Associate Director jobs at Boehringer Ingelheim - 2316 jobs

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: This role supervises activities that includes entire Takeda portfolio for pharmaceuticals including synthetic small molecules, synthetic peptides and synthetic oligonucleotides. The individual in this role will collaborate with Executives (VP/SVP) in R&D (Discovery and Therapeutic area units - TAUs), GRA, GMS, Global Quality and Commercial. Accountabilities: Develop innovative strategies for the management of the development products Develop processes, systems and build the infrastructure to assure regulatory conformance prospectively while also managing conformance retrospectively for the products in the post approval space. Manage the pipeline combination products, while bringing the current products to today's standards. Represent CMC and GRA on key governance committees and play a critical role in driving the organization towards innovative approaches for adoption and registration of new technologies/molecules in the pipeline, such as small molecules, synthetic peptides and oligonucleotides - novel and delivery approaches that are unprecedented. Lead senior individuals with varying backgrounds and will need to enable them to hire, mentor, and develop capable individuals who can represent the organization internally and externally on critical topics. This will be a critical success factor for this individual and is a challenging task due to the varying nature of talent available for these modalities. Wear multiple hats as the role will involve complex interactions dealing with ambiguity and leading effectively in an uncertain environment will be a core competency. Single point of contact with key leaders at Takeda (GRA, R&D, GMS, GQ): This individual will serve as the key point of contact on Small Molecules and Oligonucleotides interfacing with: Research - to enable the fast prosecution of the portfolio and support the adoption of novel in-silico approaches. GMS - serve as the GRA representative on Small Molecules and Oncology Operations Leadership team to maintain the product licenses globally through proactive management of changes while also addressing the conformance challenges on legacy portfolio. GQ- Serve as the GRA representative on the Small Molecule quality council and in collaboration with head of Small Molecule and Oncology quality, enable proactive approaches to quality/compliance GRA LT /Commercial/GPT: Engage with GRA therapeutic area heads as well as GPT's/commercial teams and pharm sciences proactively to advance innovation using risk based principles and informed decision making as the core. Leadership: The individual will need to manage ambiguity and should have the ability to lead and guide the teams in situations of high stress where the stakes are high. He/she will need to lead the team and manage change, while not impacting current work and timelines. The ability to assess situations and resolve them using risk-based approaches would be a critical attribute. Communication: Ability to communicate concisely and clearly across all levels of the organization including stakeholders in R&D, GMS, GQ and Commercial. Ability to take complex issues and communicate them in a simple and understandable manner. Education & Competencies (Technical and Behavioral): Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline. Languages: Fluent in English (oral and written); additional languages desirable Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO). Actively engaged in major industry associations (e.g. EFPIA, PhRMA, AAPS, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH). Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients. Ability to relate to stakeholders internally and also interface with external stakeholders (regulatory authorities), with the intent of enabling Takeda's success and positions that are science and risk based. High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams. Desired technical skills: Experience in technical development, manufacturing and/or testing of pharmaceuticals This position is currently classified as “hybrid” by Takeda's Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $255,800.00 - $401,940.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description AbbVie's Analytics and Performance Excellence (APEX) function is seeking a highly strategic, analytical, and collaborative Associate Director to provide analytics leadership for the Business Evolution Strategic Development (BESD) Team. This role will drive impactful business analytics and insights to help AbbVie anticipate and navigate evolving healthcare environments, especially focusing on market access and policy disruptors. The Associate Director will bridge Market Access and Patient Services (MAPS) Team within APEX and BESD (Business Evolution Strategic Development) team objectives by leading modelling, advanced insights and analytics supporting forward-looking strategies, enabling enterprise readiness, and shaping market access policies and outcomes for AbbVie's diverse U.S. portfolio. This role requires a strong grasp of healthcare policy, payer analytics, and strategy formulation within a collaborative, cross-functional environment. Key Responsibilities: Lead the planning and execution of analytics to inform market access strategies, price reform and policy analysis, with actionable recommendations for AbbVie leadership. Identify payer opportunities/threats through deep dive analytics ('Follow the Dollar', claims analysis, and scenario modeling). Foster positive relationships and close collaboration with teams including Government Affairs, Finance, Legal, Corporate Affairs, Brand, and Market Access. Communicate complex findings and insight-driven narratives to senior leadership and cross-functional teams, enabling improved payer knowledge and strategic decision-making. Monitor external environment and translate emerging trends (political, regulatory, legislative, commercial) into strategic recommendations for AbbVie's business evolution. Advise on analytics infrastructure enhancements to drive business impact. Skills Action and Accountability: Own responsibility for activities within relevant workstreams, and engage and inspire cross functional stakeholders to advance towards clear objectives and strategies; make quick, but informed decisions, as appropriate, to ensure best paths forward in the midst of change market and policy dynamics. Constantly engage, guide, and support cross-functional team to address roadblocks, challenges, resourcing constraints and other dynamics. Leadership and Influence: Influence and persuade across multiple external and internal stakeholders. Collaboration and Teamwork: Work effectively with internal stakeholders, external market experts and partners. Qualifications Bachelor's degree required; master's degree (MBA or related business/science) preferred. 10+ years of progressive analytical/ insights experience in healthcare industry (pharma, consulting, government affairs, market access, public policy, etc.). 1-2 years pharmaceutical market access experience with deep understanding of Health Plans, PBMs, Hospitals, Specialty Pharmacies, and healthcare policy stakeholders. Strong insurance channel experience and understanding (i.e. Medicare, Commercial etc.) Strong business acumen, strategic and analytical thinking, and executive presence. Exceptional communication and influencing skills, with the ability to distill complex information into compelling, concise messages. Strong organizational skills, flexibility, attention to detail, and experience in collaborative, dynamic environments. Exceptional communications and executive presence, critical thinking and interpersonal skills, strong ability to influence without authority, the ability to speak and write persuasively and with clarity, strong organizational skills, flexibility, and adaptability to changing requirements, resourcefulness and creativity, strong attention to detail, a proven track record of being able to work drive towards deadlines and an ability to work collaboratively in a fluid organizational and external environment. Must be an individual who works well in a team environment and enjoys working in a collegial, collaborative and fun, yet highly demanding culture Preferred: * Experience in policy shaping, price reform strategy, and enterprise-level stakeholder partnership. * Proficiency with pharmaceutical data sources (formulary, claims). Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************

