13 Boston Scientific jobs in Ireland

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
R&D Product Development
**Job Sub** **Function:**
R&D Mechanical Engineering
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Galway, Ireland
**Job Description:**
**Role: Principal Research & Development Engineer - Interventional Vascular Technologies**
**Location:** Ballybrit, Galway
**Reports to:** Director of R&D or Senior R&D Manager
**Live Our Credo & Pursue Our Purpose:**
As part of the Johnson & Johnson family of companies, Our Purpose is 'We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.' We are guided by the values in Our Credo. With responsibility to patients, employees, communities, and stakeholders, Our Credo puts the needs of each of those first.
**About Johnson & Johnson MedTech**
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at is it like to work at Johnson & Johnson Medtech | Neurovascular**
+ Culturally, we are putting the needs of Our Credo stakeholders first through pursuing the highest standards of quality, compliance, and ethics, ensuring everyday actions contribute to Our Purpose.
+ We are continuing to better our understanding of clot science, through our Neuro Thromboembolic Initiative (NTI). This is a commitment to advance the treatment of stroke through interdisciplinary collaboration and investment in clot and stroke research. How we understand clots and their behaviour enhances our opportunity to design devices that improve patient outcomes and, overall, advance the treatment of acute ischemic stroke.
+ Strong new product pipeline and one of fastest growing areas within J&J.
+ From a People perspective, we invest in our people, and take great pride in providing a positive work environment which respects diversity, supports wellbeing, and embraces innovation. This is empowered through our employee resource groups (ERGs) focused on further balances of gender, nationality, capability and more, including the additional attracting of qualified diverse candidates for our open roles.
**Job Summary:**
Johnson & Johnson Medtech | Neurovascular is recruiting for a **Principal R&D Engineer** in Galway, Ireland.
The Principal R&D Engineer will be responsible for providing technical leadership in the design and development of vascular interventional devices from early stage to commercialization. Overall responsibility for technical aspects of new product development projects, including product specification generation and identification of optimal solution through design development, technical risk management and test capability development.
**The responsibilities and the impact YOU will have:**
**Technical Leadership, Product & Process Development:**
+ Cross project ownership of device design and development, working with design engineers to identify novel solutions to meet product performance requirements while leveraging existing capabilities to meet cost of goods targets.
+ Provide technical leadership and take ownership of critical technical tasks in the execution of product development projects.
+ Design new products, optimise product performance and refine product design to meet technical specifications and unit cost target.
+ Leading and developing project engineers, identifying and implementing best practice in the design and development of catheters
+ Identify and manage technical risk across projects, in partnership with project leads.
+ Build and test prototypes, analyse test data and interpret to identify optimal solution(s).
+ Develop test capability to evaluate product performance and safety requirements.
+ Identify and support development of processes for new products.
**Culture -Improving the Way We Work & Building Capability**
+ Foster a culture of creativity; generate creative product solutions to address unmet needs.
+ Mentor those around you to grow in capability by open questioning to drive self-reflection and development.
+ Actively identify technical and adaptive opportunities for improvements and take action to address.
**Customer Connection to Drive Innovation:**
+ Liaise with key opinion leaders to develop a deep understanding of the disease state, gather user needs; and articulate throughout the team.
+ Attend external meetings with key opinion leaders to present the product portfolio and gain feedback on new product development.
+ Support generation of Intellectual Property by filing new ideas and drafting patents as required.
**We would love to hear from YOU, if you have the following essential requirements:**
**Qualifications -**
+ Honours degree in Mechanical or Biomedical Engineering or equivalent.
+ Extensive experience in the medical device industry.
**Experience and skills -**
+ Strong technical leadership capability in the development of new products, expert understanding of disease state and generates creative product solutions to address unmet needs.
+ Specific experience in cardiovascular, peripheral or neurovascular implants an advantage.
+ Excellent technical problem solving and analytical ability.
+ Strong device design, development and technical ability is essential, based on a solid foundation of fundamental engineering principles.
+ Data review and statistical methods expertise.
+ Experience of intellectual property generation and filing.
+ Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
+ Creative problem solver.
+ Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
+ Excellent interpersonal skills and ability to work with people to achieve results.
+ Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
**Location & Travel**
+ This role will be an onsite role based in Galway, Ireland with flexible work arrangements from time to time in agreement with management and per the J&J Flexible Work policy.
+ As part of a global company, travel will be required from time to time, up to 20%
**This is what awaits YOU at J&J:**
This is an opportunity to work with a ground-breaking biomedical operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.
We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.
Whether you're one of the people who already work here, or you're considering joining the team, we offer:
+ An opportunity to be part of a global market leader.
+ A dynamic and inspiring working environment.
+ Opportunities to work on challenging projects and assignments.
+ Possibilities for further personal and professional development/education.
+ Excellent benefits.
