Associate Director, Clinical Quality Management

Kyowa Kirin

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary of Job: The Associate Director, Scientific Communications, Rare Disease is responsible for supporting the development, execution, and continuous optimization of scientific communications initiatives for the Rare Disease Medical Affairs organization in North America. The role leads the planning, development, review, and implementation of scientific materials and educational programs that support Medical Affairs strategic objectives and ensure the accurate, balanced, and compliant dissemination of scientific information. Core focus of the role includes overseeing the development and lifecycle management of Field Medical materials; creating scientific content and supporting the execution of Medical Advisory Boards, Scientific Symposia, Medical Education initiatives, and conference-related deliverables; and managing external Medical Communications agencies and Medical Education partners to ensure the timely delivery of high-quality, scientifically accurate materials. The Associate Director collaborates cross-functionally with Medical Affairs and other internal stakeholders to ensure scientific communications activities are aligned with organizational priorities and compliant with applicable policies and regulatory requirements. Essential Functions: * Support data disclosure and scientific dissemination activities associated with clinical trial milestones and major medical congresses for U.S. Medical Affairs. * Provide content and editorial support for regional publications and scientific presentations. * Ensure regional publication priorities are represented in the global publication plan and support localization of global publication activities to meet regional needs. * Collaborate with global and regional Medical Affairs teams to ensure consistency of scientific messaging and alignment with regional medical strategy. * Partner with external medical communications agencies and vendors to manage the quality, timelines, and budgets of scientific communications deliverables. * Support external expert engagement and steering committee activities, including coordination of content review and approval workflows. * Support scientific and medical operations, including advisory board planning and execution, medical information initiatives, and Medical Science Liaison (MSL) training. * Represent Medical Affairs at Medical Review Committee (MRC) and Promotional Review Committee (PRC) meetings, as needed, ensuring materials are scientifically accurate, current, appropriately substantiated, and properly referenced. * Ensure all scientific communications activities are conducted in compliance with applicable SOPs, policies, regulatory requirements, ICMJE recommendations, Good Publication Practice (GPP) guidelines, and company compliance standards. * Perform additional duties and special projects as assigned. Job Requirements: Education Advanced degrees in life sciences, health sciences, pharmacy, medicine, nursing, or a related scientific discipline (MD, PharmD, PhD, DNP, or equivalent) required.  Experience * Minimum of seven (7) years in the pharmaceutical, biotechnology, or medical communications industry within Medical Affairs or Scientific Communications. * Minimum of three (3) years supporting Scientific Communications, Publications, or Medical Communications functions. * Demonstrated success developing and executing scientific communication initiatives, including field medical materials, advisory boards, scientific symposia, medical education programs, publications, and congress deliverables. * Proven ability to collaborate with cross-functional stakeholders and manage external medical communications agencies and vendors to deliver high-quality scientific materials. * Background supporting publication planning, scientific dissemination, and data disclosure activities associated with clinical development and medical congresses. * Familiarity with medical, promotional, and publication review processes within a regulated pharmaceutical or biotechnology environment. * Rare Disease experience is strongly preferred. Technical Skills * Working knowledge of scientific communications, publication planning, Good Publication Practice (GPP) guidelines, International Committee of Medical Journal Editors (ICMJE) recommendations, and applicable regulatory requirements. * Excellent written and verbal communication skills, with the ability to effectively communicate complex scientific information to diverse internal and external audiences and facilitate cross-functional collaboration. * Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), Microsoft Teams, and SharePoint. * Skilled in using Veeva Vault MedComms, Veeva PromoMats, publication management systems, and other platforms supporting scientific content development, review, approval, and distribution. * Strong scientific writing, editing, literature evaluation, and content development skills, with the ability to translate complex scientific information into clear, accurate, audience-appropriate materials. * Ability to leverage AI-enabled tools and platforms to support scientific content development, literature synthesis, data visualization, and operational efficiency while ensuring compliance with company policies and regulatory requirements. * Demonstrated project management and organizational skills, with the ability to manage multiple priorities and deliver high-quality work within established timelines. Non-Technical Skills Strong analytical skills, attention to detail, and ability to manage/prioritize multiple projects from concept to completion in a fast-paced environment.  Strong written and oral communication skills.  Ability to work well in cross-functional teams (across geography and culture) with a group of people with diverse skill sets and personalities.  Team player, flexible and adaptable. Ability to build good working relationships, both inside and outside the organization.  Self-starter.  Must possess integrity and be innovative in how they work on a day-by-day basis.  Has a passion for personal learning and development to be able to grow with the company.  Cultural sensitivity and ability to develop consensus within a multinational organization.  Physical Demands: Normal office environment with prolonged sitting and extensive computer work Working Conditions: Minimal domestic travel required (<10%), primarily for conference attendance or key meetings; occasional weekend travel may be required.   The anticipated salary for this position will be $180,000 to $196,900.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1