A leading pharmaceutical company in Boston is hiring a Senior Director in Statistics to enhance their R&D capabilities. The role emphasizes strategic leadership, cross-functional collaboration, and improving therapeutic outcomes through data-driven methodologies. Candidates should possess advanced knowledge of drug development processes and strong statistical programming skills. An equitable compensation package includes a base salary range of $208,200 - $327,140 and comprehensive benefits for full-time employees. #J-18808-Ljbffr

Objective / Purpose: The Head of Design & Delivery, PharmSci will lead the global digital product strategy across Takeda's Pharmaceutical Sciences Digital Data & Technology (DDT) portfolio, driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering innovative, compliant, and business‑aligned digital solutions. You will manage a global team of product managers and work cross‑functionally to ensure that Takeda's technology platforms are innovative, modern, scalable, and enable faster delivery of medicines to patients. Responsibilities Drive the delivery strategy for multi‑year enterprise impacting programs and products including critical digital transformation initiatives such as Aedificus Fortis (AF), In Silico First and digitization of internal clinical manufacturing projects. Elevate the product management teams to be seen as strategic partners ensuring delivery of fit for purpose digital solutions that meet the evolving needs of PharmSci and beyond. Define and execute the strategic product roadmap across PharmSci products including but not limited to Scientific Data products (Tetrascience, ECM, SDMS), GMP Clinical Manufacturing products (MES, ERP, MODA, LIMS), Knowledge management product (PLM, R&D Search), and Drug and Device Management Lab Validation. Structure and resource product teams based on demand planning to support strategic roadmaps. Ensure platforms are integrated, compliant, and user‑centric across all business areas. Build, upskill, and lead a high‑performing global product management team. Foster a product‑driven agile culture to support delivery excellence. Collaborate with senior leaders across PharmSci, Research and RDDT including Business Partners, Tech Services, Data and AI delivery to align technology strategies with evolving business needs. Identify and integrate emerging technologies (e.g., automation, AI/ML, NLP) into the product portfolio to drive operational excellence and innovation in CMC and device design. Ensure all products are developed and maintained in compliance with global regulations (e.g., GxP, 21 CFR Part 11, FDA) and Takeda's quality and risk management standards. Work closely with architecture, engineering, quality, and data teams to ensure scalable and interoperable solutions across R&D. Represent PharmSci product leadership in strategic governance forums, investment planning committees, and external regulatory or industry working groups as needed. Ensure alignment of product solutions to Takeda's short and long‑term goals, both tactical and strategic. Lead and mentor Product Oriented Delivery (POD) Leads, Technical Leads, Business Analysts, and Quality Engineers, fostering a collaborative and high‑performing environment. Provide guidance and coaching to team members and teams, reviewing and assessing team performance and identifying areas for improvement. Drive alignment between POD capacity and evolving business needs ensuring agility in responding to high‑impact initiatives. Responsible for stakeholder management, driving cross‑functional collaboration, cross‑enterprise influence and communication to ensure smooth product delivery and alignment with stakeholder expectations. Handle risk management, identifying potential project/product risks and implementing mitigation strategies. Oversee project budgets, resource allocation, and timelines to ensure timely delivery of projects within budget and in adherence to quality standards. Education & Competencies (Technical and Behavioral) Required Bachelor's degree in Life Sciences, Information Technology, Engineering, or a related field; advanced degree (e.g., MBA, MS) strongly preferred. 12+ years of experience in pharmaceutical R&D technology or digital product leadership roles, with deep expertise across Pharmaceutical Sciences. Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards. Demonstrated ability to lead product teams through complex, regulated environments using modern product management and agile delivery frameworks. Strategic thinker with outstanding leadership, communication, and stakeholder engagement skills. Proven success managing global teams, product portfolios, and vendor ecosystems. Minimum 8 years of people leadership experience within a technology or product development environment and influencing senior‑level management and key stakeholders. Preferred Master's degree in Information Technology, Life Sciences or a related field. Technical Competencies Experience with technology platforms such as Tetrascience, PLM, OpenLabs, MES, SAP ERP, and/or both regulated and non‑regulated lab informatics and automation tools. Knowledge of current industry trends and emerging technologies in the R&D and Pharmaceutical Sciences. Ability to propose and prioritize future technical investments, assessing trade‑offs between technical risks and potential benefits/rewards. Knowledge of product management and key trends associated with them. Knowledge of project management principles and methodologies with a proven track record in delivering complex technology projects. Behavioral Competencies Ability to thrive in a dynamic environment. Experience with prototyping tools and techniques. Demonstrated verbal and written communication, presentation, and negotiation skills. Ability to manage and influence a variety of stakeholders at all levels. Ability to make highly complex decisions that impact the enterprise. Demonstrated problem‑solving skills, with the ability to work effectively under pressure and adapt to changing priorities. Ability to manage financial and people resources across multiple business functions, portfolios, and projects. Ability to understand and collaborate with customer and/or business partner needs through dialogue to resolve conflict in a constructive manner, before recommending solutions. Demonstrated ability to work across functions, regions and cultures. Enterprise level leadership with the ability to inspire, motivate and drive results. Ability to present complex information clearly and with confidence. Proven skills as an effective team player who can engender credibility and confidence within and outside the company. Foster solutions‑oriented thinking by fostering a culture of performance, accountability, simplicity, empowerment, external orientation and curiosity. Effectively navigate the changing external and internal environment and lead others through change by creating and inspiring and engaging workplace. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. Location Boston, MA U.S. Base Salary Range $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Worker Type Employee Worker Sub‑Type Regular Time Type Full time Job Exempt Yes. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr

Title: Associate Director of Regulatory Strategy A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development. Key Responsibilities Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning. Prepare and represent the company in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters. Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor. Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements. Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities. Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation. Qualifications Bachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development. Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies). Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA). Familiarity with 505(b)(2) development strategies or innovative delivery platforms. Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas. Proven track record of successful interactions with the FDA and/or global regulatory agencies. Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies. Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.

A leading biotechnology company in Boston seeks an HCP Marketing Associate Director to develop and execute marketing strategies. The ideal candidate will have significant experience in pharmaceutical marketing, strategic planning, and strong analytical skills. Responsibilities include collaborating on brand strategies, overseeing agency partnerships, and measuring marketing effectiveness. A Bachelor's degree and at least 8 years of experience are required. This position offers a hybrid or on-site work model and a competitive salary range of $162,800 - $244,200. #J-18808-Ljbffr

HCP Marketing Associate Director page is loaded## HCP Marketing Associate Directorlocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-27530**Job Description****General Summary:**The Marketing Associate Director is accountable for understanding the market landscape, defining and developing key business activities and tactics to support goals of the brand/portfolio, and measuring the success of those activities/tactics.**Key Duties and Responsibilities:*** Partners with brand/team-lead to help shape the brand strategy, segment the market, develop messaging and launch into new segments, including label expansions* Directs the development and implementation of strategic and tactical plans for assigned product* Collaborates with Vertex external communications review committee to approve materials for external use with customers* Generates and consolidates key insights across HCPs and patient stakeholders through market research, ad boards, etc.* Develops strong partnerships with cross-functional team to support business goals* Ensures appropriate metrics are in place to measure impact of tactics in field* Leads and manages agency partners to ensure on budget and timely deliverables* Acts as an advisor or coach to mentor other members of the team**Knowledge and Skills:*** Direct experience with communications review committee for review of tactics* Ability to oversee generation of insights and apply those insights to business problems/opportunities* Strong analytical mindset to lead others to solve complex problems* Demonstrated ability to develop strategy, make strategic recommendations, and monitor performance* Strong working knowledge of market forecasts and relationship of business drivers to revenue* Strong working knowledge of MS Office applications, including PPT, Excel and Word* Experience in pharmaceutical marketing or closely related field(s) (e.g., pharmaceutical sales, ad agency, etc.)**Education and Experience:*** Bachelor's degree in marketing, business, or scientific degree* Typically requires 8 years of experience or the equivalent combination of education and experience**Pay Range:**$162,800 - $244,200**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com #J-18808-Ljbffr

Director, Clinical Operations San Francisco Bay Area (Hybrid) $180,000 - $230,000 About the Opportunity A privately held, early‑stage biotechnology company in the San Francisco Bay Area is seeking a Director of Clinical Operations to lead operational strategy and execution across its emerging therapeutic pipeline. The organization is currently in a growth and scaling phase, having recently closed their series A funding. The company is developing next‑generation, extended‑duration therapeutics designed to enable monthly or quarterly dosing, primarily within metabolic and obesity‑related diseases. Their technology centers on proprietary drug‑delivery innovations that enable controlled, predictable, long‑acting release of small molecules, peptides, and proteins. This is an exciting opportunity to help shape clinical operations at a small, dynamic company Key Responsibilities Oversee global clinical trial execution (Phase 1-2), from trial start‑up through close‑out. Build and operationalize clinical development processes as the organization scales. Lead vendor and CRO oversight, including metrics, budgets, and timelines. Drive inspection readiness and ensure compliance with all regulatory and GCP/ICH standards. Partner cross‑functionally with Clinical Development, CMC, Regulatory, and Program Leadership. Develop and mentor a growing clinical operations team. Contribute to long‑range planning, risk mitigation strategies, and portfolio execution. Qualifications Bachelor's degree in a scientific discipline required; advanced degree preferred. 10+ years of clinical operations experience in biotech/pharma, with leadership responsibility, metabolic experience highly favored. Demonstrated success running early‑phase clinical trials. Strong understanding of operationalizing first‑in‑human and dose‑escalation studies. Experience in fast‑paced, resource‑lean, early‑stage environments. Exceptional vendor management, communication, and cross‑functional leadership skills. Ability to thrive in a dynamic, evolving company nearing and entering clinical development. Why Join High‑impact leadership role with strategic influence in a rapidly growing biotech. Mission‑driven culture focusing on transformative medicines that may improve long‑term disease management. Competitive compensation, equity participation, and comprehensive benefits. If you are interested in this role, please apply today and we will be in touch with qualified candidates.