**Equal Opportunity:**
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Overview The Manager, Research and Development will be responsible for leading Research and Development teams in the execution of product development projects in line with the Vascular Vision. This role will specifically support the embolization portfolio, leading a global project across multiple sites, with a requirement for regular travel to Denmark and the US. Reporting to: Senior Manager, Research and Development / Director, Research and Development Find out more about Cook Medical here Responsibilities Manage, schedule, costs/budget and resources for project(s) assigned. Interact with physicians for deep clinical understanding and research new unmet needs in a clinical area. Technical responsibility for all Research and Development activities assigned. Improve team processes and systems for quality and delivery of work. Identifying new vendors and strategic partners for product development and component/subassembly supply. Maintain and improve high standard of medical device engineering. Works with other Research and Development Managers, Global Program Managers and Global Directors to ensure sharing of Research and Development best practice. Manage the development of the IP portfolio for their area of responsibility. Team Management: Mentoring, coaching and development of direct reports to attain best performance. Perform routine appraisals to deliver best results and to obtain the maximum team performance. Manage the activities of the Research and Development Engineering team and hold regular team meetings. Foster and maintain a workplace culture respectful and supportive of individual differences. Ensure KPI's and business metrics are achieved. Ensure the Research and Development Engineering team are in compliance with Cook's Quality System requirements and Company HR policies. Ensure team/teams deliver quality designs in a timely manner. Foster relationships and collaborate with other functional stakeholders required for the successful completion of development projects. Must ensure effective communication of project progress and risks to all relevant stakeholders. Must work and interact effectively and professionally with and for others throughout various levels of the global organisation. Must strictly adhere to safety requirements. Must maintain company quality and quantity standards. Ability to remain calm and receptive in fast paced situations. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Bachelor's degree in engineering or related field is required and 10 years' relevant experience. Strong proven people management skills - a minimum of 5 years previous experience in a supervisory position leading and motivating a group of talented engineering staff is desired. Proven project management skills. Strong technical writer. Good mechanical design, materials aptitude and understanding of engineering fundamentals with extensive medical device materials knowledge. Must have good understanding of IP process. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. Willingness and availability to travel on company business. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit  embecta.com  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and X ( . 
**Why join us?**
A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life's purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees.
Join embecta, a global leader in diabetes care, as Principal Engineer driving innovation across our product and technology development programs. This is a high-impact role where you'll lead complex engineering initiatives, mentor technical talent, and shape the future of healthcare solutions.
**Responsibilities**
+ Lead the development of novel technologies and product concepts that align with embecta's strategic roadmap.
+ Solve advanced technical challenges and ensure the success of R&D deliverables across multiple projects.
+ Manage technology budgets, resource planning, and cross-functional collaboration.
+ Drive innovation and process effectiveness while ensuring compliance with quality and safety standards.
+ Represent R&D in core team meetings and external engagements.
+ Mentor technical talent, promote continuous learning, and foster a culture of innovation.
+ Build partnerships with internal and external stakeholders to accelerate technology transfer and product development.
+ Promote inclusive collaboration and lead with courage and clarity in ambiguous environments.
**Experience and Education**
+ Bachelor's degree in Mechanical or Biomedical Engineering
+ 10+ years in product development, including 5+ years in medical devices.
+ Proven leadership in complex R&D programs.
+ Strong technical and organizational capabilities across:
+ **Execution & Planning** : Deliver milestones on time and budget.
+ **Risk & Budget Management** : Lead mitigation strategies and manage R&D budgets.
+ **Communication & Collaboration** : Foster cross-functional alignment and clarity.
+ **Analytical Thinking & Problem Solving** : Break down complex challenges and drive solutions.
+ **Customer Understanding & Product Architecture** : Translate user needs into impactful designs.
+ **Innovation & Initiative** : Champion new ideas and take ownership in ambiguity.
+ **Diversity & Inclusion** : Build inclusive teams and welcome diverse perspectives.
+ **Flexibility & Resilience** : Thrive in dynamic environments and adapt to change.
#LI-HYBRID
#LI-DF1
embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Research and Development Tax Manager An emerging consultancy firm in Dublin is seeking a Research and Development Tax Managerto join their dynamic team. This is an exciting opportunity that offers a driven professional the chance to expand their skillset and knowledge within a consultancy through managing their own portfolio of clients while providing strategic guidance on research and development matters. About the Role As Research and Development Tax Manager, you will: Collaborate with the project team to ensure that comprehensive R&D claims while being the main point of contact with a range of stakeholders; Prepare well-structured reports and summaries to detail the approach taken in compiling clients' R&D Tax Credit claims to authorities; Maintain up-to-date knowledge of external developments including industry trends and legislation updates; Enhance visibility in the market and identify new opportunities to develop the business; Develop a strong internal network within the business; Coach, mentor and develop a team of professionals through knowledge sharing. What Were Looking For Youll bring: Experience in Research and Development Tax ACA, ACCA and CTA qualifications preferred, but not essential Proven management skills with excellent communication and interpersonal skills. Remuneration A Strong Remuneration package will be on offer for the right candidate If this role is of interest to you, please feel free to reach out to me at for a confidential chat.If you know of any friends or colleagues who might suit this role and would like to refer them, you will receive a €250 voucher should we successfully place them. Skills: Research And Development Taxation Relationship Management

