3,727 Project Management Expertise jobs in the United States

Job Details

Your work will change lives. Including your own.

The Impact You'll Make

At Recursion, our mission is to industrialize and transform the development of medicines by integrating data-driven insights and advanced analytics throughout the entire development lifecycle. As Director, Asset Project Leadership, you will play a pivotal role ensuring advanced computational approaches and proprietary Recursion advantages are leveraged across the portfolio continuum, redefining traditional paradigms of drug development. As a project leader, you will work closely with functional lines to help craft, optimize and execute asset strategy, leveraging Recursion OS and ClinTech insights to enhance program rigor and elevate the scientific bar. You will partner with preclinical, clinical and platform teams, promoting communication, alignment and optimization of functional processes to ensure delivery of portfolio goals & transformative medicines for patients.

In this role, you will:

• Collaborate with functional leads across the portfolio continuum to ensure seamless execution of data-driven strategy from preclinical discovery through clinical development
• Drive and enable a culture of accountability, ownership and scientific innovation aimed at delivering prioritized medicines to patient populations in need.
• Partner with key stakeholders including finance and functional line leadership to ensure project resourcing is strategically prioritized for the most pressing scientific workstreams.
• Establish and refine processes that maximally leverage Recursion OS and ClinTech insights for advancement of the internal/external drug discovery & development portfolios.
• Propagate the Recursion mindset of decoding biology to radically change lives by constantly seeking transformative improvements in how we advance innovative concepts for clinical benefit.

The Team You'll Join

As Director, Asset Project Leadership, you will work within the Development team, reporting directlyto the Global Head, Project Leadership. The Development Team is an empowered, execution-minded group of clinical development professionals responsible for translating and industrializing Recursion's innovative science to patients. Our team leverages cutting-edge clinical technology to accelerate drug development, optimize trial design, and enhance patient outcomes. From deploying AI-powered platforms for data analysis and predictive modeling to integrating real-world evidence and biomarker discovery tools, we ensure our clinical programs are both efficient and precise.

The Experience You'll Need

• A PhD or MD in life sciences or related scientific discipline with deep expertise in drug discovery & development
• 8+ years of biotech/pharmaceutical industry experience with a proven track record of scientific project leadership, and progression of drug discovery programs through stage-gates using data-driven decision making
• Expertise in cross-functional drug development and in-depth experience leveraging computational approaches to optimize assets
• Deep technical expertise in oncology, strength in additional therapeutic areas such as rare disease and immunology/inflammation a bonus
• Strong resource management skills and financial acumen

Working Location & Compensation:

This is an office-base, hybrid role in our New York City, NY or Salt Lake City, UT office. Employees are expected to work in the office at least 50% of the time.

At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $217,200 - $295,900.

You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.

#LI-EP1

The Values We Hope You Share:

• We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
• We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
• We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
• We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
• We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
• We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.

Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.

More About Recursion

Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at , or connect on X (formerly Twitter) and LinkedIn .

Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.

Accommodations are available on request for candidates taking part in all aspects of the selection process.

Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.

Your work will change lives. Including your own.

The Impact You'll Make

At Recursion, our mission is to industrialize and transform the development of medicines by integrating data-driven insights and advanced analytics throughout the entire development lifecycle. As Director, Asset Project Leadership, you will play a pivotal role ensuring advanced computational approaches and proprietary Recursion advantages are leveraged across the portfolio continuum, redefining traditional paradigms of drug development. As a project leader, you will work closely with functional lines to help craft, optimize and execute asset strategy, leveraging Recursion OS and ClinTech insights to enhance program rigor and elevate the scientific bar. You will partner with preclinical, clinical and platform teams, promoting communication, alignment and optimization of functional processes to ensure delivery of portfolio goals & transformative medicines for patients.

In this role, you will:

• Collaborate with functional leads across the portfolio continuum to ensure seamless execution of data-driven strategy from preclinical discovery through clinical development
• Drive and enable a culture of accountability, ownership and scientific innovation aimed at delivering prioritized medicines to patient populations in need.
• Partner with key stakeholders including finance and functional line leadership to ensure project resourcing is strategically prioritized for the most pressing scientific workstreams.
• Establish and refine processes that maximally leverage Recursion OS and ClinTech insights for advancement of the internal/external drug discovery & development portfolios.
• Propagate the Recursion mindset of decoding biology to radically change lives by constantly seeking transformative improvements in how we advance innovative concepts for clinical benefit.