Relation Therapeutics

Location: London Relation Therapeutics is an end-to-end biotech company developing transformational medicines, with technology at our core. Our ambition is to understand human biology in unprecedented ways, discovering therapies that will treat some of life's most devastating diseases. We leverage single-cell and multi-omics measurements directly from patient tissue, functional assays, and machine learning to drive disease understanding — from cause to cure. Our medicines are born from high-resolution biology, machine learning, and clinical insights. At the heart of our discovery engine is our Lab-in-the-Loop, which seamlessly integrates single-cell analysis, genomics, and machine learning. This powerful technology allows us to identify druggable targets and develop transformational medicines. Interdisciplinary collaboration. Immense impact. Led by experienced drug developers, computational scientists, and entrepreneurs with backgrounds in biotech, pharma, venture, and academic research, we are driven by a shared hunger to transform drug development — because the patient is waiting. The opportunity As the Head of Data Strategy, you will play a pivotal role in shaping and executing the company’s data strategy, ensuring that Relation can leverage the full value of its data assets. This is a unique opportunity to lead the charge in building and governing the data foundations that will fuel the next generation of drug discovery at Relation. * Develop, implement, and oversee a comprehensive data strategy that positions data as a critical and compounding asset for Relation's research and business initiatives. This will include every aspect of data management, governance and acquisition and will involve working closely with the VPs of Engineering and Data Science and the CTO. * Lead the acquisition, integration, and governance of high-quality datasets from diverse sources, including open-access platforms, biobanks, proprietary studies, and external partnerships. * Ensure the highest standards of data quality, security, and compliance with relevant regulatory frameworks. * Collaborate closely with teams across the organisation, including Data Science, Machine Learning, Computational Biology, Bioinformatics, and our Wet Lab teams, to ensure data is accessible, standardised, and optimised for scientific discovery and innovation. * Guide the creation of data systems that support scalable and efficient data operations. * Drive external relationships with academic consortia, data providers, and industry partners to continuously expand Relation’s data ecosystem. Your Responsibilities * Data Strategy: Define and execute Relation’s data strategy in partnership with key stakeholders, ensuring that Relation’s data is a compounding asset that supports all aspects of drug discovery, research and development. * Data Management: Create and maintain data catalogues, define data standards and ontologies, and ensure proper metadata and data lineage tracking. * Data infrastructure: Work closely with the VP Engineering to guide the development of a robust data infrastructure in a rapidly scaling TechBio * Collaboration: Work closely with interdisciplinary teams, such as machine learning engineers, bioinformaticians, and scientists, to ensure data is ready for use in research and drug discovery. * Data Acquisition: Procure and integrate external datasets (e.g. UK Biobank, public databases) and manage data partnerships to enrich Relation's data ecosystem. * Governance: Implement data governance policies that ensure responsible, secure, and compliant data usage, aligning with evolving regulatory requirements. * Quality Assurance: Lead data curation efforts, ensuring the quality and integrity of data assets across multiple domains including omics, imaging, and clinical data. * Team Leadership: Build and manage a high-performing data strategy, governance and acquisition team, fostering a culture of excellence and continuous improvement. Professionally, you have: * A graduate degree in Bioinformatics, Computer Science, Computational Biology, or a related field (PhD preferred). * Demonstrated success in leading data strategy, including planning and execution in a matrix environment * Extensive experience with data strategy, management and acquisition in the life sciences, preferably including working with large biobanks and public databases. (7 years + experience) * Familiarity with data management, storage and processing tools and cloud-based data management platforms * Ideally, fluency in writing functioning code for a variety of tasks (such as data pipelines), including the skilled use of modern coding agents. Basic knowledge of computer science concepts sufficient to understand important concepts including latency, throughput, bottlenecks, race conditions etc. * Experience of acquisition, curation, and quality assurance efforts in research or drug discovery or a similar regulated setting * Deep understanding of various data types and ontologies, including -omics, imaging, and clinical data. * Proven experience with data governance frameworks and ensuring compliance with data protection regulations. * Ability to lead cross-functional initiatives and manage stakeholder relationships across a wide range of scientific and technical disciplines. * Experience working with machine learning teams and an understanding of data needs for model development. * Experience with large-scale data integration efforts, biobanks like UK Biobank, or databases such as dbGaP. * Knowledge of FAIR data principles and experience implementing data governance strategies in compliance with industry standards. Personally, you are: * collaborative team player with a strong desire to drive impact. * an excellent communicator and are comfortable presenting complex data strategies to both technical and non-technical stakeholders. * detail-oriented, curious, and passionate about using data to drive scientific innovation. * Comfortable and thrive in fast-paced, dynamic environments * Driven by impact, motivated and curious * Humble and hungry to learn and have a strong sense of accountability * Passionate about making a difference in patients’ lives WORKING STYLE & CULTURE AT RELATION At Relation, we operate in a matrixed, interdisciplinary environment, where impact is driven through collaboration across scientific, technical, and operational domains. We collaborate, and you will partner with colleagues across multiple teams and projects, contributing your expertise while aligning to shared company priorities. We work together and win together! The patient is waiting!   RECRUITMENT AGENCIES Please note that Relation does not accept unsolicited resumes from agencies. Resumes should not be forwarded to our job aliases or employees. Relation will not be liable for any fees associated with unsolicited CVs. Relation is a committed equal opportunities employer.

