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You Lead the Way. We’ve Got Your Back.
With the right backing, people and businesses have the power to progress in incredible ways. When you join Team Amex, you become part of a global and diverse community of colleagues with an unwavering commitment to back our customers, communities and each other. Here, you’ll learn and grow as we help you create a career journey that’s unique and meaningful to you with benefits, programs, and flexibility that support you personally and professionally.
At American Express, you’ll be recognized for your contributions, leadership, and impact—every colleague has the opportunity to share in the company’s success. Together, we’ll win as a team, striving to uphold our company values and powerful backing promise to provide the world’s best customer experience every day. And we’ll do it with the utmost integrity, and in an environment where everyone is seen, heard and feels like they belong.
If you have a strong will to learn and educate, as well as are motivated by the opportunity to help grow our team and be a part of an industry-leading technology and innovation organization, then look no further! This is an opportunity to use Data Science, A.I./Machine Learning, and Technology skills to solve very interesting problems that directly and greatly impact millions of individuals worldwide.
Join Team Amex and let's lead the way together.
If you have a strong will to learn and educate, as well as are motivated by the opportunity to help grow our team and be a part of an industry-leading technology and innovation organization, then look no further! This is an opportunity to use Data Science, A.I./Machine Learning, and Technology skills to solve very interesting problems that directly and greatly impact millions of individuals worldwide.
You will be leading an energetic A.I./Machine Learning cross-functional team, collaborating with various business/product partners (e.g. Credit, Fraud, Risk, Web, Mobile, Marketing, Enterprise Automation, etc.) to drive a cohesive set of solutions enabling the ever-growing strategic capabilities in the AI field.
This role within American Express Technology (AET), will report into the Vice President, Enterprise Services Decision Science Center of Excellence (CoE).
Responsibilities:
Qualifications:
Expert in at least one of the following fields:
Hands-on Experience with most of the following open-source solutions:
Development:
Official account of Jobstore.
I am presently representing a company in their search for a Quality Assurance Leader to bolster their ambitious business expansion endeavors. The selected candidate will be entrusted with spearheading a team of QA professionals to bolster the company's achievements and successes.
1. Team Leadership:
2. Driving change and transformation:
3. Collaboration and Stakeholder Engagement:
4. Operational Success
To apply, submit your most updated resume showcasing relevant qualifications and experience.
We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
Official account of Jobstore.
WhatsApp: +65 90820021 (Kyler)
Email: kylergan.supreme@gmail.com
Report to CEO
Main Duties & Responsibilities:
Requirements:
The Supreme HR Advisory Pte. Ltd | 14C7279
Gan Kai Le | R23112683
Official account of Jobstore.
We are looking for an experienced Food Science and Innovation Director with passion for food, people and innovation, who can generate and manage major innovation projects.
This critical role oversees the development of innovative products from conceptualization to commercial launch. They oversee all aspects of the NPD process including identifying market trends and opportunities, managing projects and teams, developing intellectual property, bringing new products and services to market, and evaluating opportunities for licensing or acquisition.
Accountabilities:
Minimum Skills Required:
Official account of Jobstore.
You Lead the Way. We’ve Got Your Back.
With the right backing, people and businesses have the power to progress in incredible ways. When you join Team Amex, you become part of a global and diverse community of colleagues with an unwavering commitment to back our customers, communities and each other. Here, you’ll learn and grow as we help you create a career journey that’s unique and meaningful to you with benefits, programs, and flexibility that support you personally and professionally.
At American Express, you’ll be recognized for your contributions, leadership, and impact—every colleague has the opportunity to share in the company’s success. Together, we’ll win as a team, striving to uphold our company values and powerful backing promise to provide the world’s best customer experience every day. And we’ll do it with the utmost integrity, and in an environment where everyone is seen, heard and feels like they belong.
If you have a strong will to learn and educate, as well as are motivated by the opportunity to help grow our team and be a part of an industry-leading technology and innovation organization, then look no further! This is an opportunity to use Data Science, A.I./Machine Learning, and Technology skills to solve very interesting problems that directly and greatly impact millions of individuals worldwide.
Join Team Amex and let's lead the way together.
If you have a strong will to learn and educate, as well as are motivated by the opportunity to help grow our team and be a part of an industry-leading technology and innovation organization, then look no further! This is an opportunity to use Data Science, A.I./Machine Learning, and Technology skills to solve very interesting problems that directly and greatly impact millions of individuals worldwide.
You will be leading an energetic A.I./Machine Learning cross-functional team, collaborating with various business/product partners (e.g. Credit, Fraud, Risk, Web, Mobile, Marketing, Enterprise Automation, etc.) to drive a cohesive set of solutions enabling the ever-growing strategic capabilities in the AI field.
This role within American Express Technology (AET), will report into the Vice President, Enterprise Services Decision Science Center of Excellence (CoE).
Expert in at least one of the following fields:
Hands-on Experience with most of the following open-source solutions:
Development:
Official account of Jobstore.
Manage and deliver analytics benchmarking reports from conception to completion with actionable insights and recommendations.
High interaction with external clients and manage internal and external stakeholders.
Define detailed scope and methodology, creating and executing on the framework with appropriate data mining techniques
Work with the broader Visa data science team to create data driven solutions.
Focus on building data science visualization capabilities to solve client's problems.
Drive innovation through using data science techniques
Act as data science advocate within our partners, advising and coaching analytical teams and sharing best practices and case studies.
Continually look at the environment to challenge our assumptions around new sources of data, potential analytics partners, tools, talent and infrastructure.
Explore leading methodologies and best practices to other teams and importing successful methodologies from other international markets
This is a hybrid position. Hybrid employees can alternate time between both remote and office. Employees in hybrid roles are expected to work from the office 2-3 set days a week (determined by leadership/site), with a general guidepost of being in the office 50% or more of the time based on business needs.
Official account of Jobstore.
Job Description
Our Artificial Intelligence and Machine Learning (AI/ML) capabilities are vital catalysts for our mission to invent new medicines that save and enhance lives. The Data, AI, and Genome Sciences (DAGS) function at our organization adopts an AI/ML-first approach to enhance target and biomarker discovery by driving the understanding of complex disease mechanisms. As the Director of Data Science and AI, Data Lead, you will leverage your expertise in genomic technologies, multi-omics data, and computational and AI/ML techniques to drive the development of a scalable, FAIR data infrastructure and evidence-based knowledge graph. You will collaborate with Computational Biologists, Bioinformaticians, Data Scientists, Software Engineers, and AI/ML Engineers as part of a cross-functional team dedicated to identifying therapeutic targets. You will report to the Executive Director and Head of AI/ML.
Primary Responsibilities:
Provide guidance for the data strategy to support target and disease biology discovery, collaborating with cross-functional teams to understand project goals and data requirements.
Serve as a subject matter expert to AI/ML Scientists and Engineers, providing guidance on data, data pipelines, and disease biology.
Take ownership of the framework for data specifications and processes for integrating different data modalities (multi-omics, high-throughput screening data, clinical data, images) from internal and external sources into a Common Data Model for computational and AI/ML-driven target discovery.
Lead the development of data specifications and processes for a multi-modal Knowledge Graph by integrating information from internal and external data and knowledge bases for analytical and AI/ML model consumption.
Work with different data producers and owners to implement framework and processes effectively.
Collaborate closely with product and engineering teams to design and implement data management strategies ensuring the quality, organization, and accessibility of our multi-omic data.
Required Experience and Skills:
PhD in a relevant field such as computational biology, bioinformatics, systems biology, or a related discipline, with 8+ years of experience in genomic technologies, multi-omics analysis, therapeutics sciences, and disease biology OR MS in relevant field with 10+ years of experience OR BS in relevant field with 14+ years of experience
Strong understanding of multi-omic data, including analysis techniques, algorithms, statistical approaches, and relevant tools.
Proficiency in programming languages such as Python or R, with experience in data analysis and machine learning libraries.
Good knowledge of cloud-based infrastructure such as AWS.
Demonstrated experience in developing and implementing standardized analytical workflows and processes.
Excellent communication skills and ability to work collaboratively in a multi-disciplinary team.
Preferred experience:
Experience with Knowledge Graphs, including graph databases and query languages, would be advantageous.
Hands-on experience with omics data generation is a plus.
Strong track record of publications in peer-reviewed journals, patents, or other evidence of innovative expertise.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
#EligibleforERP
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management, Software Development, Stakeholder Relationship ManagementPreferred Skills:
GenomicsOfficial account of Jobstore.