The Team You'll Join

As Director, Asset Project Leadership, you will work within the Development team, reporting directly to the Global Head, Project Leadership. The Development Team is an empowered, execution-minded group of clinical development professionals responsible for translating and industrializing Recursion's innovative science to patients. Our team leverages cutting-edge clinical technology to accelerate drug development, optimize trial design, and enhance patient outcomes. From deploying AI-powered platforms for data analysis and predictive modeling to integrating real-world evidence and biomarker discovery tools, we ensure our clinical programs are both efficient and precise.

The Experience You'll Need

• A PhD or MD in life sciences or related scientific discipline with deep expertise in drug discovery & development
• 8+ years of biotech/pharmaceutical industry experience with a proven track record of scientific project leadership, and progression of drug discovery programs through stage-gates using data-driven decision making
• Expertise in cross-functional drug development and in-depth experience leveraging computational approaches to optimize assets
• Deep technical expertise in oncology, strength in additional therapeutic areas such as rare disease and immunology/inflammation a bonus
• Strong resource management skills and financial acumen

Working Location & Compensation:

This is an office-base, hybrid role in our New York City, NY or Salt Lake City, UT office. Employees are expected to work in the office at least 50% of the time.

At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $217,200 - $295,900.

You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.

#LI-EP1

The Values We Hope You Share:

• We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
• We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
• We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
• We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
• We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
• We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.

Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.

More About Recursion

Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at or connect on X (formerly Twitter) and LinkedIn.

Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.

Accommodations are available on request for candidates taking part in all aspects of the selection process.

Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with a high employer contribution
+ Tuition reimbursement, the Freedom 2 Save ( student debt program, and FreeU ( education benefit - an affordable and convenient path to getting a bachelor's degree.
+ A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
Abbott Diabetes Care (ADC) is seeking a Senior Manager, Project Leadership in the Business Enablement PMO. As a leader in the PMO you will drive complex projects aimed to optimize internal operations and adhere to evolving global compliance standards. This person will be responsible for project leadership of IT programs that support business critical quality systems. Projects may include
+ Replacement of Product Lifecycle Management software
+ Introduction of new data mesh solutions that enable seamless use of data systems
+ Advanced analytics and AI solutions
As a Senior Manager of Project Leadership, you will work with a cross functional team to set strategy, evaluate ideas, prioritize features, define releases, define new operating procedures, manage product roadmap, timelines, and budget while coordinating with cross functional ADC and Abbott team members worldwide. You will be responsible for reporting project status and progress to ADC senior Management. **This is an onsite opportunity in Alameda, CA.**
**What You'll Work On:**
+ Formulates, harmonizes and consolidates project scopes, plans, strategies, and budgets for one or more projects, working closely with functional Project Managers and other Subject Matter Experts from IT, R&D, Commercial, Clinical, Regulatory, Quality, Manufacturing, and other functions.
+ Confirms the ongoing strategic rationale and value proposition for projects
+ Leads project planning, scheduling, monitoring and reporting of projects.
+ Ensures Division-wide thinking and problem-solving are incorporated into project execution.
+ Drives for resolution in cross-functional problem solving, communication, and integration.
+ Liaise with other Project Owners, functional managers, and management to prioritize activities across programs to balance resource availability, program deliverables and schedule, and business needs.
+ Liaise with other Project Owners, functional managers, and management to monitor business processesprioritize activities across programs to balance resource availability, program deliverables and schedule, and business needs.
+ Serves as the liaison between project teams and management.
+ Executes programs to completion and assures successful market entry, or makes a timely recommendation to Management to terminate a program if required by technical, commercial or other developments that may result in project failure if not resolved through creative problem solving.
+ Identifies areas for process improvement, and defines and implements solutions, liaising with other stakeholders such as Project Owners, functional managers and senior management as appropriate
+ Serves as a mentor, trainer, and change agent to other stakeholders as processes are defined and implemented
+ Note: The above describes general principals and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.
Accountability / Scope / Budget
+ This position is responsible for strategic scoping, value definition, and successful and timely implementation of product-related projects
+ Projects under the direction of the incumbent will often have material business impact, often exceeding $1MM in annual margin impact
+ This position is highly visible and accountable, responsible for liaising with management in driving alignment on key decisions, and reporting to senior management project status
+ Accountable for driving scope, budget, and quality tradeoffs, not only for a given project, but across projects in conjunction with other stakeholders to optimize portfolio value creation
+ Incumbent has limited direct fiscal responsibility for departmental expenses, but has indirect responsibility, along with departmental budget holders, for ensuring that functional budgets are consistent with project scope and plans
+ Generally, the incumbent will not have direct reports, but will lead a matrix team with a high degree of accountability to ensure that team is appropriately resourced and that team members are defining plans and adhering to commitments
**Required Qualifications:**
+ Bachelor's Degree in a discipline appropriate to the project or an equivalent combination of education and work experience
+ Minimum 10 years of related work experience with medical device product development
+ Has successfully led several high complexity projects from beginning to end.
+ Demonstrated technical skills and management judgment appropriate to the project.
+ Demonstrated expertise in PM tools and processes.
**Preferred Qualifications:**
+ Experience designing and implementing design control tools within medical device industry.
+ Require strong technical experience in cross-functional program management and team leadership.
+ Understand the fundamental solution being developed/deployed - its business value, roadmap, how it fits with the overall strategy or risks
+ Require strong interpersonal skills and a demonstrated ability to work and negotiate with a wide variety of stakeholders at all levels of the organization and across companies to align plans and resolve conflict
+ Require process-oriented thinking, focused on continuous improvement and lessons learned; have demonstrated ability to define and implement complex and interdependent business processes
+ Ideally the incumbent has general knowledge of regulations and standards related to medical devices (eg FDA, ISO, QSR design controls).
+ Experience Web applications or App Development Projects/Programs
+ Experience in Managing Global Operating System Releases
+ Digital Experience in Consumer Tech, Medical Device or Healthcare
+ Experience in Medical Health Records and sensitive data processing
+ Experience in Project Management tools such as Product Board or Plan view is a Plus
+ May required to travel up to 20%.
Apply Now ( more about our health and wellness benefits, which provide the security to help you and your family live full lives:** ( your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at abbott.com , on LinkedIn at , and on Facebook at .
The base pay for this position is $46,700.00 - 293,300.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

Our client is searching for an experienced and results-oriented Strategic Operations Manager to oversee key operational initiatives and drive efficiency within their rapidly growing enterprise in Denver, Colorado, US . This role demands a blend of strategic thinking, process optimization, and effective people management. The successful candidate will be instrumental in developing and implementing operational strategies that align with the company's long-term goals, ensuring seamless execution across various departments.

Key Responsibilities:

• Develop and implement comprehensive operational strategies and plans to enhance productivity and profitability.
• Lead and manage cross-functional project teams to achieve strategic objectives.
• Analyze existing business processes, identify areas for improvement, and implement best practices for operational efficiency.
• Oversee resource allocation, budget management, and performance metrics for key operational projects.
• Foster a culture of continuous improvement and innovation within the operations team.
• Develop and maintain strong relationships with internal stakeholders and external partners.
• Identify and mitigate operational risks, ensuring business continuity and compliance.
• Prepare regular performance reports and presentations for senior leadership, highlighting key achievements and challenges.
• Mentor and develop junior team members, fostering their professional growth.
• Stay abreast of industry trends and emerging technologies to identify opportunities for strategic advantage.

Qualifications:

• Bachelor's degree in Business Administration, Operations Management, Engineering, or a related field. A Master's degree or MBA is highly desirable.
• Minimum of 7 years of progressive experience in operations management, project management, or a related strategic role.
• Proven track record of successfully leading complex projects from conception to completion.
• Strong understanding of business process re-engineering, lean principles, and Six Sigma methodologies.
• Excellent leadership, communication, negotiation, and interpersonal skills.
• Proficiency in project management software and tools.
• Demonstrated ability to think strategically and translate strategic goals into actionable plans.
• Strong analytical and problem-solving skills with a data-driven approach to decision-making.
• Experience in managing budgets and financial performance of operational units.
• Ability to thrive in a fast-paced, dynamic work environment and manage multiple priorities effectively.

