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AstraZeneca jobs in New Haven, CT

- 86 jobs
  • Clinical Product Quality Lead

    Astrazeneca 4.6company rating

    Astrazeneca job in New Haven, CT

    Introduction to role: Are you ready to make a significant impact in the world of clinical product quality? As a Clinical Product Quality Lead (CPQL), you'll be at the forefront of ensuring the highest standards of quality from candidate selection through to commercial approval. You'll be the Quality representative on the CMC Team, collaborating with cross-functional stakeholders to support clinical product scale-ups, accelerations, integrations, and partnerships. Your expertise will guide strategies for compliant, on-time release of first-in-human (FIH) products and oversee quality activities throughout early and late-stage clinical programs. Are you up for the challenge? Accountabilities: As a CPQL, you will provide quality oversight for various clinical products across different presentations, from pre-clinical stages up to commercial launch. You will act as a Quality advocate and single point of contact for CMC program strategy teams, ensuring consistent quality approaches and deliverable completion for GMP manufacturing, testing, release, and regulatory filings. Your role involves proactively managing clinical product quality risks, serving as Quality Assurance support and SME for clinical manufacturing, and chairing Quality Subteams to align Operations Quality, External Quality, and QP on timelines and risks. You will establish release strategies for new products, review significant product-related deviations, facilitate change controls, support CMO selection and management, and serve as a Quality SME for regulatory submissions. Essential Skills/Experience: 8 years+ experience in GMP Quality Assurance in a pharmaceutical manufacturing environment, including 5 years + experience with Phase I, II and III product development. BSc. degree in biological / chemical sciences, or a related pharmaceutical science. Minimum 5 years' experience with genomic medicines (essential) Experience with review of market applications, INDs, supplements, and similar regulatory documentation. Experience working with contract manufacturing and laboratory organisations. Understanding of phase appropriate cGMP, pharmaceutical drug product development and manufacturing. Knowledge of quality systems, including product release (Annex 16) and quality control. Successful candidates will demonstrate learning agility and a growth mindset. Ability to make decisions, solve problems, and manage ambiguity. Ability to collaborate, negotiate, influence and lead in a matrix organisation. Excellent verbal and written communication skills. Desirable Skills/Experience: Prior experience with combination products. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, we are driven by a passion to innovate and create meaningful value in all we do. Our culture is rooted in integrity and inclusiveness, empowering us to make a difference where it truly counts. With a rapidly expanding portfolio and an entrepreneurial spirit, we offer an environment where you can grow and explore new ideas that profoundly impact patients' lives. Join us in our mission to change lives for the better every day. Ready to take the next step in your career? Apply now and become part of our dynamic team! Date Posted 03-Dec-2025 Closing Date 18-Dec-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
    $107k-135k yearly est. Auto-Apply 10d ago
  • Pharmaceutical Sales Specialist - Respiratory Specialty - New Haven, CT

    Astrazeneca 4.6company rating

    Astrazeneca job in New Haven, CT

    At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Senior Pharmaceutical Sales Specialist for the Specialty Care Team, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Accountabilities - Develop and demonstrate strong knowledge of clinical disease states and treatment guidelines. - Effectively communicate product information to healthcare professionals to influence prescribing behavior. - Execute call plans and Brand Strategy by translating data to actionable insights. - Build and maintain working relationships with healthcare professionals. - Drive portfolio demand performance through meaningful customer interactions leveraging multiple channels, such as digital platforms and face-to-face engagements to reach the customers. - Demonstrate openness to new ideas and seek innovative approaches to sales and customer engagement. Essential Skills/Experience - Bachelor's Degree - 2+ yrs of demonstrated Sales or Commercial experience or a combination of: pharmaceutical, healthcare, scientific, clinical, institutional or related industry experience - A valid driver's license and safe driving record Essential Skills and Capabilities - Customer Engagement: Demonstrated commitment to improving patient outcomes through effective engagement with healthcare professionals. - Advanced Sales Techniques: Experience with advanced sales techniques and strategies tailored to specialty care markets. - Clinical Acumen: Strong understanding of clinical trial data and the ability to communicate complex scientific information clearly. - Business Acumen: Ability to conduct detailed market analysis and leverage insights for strategic planning. Desirable Skills/Experience - Therapeutic area experience, specialization in clinical setting, and sales experience At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We shape the future by spotting scientifically led commercial opportunities and acting now to operationalize and scale them. Driven by the solutions we bring to the healthcare ecosystem, we make an impact at every step of the patient journey, improving their experience and outcomes. Our inclusive team draws on diverse backgrounds, skills, and experiences to create innovative solutions that make a difference. Join us in making a meaningful impact on patients' lives by applying today! The annual base salary (or hourly rate of compensation) for this position ranges from $107,172 -$160,758. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 04-Dec-2025 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
    $107.2k-160.8k yearly Auto-Apply 9d ago
  • Admin Asst IV - Administrative Support Center 1

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    To provide administrative support to specified department personnel. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees. **Duties & Responsibilities** + Utilizes advanced knowledge to provided support to one or more individuals within a specified department or departments. + Support may include: generation of reports, management of the administrative aspects of a department process or processes, coordination of conference calls and meetings, travel arrangements, records retention and file management, input and tracking of purchase orders, tracking of department budgets, processing check requests and invoices through the internal system, ordering and managing departmental supplies, expense report reconciliation, training class support, and general staff support. + Uses appropriate interpersonal styles to work collaboratively with colleagues and team members to achieve departmental objectives.Helps to overcome barriers, provides on-going feedback to the work team, and facilitates adjustments as directed by management.Fulfills work team responsibilities and demonstrates a personal commitment to accomplishing departmental objectives.Proactively identifies opportunities for process improvement within specified department. + Demonstrates advanced knowledge of Boehringer´s mission, business processes, policies and practices, and applies knowledge within own technical area to develop work results. + Performs all Company business in accordance with all regulations and Company policy and procedures. Demonstrates high ethical and professional standards with all business contacts and BIPI employees in order to maintain the Company´s excellent reputation within the medical and pharmaceutical community. **Requirements** + Business school/certification or Associates degree from an accredited institution preferred. + Minimum of five (5) years of administrative, customer service and/or relevant business experience. + Applies knowledge / skills to a range of interdepartmental responsibilities and serves as a resource to others. + Satisfactory performance record. + Demonstrates acceptable level of performance for all Administrative Assistant IV competencies as defined in the Career Pathway criteria. + Proficient knowledge of Microsoft Office (Word, Excel and PowerPoint). + Demonstrated strong attention to detail with demonstrated high work standards. + Demonstrates excellent verbal and written communication skills. **Desired Skills, Experience and Abilities** This position offers a base salary typically between $60,000 and $90,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here (***************************************************************** . All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $60k-90k yearly 10d ago
  • Oncology Immune Regulation Spring Co-Op