The Role:
The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for a commercial product, including most notably, post-approval variations. The Associate Director will be responsible for developing US regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with US regulatory requirements and business priorities. The individual will be expected to provide guidance to CMC teams and collaborate within the Global Regulatory CMC team. The Associate Director will be responsible for preparation of CMC and Quality related agency correspondence and regulatory submissions. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on maintaining a new, transformative medicine for patients. The Associate Director will be based at the Norwood, MA site.
Here’s What You’ll Do:
Develop/implement effective regulatory CMC strategies for US submissions (ex. CMC PAS, CBE-30) and identify regulatory risks
Provide regulatory CMC advice to manufacturing and quality teams,
Review documents for submission-readiness, to ensure that all submissions conform to US regulatory requirements,
Lead regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions,
Assess change controls,
Support development of regulatory processes and procedures,
Support the creation and maintenance of CMC submission tools and templates,
Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
Here’s What You’ll Bring to the Table:
BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
5+ years of experience in Biologics focused Regulatory CMC
Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions,
Knowledge of current CMC regulations outside of the US, as well, is preferred,
Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects of drug development, product registration, and post-approval lifecycle management (LCM),
Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet critical regulatory milestones
Ability to work independently
Exceptional written and oral communication
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
#LI-LG1-
Official account of Jobstore.
Job Description
Our company is a leading global pharmaceutical company dedicated to improving the health and well-being of people around the world. With a rich history spanning more than a century, our company focuses on discovering, developing, and delivering innovative products spanning both the human and animal health domains. Committed to scientific excellence, our company invests heavily in research and development to advance medical science and provide effective solutions for patients. Through collaboration, innovation, and a patient-centric approach, our company strives to make a meaningful impact on global healthcare by providing high-quality, safe, and accessible treatments.
Based in the Global Animal Health Manufacturing, the Manufacturing Data Science team is looking for a Bio-statistician to join our team. The team plays a critical role making data-informed manufacturing decisions spanning all key areas within manufacturing e.g., quality control, maintenance, yield optimization, regulatory filing for new products, and deviation management etc.
As a Bio-statistician in the Manufacturing Data Science team, you will perform the following activities:
How we see an ideal candidate:
What we offer:
Ready to take up the challenge? Apply now!
Know anybody who might be interested? Refer this job!
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Data Modeling, Data Science, Project Management, Stakeholder Relationship Management, Statistical Analysis Techniques, Statistical Process Control (SPC)Preferred Skills:
Official account of Jobstore.
Are you an experienced high-level Assistant who is interested in working in an unique environment? Keen to join a department which is at the forefront of SMG's ambitious plans for the future?
About the role
As Executive Assistant to the Director of Estates and the Director of Masterplan, you will have an intimate viewpoint of the organisation and the 5 museums within the Group.
Diligently supporting both Directors, you will managing diaries and often act as first point of contact with inbox management. You will also lead the organisation, support and minuting committees and other instrumental meetings. The glue to the efficient management of a proactive and inspired office, you will communicate on behalf of the Directors with key external contacts, and with colleagues at all levels across the organisation.
The role has real scope for impact - consisting of managing a complex and diverse workload to tight deadlines, and with your own projects to lead. Using your expert judgement, you will proactively manage the correspondence and schedule of the Directors, to ensure the skilful co-ordination of their activities across the Group.
We can offer a hybrid working patter for this position, with a mix of office and home working, however you will need to be able to work from our Manchester site 3 days a week.
Contract: Permanent, Full time 35hour per week
Salary: up to £30,500 per annum, depending on experience
Download the Vacancy Information Pack file under 'Attachments' on this vacancy listing on the Science Museum Group website for more details about the role and the application process.
About you
Highly proactive and confident working with colleagues across all levels of the organisation, as well as the offices of high-profile external leaders - You have exceptional interpersonal and communications skills to maintain positive working relationships with stakeholders at all levels. With extensive experience of prioritising and managing multiple and conflicting tasks, diaries and deadlines; responding flexibly to requests, you have a pre-emptive approach to time management that of your own as well as others.
You have a demonstrable ability to take minutes, ideally for board level audiences, to a professional, accurate standard; with the capacity to produce minutes in a timely manner and convert technical jargon to relevant audiences. Resourceful by nature, you can take the reins to draw together people and resources needed to make things happen, with little supervision.
Crucially, you will be highly organised and efficient, with good attention to detail, and an ability to show tact and discretion.