This is a pivotal role offering the opportunity to shape the operational future of a forward-thinking organization. If you possess a strategic mindset and a passion for driving operational excellence, we encourage you to apply.

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.
Our diverse ADME team is seeking a dedicated scientist with an interest in the discovery and clinical development of genetic medicines, including siRNAs, ASOs, mRNAs, gene editing, and gene therapy. We are committed to advancing scientific boundaries to develop transformative therapeutics that address the underlying causes of diseases across a wide range of therapeutic areas. Applicants with strong problem-solving abilities and innovative thinking are encouraged to apply to join our team at the expanding Boston campus.
Lilly's agile ADME team collaborates closely with biologists, chemists, engineers, and various other R&D functions to deliver novel genetic medicines to patients. Team members support each other through shared learning and collective responsibility for all stages of the discovery and development process for next-generation genetic therapies. We strive to foster professional growth while advancing science to provide safe and effective new treatments to patients. Prospective candidates who are motivated, collaborative scientists interested in spearheading innovation in genetic medicine therapies are invited to connect with us and contribute to improving patient outcomes globally.
**A high-quality candidate will demonstrate the following:**
+ High learning agility and a keen ability to articulate and efficiently test ADME and DMPK hypotheses for complex novel molecules
+ Strong working knowledge in fundamental pharmaceutics, pharmacokinetics/pharmacodynamics, and ADME principles - especially as they relate to novel genetic medicine therapeutic modalities
+ Understanding of pharmaceutical regulatory guidance and expectations
+ Agile interrogation of diverse data (e.g., in silico, in vitro, in vivo) to interpret complex data sets and to derive mechanistic understanding of drug action and ADME/DMPK characteristics
**Lilly seeks a skilled ADME / DMPK scientist who will:**
+ Lead and innovate in a multidisciplinary team environment with primary responsibility for ADME studies to support preclinical and clinical development of the Lilly genetic medicines portfolio
+ Design, implement, and interpret hypothesis-driven studies to inform key ADME, PK/PD, and toxicokinetic (TK) questions
+ Integrate ADME, PK and PK/PD endpoints with discovery chemistry and biology data to guide preclinical drug design, optimization, and delivery strategies.
+ Engage, innovate, and collaborate with cross-functional colleagues and interdisciplinary teams
+ Lead the preparation of ADME portions of regulatory communications and documents to support clinical development, new drug applications, and line extensions and interact with global regulatory authorities
+ Mentor and support junior scientists and build relationships through coaching and mentorship with fellow scientists at all levels
+ Possess excellent written and verbal technical communication and the ability to constructively lead, guide and influence teams
**Basic Requirements:**
Ph.D. in Biochemistry/Biology/Pharmacokinetics/Bioengineering/Pharmacology or a related scientific field
Greater than five years of experience as a scientist in a pharmaceutical and/or biotechnology company in a role related to ADME or PK/PD
**Additional Skills/Preferences:**
+ Knowledge of DMPK and/or bioanalytical considerations for gene editing therapeutics
+ Experience with PK/PD modeling and simulation
+ Experience with targeted delivery and biodistribution of oligonucleotides and/or gene therapies
+ Understanding of and experience with PCR, immunoassay, and/or LC/MS bioanalytical methodology
**Additional Information:**
This is a full-time position located in Boston, MA.
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), enAble (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
$184,500 - $321,200
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