Overview

Job title: Principal Research & Development Engineer - Interventional Vascular Technologies
Location: Ballybrit, Galway
Benefits: Top salary, bonus, pension and healthcare

Company:
My client are experts in the Medical Device Technology fueled by innovation at the intersection of biology and technology. Continuing to better their understanding of clot science, through our Neuro Thromboembolic Initiative (NTI). Strong new product pipeline and takes great pride in providing a positive work environment which respects diversity, supports wellbeing, and embraces innovation.

Job Summary

As a Principal R&D Engineer you will be responsible for providing technical leadership in the design and development of vascular interventional devices from early stage to commercialization. Overall responsibility for technical aspects of new product development projects, including product specification generation and identification of optimal solution through design development, technical risk management and test capability development.

Responsibilities

• Cross project ownership of device design and development, working with design engineers to identify novel solutions to meet product performance.
• Provide technical leadership and take ownership of critical technical tasks in the execution of product development projects.
• Design new products, optimise product performance and refine product design to meet technical specifications and unit cost target.
• Leading and developing project engineers, identifying and implementing best practice in the design and development of catheters
• Develop test capability to evaluate product performance and safety requirements.
• Identify and support development of processes for new products.
• Liaise with key opinion leaders to develop a deep understanding of the disease state, gather user needs; and articulate throughout the team.
• Attend external meetings with key opinion leaders to present the product portfolio and gain feedback on new product development.