Don't feel you meet all the criteria? We welcome you to apply even if your experience doesn't match perfectly. With your transferable skills, you could be the right candidate for this, or other opportunities that we have.
What we offer
Joining us as an employee, you will have the opportunity to develop your career in a world-class museum group. We understand that work/life balance and wellbeing is crucial to our colleagues, so we offer the perks listed below, as well as support for things that happen in life such as parental and adoption leave, sickness, and career breaks.
Open for All is one of the Science Museum Group's five core values and sets out our important aspiration to be a place for everyone. We are working hard to understand our organisation better and to foster a culture that recognises and values different backgrounds, mindsets, skills, experience, knowledge, and expertise. By having greater diversity, we believe that we will be a stronger and better organisation, capable to continue to Inspire Futures.
Official account of Jobstore.
If you’re looking for a special place to build or grow your career, you’ve found it. Whether you’re an experienced professional, a recent college graduate or somewhere in between, IDEX is a place where you can apply your existing skills and learn new ones in an environment where you can make an impact.
With interesting opportunities in engineering, marketing, sales, supply chain, operations, HR, finance, and more across more than 40 diverse businesses around the globe, chances are, we have something special for you.
If you are looking for a career where you can aspire to grow while contributing to the science and having an impact on improving lives, be a part of our Integrated Analytical Solutions team. We help our customers solve problems directed at treating human disease and protecting the environment as we aspire to change the way the world innovates.
As a business unit of IDEX Corporation, IH&S has a long history of driving growth in life sciences and healthcare by embracing innovation and redefining the supplier-customer partnership. The work we do every day allows us to discover key insights and break new ground to create some of the most meaningful technologies that have a lasting impact on companies, industries, and society. One of our business segments in IH&S is Life Science Fluidics, Integrated Analytical Solutions and we are looking to add more talent to our team.
POSITION SUMMARY
The Director of Product Management is a global position leading a team of seasoned product managers responsible for the growth and profitability of the Integrated Analytical Solutions business line portfolio. The Product Managers own the various fluidic product lines life cycle management and work cross-functionally in the development of high-performance fluidic components and sub-assemblies for the LC-MS market analytical and sample prep workflows.
Responsibilities include team leadership, product portfolio strategy and day-to-day execution for our business. This cross-functional role will work together with our Sales, Marketing, Engineering and Operations teams to support the business line. This position is an integral part of the business unit’s leadership team and requires leadership coaching and development of direct reports.
A strong track record in product management, product life cycle management, strategic planning, roadmap design, pricing excellence, product development, customer relationship management, and outstanding team leadership skills is critical to success. You will need to be a self-directed, highly motivated individual with strong business acumen as well as have technical understanding of life science markets. Domestic and international travel of up to 25% is required.
The Director of Product Management will drive sustained growth and profitability of the Integrated Analytical Solutions portfolio. This is achieved by establishing best practices and processes for your direct reports, which includes, owning the global portfolio strategy and contributing to the business line strategic plan. You will also lead activities associated with setting the Annual Operating Plan (AOP) including, reporting, and orders forecasting.
WHAT WILL YOU DO?
WHAT DO WE NEED?
CHARACTERISTICS:
Are you ready to join a different kind of company where our people, our culture, and our commitments are centered around providing trusted solutions that improve lives around the world?
Total Rewards
The compensation range for this position is $147,800.00 - $221,800.00, depending on experience. This position may be eligible for performance based bonus plan.Benefits Package
Our comprehensive U.S. benefit offerings include: Health benefits, 401(k) retirement savings program with company match, PTO, and more. More information on our benefits and rewards can be found on our career page: https://www.idexcorp.com/careers/our-benefit-and-rewards/
IDEX is an Equal Opportunity Employer and Affirmative Action Employer. IDEX gives consideration for employment to qualified applicants without regard to race, color, religion, creed, genetic information, sex, sexual orientation, gender identity or expression, marital status, age, national origin, disability, protected veteran status, or any other consideration or protected category made unlawful by federal, state or local laws (Minorities/Females/Protected Veterans/Disabled).
Attention Applicants: If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, please let us know. Likewise, if you are limited in the ability to access or use this online application process and need an alternative method for applying, we will determine an alternate way for you to apply. Please contact our Talent Acquisition Team at lfcareers@idexcorp.com for assistance with an accommodation. These contact tools may be used only by individuals with a disability for accommodation requests. Do not inquire as to the status of an application.
Official account of Jobstore.