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.
Our diverse ADME team is seeking a dedicated scientist with an interest in the discovery and clinical development of genetic medicines, including siRNAs, ASOs, mRNAs, gene editing, and gene therapy. We are committed to advancing scientific boundaries to develop transformative therapeutics that address the underlying causes of diseases across a wide range of therapeutic areas. Applicants with strong problem-solving abilities and innovative thinking are encouraged to apply to join our team at the expanding Boston campus.
Lilly's agile ADME team collaborates closely with biologists, chemists, engineers, and various other R&D functions to deliver novel genetic medicines to patients. Team members support each other through shared learning and collective responsibility for all stages of the discovery and development process for next-generation genetic therapies. We strive to foster professional growth while advancing science to provide safe and effective new treatments to patients. Prospective candidates who are motivated, collaborative scientists interested in spearheading innovation in genetic medicine therapies are invited to connect with us and contribute to improving patient outcomes globally.
**A high-quality candidate will demonstrate the following:**
+ High learning agility and a keen ability to articulate and efficiently test ADME and DMPK hypotheses for complex novel molecules
+ Strong working knowledge in fundamental pharmaceutics, pharmacokinetics/pharmacodynamics, and ADME principles - especially as they relate to novel genetic medicine therapeutic modalities
+ Understanding of pharmaceutical regulatory guidance and expectations
+ Agile interrogation of diverse data (e.g., in silico, in vitro, in vivo) to interpret complex data sets and to derive mechanistic understanding of drug action and ADME/DMPK characteristics
**Lilly seeks a skilled ADME / DMPK scientist who will:**
+ Lead and innovate in a multidisciplinary team environment with primary responsibility for ADME studies to support preclinical and clinical development of the Lilly genetic medicines portfolio
+ Design, implement, and interpret hypothesis-driven studies to inform key ADME, PK/PD, and toxicokinetic (TK) questions
+ Integrate ADME, PK and PK/PD endpoints with discovery chemistry and biology data to guide preclinical drug design, optimization, and delivery strategies.
+ Engage, innovate, and collaborate with cross-functional colleagues and interdisciplinary teams
+ Lead the preparation of ADME portions of regulatory communications and documents to support clinical development, new drug applications, and line extensions and interact with global regulatory authorities
+ Build relationships through coaching and mentorship with fellow scientists at all levels
+ Possess excellent written and verbal technical communication and the ability to constructively lead, guide and influence teams
**'**
**Basic Requirements:**
Ph.D. in Biochemistry/Biology/Pharmacokinetics/Bioengineering/Pharmacology or a related scientific field
Zero to five years of experience as a scientist in a pharmaceutical and/or biotechnology company
**Additional Skills/Preferences:**
+ Knowledge of DMPK and/or bioanalytical considerations for gene editing therapeutics
+ Experience with PK/PD modeling and simulation
+ Experience with targeted delivery and biodistribution of oligonucleotides and/or gene therapies
+ Understanding of and experience with PCR, immunoassay, and/or LC/MS bioanalytical methodology
**Additional Information:**
This is a full-time position located in Boston, MA.
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), enAble (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
$156,750 - $250,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly

Regeneron is currently looking for a Principal/Staff Device Development Engineer to join our project lead team. This is a non-lab based position. They will drive the end-to-end platform development of a device combination products and/or innovative platform drug delivery systems, that will eventually be utilized by our patients on the market. In this role you will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and cross-functional collaboration with internal and external stakeholders, for the internally design platform delivery systems.
A typical day for a Principal/Staff Device Development Engineer might include:
+ Leads multidisciplinary engineering project teams (Design Engineering, Human Factors, V&V Engineering, Manufacturing Engineer, Quality Engineering) through the complete device design and development lifecycle of an off the shelf, or an internally designed platform medical device delivery system.
+ Defines detailed product requirements and specifications with commercial, clinical, and other development/strategy partners.
+ Targeted to have direct reports or mentees within the device project leadership team/organization, to support multiple platform device developments.
+ Responsible for all user needs and requirements to be validated through design and development
+ Develops, leads, and communicates development program plans, risks, timelines, and budgets to internal and external collaborators.
+ Manages relationships with all CDMOs and manufacturers related to device component manufacturing.
+ Support the integration of developed device platforms with the pairings of upcoming drug products within the Regeneron pipeline, based on need and scope.
+ Supports internal and external manufacturing teams around relevant design and process development information transfers (understands design for manufacturing principles, is a plus).
+ Ensures comprehensive and compliant Design History File (DHF) is developed and ensures to meet regulatory and quality requirements (21 CFR 820.30)
+ Supports and aligns all clinical and commercial regulatory activities related to device development, including (not limited to): 510K Submission, Biologics License Application (BLA) Submissions, Information Requests (IRs)
+ Defines technical specifications and design requirements in collaboration with engineering teams (product design, manufacturing, verification, packaging etc.)
+ Manages product development timelines and critical milestones with internal design teams and external partners/CDMOs.
+ Leads all aspects of product testing and quality assurance processes for the specific device development.
+ Drives strategic product launch and go-to-market plans with new technologies management and combination product leadership teams.
+ Understands crucial design inputs and outputs of different types of delivery systems (different delivery sites) and how it can impact end users.
+ Builds comprehensive product roadmaps and helps supports strategic plans to ensure a clear, compelling product vision is articulated to senior leadership.
+ Crafts and analyzes cases to support value propositions of new delivery systems being developed for the Regeneron Pipeline.
This role might be for you if you:
+ Successfully managing sophisticated, multi-disciplinary development projects.
+ Understand regulatory compliance and clinical trial processes (thorough understanding of relevant FDA regulations, particularly 21 CFR 820.30 and 21 CFR Part 3, is a plus).
+ Understand design of manufacturing principles and component manufacturing (ie: plastic molding), is a plus.
+ Possess strong project management and interpersonal skills, analytical and problem-solving capabilities.
+ Have experience with regulatory submissions and clinical protocol development.
+ Can balance business objectives with technical constraints.
+ Enjoy working in a fast-paced, multifaceted research and development environment.
+ Are willing/able to travel occasionally for collaborator meetings, audits, and project coordination.
To be considered for the Principal/Staff Device Development Engineer you must have a B.S in Engineering; biomedical engineering or mechanical engineering is preferred. You must be willing and able to work Monday-Friday, 8am-4:30pm. For various levels you must have the following:
+ Principal Device Development Engineer: 8+ years of relevant experience
+ Staff Device Development Engineer: 10+ years of relevant experience
+ Or equivalent combination of education and experience
Previous experience in combination product/medical device development or similar area is required. Experience with design history file management (21CFR 820.30), is preferred. Level is determined based on qualifications relevant to the role.
#LI-MB1
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$101,800.00 - $194,500.00

Lilly's Drug Metabolism And Pharmacokinetics (Dmpk) Team

Lilly's Dmpk team is searching for an experienced pharmaceutical scientist to lead the application of absorption, distribution, metabolism, excretion (Adme) science to advance our portfolio.

Working on cross-functional teams, our diverse group is multidisciplinary, applying in vitro, in vivo, and in silico approaches to mechanistically study the pharmacokinetics, absorption, and disposition of biologics/antibodies. You will serve as technical leader within the department and across portfolio cross-functional teams. This role will require engaging in experimental design and data interpretation to deliver the discovery and development portfolio of investigational targets and novel therapeutics. We are passionate about making an impact in the lives of our patients. Consider joining our efforts!

Responsibilities:

• Accountable for the delivery of scientifically integrated data packages to guide compound selection, study design, portfolio decisions, and regulatory submissions.
• Partner with cross-functional colleagues in both Discovery and Development (eg. Toxicology, Pharmacology, Chemistry, Clinical Pk/Pd, Clinical Pharmacology, Regulatory, and Medical) to assess drugability and optimize Adme properties to deliver drug candidates to the clinic, as well as to design and support nonclinical and clinical studies, supporting global registration packages.
• Lead R&D initiatives to grow and develop Adme/Dmpk capabilities for across experimental and drug modalities including biologics/antibodies.
• Integrate in vitro, in vivo, and in silico Adme data with Biology and Chemistry understanding to define structure-activity- and structure-property-relationships and deliver favorable molecular and experimental design strategies.
• Prepare data packages and develop content in regulatory documents (eg. Ib, Ind, Impd, Nda/Bla, etc.) to support global regulatory submissions (including sections 2.6.4./non-clinical pharmacokinetics and 2.7.2./clinical pharmacology) and correspondence as well as represent Adme in face-to-face discussions with regulators.
• Guide junior, peer, and upper level scientists in best and modern practices of multi-property optimization through the use of mechanistic Adme principles.
• Effectively partner to apply innovative Pbpk approaches to translate and predict human Pk, inform clinical plans and support registration.
• Communicate the value of mechanistic Adme approaches both internally within R&D and externally including regulatory agencies.
• Build a strong external network (e.g. academia, consortia) and keep up to date with emerging literature and science in the area.