The Director Revenue Cycle Management is responsible for the overall performance, strategy, and operational management of the organization's revenue cycle. This role oversees all revenue cycle functions including registration, insurance verification, billing, collections, accounts receivable, credentialing, and patient financial processes. Position will develop and implement strategies to improve cash flow, reduce bad debt, maximize net revenue, and ensure compliance with all regulatory requirements. The ideal candidate brings strong healthcare financial management experience, a hands-on leadership style, and the ability to standardize and optimize revenue cycle processes across the organization. Key Responsibilities Leadership & Strategy Serve as a strategic resource to senior management, operations leadership, billing trainers, and revenue cycle staff. Develop and manage revenue cycle strategies to meet short-term and long-term organizational goals. Establish clear goals, objectives, and performance metrics for revenue cycle operations. Develop, implement, and enforce revenue cycle policies, procedures, and guidelines with consistent company-wide application. Revenue Cycle Operations Plan and direct patient registration, insurance verification, billing, collections, and data processing to ensure accurate billing and efficient collections. Oversee front office and patient service functions as they relate to revenue cycle performance. Set clear productivity expectations and quality standards for reception, patient service representatives, and business office teams. Standardize workflows across the revenue cycle to ensure consistency with company standard operating procedures. Financial Performance & Analytics Monitor and evaluate collection effectiveness and ensure insurance billing remains current within established departmental timelines. Maximize revenue through accurate charge capture and appropriate charge structures aligned with payer contracts, industry standards, and market conditions. Analyze accounts receivable to optimize net revenue, stabilize cash flow, reduce denials, and minimize write-offs. Perform audits and develop comprehensive monthly revenue cycle performance reports for leadership. Implement recommendations from internal and external audits, consultants, and compliance reviews. Billing, Coding & Credentialing Oversee charge master maintenance, including review and approval of pricing, CPT, HCPCS, and revenue codes. Establish and maintain relationships with third-party payers and insurers. Manage physician credentialing and re-credentialing processes with private and government payers. Ensure compliance with federal, state, and payer-specific regulations. Process Improvement & Compliance Develop and implement process improvements to enhance quality, efficiency, and productivity. Ensure consistent communication and enforcement of revenue cycle policies. Maintain up-to-date knowledge of healthcare regulations, reimbursement trends, and best practices. Other Perform additional duties as assigned. Education Bachelor's Degree required or equivalent combination of education and experience. Experience & Qualifications Minimum of three (3) years of experience in healthcare management, including clinic management, patient management, or accounts receivable. Strong background in healthcare financial management and revenue cycle operations. Knowledgeable of federal and state healthcare laws and regulatory requirements. Experience with Athena EMR preferred. Proficiency in Microsoft Word, Excel, and PowerPoint. Strong leadership, analytical, and communication skills. Ability to manage multiple priorities in a fast-paced healthcare environment.

Vertex Pharmaceuticals is seeking to hire a talented HCP Marketing Associate Director - Kidney, US reporting to the Director, HCP Marketing - Kidney, US, to join our growing team in Boston, MA.The HCP Marketing Associate Director (AD) will be responsible for understanding the healthcare professionals we hope to serve, and developing and implementing marketing strategies and tactics that are customized and relevant to them. This role is critical as we prepare for the launch of our first kidney therapy that has the potential to transform the lives of patients across multiple serious diseases. This role involves cross-functional collaboration, strategic planning, and the ability to translate clinical data into impactful marketing initiatives that drive brand awareness, product adoption, and customer engagement. The successful candidate will have an ability to thrive in an environment of rapid change, demonstrate strong communication, work effectively within cross-functional teams, and have a problem-solving and strategic mindset.Ensure all marketing materials comply with regulatory and legal requirements, working closely with Legal, Regulatory, and Medical Affairs* Direct experience with communications review committee for review of tactics* Experience in the following areas: kidney, specialty product launch experience, work within highly competitive markets* Proven track record of developing and executing successful HCP marketing campaigns* Demonstrated ability to work independently and manage multiple initiatives that require collaboration across functional areas* An entrepreneurial spirit and an ability to develop creative solutions to complex problems* Advanced strategic, problem-solving, and analytical skills, with the ability to interpret complex data and translate it into actionable insights* Excellent written communication skills, presentation delivery, and interpersonal skills* A solid compliance mindset and demonstrated integrity on the job* Bachelor's degree in marketing, business, or scientific degree* Typically requires 8 years of experience or the equivalent combination of education and experience The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility. #J-18808-Ljbffr

A leading biotechnology company is looking for an HCP Marketing Associate Director to lead innovative marketing strategies for a new kidney therapy. The ideal candidate will have experience in specialty product launches and a proven track record in healthcare marketing. This role offers a hybrid work schedule, with options for remote work and extensive benefits including generous paid time off and educational assistance programs. Join a team dedicated to transforming patient lives through strategic marketing initiatives. #J-18808-Ljbffr