CoMind

At CoMind, we are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. In joining us, you will be helping to create cutting-edge technologies that will improve how we diagnose and treat brain disorders, ultimately improving and saving the lives of patients across the world. THE ROLE: The Mechanical Engineering team at CoMind is responsible for the design of CoMind’s device, spanning mechanical design of instruments and consumables, opto-mechanical components, electronic assemblies and packaging. The role reports in the Director of Hardware Engineering. With close collaboration with Product and Program Management the team works from concept through to production, ensuring that mechanical designs meet the performance and reliability demands of a clinical medical device. As Engineering Manager for Mechanical Engineering, you will lead a team of mechanical engineers through the iterative design, build and test phases to create mechanical designs which fulfil design input requirements and successful complete design verification and validation campaigns. Working alongside CoMind’s contract manufacturing partners, you will ensure that design deliverables can be successfully transferred into serial production. This is a hands-on leadership role: you will drive technical decisions, own the mechanical workstream, and personally contribute to complex design challenges, while managing the team to programme milestones and design control processes. You will lead and mentor the team of mechanical engineers, and establish and maintain the development process and tools (CAD, PDM, modelling) required by the Mechanical Engineering Team, maintaining a high standard of quality and performance. At CoMind, all team members work at least 4 days per week in the office, plus a flexible work-from-home day. This role can be based in either our London (Kings Cross) or Bristol office. RESPONSIBILITIES: * Lead and develop a team of mechanical engineers, setting clear development goals, providing technical mentorship, and maintaining a high standard of engineering practice * Own the mechanical engineering function and lead the realization of mechanical components from concept through to validated hardware. * Personally contribute to mechanical design work, including CAD modelling, tolerance analysis, FEA simulation, and design for manufacture and assembly * Drive design reviews, risk assessments, and V&V activities across mechanical subsystems, ensuring performance is robustly characterised before design freeze * Own the mechanical interfaces with optical, electronic, and manufacturing subsystems, working cross-functionally to resolve integration challenges * Establish and maintain mechanical design standards, toolchain choices, and documentation in line with CoMind’s QMS, ISO 13485, and IEC 60601-1 * Manage relationships with contract manufacturers and key suppliers for mechanical components and assemblies, supporting DFM and manufacturing readiness reviews * AI is fundamental to our culture — it’s not just a tool, but a core part of how we work, collaborate, and innovate. We expect all team members to embrace AI in their daily work and continuously find new ways to use it effectively SKILLS & EXPERIENCE * 8+ years of experience in mechanical engineering, with at least 2 years in a team lead or engineering management role * Hands-on experience designing precision mechanical or optomechanical systems, with a track record of delivering complex hardware products from concept through to validated production * Proficiency with 3D CAD tools (SolidWorks or equivalent) and associated tools for tolerance analysis, FEA, and thermal modelling * Experience designing for manufacture and assembly (DFM/DFA), including managing relationships with contract manufacturers and component suppliers * Experience in a regulated industry (medical devices, defence, or similar), with familiarity with IEC 60601, ISO 14971, ISO 13485, and design control processes * Strong cross-functional communication skills, with the ability to represent the mechanical team in system-level technical discussions * Experience with manufacturing assembly processes or precision manufacturing at production scale for instrumentation and/or high volume products. NICE TO HAVE * Background in optomechanical design or integration of precision optical systems * Experience with miniaturisation of complex electromechanical assemblies for portable or wearable devices BENEFITS: * Company equity plan so all employees share in the success of the company * Salary-sacrifice pension scheme * Private medical, dental and vision insurance (medical history disregarded) * Group life assurance at 4x annual income * Comprehensive mental health support, including unlimited access to 1:1 sessions with trained professionals * Unlimited holiday allowance (+ bank holidays) and one week of remote working per quarter * Lunch voucher (£10) every day for JustEat and free dinner on those days where you need to work later * Twice weekly deliveries of fresh fruit and an extensive selection of snacks and drinks * YuLife subscription, allowing you to turn your daily steps and meditation into discounts at a range of stores DISCLAIMER - We use AI notetaking tools to transcribe interviews for internal review. 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