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    Boehringer Ingelheim is currently seeking a talented and innovative Spring Co-Op candidate to join the Immune Regulation team within the Oncology Research department located at our Ridgefield, CT facility. As an Immune Regulation Co-Op, you will collaborate with scientists on in vitro experiments in the field of cancer immunology, with a focus on enhancing inflammation within the tumor microenvironment and promoting tumor cell killing. Your primary project will involve developing and optimizing functional assays: 1) to measure shedding dynamics of a soluble antigen targeted by therapeutic antibodies in samples from cancer patients versus healthy donors, and 2) to investigate the internalization behavior of antibody-receptor complexes in immune cells to inform optimal therapeutic design. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees. **Duties & Responsibilities** - Develop and optimize in vitro functional assays using primary human immune cells - Analyze, interpret, and report the data obtained from experiments - Complies with applicable regulations; maintains proper records in accordance with SOPs and policies **Requirements** + Must be a current graduate or advanced degree student in good academic standing. + Student must be enrolled at an accredited college or university for the duration of the **co-op** . + Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred. + Major or minor in related field of **co-op:** Immunology, Oncology, Cell Biology. + Graduate and advanced degree students must have completed at least 9 credit hours at current college or university. **Desired Experience, Skills, and Abilities:** - Strong scientific understanding and interest in one or more of the following: immunology, oncology, and cell biology - Previous experience in cell line or primary cell culture is required, preferably cancer cells, T cells and/or myeloid cells - Hands-on skills in relevant in vitro assay (FACS, ELISA/MSD, and/or immune cell isolation) - Experience in vitro system setup is a plus - Ability to troubleshoot both individually and as part of a team - Excellent record keeping - Strong writing and oral communication skills - Must enjoy working in a multi-disciplinary and collaborative environment - Additional skills and interests that demonstrate soft skills are highly encouraged - Inquisitive, open-minded **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Compensation Data** This position offers an hourly rate of $20.00 - 33.00 USD / hr. commensurate to the level of degree program in which an applicant is actively enrolled. For an overview of our benefits please click here (***************************************************************** . All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $20-33 hourly 60d+ ago
  • Sr. AD, AI Content/HPRC Products

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    **Compensation Data** This position offers a base salary typically between $170,000 and $269,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here. (***************************************************************** **Description** The Sr. AD, AI Content/HPRC Products manages BI HP's overall structure, framework/governance of AI Content/HPRC products and corresponding processes across the portfolio. S/he supports multiple customer groups and/or therapeutic areas and will be an expert in AI Content/HPRC products will have a broad understanding of the pharmaceutical industry and a deep familiarity with AI technologies. This position manages the development, execution, and implementation of compelling AI driven content strategies. Through the utilization of AI capabilities, the Sr. AD will identify and implement BI 1 Content roadmap which expedites the use of AI, Machine Learning and Agentic AI technologies and fosters content auto-tagging, atomic content creation, content hyper-personalization, content automation and production. The Sr. AD must excel at working with cross-functional teams in HP Operations, Brand Marketing, agency partners, Corporate and IT in forming an end-to-end Agentic AI content strategy that enhances customer experience and establishes the KPI's that demonstrate this impact, through thought leadership, proven expertise and consideration. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. This role is based on-site at our Ridgefield, CT location with hybrid flexibility of 2-3 days per week on-site. **Duties & Responsibilities** + As a change agent, accelerate shift to AI Content product by collaborating across HP Ops and Marketing leadership team to evaluate business need, collect stakeholder input, and design solutions that meet the customer need in a multi-workstream environment; Provide inputs to the Training & Communications team for optimal adoption; Simplify operational complexities, challenge status quo, explore the art of the possible. + Create 1Content roadmap based on Artificial Intelligence (AI), Machine Learning and Agentic AI systems. + Implement an overall governance approach to content auto-tagging, atomic content creation, content hyper-personalization, automated FDA submission, utilization of AI capabilities in NTA processes and content automation/production. + Seek, launch, and lead proof of concepts with innovative technology solutions supporting content automation, as well as being able to capture/interpret user requirements, user stories, and identifying minimal viable products in Agile methodology. Once POC's are proven positive, being able to scale up for a full content automation roll out which can include integration with existing enterprise content management systems. + Establish, routinely track and communicate Key Performance Indicators (KPI's) that demonstrate benefits of AI (i.e. reduce reviewer/stakeholder effort, improved speed to market, etc.) + Drive continuous improvement collaboratively for AI Content/HPRC Products by developing, socializing, and executing action plans to improve speed to market, reduce operational costs and enhance customer experience. Author any new changes to departmental guidelines based on the results of continuous process improvements. Identify departmental best practices that can be shared across the therapeutic teams, ensuring consistency of approach. **Requirements** + Bachelor's Degree required; MBA preferred. + 7 years experience in a Pharmaceutical Sales/Marketing/Market Access/Medical and/or agency organization with a solid understanding of AI content products strategy. + 3 years of AI content management experience and/or knowledge of content automation/MLR technology landscape highly preferred. + 3-5 years demonstrated leadership abilities leading cross-functional teams, coaching/mentoring individuals and/or equivalent experiences required. + Demonstrated strong communication, organizational, time management, ability to facilitate, attention to detail, and process/systems skills required. + Demonstrated relationship management, influencing abilities, ability in conflict management and negotiation required. + History of successful performance through fast and focused execution, strategic thinking, and ability to foster a collaborative environment. + Demonstrated track record in continuous process improvements and sharing of best practices. + Strong understanding of agile approach to capability development. + Strong system and technology platform knowledge. + Lean Six Sigma Green Belt Certification is highly preferred + Strong interpersonal abilities. + Ability to manage multiple projects at the same time. + Functional competencies: analytical skills, business orientation, influencing skills. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $170k-269k yearly 37d ago
  • Material and Analytical Sciences - Intern

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    **Compensation Data** This position offers an hourly rate of $24.00 - $33.00 USD / hour commensurate to the level of degree program in which an applicant is actively enrolled. For an overview of our benefits please click here (***************************************************************** . **Description** Boehringer Ingelheim is currently seeking a talented and innovative Summer Intern candidate to join our Material and Analytical Sciences department located in Ridgefield CT. As an Intern, you will tackle cutting edge research in development of a Python Graphical User Interface for biomolecular modeling programs. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** - Develop a GUI program using python that can interact with biomolecular modeling programs. - Maintain awareness of the competitive landscape of peer-reviewed publications to advance knowledge database. - Writes reports and adheres to protocols to meet objectives in a timely manner. **Requirements** + Must be a current graduate or advanced degree student in good academic standing. + Student must be enrolled at an accredited college or university for the duration of the internship. + Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred. + Major or minor in related field of internship. + Graduate and advanced degree students must have completed at least 9 credit hours at current college or university. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** - Strong programming background in python. - Familiar with molecular modeling programs and structural chemistry concepts. - Working experience with software from companies such as Chemical Computing Group, Schrodinger, Gaussian, Molsof, Chemaxon, Knime, RDKit and ICM Molsoft - Knowledge of computing infrastructure is a plus. - Stays current with literature in identifying emerging science to advance computational platforms. - Excellent documentation and record keeping skills. - Ability to communicate clearly and effectively in oral and written format. - Work independently and in a team environment. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $24-33 hourly 46d ago
  • Senior / Principal Scientist, Material and Analytical Sciences