Experience required

• Strong technical leadership capability in the development of new products, expert understanding of disease state and generates creative product solutions to address unmet needs.
• Specific experience in cardiovascular, peripheral or neurovascular implants an advantage.
• Excellent technical problem solving and analytical ability.
• Strong device design, development and technical ability is essential, based on a solid foundation of fundamental engineering principles.
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
• Creative problem solver.
• Excellent interpersonal skills and ability to work with people to achieve results.
• Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.

What awaits you

• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to work on challenging projects and assignments.
• Possibilities for further personal and professional development/education.
• Excellent benefits.

How to apply

Does this sound like your next career move? To apply and for more info forward your application to the link provided or contact me on OR

Capital Project Manager GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. Major Duties and Responsibilities Project Management: Is a Project Management Subject Matter Expert. Independently Scope, Plan, Execute/Monitor and Close complex long duration projects. Uses Project Management tools and methodologies e.g. PMBOK, PRINCE 2, to deliver projects consistently. Strategic and Results Orientation: Demonstrates fiscal responsibility through project scoping and execution and defines actionable recommendations. Translates top-level project goals to specific project tasks, milestones and deliverables. Financial Control: Ensure financial control of the project with monthly updates on cashflow for the duration of the project. Communication: Develops communication strategy for projects to ensure Project teams, Project Sponsor, key stakeholders and site/external management understand project plans, risks and progress. Stakeholder Management: Garners support from and manages key stakeholders to enable successful project outcome including resource allocation negotiation. Establishes and cultivates an extensive network of support to facilitate completion of assignments. Risk Management: Performs project risk management from project outset and develops appropriate contingency plans. Effectively balances compliance risk and business risk when developing project plans. Contingency Planning: Develops contingency plans to mitigate impact of project issues that may impact on project delivery. Scope Management: Develops and agrees Scope with Project Sponsor. Actively manages project scope to prevent scope creep. Evaluates impact of Scope changes and adjusts project plans as required. Quality Management: Ensure that assigned projects are performed to meet the quality requirements of customers, internal quality systems, internal & external auditors and other external agencies. Knowledge Sharing: Shares project management knowledge and assists/mentors more junior project managers in project management processes and techniques EHS: Complete all activities in a safe manner ensuring that any potential safety issues and areas for improvement are highlighted to Manager. Ensure Environmental procedures e.g. recycling, waste minimization are adhered to and improvements made where possible. Leadership Activities Provides leadership and direction to project teams to meet established timelines and site goals and objectives. Independently manages external facing complex projects Education: Third Level Qualification in a relevant discipline Experience/ Background Experience in areas such as Technical Support, Supply Chain, Operations, Quality, Engineering and/or Business Excellence. History of successful project delivery in at least one area of the business. Working within a highly regulated manufacturing environment with project management skills as this provides a good foundation for this job function. Strong planning and organizational skills coupled with necessary knowledge of diagnostics technical, manufacturing and/or supply activities. Projects Examples: Heat pump installation New loading Bay in warehouse A warehouse sprinkler upgrade A palletizing robot on a manufacturing line To start the process click the Continue to Application or Login/Register to apply button below.

Medical Device Product Specialist | Nationwide (Ireland)

Are you a confident communicator with a passion for healthcare and innovation? A dynamic opportunity awaits for an ambitious individual to join a forward-thinking medical device organization as a Medical Device Product Specialist . If you're driven by results, eager to grow your career, and excited to work at the intersection of science, technology, and patient outcomes — this could be your next big move.

The Ideal Candidate :

All candidates must hold a third-level qualification (minimum: NFQ Level 8 – Honors Bachelor Degree) and ideally bring 3+ years of experience from one or more of the following areas:

• Healthcare (clinical, surgical, or healthcare-related background – an advantage, but not essential as training is provided)

• Business (B2B Sales, Marketing, Finance, Accounting, Commerce)

• Engineering (Biomedical, Biochemical)

• Science (Microbiology, Biochemistry, Neuroscience, Mathematical Sciences, Biology, R&D)

Our Client is looking for someone who:

• Is a self-starter with an entrepreneurial drive and a hunger to succeed.