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description TheAssociate Director, Statistics - Oncology provides statistical leadership for clinical development and life‑cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients. This role will work a hybrid schedule in one of the AbbVie locations: Lake County, IL South San Francisco, CA Responsibilities Provide statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans. Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, and GMA, etc.) to create development strategies for assigned projects. Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately. Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff. Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures. Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics Department. Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements. Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required. Qualifications MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field. High degree of technical competence and excellent communication skills, both oral and written. Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others. Able to manage project timeline and quality of deliverables. Able to build strong relationship with peers and cross‑functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo. Have strong leadership skills and experience in working/managing cross‑cultural or overseas teams. Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life‑cycle management in the regulated environment. (SSG) Experience leading safety‑related projects (eg, ISS, benefit‑risk assessment, signal detection). (GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short‑term incentive programs. This job is eligible to participate in our long‑term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* #J-18808-Ljbffr

A leading global pharmaceutical company seeks a seasoned professional to lead their federal legislative engagement strategy. The role requires over 10 years of experience in legislative or government affairs, with a strong understanding of the political landscape affecting patient access to medicines. Responsibilities include monitoring legislative developments, engaging with Congress, and collaborating with internal teams to advocate for the company's priorities. Candidates must be based in the Washington D.C. area and should possess strong strategic thinking and stakeholder management skills. #J-18808-Ljbffr

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. Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings. Company: Bionova Scientific LLC Job Description: Company Summary: Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products. As part of our business expansion plan, we are building a state-of-the-art facility that specializes in the development and manufacturing of Plasmid DNA. This facility will be equipped with cutting-edge technology and staffed by a team of highly skilled professionals who are dedicated to advancing the field of Plasmid DNA process development and manufacturing. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client challenges. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Position Summary: The Associate Director of Analytical and Formulation Development will be responsible for managing analytical activities in support of drug substance and drug product development. This position requires experience with clinical-stage product development, and method development/validation/transfer. Essential Duties and Responsibilities: Oversee and manage a team engaged in AFD and QC transfer activities. Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry and formulation development. Provide technical review of analytical data integrity, method development, and method validation protocols/reports. Represent functional CMC role and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of drug to support GLP toxicology studies and IND-enabling activities across a portfolio of programs. Act as primary liaison for analytical testing performed by external contract organizations and review data collected. Ensure that testing methodologies meet phase-appropriate cGMP requirements. Work with internal subject matter experts to author and review analytical test methods, protocols, and development reports. Review method transfer reports/qualification/validation plans and reports by clients. Author analytical CMC modules to support regulatory filings. Develop sensitive and robust analytical test methods to support release testing and characterization of drug products. Lead and guide the junior analysts for daily analytical activities. Working Conditions: This position requires working in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently. Qualifications: Ph.D. or Master's degree in biochemistry, analytical chemistry, biology or related discipline with 8-10+ years' experience, or BS for 15+ years' experience in an analytical and/or QC laboratories. In-depth hands-on experience and understanding of protein chemistry and industry-standard analytical tools (CE, HPLC/UPLC, Mass Spec, ELISA, qPCR assays, compendial assays, etc.) and troubleshooting. in depth understanding of process development from early to late stage. Demonstrated expertise with analytical method development, phase appropriate method qualification/validation, release and stability testing, product characterization and specification development and justification. Exhibited track record of success in delivering timely execution of CMC activities ranging from non-GMP and IND-enabling material supplies, through GMP clinical trial supplies. Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia. Prior experience in early phase and late phase development (both drug substance and drug product). Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines. Exhibited strong organizational and critical thinking skills with an attention to detail enabling sound, technically driven decision making. Proven strong interpersonal, organization and problem-solving skills Compensation Range: The base compensation range for this role is between $150,000 and $170,000. However, the actual compensation may vary depending on your experience and qualifications. Health Benefits and Program: Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) Up to 8% of Employer Match Paid time off up to two weeks 10 days of Holidays and 5 days of Sick Leave. 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.

We are building an integrated discovery-to-development engine that connects vector innovation with translational impact. Join us to shape platform strategy, deliver differentiated candidates, and help patients faster. As a proud new member of the AstraZeneca group, Esobiotec continues to set new standards in pioneering biotechnological research. With a shared vision to transform the future of medicine, our partnership uses AstraZeneca's global reach and rich heritage in scientific innovation, amplifying Esobiotec's unique culture of creativity and breakthrough advances in cell-based therapies and immunology. At Esobiotec, now backed by the resources and expertise of one of the world's leading biopharmaceutical companies, you'll find a dynamic, collaborative environment where scientific passion drives real-world impact. Be part of a team where your work will contribute to shaping the next generation of life-changing treatments and help us push the boundaries of science to improve patients' lives worldwide. What You'll Do Discovery Strategy: Support and evolve the discovery strategy for novel LVVs aligned to target product profiles, manufacturability, and clinical use cases. Vector Engineering Leadership: Drive hypothesis-driven engineering from concept to preclinical candidate selection, including envelope/pseudotype, regulatory elements, payload design, and transduction specificity. Innovation Sourcing: Source and prioritize new concepts from literature, IP, conferences, and internal takeaways; establish efficient triage and proof-of-concept workflows. Screening Platforms: Build and scale in vitro and in vivo screening platforms and assays to characterize potency and safety, implementing robust data and analytics workflows. Product Translation: Translate indication/product requirements into vector design criteria; collaborate with biological engineering, CAR/TCR discovery, nonclinical, safety, and clinical to de-risk translation. Developability & CMC: Integrated developability and CMC considerations early with in development to ensure scalability, yield, purity, and stability. Rigor & Decision-Making: Establish experimental rigor, statistical standards, and clear go/no-go criteria to enable reproducible, high-quality decisions. External Leadership: Identify, negotiate, and manage external collaborations and CROs; assess BD and licensing opportunities for vector technologies. IP & FTO: Drive invention disclosures and FTO assessments; contribute to patent drafting and defence for vector innovations. Team Building: Recruit, mentor, and develop discovery scientists; foster a culture of scientific excellence, product focus, urgency, and accountability. Program Ownership: Manage budgets, resources, and timelines across programs/platforms with transparent portfolio reporting and prioritization. Compliance & Representation: Ensure biosafety and ethical research compliance; represent the function in technical reviews, governance, and external forums, raising risks and securing decisions. What You'll Bring Education: PhD in molecular biology, virology, bioengineering, or related field (or equivalent experience), with postdoctoral or advanced industry training. Experience: 8+ years (Associate Director) or 12+ years (Director) in gene therapy R&D focused on viral vector engineering, preferably LVV. Technical Track Record: Demonstrated success designing, building, and optimizing viral vectors; LVV expertise strongly preferred (AAV or related systems a plus). Product Approach: Clear history of linking vector design to therapeutic product needs, clinical requirements, and manufacturability. CMC Collaboration: Proven partnership with process development/CMC across upstream/downstream production, release testing, and scalability. Leadership: Experience leading small-to-medium discovery teams and matrixed initiatives to timely, high-quality outcomes. Innovation & IP: Evidence of innovation via publications, patents, or internal inventions; facility with FTO analyses and IP strategy. Data Fluency: Proficiency with statistical design and analysis, data visualization, and collaboration with computational teams, including DoE and high-throughput screening. Attributes: Product-focused, decisive, rigorous; thrives in ambiguity while maintaining quality, compliance, and speed. So, what is next: Ready to make an impact? Apply now to join our mission-driven team ! Welcome with your application, in English, at the latest by the 23rd of January 2026 To find out more: Company site: ************************** Group site: **************************** Our social media, Follow us on LinkedIn: Esobiotec and AstraZeneca Inclusion & Diversity: *************************************************** Career site: ******************************** Date Posted 09-Jan-2026 Closing Date 22-Jan-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr

Head of Analytical Development: NYC We are seeking a Director or Senior Director of Analytical Development to lead and expand the analytical development function. This individual will play a pivotal role in supporting late-stage programs, ensuring robust analytical strategies for drug substance and drug product, and driving method development, validation, and transfer activities. This is a hands-on leadership role for someone who thrives in a dynamic environment, enjoys rolling up their sleeves, and is committed to building best-in-class analytical capabilities. The ideal candidate will be comfortable commuting to the New York site four days per week and collaborating cross-functionally with CMC, Quality, and external partners. Key Responsibilities Lead the Analytical Development team responsible for method development, qualification, validation, and transfer for drug substance and drug product. Develop and implement analytical strategies to support late-stage development, scale-up, and commercialization. Oversee characterization studies, stability programs, and specification setting in alignment with regulatory requirements. Partner closely with Process Development, Quality, and Regulatory teams to ensure seamless integration of analytical deliverables. Manage relationships with CDMOs and external testing labs, ensuring timelines and quality standards are met. Provide technical leadership and mentorship to a growing team, fostering a culture of scientific excellence and accountability. Contribute to regulatory submissions (IND, NDA) and represent Analytical Development in health authority interactions as needed. Qualifications Ph.D. or M.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline. 10+ years of experience in analytical development within the biotech or pharmaceutical industry, with a strong focus on small molecule late-stage development and commercialization. Proven track record of leadership in method development, validation, and transfer for complex modalities (biologics experience strongly preferred). Deep understanding of ICH guidelines, regulatory expectations, and CMC requirements for global filings. Excellent communication and collaboration skills; ability to work effectively in a fast-paced, matrixed environment. Willingness and ability to be onsite in New York 4 days per week. Why Join? Opportunity to shape analytical strategy for a late-stage pipeline with high-impact programs. Work in a well-funded biotech with strong pharma partnerships and a clear path to commercialization. Collaborative, science-driven culture where your contributions make a tangible difference.

EVERSANA has partnered with Mitsubishi Tanabe Pharma America, Inc. for this Direct Hire opportunity. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan's most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson's (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology. MTPA is rapidly expanding its operations across all functional areas. MTPA's commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare disease treatments including RADICAVA (edaravone) injectables in 2017 and RADICAVA (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness. Job Description Direct Hire Opportunity! The Senior Director, Trade & Distribution, will build, lead, and manage the team while focusing on developing strategies to support the launch and lifecycle management of our leading Parkinson's and ALS therapies, as well as future products in the United States. The primary responsibility of the Senior Director Trade & Distribution is to develop and implement the distribution strategies across the specialty businesses. This includes specialty pharmacies, distributors and all channels that would support any present or future MTPA products. This person will have an intimate knowledge of the distribution systems from all aspects including durable medical equipment. The ideal candidate will possess strong leadership experience in managing teams that work both directly and indirectly with specialty vendors, coupled with exceptional analytical skills to identify operational gaps and implement effective solutions. Cross-functional collaboration with supply chain, marketing, sales, and customer-facing teams will be key to success in this role. Responsibilities Provides overall leadership and direction for Trade Market Access strategy for Mitsubishi Tanabe Pharma US' lead Parkinson and ALS products Evolve and innovate distribution network by aligning it with business needs, identifying growth opportunities, and addressing operational gaps to overcome challenges and drive access. Serves as the Distribution and Trade Strategy Team Leader, representing trade across all teams and driving key success factors to support long-term distribution strategies. Lead the development and execution in Federal Markets, including VA and Department of Defense to drive product access, distribution, and growth. Act as subject matter expert from a Market Access perspective for 340B program and other government programs. Informs senior and corporate executives informed about changes and emerging issues in the broad, trade customer environments and subsequent implications for Mitsubishi Tanabe Pharma US Develops awareness of market and government policy changes in collaboration with legal and compliance and implications across key stakeholders to help inform/update commercial strategies Assists market access marketing agency (and other vendor relationships) to develop promotional programs, tactics and materials aligned with our distribution process Develops/maintains thorough understanding of dynamics driving various market access segments and channels and how distribution impacts each function Effectively manages budgets and project timelines including contract management Oversight in the negotiation, execution, and adherence to the Distribution Service Agreements (DSAs), Product Purchase Agreements, and other contract offerings as appropriate Develop account metrics against strategic, financial, and product access KPI's Develops and monitors KPIs, continually assessing impact and execution of access services & offerings including feedback from service users and internal stakeholders Attends professional, provider programs, and patient conferences, and keeps up to date on innovation and recommends ways to improve business. This is a home office based position. The expectation is to be in the office 3 days a week. Qualifications Bachelor's Degree Required, Masters preferred Must have 15 plus years within the pharmaceutical industry and 10 years' experience in Distribution, Account Management or Aligned Market Access functions. Experience with distribution for early-stage pipeline programs Experience in Federal Markets including VA, Department of Defense and 340B Program preferred. Device/Drug combination strongly preferred Minimum 5 years of people management experience required Track record of closing complex negotiations within the specialty pharmacy arena Preferred experience includes: All aspects of distribution Launch and life cycle management for the distribution process Experience in Market Access marketing History of successful negotiations Broad based knowledge of the Pharma/Biotech industry, healthcare finance, and all forms of product distribution: DME, Orals, and Solutions Firm grasp of legal, regulatory and compliance issues in the healthcare space Analytical/strategic thinker with proven ability to: conduct situation analysis of the external distribution environment; synthesize relevant information to develop strategic plans understand the best pathway for distribution based on the product and its attributes conduct strategic gap analysis and implement metric-based solutions Strong interpersonal and internal/external relationship-building skills in order to drive change and innovation and succeed in a highly specialized distribution environment Excellent oral/written communication skills, coupled with exceptional presentation skills, including ability to present to large audiences Ability to prioritize and manage complex projects, with multiple stakeholders, and drive high-quality results within allotted budget Highly proficient in MS Office; advanced Excel skills Must be able to travel domestically and internationally (approximately 40%) Additional Information Mitsubishi Tanabe Pharma America Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits. MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

Company Background: Plus Therapeutics is a U.S. public healthcare company focused on improving survival for patients with brain cancer. Plus brings together novel therapeutics, diagnostics, and data analytics to achieve its goal. Plus is staffed by a talented and diverse team working alongside world experts in brain cancer. We operate principally from 3 facilities in Houston, Texas, San Antonio, Texas, and Charlottesville, Virginia. Role: The Director of Clinical Operations will work across all areas of the company, therapeutics, diagnostics, and data analytics, to support Plus Therapeutics' various preclinical, clinical, and commercial programs. This includes Plus' lead drug REYOBIQ for conditions such as leptomeningeal metastases, recurrent GBM in adults, and pediatric brain cancer. This position will involve helping to design and oversee clinical trials, contributing to scientific manuscripts, abstracts, and presentations, supporting grant applications and management, and reporting to the CEO and President. The Director will work cross-functionally to ensure the successful execution of Plus' programs in line with regulatory and corporate objectives. Responsibilities: Assist in the strategic planning, design, and execution of clinical trials for products, ensuring alignment with regulatory requirements and company goals. Aid in oversight of clinical study operations, including protocol development, site selection, patient recruitment, data analysis, and regulatory submissions. Collaborate with cross-functional teams (regulatory affairs, medical affairs, biostatistics, and CMC) to advance products toward regulatory approval. Contribute to the preparation of scientific manuscripts, abstracts, and presentations for peer-reviewed journals, conferences, and regulatory bodies. Support the identification and application for grant funding opportunities, including drafting proposals and managing grant timelines and deliverables. Monitor clinical trial progress, ensuring adherence to timelines, budgets, and quality standards. Provide scientific and clinical expertise in neuro-oncology and/or radiotherapeutics to guide program strategy and decision-making. Engage with key opinion leaders (KOLs), investigators, and external partners to support clinical development and build strategic relationships. Ensure compliance with FDA, ICH, and other regulatory guidelines throughout the clinical development process. Mentor and guide junior team members, fostering a collaborative and innovative team environment. Qualifications: Advanced degree (PhD, MD, PharmD, or MD/PhD) in a relevant scientific or medical field. 7-10 years of experience in clinical development within the pharmaceutical or biotechnology industry, preferably in a small biotech environment. Expertise in neuro-oncology is strongly preferred; experience in radiotherapeutics or nuclear medicine is highly desirable. Proven track record in designing and managing clinical trials, including Phase I-III studies. Strong understanding of regulatory requirements (FDA) and experience in preparing regulatory submissions (e.g., IND, NDA). Demonstrated ability to author scientific manuscripts, abstracts, and presentations for peer-reviewed journals and conferences. Experience in grant writing and management, with a focus on securing funding and ensuring project milestones are met. Excellent project management skills, with the ability to prioritize and manage multiple tasks in a fast-paced environment. Strong communication and interpersonal skills, with the ability to collaborate effectively with internal teams and external stakeholders. Ability to thrive in a dynamic, entrepreneurial setting with a focus on innovation and patient-centric solutions. Requirements: Familiarity with radiopharmaceutical development and associated regulatory considerations. Experience working with CROs, academic collaborators, and clinical trial sites. Knowledge of pediatric oncology and rare disease clinical development. Proficiency in data analysis and interpretation, with familiarity in clinical trial software and tools. Plus Therapeutics, Inc. and CNSide Diagnostics, LLC are Equal Employment Opportunity employers and consider all qualified applicants without regard to protected status.

The Director Trauma is a registered nurse who in partnership with the Trauma Medical Director and hospital administration is responsible for oversight and authority of the trauma program as defined by the level of designation, including the trauma performance improvement and patient safety processes, trauma registry, data management, injury prevention, outreach education, outcome reviews, and research as appropriate to the level of designation. Responsibilities Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders. Customer Focus - Is dedicated to meeting the expectations and requirements of internal and external customers; gets first‑hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect. Drive for Results - Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom‑line oriented; steadfastly pushes self and others for results. Business Acumen - Knows how businesses work; knowledgeable in current and possible future policies, practices, trends, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace. Ability to impart knowledge to a variety of operating constituencies. Managing Vision and Purpose - Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision shareable by everyone; can inspire and motivate entire units or organizations. Strategic Agility - Sees ahead clearly; can anticipate future consequences and trends accurately; has broad knowledge and perspective; is future oriented; can articulately paint credible pictures and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans. Developing Direct Reports - Is excellent at establishing clear directions; sets stretching objectives; distributes the workload appropriately; lays out work in a well‑planned and organized manner; maintains two‑way dialogue with others on work and results; brings out the best in people; is a clear communicator. The Director of Trauma is to assume at minimum, the following leadership responsibilities in conjunction with the Trauma Medical Director and hospital administration: Assist with the budgetary process for the trauma program Develop and implement clinical protocols and practice management guidelines Provide educational opportunities for staff development Monitor performance improvement activities in conjunction with a PI Coordinator (where applicable) Serves as the liaison to administration and represent the trauma program on hospital and regional committees to enhance trauma care Adheres to current standards as defined by the designated/verifying organization for the specific level trauma center Responsible for the organization of services and systems necessary for a multidisciplinary approach to providing care to injured patients Manages care by maintaining effective lines of communication with all concerned parties Demonstrate ability to problem solve and be supportive/innovative in the process of change Demonstrate strong human relations skills with an ability to handle difficult/sensitive issues with regard to patient confidentiality Demonstrate excellent written/oral communication skills Integrate and interpret data from diverse sources addressing issues of moderate to high complexity Develop strong relationships with customers (i.e. patients, physicians, and support departments) Promote optimal trauma care through clinical activities such as rounding Facilitate professional and public education to EMS, physician, nursing staff, and ancillary staff Facilitate Outreach programs Quality Improvement activities such as risk adjusting benchmarking using registry data to guide quality improvement activities Facilitates and prioritizes injury prevention work based on trends identified in the trauma registry Participate in Regional Advisory Council Participate in MCI drills as defined by designated/verifying organization Job Requirements Education/Skills Master's degree of Science in Nursing or another related field preferred The following courses are required upon hire Trauma Outcomes Performance Improvement Course (TOPIC) Trauma Program Manager Course by the American Trauma Society (ATS) or the Texas Trauma Designation Education Course by the Texas Trauma Coordinators Forum (TTCF) Abbreviated Injury Scale course by the Association for the Advancement of Automotive Medicine (AAAM) ICD-10 course in trauma; needs to be renewed every 5 years Experience 2 years of experience in trauma patient care required 2 years of healthcare leadership required 2 years of trauma registry or data management required Working knowledge of CQI tools and techniques required Licenses, Registrations, or Certifications RN License in the state of employment or compact required BLS required ACLS required ENPC or PALS required Trauma Nurse Core Course (TNCC) or Advanced Trauma Care for Nurses (ATCN) required Certified Emergency Nurse (CEN), Trauma Certified Registered Nurse (TCRN) and/or Critical Care Registered Nurse (CCRN) certifications preferred TNCC and/or ENPC Instructor preferred Work Schedule 8AM - 5PM Monday-Friday Work Type Full Time #J-18808-Ljbffr