Ascendis Pharma Jobs in Usa

367 positions found — Page 2

Senior Analyst/Manager, Commercial
Salary not disclosed
Princeton, NJ 3 days ago

Company Overview:

Luye Pharma is fast-growing pharmaceutical company committed to advancing innovative therapies for Central Nervous System (CNS) disorders, with a primary focus on schizophrenia. Our pipeline includes promising new treatments such as Erzofri and Rykindo, which are set to launch in the U.S. market.


Position Summary:

In this role, you will collaborate closely with the US Head of Commercial Operations to design, implement, and manage data analytics and performance reporting systems. Your main responsibility will be to provide actionable insights that support decision-making and drive improvements in commercial outcomes. As the Manager of Commercial Analytics, you will serve as a key analytics partner for commercial leaders across sales, marketing, and operations in the US. You will offer valuable insights and recommendations to fuel growth, optimize field performance, and analyze market and patient trends. Additional key responsibilities include developing reporting processes and assisting with the coordination of Monthly Business Reviews, focusing on KPIs, forecasting variances, and updates to the Latest Estimate.


Report to: Head of Commercial Operation


Key Responsibilites:


  • Develop and maintain performance dashboards and reports, integrating internal KPIs and external datasets to track business metrics, monitor progress toward sales goals, and evaluate operational performance.
  • Conduct in-depth analysis of market trends and product performance to identify growth opportunities and risks.
  • Evaluate overall business performance, including volume, market share, new patient starts, and KPIs, comparing actuals against forecasts and targets.
  • Partner with Sales and Commercial Leadership to optimize territory alignments, call planning, and customer targeting, using analytical insights to improve sales coverage and operational efficiency.
  • Assess performance and activity trends at sub-national levels to uncover opportunities, inefficiencies, and areas for improvement within the sales force.
  • Prepare monthly business reviews, utilizing a combination of third-party market data (e.g., prescriber, chargebacks, 867, 852 data) and internal performance metrics to guide executive decision-making.
  • Build and maintain performance dashboards and reports by integrating internal KPIs and third-party datasets to monitor business metrics, track progress against sales goals, and evaluate operational performance.
  • Assist in designing incentive compensation structures and performance metrics, including goal setting and attainment analysis.
  • Analyze market trends, physician and account-level data, and promotional effectiveness to support segmentation, targeting, and brand strategy.
  • Provide support to field teams by addressing data and reporting requests, resolving inquiries, and delivering actionable insights for daily execution.
  • Collaborate with cross-functional teams to develop demand forecast models.
  • Conduct data analysis, reporting, and generate actionable insights to support commercial brand strategy and execution.
  • Other duties as assigned.



Qualifications:


  • Bachelor’s degree
  • 3-5 years of experience in relevant analytics roles within the pharmaceutical or life sciences industry.
  • Strong understanding of the pharmaceutical industry and familiarity with third-party data sources (e.g., Symphony Health, IQVIA, etc.).
  • Strong proficiency in Excel
  • Exceptional analytical capabilities, including the ability to manipulate large data sets and apply advanced analytical methodologies.
  • Experience with BI tools (Tableau, Power BI, Qlik etc.) preferred.




To all recruitment agencies: Luye does not accept unsolicited third party resumes, and all resumes must be submitted to HR Function.


The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.


Luye Pharma 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, or protected veteran status and will not be discriminated against on the basis of disability

Not Specified
Supply Chain & Logistics Supervisor
✦ New
Salary not disclosed
East Brunswick, NJ 1 day ago
Company Description

Cronus Pharma, headquartered in East Brunswick, NJ, is an integrated animal health pharmaceutical company focused on research and development, manufacturing, and marketing. The company offers high-quality, cost-effective pharmaceuticals for companion animals, equines, and production animals. These products are distributed nationwide, ensuring accessibility for veterinarians and pet owners through trusted national and regional distributors. Cronus Pharma is committed to advancing health and well-being within the animal care industry.

Role Description

This is a full-time, on-site role located in East Brunswick, NJ for a Supply Chain & Logistics Supervisor. The responsibilities include overseeing daily supply chain and logistics operations, managing inventory levels, coordinating with warehouses, supervising logistics staff, and ensuring adherence to operational processes. The role also involves collaborating with stakeholders to resolve supply and demand conflicts, enhancing customer service, and identifying process improvement opportunities to increase efficiency and reduce costs.

Qualifications
  • Proven Supervisory Skills and the ability to manage and lead teams effectively
  • Strong Operations Management experience related to logistics and supply chain processes
  • Excellent Communication and interpersonal skills for collaboration with team members, partners, and stakeholders
  • Expertise in Inventory Management, including tracking stock levels and coordinating supply and demand
  • Customer Service skills to ensure client satisfaction and address service-related concerns
  • Familiarity with logistics software and systems
  • Ability to analyze and improve operational processes
  • Bachelor's degree in Supply Chain Management, Business Administration, Logistics, or a related field
  • Previous experience in the pharmaceutical or animal health industry is an advantage
Not Specified
Quality Control Analyst II
✦ New
Salary not disclosed
Winchester, KY 1 day ago

*SHIFT - SAT, SUN & MON 6AM - 6PM & EVERY OTHER TUES 6AM - 2:30PM.


A QC Analyst is an entry level position for individuals who use their understanding of science to perform the basic and critical experimental work of day-to-day analysis, including generation and analysis of data. Their work is “hands on” in an analytical lab and requires analytical testing, computer operating, record keeping, and report writing abilities. This position performs the quality testing needed for raw material, in-process, finished goods, stability, and cleaning validation analysis, while following all regulations and SOP’s.


Duties may include but are not limited to:

• Perform efficient/reliable/high quality analytical testing in accordance with USP/NF/EP/JP/FCC/etc. or customer supplied guidelines. Typical testing may include Dissolution, Titration, Polarimetry, Loss on Drying, Viscosity, Residue on Ignition, Heavy Metal Content, FTIR, HPLC, and GC, etc.

• Maintain accurate written records of all analysis performed.

• Accurately interpret and effectively communicate analytical results and issues.

• Schedule daily tasks in an organized and efficient manner.

• General knowledge of the use and operation of basic laboratory equipment.

• Calibrate and maintain lab equipment and instrumentation.

• Responsible for operating in a safe manner, must be familiar with basic laboratory and chemical hygiene practices

• Become proficient in standard operating procedures and test methods.

• Ability to work in a “flow to the work” team environment.

• In combination with other lab personnel, be responsible for a clean and safe work environment.

• Perform peer review of analytical testing and write up.

• Write SOPs on an as needed basis.

• Other duties as required in support of Catalent Pharma Solutions high performance


Education or Equivalent Requirements:

Minimum education required to perform the job:

• Bachelor’s degree in a scientific field.

• Alternate degrees in a non-scientific field may be accepted with at least 2 years of relevant experience in a material testing laboratory.


Minimum skills/knowledge required to perform job:

• Ability to multi-task with high efficiency.

• Ability to work well under pressure, maintain efficiency, and meet deadlines.

• Proficient in English. Ability to communicate effectively.

• Basic knowledge of lab safety and the ability to work safely with chemicals of varying potency.

• General computer literacy including use of Microsoft Word and Excel.

• Ability to perform analytical testing while standing for long periods of time

• Accurate testing on the first attempt under pressure of production details.

• Experience in the pharmaceutical industry preferred.


Preferred Qualifications:

Desirable skills, knowledge and/or experience that enhance job performance


• Bachelor’s degree in Chemistry or Biology

• Work Experience – 2 – 5 years in Quality, Laboratory, Clinical or Chemical manufacturing role (including internships or co-op experience).


Pay Rate: $27.76/Hr

Not Specified
Data Analyst III
🏢 Planet Pharma
Salary not disclosed
North Chicago, IL 3 days ago

Hybrid Onsite Schedule In office T, W, Th; Remote M, F


Job Description: Data Analyst – Global Patient Access Program (GPAP)

Location: North Chicago, IL, USA (Hybrid eligible), AP30


Overview: The Data Analyst for the Patient Assistance Program (PAP), supporting GPAP’s data transformation and governance, will be instrumental in building and maintaining the backbone of automated reporting and KPI dashboards. This role ensures a single source of truth for GPAP operations, drives analytics innovation, and supports the integration and consistency of data across the program. You’ll collaborate closely with workstream leaders, lead in bi-weekly scrum sessions, and deliver insight-rich, timely outputs for senior leadership.

Key Responsibilities:

• Develop, automate, and maintain standardized PAP reporting, KPI dashboards, and ad hoc analytics tools using Tableau, Excel, and Snowflake.

• Lead twice-weekly Scrum sessions with workstream team members, ensuring progression of data tasks, intake of new data requests, and alignment on analytics approaches in a Smart Sheet-driven, agile environment.

• Ensure data consistency, quality, and accuracy across all platforms, supporting GPAP governance and the creation/control of the 'source of truth.'

• Enable and facilitate self-service dashboards and reporting marts for internal and external stakeholders.

• Collaborate with cross-functional partners (BTS, ACA, GPAP, Steer Co) to support program data needs, forecasting, and reporting methodologies.

• Support quarterly and weekly reporting processes—including application, shipment, and claim-level analytics.

• Partners with data lead to document extraction methods, automate/accelerate reporting, and track program impacts, escalations, and business intelligence.

• Identify new opportunities for advanced analytics or insights to increase PAP operational efficiency and program sustainability.

Qualifications:

• Bachelors in a relevant field (Analytics, IT, Business, Data Science, or related)

• 3-5 years’ experience in data analytics, reporting, or business intelligence in healthcare, pharma, or related industry

• Advanced proficiency in Tableau and Excel; experience with Smart Sheet and Snowflake (SQL skills required)

• Demonstrated experience leading agile meetings (scrum/project management preferred)

• Strong attention to detail, data integrity, and quality control

• Experience in KPI development, dashboard design, and self-service reporting

• Effective communicator with ability to drive cross-team consensus and present findings to varied audiences

• Collaborative mindset, able to work in fast-paced, matrixed environments

• In office Tues, Wed, Thurs

Preferred:

• Experience in patient assistance programs or US healthcare market access

• Familiarity with organizational data governance or compliance requirements


Be part of a team unlocking strategic impact through advanced analytics, automation, and insight-driven transformation. Shape the way data informs patients’ access and program value across a global organization while enjoying professional growth in a supportive, inclusive culture.

Not Specified
Validation Scientist
Salary not disclosed
Sellersville, PA 3 days ago

JOB OVERVIEW:

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.


KEY ROLES/RESPONSIBILITIES:

  • Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
  • Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
  • Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
  • Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
  • Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
  • Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
  • Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
  • Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
  • Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
  • Represent Technical Services at project team meetings and provide sound technical advice.
  • Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
  • Directly interact with Piramal Pharma Solutions clients.
  • Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.


EXPERIENCE:

  • Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
  • Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
  • Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
  • Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
  • Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
  • Technical writing experience is required with attention to detail skills essential.
  • Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
  • Must have proficiency in the Microsoft Office Suite programs.
  • Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
  • Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
  • Must be innovative, proactive, resourceful and committed to continuous improvement.
  • Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.


WORK ENVIRONMENT:

The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.

Not Specified
Logistics Specialist
🏢 Planet Pharma
Salary not disclosed
King of Prussia, PA 2 days ago

Job Description:

The Logistics Specialist will coordinate inbound and outbound logistical operations, including inventory management, warehousing, and limited transportation activities, to ensure a consistent and efficient supply of goods. This role requires a proactive logistics facilitator who can align distribution processes with internal and external customer requirements, regulatory standards, and budgetary goals.


Key Responsibilities:

• Manage daily logistics operations to support production and distribution schedules

• Oversee inventory control and ensure accuracy across warehouse systems

• Coordinate transportation of raw materials, components, and finished goods (minimal focus)

• Ensure compliance with regulatory and safety standards

• Collaborate cross-functionally with procurement, planning, and quality teams

• Utilize SAP to manage logistics workflows, inventory, and reporting


Requirements:

• Bachelor’s degree (Supply Chain, Business, or related field preferred)

• 6+ years of logistics experience

• 4–6 years of experience in warehouse and distribution operations

• 4–6 years of hands-on SAP experience (required)

• Strong communication and problem-solving skills

• Experience in regulated industries (pharma/biotech) is a plus

Not Specified
Industry Champion | EXRO
Salary not disclosed
Miami, FL 2 days ago

Executive Relationship Officer or EXRO (yeah, we made the title up! and you get to write the job description)


This opportunity is for the person who's had success and wants to help build lasting change as a Strategic Pharma Industry Advisor.


Intrigued?

In a nutshell, it's about helping to bring a transformational technology disruptor to market.

Luminari has built a proprietary AI LLM that compresses clinical trial protocol development from an average of 8 weeks to just 8 minutes—WITH regulatory-grade accuracy, trained on 10,000+ FDA submissions. This shift isn't an incremental improvement; it's a fundamental transformation of how drugs reach patients.


We are looking for an Industry Savvy Champion. This opportunity is not 'a job' or 'a consulting gig', not even 'a board member seat' yet. We're looking for someone to champion our effort, open a few key doors, validate us with credibility we haven't had a chance to prove emphatically just quite yet, and help us build something that becomes the STANDARD in Pharma AI.


