio, Inc. is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Please Note: Innoviva Specialty Therapeutics does not accept unsolicited resumes or candidate submissions from staffing agencies or recruiters. Any such submissions will be considered property of Innoviva Specialty Therapeutics, and we will not be obligated to pay any fees associated with them unless a prior written agreement is in place.

Role Overview & Key Functions: If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That's why we've built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us - whether that's onsite, from home, or anywhere in between. Our summer intern program, which will run from May 25th - Aug 7th, allows students to gain real world work experience in a high energy, collaborative work culture. Role Overview & Key functions: Overview We are seeking a motivated and detail-oriented Finance / IT Intern to support a broad range of financial and operational activities across FP&A, accounting/close, accounts payable, and IT/finance systems research. This role offers unique visibility into the finance function of a growing biotech organization and includes opportunities to work directly with the CFO on strategic and ad hoc projects. The ideal candidate is analytical, proactive, eager to learn, and comfortable working with financial data, systems, and cross-functional partners. Key Responsibilities Financial Planning & Analysis (FP&A) * Assist with preparation of monthly and quarterly financial forecasts. * Update financial models, templates, and dashboards as needed. * Help compile data for executive presentations and board materials. Accounting & Close Support * Assist with monthly close activities such as accrual preparation, journal entry support, and data reconciliation. * Help gather and organize supporting documentation for account reconciliations. Accounts Payable (AP) & Operational Finance * Help maintain AP aging schedules and follow up on outstanding items. CFO & Special Projects * Conduct research, financial analysis, and benchmarking for CFO-driven strategic initiatives. * Assist in preparing materials for senior leadership meetings and special reviews. * Take on ad hoc assignments that require strong problem-solving and data analysis skills. * IT & Systems Support (Finance-Focused) * Research AI tools, automation solutions, and efficiency technologies relevant to finance processes. * Evaluate budgeting, forecasting, and planning system options; assist with vendor comparison and ROI analysis. * Support preliminary research for potential upgrades to financial general ledger systems (e.g., workflows, integrations, cost structures). * Help document requirements, summarize findings, and make recommendations to the IT team, the CFO and Finance team. Candidate profile & Qualifications * You are either currently enrolled in college or you are a recent college graduate * You have a strong interest in life sciences and are passionate about giving patients with cancer a chance to enjoy more of life's precious moments. * You feel a strong connection with our ICARE values (Innovation, Courage, Alignment & Accountability, Resilience, and Energy) * You demonstrate enthusiasm for learning and a commitment to career development Candidate Profile & Requirements: * Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025 * Currently enrolled high school or college (bachelor's program) student * Student must be returning to school in the Fall Term. * Must have a minimum GPA of 3.0 * Must be highly organized and have the ability to work in independently and collaboratively as a team * Clear, concise verbal & written communication Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school. Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!

Role Overview & Key Functions: Karyopharm Therapeutics is a commercial-stage oncology company focused on developing novel therapies for patients with cancer, particularly in areas where treatment options have remained limited for far too long. Our team is driven by curiosity, urgency, and the belief that meaningful innovation can reshape patients' lives. We are now preparing for what could become the first new combination therapy for myelofibrosis-a milestone that has the potential to change the treatment landscape and improve outcomes for people living with a challenging and under-recognized disease. It's an incredibly exciting time to join our MF team as we build toward this potential launch. About the Role We're looking for a motivated, strategic, and curious MBA candidate to join us for the summer and support key work in launch strategy and disease state awareness. This internship offers the opportunity to roll up your sleeves and contribute to high-impact projects that sit at the center of our commercial planning efforts. What You'll Work On Launch Strategy and Planning Support cross-functional planning as we prepare for a potential first-in-class combination launch. Assist with organizing key workstreams, refining timelines, and helping keep teams aligned on what needs to happen-and when. Develop go-to market, customer segmentation and adoption strategies to help maximize our launch opportunities Contribute to internal presentations and updates that highlight progress, insights, and areas where strategic choices can make a difference. Disease State Awareness & Market Education Help develop and refine the overall myelofibrosis disease narrative, including unmet needs and gaps in the current treatment landscape. Dive into research-market trends, competitive insights, audience perspectives, and external data-to help us better understand how HCPs, patients, and advocacy groups think about MF today. Identify opportunities to elevate disease understanding and urgency through thoughtful messaging, content, and education. Support development of stakeholder personas and segmentation work. Who You Are A current MBA student with an interest in healthcare, biotech, oncology, or commercial strategy. Analytical and curious-you enjoy digging into data and asking good questions. A strong communicator who can take complex information and turn it into something that's easy to understand. Someone who works well with others, stays organized, and is excited by meaningful, fast-moving work. Experience in consulting, marketing, life sciences, or healthcare strategy is a plus but not . What You'll Gain Hands-on experience supporting a potential landmark MF launch. A close-up look at how disease state education and commercial readiness come together in a real-world biotech setting. Opportunities to collaborate with talented teams across marketing, medical affairs, market access, and advocacy. A chance to contribute to work that could have a real and lasting impact on patients and the MF community. The opportunity to work on a small team that takes the work seriously-but not ourselves. Candidate Profile & Requirements: Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025 Currently enrolled high school or college (bachelor's program) student Student must be returning to school in the Fall Term. Must have a minimum GPA of 3.0 Must be highly organized and have the ability to work in independently and collaboratively as a team Clear, concise verbal & written communication Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school. Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!

Role Overview & Key Functions: This role will support continuous product supply for Karyopharm' s drug products (IMP) utilized in clinical trials. The individual will work with teams managing internal and external tasks and customers in order to accomplish project objectives and to understand the needs of the clinical trials. The Clinical Supply Chain Intern will support Clinical Supply Chain initiatives and continuous improvement activities. Responsibilities * Participate in cross-functional Project Team Meetings * Partner with PM to review, understand the Clinical Supply study process * Shadow the PM who coordinate and monitor label development process and packaging timelines with the vendors * Partner with the IRT Team to understand Randomization for Clinical Trial Studies * Manage temperature excursion process * Generate Quarterly Reports and the KPTI Performance and Risk Indicators * Overview of Commercial Global Supply Chain process * Organize and file various trial related documents Qualifications * Currently enrolled college (bachelor's program) student * Must be highly organized and have the ability to work in independently and collaboratively as a team * Must be able to complete the Karyopharm Internship Program 28May - 09Aug2024 Required Skills * Clear, concise verbal & written communication * Curious and willing to learn and use new tools / skills. * Proficiency in Microsoft Word, Excel, PowerPoint * Familiarity with advanced Excel tools * Familiarity with Process mapping * Zoom & Microsoft teams. Candidate Profile & Requirements: * Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025 * Currently enrolled high school or college (bachelor's program) student * Student must be returning to school in the Fall Term. * Must have a minimum GPA of 3.0 * Must be highly organized and have the ability to work in independently and collaboratively as a team * Clear, concise verbal & written communication Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school. Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary Reporting to the Sr. Director, Drug Substance, the Principal Scientist of Drug Substance will primarily provide technical leadership for late-stage product development, process optimization, and manufacturing to support Phase 3 and registration activities for Akebia's praliciguat program. The Principal Scientist will be responsible for the identification of critical process parameters, process scale-up and technical transfers, and the oversight of contract drug substance manufacturing sites relating to the program. The Principal Scientist will ensure timely delivery of drug substance supplies for research, non-clinical and clinical activities, provide support to internal and external deviation/investigation, change controls, and authoring and/or review of protocols, reports and relevant sections of IND/IMPD and NDA/MAA Essential Functions & Duties * Provide technical and tactical leadership for the phase-appropriate execution of drug substance strategies to support the development, optimization, scale-up, and manufacturing of praliciguat drug substance. * Lead Praliciguat CMC drug substance Project Team. Provide oversight of project milestones, drive activities with additional project team members, as required, manage timelines, contracts, invoices and be both responsible and accountable for project deliverables. * Assist functional and senior CMC leadership to develop risk-based strategies with respect to process development and commercial activities that include but are not limited to route scouting, registration, validation and clinical/commercial manufacturing. * Assist in the identification and characterization of process impurities. Provide the technical rationale for impurity structures and routes of formation. * Author/review and approve technical protocols, reports, and batch records. * Oversee and manage activities at contract manufacturing organizations (CMOs); ensure timely production of drug substance inventory, ensuring robust compliance with Akebia processes, procedures, and regulatory requirements. * Use statistical tools to develop process understanding, analyze data to establish critical process parameters and in-process controls, and identify process improvements. * Foster a collaborative team environment that contributes to cross-functional problem solving and decision-making. * Support regulatory submissions by writing and reviewing drug substance-related sections. * Up to 25% of time allocated to domestic travel, as required. Some international travel may be required. Skills & Experience Required Skills: * Bachelor's, Master's, or Ph.D. Degree in Organic Chemistry, Biochemistry, Chemical Engineering or a related discipline * 10+ years of relevant experience * Experience in small molecule chemical process development, technology transfer and oversight of activities at external partners. * Direct experience in managing activities at contract development and manufacturing organizations. * Advanced writing skills required. Includes the ability to draft protocols, technical reports, impact assessments, process justification reports, policies and procedures. * Ability to review and approve clinical/commercial batch records and extract relevant data for analysis and trending. * Experience with review and approval of commercial process validation related documentation: validation plan, manufacturing stage specific protocols, validation reports. * Experience with the use of statistical tools preferred. * Experience in performing activities supporting registration and validation including but not limited to: * Impurities fate/purge assessments. * Identification and setting of critical process parameters and in process controls. * Identification of additional key process parameters to be monitored. * Writing/Reviewing/approving protocols and reports. * Manufacturing oversight. * Ability and desire to work in a fast-paced, start-up environment. * Effective time management skills. * Sound judgment and commitment to ethical conduct. * Working knowledge of relevant ICH guidelines, GMPs and global regulatory requirements. * Strong collaboration, team-building skills and communication skills required. Compensation: Targeted Base: $153,362 - $189,447* * Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: **************

Role Overview & Key Functions: This internship offers a high-impact opportunity to work across multiple functions at Karyopharm, with exposure to Strategy & Portfolio Management, Business Operations, and Program Management. The intern will play a key role in evaluating and enhancing Program Team resources that define the drug development end-to-end process, ensuring they are accurate, up to date, and easily accessible. A major focus will be assessing usage patterns and upgrading the Program Team intranet site-improving content quality, presentation, navigation, and overall user experience. The intern will collaborate closely with Program Team members and functional stakeholders to gather feedback, synthesize insights, and translate them into a structured update/upgrade plan. Key deliverables include refining Karyopharm's drug development process materials, developing and executing an awareness and engagement campaign for the intranet site, and building practical skills in stakeholder feedback collection, analysis, and implementation. This role provides hands-on experience in cross-functional collaboration, strategic communication, and operational excellence within a dynamic biotech environment. Responsibilities: Understand the interplay between different departments in drug development and commercialization (e.g. Clinical Operations, Medical, Pre-clinical, MSLs, Regulatory, Research, Drug supply, Market Access, Commercial, HEOR, Medical Affairs, Publications, Corporate Communications, Investor Relations, Launch Excellence, Patient Advocacy, Alliance Partners as well as Investigators, and Patient Advocacy groups). Assess current drug development end-to-end process materials for accuracy and currency Assess current usage patterns/upgrade an intranet site that serves as a central hub, providing essential resources and tools to empower Program Teams as they navigate each stage of the development process. Gather and synthesize feedback on content and user experience from Program Team members Establish and drive a Program Team TEAMs Site/SharePoint Engagement Campaign to further increase awareness, tool adoption, and collaboration Create bite-sized content on high performing team best practices that elevate our values (e.g. best practices around meetings, collaboration, alignment, decision making and recognizing Program Team and/or Functional achievements) which can be included on the intranet site and in Karyopharm internal communications outlets. Support cross-functional integrated program planning via creating and updating timeline templates, as well as templates for translating timelines into various reports and visual materials Other Program Management Office related deliverables as prioritized by the business at that time. Qualifications: Currently pursuing a Master's. Ability to collaborate and interact with individuals at all levels. Performs well under pressure and delivers results. Communication Skills: Website development, powerpoint presentation design, content creation Awareness of core pharmaceutical business metrics; good knowledge of current affairs. Strategic, critical and creative thinking skills; Sound judgment and impeccable discretion in handling sensitive and confidential information. Candidate Profile & Requirements: Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025 Currently enrolled high school or college (bachelor's program) student Student must be returning to school in the Fall Term. Must have a minimum GPA of 3.0 Must be highly organized and have the ability to work in independently and collaboratively as a team Clear, concise verbal & written communication Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school. Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary: Akebia is currently expanding its Regulatory team to support early and late-stage assets and is searching for a Senior Director, Regulatory Affairs to support the continued development of vadadustat in the treatment of anemia, as well as other pipeline products in chronic kidney disease or other therapeutic indication spaces. This individual will operate in a high visibility role and will be responsible for developing and coordinating regulatory strategies and leading IND/CTA and sNDA/NDA preparation and submissions to regulatory agencies. This position reports to the Vice President, Regulatory Affairs. Essential Functions & Duties Design and support implementation of well-informed global regulatory strategies Represent Regulatory Affairs on project sub-teams (e.g., Product Team, Clinical Team, etc.) and provide regulatory strategy and guidance (e.g. protocol reviews, report reviews, development plans) Liaise with and lead the preparation, as well as meetings with Regulatory Health Authorities (e.g. U.S., E.U, Japan) Lead the coordination, preparation and timely submission of regulatory documents (e.g. briefing documents, pediatric plans, INDs, NDAs). Manage, mentor, and develop direct reports, who may lead their own development programs Write regulatory documents (e.g. pediatric plans, briefing documents) to support regulatory agency submissions Establish relevant processes and procedures to support the Regulatory Affairs function activities Maintain knowledge of US, EU and ROW regulatory requirements and ensure compliance with regulatory requirements Articulate