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    Boehringer Ingelheim is currently seeking a Senior or Principal Scientist to support our Material and Analytical Sciences team to join our Ridgefield, CT facility. This role is part of Boehringer Ingelheim's Drug Substance-Drug Product Interface organization, driving innovation in small molecule development. The Principal Scientist/Sr. Scientist will lead efforts in solid-state chemistry and API engineering, focusing on phase-appropriate isolation processes and DS-DP co-processing technologies to ensure optimal material attributes-purity, crystal form, and physical properties. This position offers the opportunity to shape strategies for next-generation drug substance/drug product integration, collaborate across CMC Development and Operations, and implement cutting-edge solutions in manufacturing. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees. **Duties & Responsibilities** - Lead experimental design and hands-on execution for solid form, crystallization and isolation, and DS-DP co-processing development, applying QbD principles and appropriate engineering tools. - Champion DS-DP Co-processing as a platform technology; drive implementation across Boehringer's portfolio. - Develop scalable crystallization and isolation processes, identifying CPPs and establishing robust control strategies. - Conduct solid form screening (polymorphs, salts, co-crystals) and advanced characterization using XRD, DSC, TGA, DVS, Raman, and PAT tools. - Collaborate with cross-functional CMC teams to ensure process robustness, scalability, and tech transfer to GMP manufacturing. - Resolve scale-up challenges related to crystallization, particle engineering, and DS-DP integration; perform risk assessments and mitigation planning. - Author technical reports, regulatory documentation, and contribute to IND/NDA filings. - Serve as a scientific leader and mentor, fostering innovation and knowledge sharing within Material & Analytical Sciences. - Stay ahead of emerging technologies (AI/ML, automation, continuous crystallization) and regulatory trends. **Requirements** **Requirements for Both Levels:** - Strong expertise in solid-state chemistry, polymorphism, crystallization development, and Drug Substance (DS)-Drug Product (DP) interface. - Proven ability to design processes, generate and analyze data, and interpret results independently. - Hands-on development of cGMP isolation processes and scale-up principles. - Excellent communication and collaboration skills; ability to influence in a matrix environment. - Physical requirements: lift/carry up to 50 lbs.; respirator use may be required. - Appropriate level of understanding of applicable regulations **Requirements for Senior Scientist:** - Ph.D. Degree in Chemical Engineering, Organic Chemistry, Pharmaceutical Science, Polymer Science, or related field or equivalent with experience in a related field - Demonstrates a broad knowledge of field - Appropriate level of understanding of applicable regulations **Requirements for Principal Scientist:** - Ph.D. Degree in Chemical Engineering, Organic Chemistry, Pharmaceutical Science, Polymer Science or related fields or equivalent with five plus (5+) years related experience in a related field - At least 4 years post-graduation of pharmaceutical industry or relevant industrial experience in chemical engineering, process chemistry, physical chemistry or related fields. - One (1) to three (3) years project management/leadership experience - Has a proven track record of publication in peer-reviewed journals. **Desired Skills, Experience and Abilities:** - Experience in polymer science and DS-DP co-processing. - Familiarity with predictive modeling tools, PAT, and CFD. - Application of AI/ML for process optimization and digital development strategies. **Compensation Data** This position, Senior Scientist, MAS, offers a base salary typically between $140,000 and $222,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here (***************************************************************** . **Eligibility Requirements** Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $140k-222k yearly 23d ago
  • Design Intern

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    **Compensation Data** This position offers an hourly rate typically between $24/ hour and $33/ hour commensurate to the level of degree program in which an applicant is actively enrolled. For an overview of our benefits please click here. **Description** As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Boehringer Ingelheim is currently seeking a talented and innovative Intern to join our Creative Services department located at our Ridgefield facility. As an Intern, you will provide an opportunity for a design student to be part of a creative department learning from our team and supporting in the creation of marketing assets. **This role is based on-site at our Ridgefield, CT location with hybrid flexibility of 2-3 days per week on-site.** **Duties & Responsibilities** + Design digital and print assets as assigned + Participate in creative reviews, department meetings and weekly stand ups, speaking to assigned projects + Manage assigned projects within project management tool, ensuring deadlines, and required approvals are met + Participate in conceptual design projects as assigned + Gain an understanding of BI's requirements for MLR review **Requirements** + Must be a current undergraduate, graduate, or advanced degree student in good academic standing + Student must be enrolled at a college or university for the duration of the internship + Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred + Major or minor in related field of internship + Undergraduate students must have completed at least 12 credit hours at current college or university + Graduate and Advanced Degree students must have completed at least 9 credit hours at current college or university **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** + Portfolio that demonstrates a clear graphic design point of view, understanding of design for print and digital + Hands on experience with Adobe Suite, PPT/Google Slides a plus + Facility with new software e.g., project management tools + Strong communication skills, verbally and in writing + Proactive attitude and desire to understand the design pharma landscape All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $24-33 hourly 3d ago
  • Oncology Territory Manager, Breast - Hartford

    Daiichi Sankyo 4.8company rating

    Hartford, CT job

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. This territory includes: CT, RI and Western MA Responsibilities: Represents the assigned products to health care professionals in assigned sales territory. Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers. Develop and execute comprehensive business plans. Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices). Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient treatment. Analyze customer needs and interests, territory performance, program outcomes, and business trends; develop and execute business plans that optimize the commercial potential of our products. Maintain expert understanding of the relevant disease state(s), assigned Daiichi Sankyo brands, and competitor products. Completes all assigned training. Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts. Communicates on a regular basis with District Manager, internal and co-promote peers and discuss issues and opportunities. Builds relationships with Daiichi Sankyo customer base and key opinion leaders. Communicates products approved indications, features and benefits in both individual and group settings. Meet all administrative expectations and standards, including budgets, reporting, and communication. Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. Submits completed reports on-time and communicates matters that are relevant to the marketplace to the District Manager. Maintains all equipment and territorial records in the prescribed manner. Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. Adhere to compliance and operating principles and expectations. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): Bachelor's Degree required Experience Qualifications: 4 or More Years of sales/marketing experience in the pharmaceutical or medical industry required 4 or More Years of oncology therapeutic experience strongly preferred 1 or More Years additional therapeutic experience in diverse roles - training, marketing, market access preferred Oncology product launch experience preferred Copromotion experience a plus Strong verbal and written communications skills Proficiency in MS Word, Excel, PowerPoint and Outlook Additional Qualifications: Must be able to travel approximately 40% to 60% Must have a valid driver's license with a driving record that meets company Compensation and seniority level/title based on experience and qualifications Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $139,440.00 - $209,160.00 Download Our Benefits Summary PDF
    $25k-59k yearly est. Auto-Apply 24d ago
  • Environmental Health and Safety, Summer Internship

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    Boehringer Ingelheim is currently seeking a talented and innovative Summer Intern to join our Global Facilities and Engineering (GFE) department located at our Ridgefield Connecticut facility. As an Intern, you will assist the Environmental, Health, Safety (EHS) & Sustainability groups in the planning and implementation of safety, health and environmental programs, to meet regulatory and corporate requirements for site activities. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees. This Internship will require someone to be onsite Monday-Friday at our Ridgefield, CT facilities. This position offers an hourly rate of $20.00 - $33.00 USD commensurate to the level of degree program in which an applicant is actively enrolled. For an overview of our benefits please click here. **Duties & Responsibilities** + Understand and assess regulatory, safety and environmental risks at a research & development facility. + Provide Environmental Program support: including Wastewater, Waste, and Air compliance. + Provide Industrial Hygiene, General Safety and Occupational Safety program support. + Support Research and Development colleagues, through Chemical and Laboratory Safety programs. + Opportunities to collaborate with colleagues in Global Facilities & Engineering - this includes Engineers, Architects, Quality Compliance, Facilities Management and Security - to support inter-departmental projects. + Assist with sustainability programs and green initiatives. **Requirements** + Must be an Undergraduate, Graduate, or Professional Student in good academic standing. + Must have completed 12 credit hours within a related major and/or other related coursework. + Overall, cumulative GPA (from last completed quarter) must be at least 3.000 (on 4.0 scale) or better (No rounding up). + Major should include coursework in any of the following: sciences (i.e., chemistry; biology), engineering, environmental studies, sustainability, or occupational health and safety. Desired Experience, Skills and Abilities: + Basic understanding of Environmental Health and Safety Management. + Ability to work effectively as a sole contributor and on teams with minimal supervision. Eligibility Requirements: + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required) + Must be 18 years of age or older All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $20-33 hourly 29d ago
  • Drug Metabolism and Pharmacokinetics - Intern

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    **Compensation Data** This position offers an hourly rate of $24.00 - $33.00 USD / hour commensurate to the level of degree program in which an applicant is actively enrolled. For an overview of our benefits please click here (***************************************************************** . **Description** As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Boehringer Ingelheim is currently seeking a talented and innovative Intern to join our Drug Metabolism & Pharmacokinetics (DMPK) department located at our Ridgefield, CT facility. The metabolite identification (MetID) group conducts studies to identify metabolites of investigational small molecule therapeutics. As a summer intern within the MetID group, you will investigate various technologies to improve our current MetID workflow and evaluate innovative technologies within the drug metabolism field. You will learn the fundamentals of MetID and high-resolution mass spectrometry while collaborating with experienced scientists. **Duties & Responsibilities** - Evaluate new in vitro tools to biosynthesize and purify human metabolites for structure elucidation. - Utilize state-of-the-art equipment to purify and characterize biosynthetically generated metabolites. - Efficiently design and conduct experiments, interpret the data generated, and present your findings to members of the DMPK group. - Comply with applicable regulations and perform all work in a safe and responsible manner. - Maintain proper records in accordance with corporate policies. **Requirements** + Must be a current graduate or advanced degree student in good academic standing. + Student must be enrolled at an accredited college or university for the duration of the internship **.** + Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred. + Major or minor in related field of internship **.** + Graduate and advanced degree students must have completed at least 9 credit hours at current college or university. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** - Completion of relevant organic and analytical chemistry courses at the graduate level. - Must possess the ability to work in the laboratory independently. - Laboratory experience should include familiarity with the handling of biological materials. - Experience with the use of LC-MS instruments and knowledge of high-resolution mass spectrometers is preferred. - Familiarity with general principles of small molecule biotransformation is considered beneficial. - Effective written, communication, and interpersonal skills. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $24-33 hourly 22d ago
  • AD, Compensation

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    **Compensation Data** This position offers a base salary typically between $140,000 and $222,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (***************************************************************** **Description** This role is based on-site at our Ridgefield, CT location with hybrid flexibility of 2-3 days per week on-site. This role is based on-site at our Ridgefield, CT location with hybrid flexibility of 2-3 days per week on-site. The Associate Director, Compensation US independently provides compensation support for their respective client groups. This role leverages in-depth knowledge of data sources, external market, and their client groups business strategy to design and recommend compensation programs for various functions within the business that are both motivating and fiscally responsible. The incumbent manages various compensation activities that include job analysis & evaluations, salary surveys, job profile administration, annual compensation & bonus planning, salary structures, broad-banding, market benchmarking and market pricing and other compensation projects. The Associate Director, Compensation US is the product owner for at least one compensation program (e.g.: sales compensation, global compensation, non-exempt compensation, general industry and specific market insights, equity compensation, monetary rewards programs, etc.) This role keeps the Executive Director informed of any client group changes, business strategy changes and updates on a regular and timely basis. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Requirements** + Bachelor's in Business Administration/Finance required. + A minimum of eight (8) years progressive compensation or HR COE experience required. + Compensation certification CCP or PHR/SPHR highly desired. + Possesses a strong business and / or financial background and strong analytical skills. + Overall HR experience and comprehensive understanding of compensation practices, programs, and plans. + Knowledge of federal and state laws and regulations relating to compensation. + Requires excellent knowledge of job analysis & evaluation methodologies (Hay) and grading programs, Microsoft Excel (also PowerPoint, Word, and Office), SuccessFactors, SAP / HR IS knowledge. + Ability to communicate (verbal / written) in a direct, concise manner. + Ability to interact with professionals at all levels, strong influencing ability. + Demonstrated project management skills. + Knowledge of Federal and State regulations as they relate to FLSA and DOL. + Understanding of Pay Equity work, Equity Compensation programs and Variable compensation elements. + Knowledge of local, global, and corporate frameworks and processes. + Requires ability to communicate complex concepts to audiences at all levels of the organization. + Ability to manage compensation projects independently. + Ability to negotiate creative solutions to sensitive and often controversial compensation situations. + Ability to maintain an overall sense of perspective and company job evaluation framework in the face of sometimes conflicting agendas. + Ability to create unique sustainable solutions to complex problems and to make independent decisions. + Strong process management skills, and attention to detail with all local and global process executions. + Strong understanding of salary structures and broad-banding concepts along with career pathing. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. \#LI-AP1 All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $140k-222k yearly 24d ago
  • AD, Compliance & Transparency 1

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    Leads the US Transparency & Disclosure (T&D) Program, including setting and executing the strategic vision of the program while managing various operational aspects including management of people, process and systems. The scope of the T&D program includes the Federal Open Payments Program (Sunshine Act), and various state requirements associated with T&D, meal thresholds, gift bans, etc. This role is a highly visible business facing role that will work collaboratively with multiple departments and personnel, including stakeholders and colleagues across the globe. Unique skill in understanding the rapidly changing /challenging regulatory environment and developing solutions to meet the needs of the organization in collaboration with other teams and stakeholders. Ensure compliance with all federal and state US transparency and disclosure laws and regulations. Success requires understanding this highly regulated industry and requires constant monitoring of the enforcement environment with an ability to clearly assess its impact on key business strategies and initiatives. Must understand and respond to emerging legal considerations, enforcement actions, new regulatory requirements, etc. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. This role can be located in Ridgefield, CT or Duluth, GA. **Compensation Data** This position offers a base salary typically between $135,000 and $232,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (***************************************************************** **Duties & Responsibilities** + Daily oversight of the US Transparency & Disclosure program, including setting and managing priorities related to T&D reporting. Accountable for development and submission of US T&D reports (federal, NV, VT, MN, DC, MA, CT, OR, etc.) + Overall program administration and ongoing adherence review, point of contact with business stakeholders on T&D program questions, evaluations of activities for reporting applicability, identify and address gaps in adherence. + Business owner of US T&D policy and US T&D system, a SaaS solution managed by a third party. + Conducts routine analysis of transparency and disclosure activities, including, but not limited to, any spend alerts, fee caps and other metrics to be defined. Development and ongoing measurement against program KPIs. + Together with IT and US E&C operations team, develops and implements communication and training plan and initiatives to ensure transparency and disclosure requirements are disseminated to key personnel including third party partners. + Remains current with all laws and regulations related to transparency and disclosure, including Federal Physician Sunshine Payment Provisions, applicable state laws, and other regulations. **Requirements** Bachelor´s degree from an accredited institution preferred; 5 years Transparency and Disclosure experience with degree, preferably in the Pharmaceutical/ Medical Device industry. OR 8-10 years of Transparency and Disclosure experience without degree. Experience in project management with the ability to manage multiple projects/assignments concurrently. **Eligibility Requirements** Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $135k-232k yearly 60d+ ago
  • Sales Rep/SR Sales Representative, Pets - New Haven, CT

    Boehringer Ingelheim Group 4.6company rating

    New Haven, CT job

    Performs responsibilities in generating sales, market share and profitability results for assigned territory with appropriate direction. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Meets sales objectives and supports attainment of district and regional/ business unit performance objectives Development of market, customer, and industry knowledge along with further development of technical product knowledge is imperative. Effective utilization and management of internal and external resources is expected. Perform customer/consumer training meetings and support convention and professional association business building opportunities. Maintains and utilizes expert product knowledge and highly effective selling skills in order to influence customers to support the use of BIAH promoted products. Executes brand strategies to ensure a consistent company sales and marketing message. Uses appropriate BIAH Sales Training techniques to facilitate the sale. Utilizes CRM tools to create pre-call plans. Keeps current territory records concerning activities; communicates timely, accurately and meaningfully with Management. Utilizes CRM tool and supporting analysis to plan activity, report, monitor samples and maintain customer records. Analyzes territory information to optimize customer calls and create annual business plan for execution. Monitors market conditions for changes that impact our business. Completes objectives including achieving sales plan while operating within specified expense budget. Successfully completes all sales training requirements. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation within the animal health community and internally. Requirements Sales Representative: Bachelor's degree from an accredited institution required. Minimum of two to five (2-5) years of relevant field sales experience in a competitive selling environment required, or a minimum of two (2) years as a degreed, licensed and practicing Doctor of Veterinary Medicine in a clinic or animal health organization. Animal health or related industry experience preferred Ability to work with general supervision General knowledge of industry practices, techniques, and standards Experience presenting to various size audiences Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills PC skills and the ability to use mobile applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Senior Sales Representative: Bachelor's degree from an accredited institution required. Minimum of five-plus (5+) years of relevant field sales experience in a competitive selling environment required Animal health or related industry experience preferred Ability to work with general direction Complete understanding and application of principles, concepts, practices and standards Full knowledge of industry practices Experience presenting to various size audiences Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills PC skills and the ability to use mobile applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older Compensation This position offers a base salary typically between $65,000 and $128,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
    $65k-128k yearly 60d+ ago
  • Executive Director, Experimental Medicine Inflammation - Pulmonology

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    The Excecutive Director has overall medical strategic responsibility for Experimental Medicine Inflammation/Immunology Pulmonology. We are looking for a visionary leader to help shape our newly established Global Experimental Medicine organization. Your mission is to elevate early clinical development, accelerate the path to Proof of Concept, and pave the way for breakthrough therapies. Now is the time to act - to strengthen our organization, empower our teams, and fulfill our responsibility to patients worldwide. Join us in shaping the future of medicine! As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** - In collaboration with the Head of ExpMED of Inflammation and fellow TA leaders, exert medical and scientific strategic leadership for Inflammation / Immunology Pulmonology, with a focus on assets within his/her area of responsibility. - Maintain and spread knowledge of scientific developments, (products, mechanisms, methodologies) competitor strategies and external environment developments within his/her area of responsibility. - Ensures alignment regarding scientific platforms, medical communication and publication strategies as well as the Product Maintenance and Optimization strategies for each substance or project under their responsibility as delegated. - Review and approve final Clinical Trial Reports, Clinical Trial Protocols, scientific publications according to established procedures as delegated. - Ensures the review of the Master Plans, related Clinical Development plans and Clinical Trial Protocols and programs, by the CEG for each substance or project under their responsibility. - Key decision maker in internal committee discussions - Serve as a member of the Inflammation / Immunology Pulmonology Advisory team, responsible for preliminary, clinical evaluation of in-licensing opportunities and oversight of in-depth in-licensing evaluations as delegated by the Head of ExpMED of Inflammation. - Manage employees belonging to his/her team and establish and maintain adequate standards of people management e.g. Training and personal development, communication, interface definition and processes. - Advise, coach and develop his/her teams regarding the preparation of key deliverables within his/her area of responsibility. - Support annual international medical budgeting process as delegated by the Head of ExpMED of Inflammation. **Requirements** - MD or PhD from an accredited institution. - Sound clinical and scientific experience in Inflammation/ Immunology Pulmonology of ten to fifteen (10-15) years (combination of hospital, academic and industry experience), inclusive of senior leadership role/s; Clinical / pharma experience in the US a plus - Strong track record of designing trials that delivered milestones such as PoC (Proof of concept). - Expertise in Immunology translational and clinical research with focus on early clinical development (IND enabling activities through Proof-of-Concept studies), ideally clinical specialization Pulmonology, Allergy, Immunology or related specialty. - Solid relationships with key stakeholders. - Sound medical and scientific leadership - maintains team's focus on high priority items even under constantly changing circumstances. - Proven success leading global teams preferred. - Pragmatic leader that supports and empowers teams to remove hurdles and resolve issues. - Ability to act with grace and resilience under pressure. - Excellent communication, negotiation and influencing skills. - Excellent cross-functional collaboration skills. - Full command of English Language. - Excellent presentation, training and facilitation skills. - Strong track record of interactions with regulatory affairs authority, international societies and other relevant stakeholders. - Situational Responsiveness. - Deals with Ambiguity. - Constantly learns and improves. - Advanced Management and Sound Management Skills. - Strong leadership skills. - Ability to travel globally required **Eligibility Requirements:** - Must be legally authorized to work in the United States without restriction. - Must be willing to take a drug test and post-offer physical (if required). - Must be 18 years of age or older. **Compensation Data** This position offers a base salary typically between $250,000 and $394,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here. (***************************************************************** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $125k-165k yearly est. 60d+ ago
  • Clinical Research Scientist - Breast Cancer Franchise

    Eli Lilly and Company 4.6company rating

    Stamford, CT job

    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. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and comply with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities * Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. * Demonstrate compliance with procedures and be accountable for compliance of team members. * Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. * Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management. * Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. * Collaborate with Global Patient Safety on risk management planning. * Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. * Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. * Participate in data analysis, scientific dissemination, and preparation of final study reports. * Analyze and contextualize clinical data to support decision-making and portfolio strategy. * Contribute to strategic planning and innovation through cross-functional working groups. * Support planning and execution of symposia, advisory boards, and other external engagements. * Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. * Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development * Stay current with medical literature and scientific developments in breast oncology. * Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. * Provide scientific consultation to medical affairs, health outcomes, and commercial teams. * Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development * Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. * Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: * PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience * 3+ years of clinical research scientist experience/clinical trial experience * Direct Line Leadership experience Additional Information/Preferences: * Breast cancer disease state knowledge/experience * An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) * Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. * Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills * Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment. * Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. * Fluent in English, verbal and written communication Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $308,000 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. #WeAreLilly
    $83k-111k yearly est. Auto-Apply 24d ago
  • Senior Principal Business Analyst

    Boehringer Ingelheim Group 4.6company rating

    Ridgefield, CT job

    ELIGIBLE FOR BENEFITS UNDER EMPLOYEE REFERRAL PROGRAM Employer: Boehringer Ingelheim USA Corporation Job Title: Senior Principal Business Analyst Location: 900 Ridgebury Road, Ridgefield, CT 06877 (Telecommuting permitted: work may be performed within normal commuting distance from this office 30% of the time) Job Duties: Develop standard reporting for portfolios and deliver to internal stakeholders. Work with IT Management and give guidance on managing their portfolios (prioritization based on budget and value outcome, realistic demand forecast, track project efficiency / delivery). Foster training and certification initiatives for project managers and capability leads. Identify opportunities and lead efforts to streamline governance processes. Serve as a coach and mentor for project and product teams. Partner with IT functions to ensure flawless execution of cross-functional processes such as project financial processes, purchasing, contract and vendor management, resource management, and legal & compliance. Create and deliver training materials for internal audiences. Improve excellence in execution for project, product and portfolio management and applying innovative and “agile” methodologies. Continuously investigate new approaches and tools. *Telecommuting permitted: work may be performed within normal commuting distance from Boehringer Ingelheim USA Corporation's office in Ridgefield, CT 30% of the time. Description (cont'd) Work Schedule: 40 hours per week (8:00am to 5:00pm) Job Requirements: Master's degree (U.S. or foreign equivalent) in Computer Science, Information Technology, Business Informatics, Management Information Systems, or a related field and five (5) years of experience in the job offered or in a related role OR Bachelor's degree (U.S. or foreign equivalent) in Computer Science, Information Technology, Business Informatics, Management Information Systems, or a related field and seven (7) years of experience in the job offered or in a related role. Must have four (4) years of experience with project management tools and Atlassian tools, including Jira, Confluence, and Microsoft Project. Must have three (3) years of experience with Scrum and Agile methodologies. Must have two (2) years of experience with: Power BI or Tableau; IT project management; and Value Management framework. 10% domestic and international travel required.
    $125k-155k yearly est. 60d+ ago
  • Associate Director, Clinical Development Trial Lead (CDTL)

    Eli Lilly and Company 4.6company rating

    Stamford, CT job

    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. Position Summary: The Associate Director, Clinical Development Trial Lead (CDTL) independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The Associate Director, CDTL consistently demonstrates independent leadership, influence when working with study teams, management, and business partners, and prospective identification of issues and resolution thereof. Project Management, and Regional Operational Knowledge Broader responsibilities at Therapeutic Area/ Molecule/Indication level (e.g. attending relative critical chain network builds, providing input on strategy). Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT) as described: Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make adjustments and changes (per change control process) as needed to meet the deliverables of the trial. Timeline - Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies. Provide consultation and guidance to CDTLs on their integrated plans. Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan. Budget - Understand the cross-functional, trial-level budget components. Create and monitor the budget grants and non-grants, and assumptions using financial tracking tools. Routinely network with appropriate business partners on trial-level budget status and changes. Function as point of contact for other CDTLs on their clinical team as needed regarding budget items. Lead, influence and project manage large, complex studies and/or multiple smaller studies. Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs). Independently drive and influence local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including proactive issue management, contingency planning and issue resolution. Drive to solutions across the molecule/program. Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET) Partner with the Regional Operations to achieve regional enrollment goals. Foster relationships and serve as a single point of contact and central owner for trial communication, to and from the organization, regional clinical operations, and Third-Party Organizations (TPOs). Effectively manage and influence upward. Anticipate and resolve complex and key technical operational or business problems with cross-functional study team (including vendors, affiliates/regions, global team members, and other business partners) with little to no need for direct management support. Evaluate and identify issues that require escalation. Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc. Use expertise to make timely decisions for ambiguous and complex situations. Uphold a consistent, solution-oriented approach to conducting daily business. Demonstrate credibility and influence to enable teams and multiple business partners, both internally and externally, to make effective and timely decisions. Manage TPO (third party organization) qualification process, selection, and oversight. Serve as the CRO (Clinical Research Organization) clinical development point of contact for outsourced and fully outsourced trial execution. Ensure CRO delivery of project milestones. Clinical Trial Process Leadership and Expertise Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise in order to influence study design and program-level decisions considering regional needs. Recognize inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise across functional teams, regions, and external partners and make decisions on process and issues affecting study implementation and execution. Be knowledgeable on the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams. Single point of accountability for the Trial Master File for assigned trials, working closely with functional record owners to ensure the file is current and inspection ready at all times. Ensure inspection readiness of respective clinical trial(s). Ensures timely documentation of deviations, creation of story boards or issue summary documents (e.g. for high-risk areas/hot topics) and coaches CDTLs in these activities. Network and apply expertise to anticipate trial and regional issues, identify areas of process breakdown, analyze situations and propose innovative approaches that positively impact ability to deliver the clinical trial while reducing and/or mitigating risks, and share process learnings. Contribute to the development of others by acting as a coach for peers as well as new CDTLs, cross-functional team members and TPOs on aspects of CT process and regional specificities. Maximize shared learning opportunities within their clinical team capitalizing on best practices. Identify and lead process improvement activities. Acts as a CDTL SME resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as science allows. Lead decisively in the midst of ambiguity. Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools. Be instrumental in driving regional clinical operational processes and methodologies used. Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements. Independently detect and resolve quality issues, escalating to functional leadership or consulting other functions (e.g., Medical Quality, Legal, Compliance, etc.) to arrive at the best solution. Scientific Expertise Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates. Combine scientific regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation. Leverage clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business. Function as point of contact for Therapeutic Area and/or disease state expertise for others on their clinical team. Minimum Qualification Requirements: Bachelor's degree (scientific or health-related field preferred) 5+ years clinical research experience or relevant experience in a scientific or health-related field Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position Highly Desired Skills: Experience with oncology Experience with radioligand therapy (RLT) Applied knowledge of project management methodology, processes and tools Demonstrated ability to lead and work effectively cross-culturally with global colleagues and with TPOs Be recognized as a leader with demonstrated ability to coach others in process expertise. Embrace strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities Ability to influence without authority Previous experience working in cross-functional teams/ projects and/or ability to establish and maintain relationships Effective and influential communication, self-management, and organizational skills Demonstrated ability to handle complex situations through problem-solving, critical thinking and navigating ambiguity Other Information/Additional Preferences: Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process Prior clinical trial site-level or affiliate experience Prior experience with local/country regional requirements Strong analytical skills Proficiency in use of project management tools and techniques (e.g., Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI) Need to travel periodically to scientific/regional meetings Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $122,250 - $179,300 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. #WeAreLilly
    $122.3k-179.3k yearly Auto-Apply 2d ago
  • Director, US Product Group Regulatory Affairs

    Boehringer Ingelheim 4.6company rating

    Ridgefield, CT job

    As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. *This role requires you to work on a hybrid schedule meaning 2-3 days per week at our Ridgefield, CT location* For assigned development projects and US marketed products, the Director, US Product Group Regulatory Affairs will provide expert US regulatory leadership to the global and US cross-functional teams throughout the product lifecycle. This role will provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance. As a member of the Regulatory Excellence Team, the position holder will provide US regulatory input into the Global Regulatory strategy for assigned projects and represent US RA on US cross-functional teams. The Director, US Product Group Regulatory Affairs will act as primary company liaison with the US Food and Drug Administration. This role will develop comprehensive, well-thought through US regulatory strategies to navigate the intricate US regulatory landscape, ensuring compliance with relevant guidelines and regulations. The incumbent will assess regulatory risks, options, and opportunities, anticipate potential challenges and propose innovative solutions to accelerate the development and approval process, leveraging the full breadth of US regulatory pathways. This role will collaborate closely with US stakeholders to align US regulatory strategies with the overall business objectives. The Director, US Product Group Regulatory Affairs will maintain current expertise on developments in the assigned therapeutic area from a global regulatory, legislative, scientific, pharmaceutical, pharmacovigilance, market access and commercial perspective. This role will engage in US regulatory policy development and foster external stakeholder interactions. The incumbent will provide expertise on regulatory standards and departmental policies. The Director, US Product Group Regulatory Affairs will proactively participate in US/global cross-functional meetings and discussions, ensuring that US regulatory considerations are incorporated timely and comprehensively at key inflection points and in the decision-making process. This role is an advocate for US regulatory excellence and drive alignment between regulatory strategies and overall project and business goals. **Duties & Responsibilities** Regulatory Professionalism: + Seamlessly interacts and collaborates effectively at all levels organization (local and global) within RA and across functions. + Advocates to effectively, efficiently and proactively drives project goals, presenting well-grounded, strategically thought-through options and arguments to independently achieve success regulatory outcomes. + Maintains the highest stands of professionalism, ethics, and regulatory compliance. Regulatory Excellence Team (RET)and Intra-RA Project Responsibilities: + Recognized expert in contributing a broad range of US operational and strategic perspectives to Regulatory Excellence Team (RET). + Actively collaborates with RET to align regulatory strategies with product development plans. + Proactively provides regulatory input and options during all stages of product development to ensure potential challenges and requirements are addressed from the start. + Jointly problem-solves to address issues and find innovative solutions that align with business objectives while meeting regulatory standards. Shares successful use cases, where applicable. + Provides regular updates on US regulatory milestones and their impact on the overall project timelines. + Presents or supports review of US-specific regulatory topics to Regulatory Expert Group (REG), as appropriate. + Independently ensures US RA contributions to all local and global project related documentation (e.g., Global RA Strategy, Risk Assessments, Labeling) are clear, complete and accurate, taking on leadership of the content/information, as appropriate. Other Regulatory Contributions: + Provides US regulatory leadership in the preparation, content, and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with input/guidance from management, GRSL, US Legal, and PSPV, as appropriate. + With supervision, represents US RA during internal and external audits and Health Authority inspections. Pre-evaluations and External Partnerships: + Provides expert US regulatory input and guidance to internal and external pre-evaluation teams (e.g., Due Diligence) and contribute to assessment reports. + For projects with a CRO or licensing partner, provides and implements US RA strategic and operational perspectives/tasks, as appropriate. US-Focused Project Support: + Leads the development of IND/NDA/BLA submission ready documents, including but not limited to briefing packages, Special Designation Requests, etc. + Prepares and reviews IND/NDA/BLA annual reports (e.g., DSURs/PSURs) and PBRERS/PADERS with a focus on US specific sections. + Ensures compliance with submission in accordance with regulatory timelines. + Provides US strategic regulatory guidance and input to key internal development, registration and commercialization documents for assigned projects (e.g., development plans, protocols, clinical trial reports, pediatric development plans, core dossier elements, integrated brand plans, market access documents), with particular emphasis on the US contribution. + Provides seasoned US regulatory strategic guidance and inputs leadership and advice to US cross-functional teams during development, registration, and marketing approval for complex programs. + As a member of the Product Labeling Review Team (PLRT), provides seasoned US RA strategic input and leadership in line with approved processes to prepare initial proposed draft labeling for submission to FDA ensuring appropriate supportive information is provided. **Requirements** + Bachelor's Degree in life sciences, pharmacy, or chemistry with extensive drug development experience/knowledge with a minimum of ten (10) years' experience in Regulatory Affairs, FDA, or equivalent experience in the regulated pharmaceutical industry (biologics or small molecules) required. OR + Doctoral Degree (e.g. PharmD, PhD) and/or Master's Degree in life sciences, pharmacy, or chemistry, with drug development experience/knowledge with a minimum of eight (8) years of experience in Regulatory Affairs, FDA, or equivalent experience in the regulated pharmaceutical industry (biologics or small molecules) preferred. + Expertise in multiple therapeutic areas and broad range of regulatory and drug development topics. + Applies advanced critical thinking with the ability to self-direct workload, including prioritization and timely execution of deliverables in a fast-paced regulatory setting. + Lead team performance under pressure, cultivates a culture of adaptability, and leads strategic responses to regulatory and organizational shifts. + Demonstrated advanced interpersonal skills, sound-decision making, and leadership capabilities, fostering strategic partnerships and influencing cross-functional stakeholders across the organization. + Navigates complex, matrixed environments with agility, reprioritizing effectively in response to shifting regulatory and business landscapes. + Applies seasoned negotiation and conflict resolution skills to align teams and drive regulatory outcomes that support organizational objectives. + Drives strategic negotiations and proactively addresses high-impact regulatory issues, balancing risk and opportunity while aligning with organizational priorities and business strategy. + Excellent oral and written communication skills with the ability to provide key messages in a concise manner. + Exceptional organizational and time management skills to oversee multiple strategic projects and initiatives simultaneously. Ensures timely execution of high-impact deliverables, drives operational excellence, and maintains composure and focus under pressure in complex, fast-paced regulatory environments. + Strong strategic mindset & thinking, with the ability to step out of everyday details and provide a top-down view. + Can-do attitude and a proactive approach to work, demonstrating a willingness to take ownership and find solutions for addressing opportunities. + Demonstrated understanding of the regulatory process and technical competence in core areas of drug development. + Leads the interpretation of scientific and regulatory data across projects, translating insights into actionable strategies that align with local/global regulatory expectations and business objectives. + Advanced proficiency in regulatory information management systems (RIMS), electronic document management systems (EDMS) and submission software (e.g., eCTD tools), along with advanced skills in Microsoft Office Suite. + Excellent meeting preparation and presentation skills. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Desired Skills, Experience and Abilities** Additional Duties & Responsibilities: + Leads all FDA interactions on assigned complex projects/products, including formal meetings, FDA review of registration packages, and labeling negotiations. + Establishes and implements US regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RET. + In collaboration with the RET and project teams, leads development of FDA submission documents (e.g., briefing documents), through defining US-specific questions and content. + Provides seasoned regulatory leadership to ensure alignment with global and US team/management, as appropriate, in preparing FDA request responses. + Disseminates FDA interactions within organization, as appropriate. + Manages all formal submissions and informal communications to FDA for assigned projects/products, including INDs and marketing authorization applications for complex programs. + Recognized expertise in regulatory intelligence for assigned therapeutic area. + Proactively and critically evaluates relevant US regulations and guidelines, as well as evolving regulatory trends and developments to determine impact on existing strategies, products and submissions. + Proactively communicates the impact of regulatory changes to internal stakeholders and provide recommendations on adapting regulatory strategies, as appropriate. + Provides input on the development of contingency plans for assigned projects as necessary. + Provides timely risk/benefit analyses (including pros & cons, potential options and assessment of business implications) of issues affecting products/projects by continued monitoring of available US regulatory and competitor information. + Shares new/novel "on the job" US regulatory intelligence/experience with peers, as appropriate. + Drafts and presents overviews of US regulatory topics, as appropriate. + Independently engages and represents Boehringer Ingelheim with external industry/consortia per department and TA needs. + Independently interfaces and represents US RA with cross functional working groups and/or Gov't Affairs on specific topics, as needed. + Engages in proactive and collaborative relationships to stay informed about evolving regulatory expectations, provides input on policy developments, and contributor to shaping US regulatory framework for better patient outcomes. + Collaborating with GRSL and RET, provides seasoned leadership in the development and implementation of US regulatory strategy within a global development context including complex projects. + Independently assesses and presents US regulatory risks, strategic options and opportunities to support assigned global development projects and Asset Maximization. + Anticipates potential challenges and propose innovative solutions to accelerate the development and approval process leveraging the full breath of expedited regulatory pathways and most up-to-date regulatory science. + Defines US RA strategic considerations in the generation of global project related documents (e.g., Global RA Strategy, Risk Assessments). + Collaborates with US/Global Labeling on early target label profile shaping, to ensure labeling is aligned with regulatory requirements and business objectives (e.g., competitive differentiation). This position offers a base salary typically between $220,000 and $350,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (***************************************************************** All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $97k-124k yearly est. 43d ago
  • Cardiovascular-Renal Sales Consultant (Overlay) - Hartford, CT

    Boehringer Ingelheim Group 4.6company rating

    Hartford, CT job

    The Cardiovascular-Renal Sales Consultant is responsible for partnering in developing and implementing a plan for brand sales growth of BIPI and co-promoted cardio-renal-metabolic (CRM) products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The Cardiovascular-Renal Sales Consultant will conduct their business with key targeted healthcare providers (Cardiology specialists/Nephrology specialists/Advanced Practice Clinicians and Allied Healthcare Professionals). The consultant will have additional responsibilities for sales activities in teaching and community hospitals, federal and military hospitals, heart failure clinics, managed health care facilities, and integrated delivery networks, etc. utilizing in-person and/or digital/virtual platforms. The CR consultant is also responsible for generating advocacy for BI products with Key Decision Makers in the hospital accounts they are responsible for. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Compensation Data This position offers a base salary typically between ($95K) and ($153,100k). The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here. Duties & Responsibilities Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Leverages knowledge of cardiology, nephrology, diabetes, and the marketplace to anticipate and effectively manage business opportunities and challenges. Demonstrates knowledge of the disease state, key drivers, influencers, and prescribing patterns in territory. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. Works effectively with all customer-facing roles (i.e.. account teams, medical teams, etc.) in each geography to meet customer needs and deliver net sales objectives. Demonstrates knowledge of BIPI cardio-renal-metabolic (CRM) products and related marketplace, effective translation of product knowledge into the sales presentation and is customer focused with a priority directed towards providing solutions-based customer interactions. Delivers high level of clinical and technical value to his/her customers, assisting the health care customer in meeting their unique patient care needs, all within BI regulatory guidelines. As a trusted CR Consultant, encourages and receives requests from customers for technical information outside of standard visits. Through all these endeavors, develops trust and subsequent value with customers. Drives appropriate utilization of approved Cardiovascular-Renal products. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. CR Consultant works closely with other commercial associates to generate pull-through within local payers, hospitals, community Health Care Providers. Fosters cardio-renal customer network development and communication. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. The CR consultant must demonstrate the ability to engage with customers through a variety of digital media and platforms (live, remote video conference, marketing email etc.) and integrate digital assets and strategies into broader territory-level business plans. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. Supports the efforts in various care settings to include appropriate pull through of protocols, pathways, order sets, formularies, treatment algorithms, transition of care, and population health management initiatives to assist with the delivery of optimal care. Requirements This is a dual level posting. Candidates will be hired at the level commensurate with their experience and business need. Cardiovascular-Renal Sales Consultant Requirements: Bachelor's degree preferred. At least three (3) years of experience in pharmaceutical sales of which one-plus (1+) years of experience in the promotion of cardiovascular and/or diabetes and/or nephrology pharmaceuticals. Hospital and/or Account Management experience preferred. History of successful performance. Meets expectations for the key competencies required for this role. Proficiency in Excel, Word, Outlook, and database applications. Ability to travel (may include overnight travel). Should reside in territory geography or be willing to relocate. Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental vehicle. Executive Cardiovascular-Renal Sales Consultant I Requirements: Bachelor's degree preferred. At least five (5) years of experience in pharmaceutical sales of which two-plus (2+) years of experience in the promotion of cardiovascular and/or diabetes and/or nephrology pharmaceuticals. At least one-plus (1+) Hospital and/or Account Management experience required. History of successful performance. Meets expectations for the key competencies required for this role. Proficiency in Excel, Word, Outlook, and database applications. Ability to travel (may include overnight travel). Should reside in territory geography or be willing to relocate. Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental vehicle. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Who we are: At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family-owned company, we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative, and inclusive culture. Learning and development for all employees is key because your growth is our growth. Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $95k yearly 60d+ ago

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