• Has a natural flair for presenting, with the ability to communicate complex technical information in an engaging, relatable way.

• Approaches challenges with a solution-focused mindset and thrives under pressure.

• Enjoys building genuine relationships and sees value in long-term client trust.

• Is eager to continuously learn, grow, and evolve within a commercial healthcare setting.

Responsibilities include but are not limited to:

• Setting and achieving territory business development goals and sales targets

• Promoting a portfolio of surgical devices and healthcare solutions to medical professionals

• Building and maintaining strong customer relationships based on credibility and trust

• Gathering and sharing market intelligence, including customer feedback, competitor activity, and emerging opportunities

• Representing the brand at meetings, product demonstrations, workshops, and industry events

• Collaborating with internal teams to ensure high levels of customer service and operational excellence

• NFQ Level 8 Honours Bachelor Degree in a relevant discipline (Healthcare, Business, Engineering, or Science)

• Minimum 3 years of experience in a relevant industry

• Strong interpersonal, communication, and public speaking skills

• Proven ability to manage a territory and work autonomously

• Full, clean driving licence (essential)

• Must be currently residing in Ireland

• Willingness to travel nationwide

• A long-term vision to develop within the healthcare sales and marketing field

What’s on Offer: Competitive base salary with bonus structure; Company car, expenses, and pension contribution ; Comprehensive training and onboarding; Supportive team culture focused on innovation and continuous improvement; Opportunity to join a growing company and make a real impact in the medical device sector

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

 Pale Blue Dot® Recruitment

The Experts in STEM Workforce Solutions

Our client, a global manufacturer in the medical device industry, is partnering with us to appoint a Finance Business Partner onto their FP&A team in Galway. Within easy reach of Mayo, Roscommon, Clare, Westmeath and Offaly, its the ideal next step if you have costings or financial analysis experience within the medical device, biopharma or other manufacturing sectors as you will business partner with 2-3 large departments for all their budgeting, forecasting and financial planning needs. We are also interested in speaking to you if you have financial analysis experience from another industry in a large company. As the Finance Business Partner you will collaborate with department leaders as their trusted financial advisor on monthly variances versus their budget, financial scenario planning for new initiatives such as product launches or opening of new production lines and project accounting on areas such as new product development and capital expenditure. This brings you closer to manufacturing operations and to key decision makers across the business. You will also prepare the annual and strategic (3-5 year) budgets with your colleagues on the FP&A team for approval by the corporate team in their US headquarters. Why work with this multinational medical device manufacturer? They are a renowned brand name with multi-billion annual revenue who is growing organically and through strategic acquisitions Significant career progression opportunities for you to managerial and director level as well as onto global projects Gain valuable insights into the cost and revenue drivers of a full product lifecycle medical device manufacturer Work with cutting edge systems and AI where continuous improvement is embedded across this 3,000 employee site Flexible working models including 2 days working from home per week Commitment to sustainability with all new buildings onsite being carbon neutral Funded learning & development programmes and 3rd level post-graduate programme support Your rewards as the Finance Business Partner will be a well-rounded package worth €85,000-€90,000 including a competitive base salary, annual bonus, company pension contributions, share option scheme and full family health insurance. To become the Finance Business Partner you will have strong financial analysis skills from ideally the medical device, biopharma or other manufacturing sectors, we are also interested in speaking to you if you have financial analysis experience from another industry. You will be a qualified accountant (ACA/ACCA/CIMA) with post-qualification industry experience as noted above. Apply today or contact Shane Lynott, Talent Acquisition Manager, via the contact details in our bio. Skills: Financial Analysis Finance Business Partnering Budgeting Forecasting Benefits: Work From Home Annual Bonus / 13th Cheque Pension Hybrid Working Company Shares Medical Aid / Health Care

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Purpose:**
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Scientist - Clinical Development: Neuropsychologist is an integral member of the Neuroscience medical development team and participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.
The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.
**Overall Responsibilities** **:**
With the expansion of the Lilly portfolio, this role will be responsible for scientific support for clinical trials across the Neuroscience platform and serves a spectrum of patients with neurological and psychiatric conditions. The clinical research scientist is a scientific resource for study teams, departments, and others as needed, particularly pertaining to the selection of clinical trial endpoints, the implementation and central monitoring strategy of clinical endpoints and the translation of clinical trial outcome data into meaningful benefits. This includes, but is not limited to, design and execution of phase 2/3 studies to address the needs of the commercial organization.
The ideal candidate will be a critical thinker and understand Neuroscience, Neuropsychology, neuropsychological assessment and measurement science.
**Specific responsibilities may include but are not limited to:**
**Clinical Planning**
+ Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
+ Contribute to business unit and global alignment of clinical strategy and clinical plans.
+ Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
**Clinical Research/Trial/ Execution and Support**
+ Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline.
+ Provide protocol oversight and input into informed consent documents.
+ Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
+ Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
+ Review and collaborates with CRP on the approval of risk profiles to ensure appropriate communication of risk to study subjects.
+ Participate in investigator identification and selection, in conjunction with clinical teams.
+ Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
+ Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
+ Serve as resource to clinical operations/CTMs/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
+ Understand and actively address the scientific information needs of all investigators and personnel.
+ Review lIT proposals and publications, as requested by CRP or Director-Medical.
**Scientific Data Dissemination/Exchange**
+ Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
+ Understand and address the unsolicited scientific information needs of external health care professionals according to guidelines above.
+ Participate in reporting of clinical trial data in Clinical Trial Registry activities.
+ Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
+ Prepare or review scientific information in response to customer questions or media requests
+ Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
+ Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
+ Support the design of customer research as medical expert
+ Support medical information associates in preparation and review of medical letters and other medical information materials.
+ Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
+ Develop and maintain appropriate collaborations and relationships with relevant professional societies.
+ Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel.
+ Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
+ Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
**Regulatory Support Activities**
+ Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
+ Provide medical expertise to regulatory scientists.
+ Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
+ Participate in advisory committees.
+ Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
**Scientific I Technical Expertise and continued development**
+ Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product
+ Responsible for the scientific training of the clinical study team.
+ Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
+ Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5 years).
+ Explore and take advantage of opportunities for extramural scientific experiences
+ Attend, contribute and participate in scientific symposia, as well as administrative/business workshops and training.
**General Responsibilities**
+ Actively set and meet individual professional development goals and contribute to the development of others.
+ Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget.
+ Actively participate in recruitment, diversity and retention efforts.
+ Collaborate proactively and productively with all alliance, business and vendor partners.
+ Participate in active coaching by providing timely and constructive feedback to co-workers, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
+ Participate in committees, process improvement initiatives and task forces as requested by local/corporate management
+ Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
+ Model the leadership behaviors
+ Be an ambassador of both patients and the Lilly Brand
**Basic Requirements:**
+ Doctoral level Degree (Ph.D, Psy.D or equivalent) in Clinical Neuropsychology with 2+ years industry or academic experience beyond any postdoctoral positions.
+ Demonstrated experience in clinical and/or research settings in working with adults with neurological and/or psychiatric disorders
+ Clinical experience in conducting assessments and administering standardized scales within a clinical and/or research context.
+ Experience and agility in the conduct and interpretation of statistical and psychometric analyses
+ Evidence of scientific track record in publications, conference presentations
**Additional Information:**
+ Fluent in English, written and verbal communications
+ Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.
+ Position Location - Indianapolis, IN or Remote
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Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$142,500 - $228,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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