You Have:

  • Launched drugs - you understand the regulatory process from IND to NDA/BLA
  • Built or managed clinical operations teams at scale - you've overseen 10+ simultaneous trials.
  • Navigated FDA, EMA, and global regulatory agencies- you know how to get things approved.


You're currently interested in:

  • The AI revolution, but skeptical of the hype, and you want to see the real product before you commit.


You believe:

  • Your decades of experience are worth more than a consulting day rate—they're worth equity in something transformational.


You bring:

  • 20+ years in Pharma, biotech, or CROs. You've launched products, navigated regulatory nightmares, built teams, closed partnerships, and probably have a Rolodex that would make a McKinsey partner jealous.
  • Motivation beyond money - you're financially stable, maybe thinking about retirement, or already there.
  • A legacy mindset - you want to build something that outlasts you.
  • A drive where Impact matters more than title - you'd rather change the industry than manage a P&L.


This opportunity is:

·        This is an invitation to co-build the infrastructure that will reshape how the pharmaceutical industry develops drugs.

  • Real technology and the product – LumiPath™ is built, it works, and it's demonstrably better than the status quo.
  • Real mission - every protocol we help generate gets therapies to patients faster.


The Luminari CRO Team will work behind you:

  • An experienced CEO and a team that has over 50 years of deep, aligned pharma experience.
  • We are NOT a "couple of Stanford kids who think 'healthcare is broken' and have never filed an IND".
  • A Team that has more than a two (2) year head start in AI technology for regulatory solutions.


What you get:

In return, you get equity in what industry analysts believe will become a multi-hundred-million-dollar company, visibility as one of the architects of the AI-powered clinical trial era, and the satisfaction of knowing you helped accelerate therapies to patients who are running out of time. And, oh yes, a way to put the finishing touches on your professional legacy in this space.


How to Start the Conversation

Rather than the traditional resume model, simply send us an email with:

  1. Why are you interested in this opportunity, and why now? (75-100 words max, or be different and send a 120 sec. video): You could do many, many other things with your time and credibility. Why are you interested in this role?
  2. Tell us about your biggest skepticism (100 words max): What's the thing that makes you think "this probably won't work"? - We'd rather address it upfront.
  3. A link to your LinkedIn profile and/or personal website.


Send to:

Subject: "Champion Role - [Your Name] - Let's Talk"

We'll set up a call within 48 hours if there's a mutual fit.


Check us out on the web: Luminari or visit our LinkedIn page: Luminari CRO


Luminari CRO

8 weeks to 8 minutes.

Let's make it the standard.

Not Specified
Associate Project Leader
Salary not disclosed
Rockville, MD 4 days ago
Overview

Associate Project Leader

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.


Responsibilities

  • Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
  • Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
  • Reviews, provides input on, and approves project and study documents and processes, as needed.
  • Represents the project or company at client meetings and scientific conferences.
  • Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
  • Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
  • Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
  • Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
  • Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
  • Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
  • Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
  • Supervises, mentors, and supports lower-level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
  • Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
  • Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
  • Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
  • Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.

Qualifications

Education/Requirements


Associate Project Leader:

-Bachelor's degree, preferably in a scientific discipline, with at least 6 years of experience within pharma and/or CRO;

-Master's degree with at least 4 years of experience within pharma and/or CRO;

-PhD with at least 1 years of experience within pharma and/or CRO

  • Demonstrated working knowledge of the principles appropriate to the position with a typical tenure of at least 1 year management experience in a research environment.

  • Prior CRO/clinical trial management of late-stage clinical trials preferred

  • Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost

  • Demonstrated strong problem solving and analytical skills, combined with sound business judgment

  • Ability to work proactively and effectively, with creative problem-solving and collaboration skills
    Highly motivated with ability to work independently and as part of a multi-disciplinary team
    Strong cross-functional project management and time management skills

  • Excellent verbal and written communication skills

  • Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Flexible Approved Time Off
  • Tuition Reimbursement
  • 401k Retirement Plan
  • Work From Home Anywhere in the US
  • Maternal/Paternal Leave
  • Casual Dress Code & Work Environment


CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Not Specified
Project Leader - Vaccines & Infectious Diseases
🏢 The Emmes Company, LLC
Salary not disclosed
Rockville, MD 4 days ago
Overview

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.


Responsibilities

  • Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
  • Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
  • Reviews, provides input on, and approves project and study documents and processes, as needed.
  • Represents the project or company at client meetings and scientific conferences.
  • Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
  • Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
  • Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
  • Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
  • Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
  • Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
  • Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
  • Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
  • Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
  • Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
  • Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
  • Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.

Qualifications

Education/Requirements


Project Leader: Bachelor's degree, preferably in a scientific discipline, with at least 8 years of experience within pharma and/or CRO; Master's degree with at least 6 years of experience within pharma and/or CRO; PhD with at least 3 years of experience within pharma and/or CRO

  • Demonstrated working knowledge of the principles of clinical trial management and operations with at least 3 years of management experience in a research environment

  • Prior CRO/clinical trial management of late-stage clinical trials preferred

  • Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost

  • Demonstrated strong problem solving and analytical skills, combined with sound business judgment

  • Ability to work proactively and effectively, with creative problem-solving and collaboration skills
    Highly motivated with ability to work independently and as part of a multi-disciplinary team
    Strong cross-functional project management and time management skills

  • Excellent verbal and written communication skills

  • Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Flexible Approved Time Off
  • Tuition Reimbursement
  • 401k Retirement Plan
  • Work From Home Anywhere in the US
  • Maternal/Paternal Leave
  • Casual Dress Code & Work Environment


CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Not Specified
Robotics Project Engineer
Salary not disclosed
Branchburg, NJ 2 days ago
Title: Robotics Project Engineer

Duration: 1 year Assignment

Location: Open to candidates in cities (Chicago, IL, All Client CA location and Branchburg, NJ). Onsite preferred.

What are the top 3-5 skills, experience or education required for this position:

* Background in robotics/sales/applications engineering with hands-on experience across leading platforms (e.g., KUKA, FANUC, ABB, UR, MiR, Otto).

* Proven track record deploying robotics in manufacturing, logistics, or laboratory processes-translating operational needs into automated solutions.

* Experience in regulated industries (Pharma/biotech/medical devices) with familiarity with GMP, ISO, FDA requirements and validation (IQ/OQ/PQ).

* Competence in project documentation, risk assessments, and compliance documentation.

* Strong communication and stakeholder management across technical and non-technical teams; adaptable in multicultural, multidisciplinary environments.

Roles and Responsibilities

Primary Responsibilities:

* Support the execution of robotics projects at multiple US sites including Puerto Rico, contributing to planning, implementation, and delivery.

* Collaborate with cross-functional site teams to clearly define project scope, objectives, and deliverables that align with both business and technical needs.

* Build and maintain strong relationships with site teams, stakeholders, and vendors to anticipate challenges, resolve roadblocks, and ensure successful project outcomes across a range of environments-including highly regulated sectors like Pharma, biotech, or similar.

* Articulate the value proposition and expected benefits of robotics projects, incorporating productivity, efficiency, safety, and (where relevant) compliance considerations.

* Manage vendor and third-party relationships covering selection, procurement, and ongoing evaluation of products and services, while ensuring vendors can meet specific requirements of regulated industries if applicable.

* Provide hands-on technical leadership to fill capability gaps within project teams, from requirement gathering to solution delivery and troubleshooting.

* Identify and assess opportunities for future robotics projects, leveraging best practices from both industrial and regulated environments to build a long-term project pipeline (e.g., 2027 and beyond).

* Regularly gather input and feedback from each site to guide the organization's robotics and automation strategy, addressing both operational value and compliance readiness where necessary.

* Lead and oversee small-scale proof-of-concept (PoC) projects, including piloting new technologies and approaches in various settings such as manufacturing, logistics, or laboratory environments.

* Travel as needed within the US with an ability to adapt to diverse regulatory requirements and operational cultures.

Preferred Experience and Skills:

* Background in robotics engineering, sales engineering, applications engineering, or similar functions, ideally with experience across leading robotics platforms (e.g., Kuka, FANUC, ABB, UR, MiR, Otto, etc.).

* Proven track record of deploying robotics in manufacturing, logistics, or laboratory processes-converting operational needs into effective automated solutions.

* Experience working in regulated industries (such as Pharma, biotechnology, or medical devices) is an advantage, particularly familiarity with Good Manufacturing Practice (GMP), ISO, or FDA requirements, and validation processes (IQ/OQ/PQ).

* Competence in handling project documentation, risk assessments, and compliance documentation when required.

* Strong communication and stakeholder management skills, with the ability to work across technical and non-technical teams worldwide.

* Adaptive and open mindset, comfortable working in multicultural and multidisciplinary teams, and in both regulated and unregulated environments. .
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