Statistical Science Director -Late Oncology
Location: Macclesfield (UK)
Competitive salary and benefits
Open to part-time workers, minimum 0.8FTE
Play a critical role in making our pipeline accessible to patients.
We are open to discussing working part-time (min 0.8FTE)
Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies.
Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.
We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you'll be involved in countless submissions and a wide range of engaging projects along the complete drug development process.
Main duties and responsibilities
In this role you will be responsible in leading the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an AZ product team.
You will provide leadership to statistical staff on the indications/projects so that all work is carried out with regards to AZ standards and external regulations; through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions; quantifying the benefit, risk, value and uncertainty of the emerging product profile.
You will be holding CRO/Partners accountable for the high quality standards of their deliverables. You will represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications.
You will apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration. You will mentor/coach and support the education and training of Statistics staff in the technical arena.
Requirements
Essential
Why AstraZeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
So, what's next?
Where can I find out more?
Date role opened: 11th March 2024
Date role closed: 4th April 2024
Official account of Jobstore.
Statistical Science Director - Early Oncology
Location: Macclesfield (UK)
Competitive salary and benefits
We are open to discussing working part-time (min 0.8FTE)
Play a critical role in making our pipeline accessible to patients.
Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies.
Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.
We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you'll be involved in countless submissions and a wide range of engaging projects along the complete drug development process.
Main duties and responsibilities
In this role you will be responsible in leading the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an AZ product team.
You will provide leadership to statistical staff on the indications/projects so that all work is carried out with regards to AZ standards and external regulations; through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions; quantifying the benefit, risk, value and uncertainty of the emerging product profile.
You will be holding CRO/Partners accountable for the high quality standards of their deliverables. You will represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organisations for specific projects/indications.
You will apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration. You will mentor/coach and support the education and training of Statistics staff in the technical arena.
Requirements
Essential
Why AstraZeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
So, what's next?
Where can I find out more?
Date advert opened: 11th March 2024
Date advert closed for applications: 4th April 2024
#CTord
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The Role:
The Senior Director, CMC Regulatory Affairs will be responsible for managing a team of experts responsible for regulatory CMC activities through all stages of the lifecycle for product in their portfolio. The team will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The Senior Director will be required to oversee the activities of the team, including review and approval of CMC and Quality related agency correspondence and regulatory applications for all the products in their portfolio. The individual will be expected to actively participate in cross-functional governance teams for topics relevant for products in their portfolio. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Effective communication skills will be critical to overall success. The individual will also be responsible for mentoring and development of members of their team. The Senior Director will be based at the Norwood or Cambridge, MA site.
Here’s What You’ll Do:
Lead a team to develop/implement effective CMC regulatory strategies for submissions
(e.g. IND/CTA/BLA/MAA) and identify regulatory risks
Provide expertise for regulatory CMC aspects of product development projects
Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines and meet the need of the company
Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions at the expert level
Develop regulatory processes and procedures to support CMC components of regulatory submissions
Support the creation and maintenance of CMC submission templates
Provides CMC regulatory expertise to manufacturing and quality teams; evaluates CMC change controls
Provides interpretation of domestic and international regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs. Be a site expert.
Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) and drive Reg CMC strategy successfully
Here’s What You’ll Bring to the Table:
Minimum Qualifications
MS/PhD degree in a scientific/engineering discipline
10+ years of experience in the pharmaceutical/biotech industry
8+ years of experience in Regulatory CMC, including DMF/ASMF submissions
Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions
Strong knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance
Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
Prior management experience required
Exceptional written and oral communication
Preferred Qualifications
MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable
10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
8+ years of experience in Biologics focused Regulatory CMC
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
#LI-LG1-
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Statistical Science Associate Director (Principal level) - Late Oncology
Location: Macclesfield, UK
Competitive salary and benefits
We are open to discussing working part-time (min 0.8FTE)
Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact the early phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies.
Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.
We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you'll be involved in countless submissions and a wide range of engaging projects along the complete drug development process.
What you will do:
You will be expected to:
Depending on your experience, the role may also include:
We offer the chance to influence drug development and the opportunity to gain experience across a range of challenging and exciting projects.
Essential in the role:
Desirable in the role, dependent on experience:
Why AstraZeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
So, what's next?
Where can I find out more?
Date role opened: 11th March 2024
Date role closed: 4th April 2024
Official account of Jobstore.