complex issues and strategic recommendations concisely and effectively across all stakeholders including senior leaders Develop approaches and solutions to achieve business critical goals and/or mitigate risks Skills & Experience Bachelor's degree in life sciences required; advanced degree preferred Minimum of 8 years pharmaceutical industry experience with a minimum of 6 years in Regulatory Affairs Evidence of successful submissions to FDA and EMA (e.g. IND, NDA, MAA, briefing packages) Experience managing and developing direct reports Demonstrated evidence of writing regulatory documents (pediatric plans, Module 1, Module 2, briefing packages) Knowledge of US and EU regulatory requirements Knowledge of drug development Excellent written and oral communication skills Excellent interpersonal skills Strong project management skills and drive for excellence Previous experience working for FDA is a plus Compensation: Targeted Base: $246,330 - $304,290* *Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: ************** Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristics protected by applicable law.

Role Overview & Key Functions: Karyopharm Therapeutics is a commercial-stage oncology company focused on developing novel therapies for patients with cancer, particularly in areas where treatment options have remained limited for far too long. Our team is driven by curiosity, urgency, and the belief that meaningful innovation can reshape patients' lives. We are now preparing for what could become the first new combination therapy for myelofibrosis-a milestone that has the potential to change the treatment landscape and improve outcomes for people living with a challenging and under-recognized disease. It's an incredibly exciting time to join our MF team as we build toward this potential launch. About the Role We're looking for a motivated, strategic, and curious MBA candidate to join us for the summer and support key work in launch strategy and disease state awareness. This internship offers the opportunity to roll up your sleeves and contribute to high-impact projects that sit at the center of our commercial planning efforts. What You'll Work On Launch Strategy and Planning * Support cross-functional planning as we prepare for a potential first-in-class combination launch. * Assist with organizing key workstreams, refining timelines, and helping keep teams aligned on what needs to happen-and when. * Develop go-to market, customer segmentation and adoption strategies to help maximize our launch opportunities * Contribute to internal presentations and updates that highlight progress, insights, and areas where strategic choices can make a difference. Disease State Awareness & Market Education * Help develop and refine the overall myelofibrosis disease narrative, including unmet needs and gaps in the current treatment landscape. * Dive into research-market trends, competitive insights, audience perspectives, and external data-to help us better understand how HCPs, patients, and advocacy groups think about MF today. * Identify opportunities to elevate disease understanding and urgency through thoughtful messaging, content, and education. * Support development of stakeholder personas and segmentation work. Who You Are * A current MBA student with an interest in healthcare, biotech, oncology, or commercial strategy. * Analytical and curious-you enjoy digging into data and asking good questions. * A strong communicator who can take complex information and turn it into something that's easy to understand. * Someone who works well with others, stays organized, and is excited by meaningful, fast-moving work. * Experience in consulting, marketing, life sciences, or healthcare strategy is a plus but not required. What You'll Gain * Hands-on experience supporting a potential landmark MF launch. * A close-up look at how disease state education and commercial readiness come together in a real-world biotech setting. * Opportunities to collaborate with talented teams across marketing, medical affairs, market access, and advocacy. * A chance to contribute to work that could have a real and lasting impact on patients and the MF community. * The opportunity to work on a small team that takes the work seriously-but not ourselves. Candidate Profile & Requirements: * Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025 * Currently enrolled high school or college (bachelor's program) student * Student must be returning to school in the Fall Term. * Must have a minimum GPA of 3.0 * Must be highly organized and have the ability to work in independently and collaboratively as a team * Clear, concise verbal & written communication Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school. Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary Description: The Associate Director Regulatory Affairs, Labeling is responsible for leading cross functional teams for labeling activities for Akebia products. This role is responsible for ensuring compliance with regulatory agencies requirements and meeting Akebia's strategic labeling objectives. Additional responsibilities include monitoring regulatory compliance trends in industry, interpreting new regulations, guidance documents and enforcement letters. This role is expected to provide support, insight, sound judgment and clear direction on all labeling programs and tactics that are compliant with regulations and company policies. This role reports to the Director Regulatory Affairs, Advertising, Promotion and Labeling. Responsibilities include but are not limited to the following: Plans and manages USPI and CCDS creation, maintenance, distribution, tracking and implementation to ensure documents are produced in a timely manner according to internal operating procedures and external regulatory requirements. Regulatory lead for the development and lifecycle management of product labeling and artwork (new and revised), with a cross-functional team, ensuring all labeling/artwork is compliant with labeling regulations and Akebia quality standards. Identifies and provides guidance on the development, or improvement, of policies, processes, and standards for labeling activities; Maintains a deep and current awareness of evolving FDA, and key international labeling regulations, advisory comments, enforcement actions and policy issues; Monitors US and key international labeling for competitor updates and keep the organization up-to-date. Responsible for drug listing of original and revised SPLs to support U.S. commercial launch and post-marketing activities. Responsible for the maintenance of SPL software database to track the history and version control of each SPL. Basic Qualifications BA/BS Degree A minimum of 7 years of pharmaceutical industry experience, with at least 3 years of regulatory affairs experience focused labeling for prescription drug products Preferred Qualifications Advanced degree (MS, PhD, PharmD, or JD) Experience with launching new products and/or new indications Strong interpersonal and oral and written communication skills Able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate Solid understanding of FDA labeling regulations Demonstrated ability to influence others and foster team collaboration. Strong interpersonal, communication and leadership skills. Forward thinker with strong industry knowledge and ability to identify, synthesize and act upon strategic information and changes within the environment. Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of backgrounds and disciplines. Demonstrated decision-making and problem-solving capability; ability to negotiate skillfully to achieve a fair outcome or promote a common cause. Compensation: Targeted Base: $165,543 - 204,494* *Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: ************** Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristics protected by applicable law.

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary Reporting to the Vice President, FP&A, the Director, R&D & Technical Operations Finance will lead all aspects of financial management for the Research & Development and Tech Ops functions. This individual will partner with teams across those functions to drive operational and strategic decision-making key to Akebia's success. Duties & Responsibilities * Responsible for all aspects of the R&D and Tech Ops budget & forecast, including leading the team through annual budget development and interim updates * Provide guidance to the R&D and Tech Ops teams in financial planning and project financial management, including informing forecasts for clinical trials, cost of goods sold, and related working capital impacts * Drive various analyses to support strategic & operational decision making for the Supply & Operations Planning process (S&OP) in collaboration with the Supply Chain team * Lead departmental and cross-functional prioritization initiatives, as needed * Lead the team responsible for R&D and Tech Ops planning to ensure understanding, communication, documentation, and reporting of ongoing and future project initiatives, including scope definition and changes, contract amendments, and change orders * Ensure a culture where scope, provisions, vendor obligations and payment terms included in project work orders and contracts are understood and consistent with budgetary and accounting guidelines and methodologies * Responsible for overseeing and reviewing the monthly accounting close process for the R&D and Tech Ops functions, working closely with accounting, functional business partners, and external vendors (including CROs and CMOs) to ensure appropriate expense recognition for clinical trials & other outsourced spend * Support Company's Sarbanes-Oxley compliance efforts and ensure team's deliverables for quarterly and annual audits are met * Develop an in-depth understanding of key collaborative agreements to help the team develop processes for tracking, complying with and reporting on financial provisions/deliverables in connection with all agreements * Work closely with Alliance Management, Program Management, and Business Development to establish and foster relationships, communication, and reporting with strategic partners * Drive long-range planning activities in partnership with Corporate Finance & business partners * Define and anticipate risks and opportunities and propose solutions and plans of action to inform key decision makers, including the Leadership Team, CFO, and Executive Team * Identify and enable opportunities for operational improvements and efficiencies * Develop and manage a team of leading finance professionals Basic Qualifications * Bachelor's degree required * Minimum of 10 years' experience in finance and accounting functions * Pharmaceutical / Biotechnology industry experience required * Experience in Operational Finance, including business partnering with R&D and / or Technical Operations functions Preferred Qualifications * Deep understanding of drug development process * Strong written & verbal communication skills, including with Executive Leadership * Significant experience with clinical trial accruals and execution * Strong understanding of Cost of Goods Sold & Inventory accounting * In depth understanding of US GAAP and financial statement reporting * Excellent analytical, decision making, and organizational skills * Thrives in a dynamic, fast-paced environment * Experience with NetSuite ERP and Adaptive Planning EPM tools Compensation: Targeted Base: $199,712 - $246,703* * Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: ************** Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristics protected by applicable law.