Basic Qualifications:

Ph.D. degree in Pharmacokinetics, Pharmacology, Pharmaceutics, Biochemistry, or related field with 6 years or more of extensive training in the field of drug metabolism and disposition or clinical pharmacology.

Additional Skills/ Preferences:

• Experience in drug discovery and development across a variety of therapeutic areas.
• Experience with biologics/antibodies.
• Detailed understanding of pharmacokinetics, Adme, drug interactions and proficiency to communicate theory and concepts clearly.
• Ability to balance multiple projects and handle competing responsibilities.
• Experience with modeling software (e.g. Simcyp, Gastroplus, Nonmem, Matlab, etc.).
• Demonstrate strong communication skills with the ability to integrate diverse perspectives, adroitly deliver critical messaging, and influence leaders/key partners.
• Collaborative team behaviors and aspiration to build and sustain relationships with R&D customers and the wider scientific community.

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.
Lilly's Drug Metabolism and Pharmacokinetics (DMPK) team is searching for an experienced pharmaceutical scientist to lead the application of absorption, distribution, metabolism, excretion (ADME) science to advance our portfolio. Working on cross-functional teams, our diverse group is multidisciplinary, applying in vitro, in vivo, and in silico approaches to mechanistically study the pharmacokinetics, absorption, and disposition of biologics/antibodies. You will serve as technical leader within the department and across portfolio cross-functional teams. This role will require engaging in experimental design and data interpretation to deliver the discovery and development portfolio of investigational targets and novel therapeutics. We are passionate about making an impact in the lives of our patients. Consider joining our efforts!
Responsibilities:
- Accountable for the delivery of scientifically integrated data packages to guide compound selection, study design, portfolio decisions, and regulatory submissions.
- Partner with cross-functional colleagues in both Discovery and Development (eg. Toxicology, Pharmacology, Chemistry, Clinical PK/PD, Clinical Pharmacology, Regulatory, and Medical) to assess drugability and optimize ADME properties to deliver drug candidates to the clinic, as well as to design and support nonclinical and clinical studies, supporting global registration packages.
- Lead R&D initiatives to grow and develop ADME/DMPK capabilities for across experimental and drug modalities including biologics/antibodies.
- Integrate in vitro, in vivo, and in silico ADME data with Biology and Chemistry understanding to define structure-activity- and structure-property-relationships and deliver favorable molecular and experimental design strategies.
- Prepare data packages and develop content in regulatory documents (eg. IB, IND, IMPD, NDA/BLA, etc.) to support global regulatory submissions (including sections 2.6.4./non-clinical pharmacokinetics and 2.7.2./clinical pharmacology) and correspondence as well as represent ADME in face-to-face discussions with regulators.
- Guide junior, peer, and upper level scientists in best and modern practices of multi-property optimization through the use of mechanistic ADME principles.
- Effectively partner to apply innovative PBPK approaches to translate and predict human PK, inform clinical plans and support registration.
- Communicate the value of mechanistic ADME approaches both internally within R&D and externally including regulatory agencies.
- Build a strong external network (e.g. academia, consortia) and keep up to date with emerging literature and science in the area.
Basic Qualifications:
Ph.D. degree in Pharmacokinetics, Pharmacology, Pharmaceutics, Biochemistry, or related field with 6 years or more of extensive training in the field of drug metabolism and disposition or clinical pharmacology.
Additional Skills/ Preferences:
- Experience in drug discovery and development across a variety of therapeutic areas.
- Experience with biologics/antibodies.
- Detailed understanding of pharmacokinetics, ADME, drug interactions and proficiency to communicate theory and concepts clearly.
- Ability to balance multiple projects and handle competing responsibilities.
- Experience with modeling software (e.g. SimCYP, GastroPlus, NONMEM, Matlab, etc.).
- Demonstrate strong communication skills with the ability to integrate diverse perspectives, adroitly deliver critical messaging, and influence leaders/key partners.
- Collaborative team behaviors and aspiration to build and sustain relationships with R&D customers and the wider scientific community.
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), enAble (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
$168,000 - $294,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly