Legend Biotech is seeking a Facility Engineer as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position will be responsible for facilities engineering support, design, and implementation for mechanical systems and equipment, and work order management for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in maintaining commercial production at a state-of-the-art cell therapy facility. The role will require proven leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Key Responsibilities

• Demonstrates professional execution of the planning, development, and implementation of construction and/or repair programs for engineering driven initiatives.
• Serves as SME on engineering design projects; sets project requirements, evaluates compliance with project and engineering standards, and approves final designs and installations.
• Identifies, investigates, and analyzes a wide range of complex facilities, utilities, systems, equipment or manufacturing issues and develops a robust solution for remediation.
• Oversees, reviews, and approves the work of external engineering design and planning consultants; ensures that engineering designs are consistent with contract specifications and all relevant regulations and engineering standards.
• Supports the review of equipment, building, and other job plans within the CMMS for effectiveness, applicability, and compliance. Ensure all equipment is operated and maintained within a validated/qualified/certified state.
• Gathers and analyzes data, blueprints, and reports.
• Supports tracking and achievement of annual maintenance goals and objectives including metric improvement targets. Support continuous improvement activities such as preventive maintenance optimization, risked based asset management programs, and analyze equipment for proper balance of preventive to corrective work order ratio.
• Supports maintenance driven quality events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA’s.
• Ensures regulatory and job training remains current by promptly completing required training.
• Complies with all company and/or site policies and procedures.
• Demonstrates willingness to learn new skills as required.
• Available for other duties as required.
• Ensures site compliance with all local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Drug Enforcement Agency (DEA) as applicable (TSA) Transportation Security Administration.
• Ability to work independently and with minimal guidance/oversight.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. 

Requirements

• B.Sc./M Sc. in chemical, mechanical, electrical, industrial engineering or similar field is required
• Minimally 5+ years of experience as a facility engineer or working within an industrial manufacturing or regulated environment is required, ideally has cGMP cleanroom manufacturing experience under aseptic conditions
• Experience with HVAC and building management systems is required
• Experience with SAP and MS Office is required
• Proficiency in English (verbal and written) and strong communication skills
• Experience with a CMMS or similar maintenance management system is preferred
• cGMP manufacturing familiarity is preferred
• Ability to apply engineering principles and techniques to the solution of equipment, buildings, and infrastructure.
• Construction/project management principles. 

Legend Biotech is seeking an Associate Director, Operations Program Lead as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Operations Program Lead (OPL), Clinical Operations is accountable for accelerated operational delivery of 1-2 priority cell therapy development programs across all phases. This position is responsible for leading, managing and providing operational oversight for quality delivery within budget across all Legend Pipeline studies for 1-2 assets.

This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. This position requires a high-performing contributor with strong leadership and stakeholder management skills. This individual will collaborate with the cross functional team to develop operationally feasible program timelines and identify clinical trial operational risks and develop mitigation strategies to ensure accelerated and cost-efficient quality clinical trial execution.  In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, and represent the clinical trial operation function at internal and external meetings.

This position will oversee 1-2 contractor Clinical Trial Associates (CTA).

Key Responsibilities

Direct end-to-end clinical trial management: 

• Direct end-to-end clinical trial operations activities domestically and globally: i.e. lead and take ownership in all aspects of Study Operations for CAR-T Studies in a matrix environment.
• Responsible for the overall success of the clinical study programs
• Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Ensures audit-ready condition of clinical trial documentation including central clinical files.
• Report on all aspects of the study progress at a granular level to stakeholders and senior leaders. Effective, consistent & regular tracking of project (s). Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Senior and Mid-level management Study Management Meetings).
• Supports the Development of strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives.
• Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans.
• Define project timelines & deliverables, by working closely with the cross-functional core program team for end-to-end execution of clinical trials.
• Collaborates in the preparation and/or review of study-related documents (e.g., study protocols, informed consents and amendments, Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals).

Clinical Trial Operations Efficiency and optimization:

• The OPL will drive clinical Operations excellence by playing a critical role in Clinical Trial Operations Efficiency and optimization.
• Work with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support optimal and efficient clinical trial execution. 
• The position involves working closely with the clinical development team and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, tech ops, manufacture, supply chain, regulatory, project management, medical affairs, finance, legal and quality.
• Create and Manage study trial execution RACI to support overall trial execution and operational excellence.
• Contribute to Clinical Operations functional initiatives and institution of best practices.

Resource Management and Direct High Performing team:

• Manage and build a high-performing clinical operations support structure. Duties include hiring, onboarding, training, and development of staff to manage studies.
• Lead, develop and manage study operation manual, new work-streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance.
• Provides study-specific training and leadership to clinical research staff, including CRO, sites and other study personnel to support clinical trial execution and optimization.

Direct and Support Vendor Partnership

• Oversee vendor selection process, management, of Contract Research Organizations (CROs) and vendors involved in clinical trial Operation (CRO, Central Lab, etc).
• Participates in CRO and vendor study related calls and meetings, holds team members accountable for actions, escalates issues and oversees all aspects of daily study operations. Ability to identify issues and risks. Develops and manages mitigations and/or escalate risks appropriately.
• Negotiates vendor contracts / budgets and presents to the executive study team for approval.
• Review and confirm CRO and site payment invoices.
• Lead vendor performance assessment for continuous process improvement
• Management/oversight of external vendor deliverables reports and budgets.
• Collaborate within Clinical Operations and with study leadership team to create preferred vendor list for clinical development.

Leadership Skills

• Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream, and lateral implications of decisions that affect study outcomes and timelines.
• Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Excellent team player: willingness and ability to fill functional gaps in a small organization.
• Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities.

Key Relationships

• The Operations Program Lead in Clinical Operations works closely with the asset Core Team and cross-functional teams such as safety, study monitoring, data management, biostatistics, bioanalytics, manufacturing, supply chain, regulatory, project management, medical affairs, and quality.
• Mentoring and management of a CTA.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• Oncology and/or Immunology clinical trial operations therapeutic experience required. 10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience.
• Experience leading the operational planning and oversight of clinical trials as the point of accountability for operational delivery. (CAR-T trials experience is a plus).
• Demonstrated ability to deliver ambitious trial acceleration timelines within a competitive clinical trial landscape.
• Phase 1 clinical trial operational experience is preferred.
• Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements are essential.
• This position requires experience and leading study/project management to create study project plans, and end-to end-study timelines for execution of clinical trials.
• Demonstrated ability to multi-task and manage high performance demands.
• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• CRO/Vendor oversight experience required.
• Project Management (biotech) experience a plus.
• Regulatory authority inspection experience a plus.
• Ability to travel as necessary (approximately 10 – 15 %); both domestically and internationally.
• Effective oral, written and interpersonal communication skills.
• Strong communication and presentation skills.
• Forward and critical thinker.
• SOP development experience preferred.
• Strong organizational and project management skills, and the ability to multitask.
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
• Excellent working knowledge GCP, FDA and ICH Guidelines.

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Legend Biotech is seeking a Sr. Warehouse Operations Manager as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Sr. Manager, Warehouse Operations will work within Technical Operations and be responsible for the ongoing site ramp-up, daily operational management, as well as continuous improvement of cGMP Warehouse Operations within a state-of-the-art cell therapy manufacturing facility. This individual will partner Technical Operations with other functions to support the production and distribution of cell therapy products through safe and compliant operations according to cGMP requirements.

Key Responsibilities

• Lead, direct, coach, and develop an effective Warehouse Operations team responsible for all inbound, outbound, material receipt & inventory management, and distribution processes for raw materials and final drug products.
• Establish a strong relationship between the different teams of the department by identifying clear roles and responsibilities.
• As a management member of the Warehouse team, participate in governances structure design, decision-making process, as well as performance management and initiatives related to the continuous improvement of the warehouse operations.
• Responsible for hiring, development, and performance management of staff (including shift teams) within the warehouse as well as the establishment of key performance indicators for Warehouse Operations.
• Responsible for management of warehouse budget inclusive but not limited to headcount, materials, consumables, services, out of pocket (OOP).
• Serve as BPO of the S4 HANA EWM environment to represent the Warehouse & Operations business requirements and accuracy of inventory, processes and document track. Support implementation of improvement projects to the EWM environment.
• Support the treatment and on time closure of deviations, Quality investigations and CAPA’s related to operational activities. Ensure good CAPA effectiveness checks to keep standards on day-to-day activities and avoid recurrences.
• Take accountability for best practices as per Legend Biotech policies and GXP requirements. Ensure compliance of operational activities with GXP, quality, training, EHS, security requirements. Develop solutions to enhance quality, efficiency, capacity, safety and security.
• Participate in or coordinate projects that involve operations (e.g. material flow, people flow, continuous improvement)
• Interact with key site stakeholders, including but not limited to internal (Planning, Quality, Operations, Vein to Vein, Finance) and external (J&J, Avantor) to the department, on activities linked to his/her area of responsibilities. Be part of EHS improvement and culture change inside the teams. Participate to risk assessments within the Warehouse. Ensure safety observations identified on operational activities are addressed and support implementation of improvements.

Requirements

• Minimum: Bachelor’s degree in Supply Chain, Logistics or related equivalent field experience required. Masters degree desired.
• A minimum of 8-10 years relevant Supply Chain or equivalent experience is required.
• Experience in Pharma or Biologics manufacturing / Supply Chain is highly preferred.
• SAP and EWM experience is preferred • APICS certification is desirable and a strong plus.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Strength in communicating and working effectively with broad stakeholders in various scientific/technical/business disciplines.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Very strong influencing capabilities with an ability to interact and communicate effectively at all levels of the organization and across different functions.
• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization.
• Advanced knowledge of warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation, and qualification within a cGMP manufacturing environment.
• Advanced proficiency in the use of ERP systems, Warehouse Management Systems, and analytics Ability to promote a mindset of continuous improvement, problem solving, and prevention.

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Legend Biotech is seeking an Executive Director, Pipeline Clinical Lead as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Pipeline Clinical Lead is a senior clinical development leader accountable for the scientific and medical direction of early stage clinical programs. This role provides strategic and operational leadership across first in human through proof of concept studies, with accountability for clinical strategy, trial design, execution, interpretation, and regulatory interactions.

The Pipeline Clinical Lead will lead and develop a team of physicians and scientists, work closely with cross functional partners, and collaborate with external development partners and investigators. Deep expertise in clinical trial design, regulatory frameworks, and compliance in drug development—ideally within cell therapy—is essential.

This role requires strong scientific judgment, leadership presence, and a hands on approach in a fast paced, entrepreneurial environment, with a clear focus on patient safety and clinical impact.

Key Responsibilities

Clinical Development Leadership

• Serve as clinical science lead for early stage programs (pre IND through Phase 1/2), including study design, execution, data interpretation, and reporting.
• Define and integrate clinical strategies, including PK/PD, biomarkers, diagnostics, and translational approaches, particularly for cell and gene therapies.
• Provide clinical input into asset selection, review of preclinical data, and development path decisions.

Regulatory & Compliance

• Lead or support IND preparation and amendments, clinical sections of regulatory submissions, and responses to health authority questions.
• Represent the clinical function in pre IND, IND, and (as applicable) BLA/MAA interactions with regulatory agencies.
• Champion patient safety, ethical conduct, and compliance with GCP, corporate policies, and global healthcare regulations.

Cross Functional & External Collaboration

• Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Early Discovery,
• Manufacturing, Biomarkers, and Pharmacovigilance to ensure integrated program delivery.
• Collaborate with external development partners, academic investigators, KOLs, and study sites.
• Act as a credible scientific and clinical representative for programs in internal governance and external forums.

People & Matrix Leadership

• Provide direct line management and mentorship for Medical Directors, Clinical Research Scientists, Medical Writing, Clinical Program management and other clinical staff as applicable.
• Lead effectively in a matrix environment, anticipating cross functional needs and proactively resolving conflicts or risks.
• Contribute clinical leadership to business development, due diligence, and partnership activities when required.

Requirements

• MD or MD PhD (or equivalent) with US board certification or international equivalent.
• ≥8 years of clinical development experience in industry and/or academia, with demonstrated leadership in hematology/oncology.
• Proven experience designing and executing clinical trials from first in human through registrational stages.
• Prior involvement with IND submissions; experience with BLA/MAA filings and health authority meetings strongly preferred.
• Cell therapy and/or CAR T clinical development experience highly desirable IT Skills.
• Strong scientific judgment with the ability to navigate complex clinical and regulatory challenges.
• Demonstrated ability to lead cross functional and geographically distributed teams in a matrix environment.
• Excellent written and oral communication skills, including protocol writing, regulatory documents, publications, and senior level presentations.
• Highly collaborative, influential leader with the ability to represent programs with credibility and confidence.
• Hands on, execution oriented mindset with strong organizational and analytical skills.
• Willingness to travel up to 15–20%.

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Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. 

Role Overview

The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Schedule: Wed-Sat, 1^st Shift

Key Responsibilities  

• Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
• Support manufacturing activities for cGMP compliance through spot checks/internal audits.
• Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
• Review of all documentation, in accordance with Good Documentation Practices (GDP).
• Review, revise, or draft Standard Operating Procedures (SOPs)
• Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised.
• Support batch review & material release in SAP for In-house reagents.
• Support Floor Spot-check, audit trail review.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
• Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
• Utilize multiple electronic quality systems, batch records and SAP.
• Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
• Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas.
• Provide QA shop floor support for extended periods of time.
• Responsibilities will include but not limited to tasks mentioned above.
• Support regulatory inspections and audits as needed.
• Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
• Other duties will be assigned, as the need arises.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses
• Color Perception both eyes 5 slides out of 8.
• Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning

Requirements

• Bachelors degree required in Life Sciences or Engineering.
• 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience
  
• Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
• Experience with quality support in clinical manufacture is preferred.
  
• Flexible to work on weekends, as needed.
  
• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
  
• Is frequently required to communicate with coworkers.
  
• While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms.
  
• Ability to lift 20 lbs.
  
• Report to work on-time.
  
• Duties are required to be performed on-site at manufacturing facility.
  
• Perform other duties as assigned.
  
• Attend departmental and other scheduled meetings.
  
• Practice good interpersonal and communication skills.
  
• Demonstrate positive team-oriented approach in the daily execution of procedures.
  
• Promote and work within a team environment.
  
• Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
  
• Support and contributes to projects.
  
• Assist in troubleshooting issues related to manufacturing.
  
• Technical knowledge within functional units
  
• Demonstrate an understanding of the process in order to properly perform the assigned tasks.
  
• Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.
  
• Utilizes tools within MS Office and other systems to improve business effectiveness.
  
• Read and interpret documents such as safety rules, operating instructions, and logbooks.
  
• Review and provide feedback for SOPs.
  
• Interpret a variety of instructions furnished in written, oral, or diagram.
  
• Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process.
  
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  
• Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals,
  
• Aseptic processing in ISO 5 clean room and biosafety cabinets.
  
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
  
• Great attention to detail and ability to follow the procedures.
  
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
  
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a must.
• Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
  
• Ability to collaborate well with stakeholders, customers and peers.
  
• Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
  
• Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
  
• Ability to manage conflict and issues that arise with internal or external customers.

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Legend Biotech is seeking a Sr. Medical Director/Executive Director, Early Clinical Development as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Sr. Medical Director/Executive Director of Early Clinical Development is a critical role in the company with significant impact on the development and life cycle of drug development projects. The candidate for this role will be responsible to lead the Early Clinical Development Team, for IND submission and the design, execution and oversight of first-in-human, dose finding clinical trials. Full understanding of tenets of FIH studies (e.g. dose selection rationale, biomarker plans, etc.) and the relevant compliance framework for clinical development activities are essential. Candidate must possess passion for science and patients, as well as entrepreneurial drive to help the organization succeed.

Key Responsibilities

• Lead clinical science aspects of design, execution, interpretation and reporting of early (first in human) stage clinical trials.
• Collaborate with scientists and technical experts to integrate cellular therapy specific aspects of PK/PD, diagnostic, and biomarker plans into the overall clinical development strategy.
• Contribute clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions, and other clinical deliverables.
• Collaborate with academic scientists, clinical experts, and study investigators.
• Represent and advocate for the project in internal and external venues.
• Clinical leadership for business development and partnership activities as needed.
• Act as a champion for high standards of compliance, ethics and safety, and putting patients first.

Requirements

• MD or MD-PhD or equivalent medical degree with US board certification in hematology and/or oncology.
• 3+ (Senior) / 6+ (Executive) years’ industry/ academic clinical development experience in hematology/oncology, leading cross-functional development teams is required.
• Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable.
• Experience in biotech - preferred but not required.
• Demonstrated capacity to think creatively when addressing complex situations
• Demonstrated excellence and experience in first-in-human clinical development including the design, execution of first in human trial, and submission of INDs.
• Experience leading pre-IND and IND meetings with health authorities is highly desirable.
• Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills
• Able to anticipate biometrics, regulatory, clinical operations, development sciences, pharmacovigilance, and other development needs to ensure successful program delivery
• Ability to communicate effectively with cross functional teams such as pre-clinical scientists, clinical operations, safety-PV, biomarker, biostatistics, regulatory, and project management including peer to peer interactions with academic scientific experts, KOLs and stake holders.
• Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the team work
• Ensures compliance with corporate policies and procedures, as well as, all related healthcare laws and regulations
• Highly collaborative & effective influencing skills and the ability to operate across multiple geographies
• Strong track record of delivering results through effective team and peer leadership in matrix
• Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence. Communicate regularly and effectively with senior leaders.
• Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating medical/clinical information into clinical development strategies.
• Travel requirement up to 15-20 % of the time.

The advertised pay range covers both levels of this position.

Here's the base pay range by level:

Sr. Medical Director, Early Clinical Development- $294,483 - $386,511

Executive Medical Director, Early Clinical Development- $338,656- $444,486

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Licensed Mental Health Therapist (Telehealth)

Location: New Jersey 

FLSA Status: Exempt

Job Status: 40 hours - W2

Work Model: Remote

Work Schedule: Monday–Friday with occasional evenings and/or weekends

Vehicle Required: No

Positions Supervised: None

Reports To: Director Clinical Care Teams

Annual Base Salary Range: $85,000 - $90,000

Reema Health is both a social care and behavioral health provider. We believe that a personalized, community-based approach to care makes it easier for anyone to access the things they need to make their lives better. We know that life’s challenges often exist because the systems built to help are a burden to navigate. We believe building a relationship with a real person — someone who listens, meets our members where they are, and understands the community — can ease those burdens and effectively connect members to health care. Our mission-driven and member-focused company is seeking an experienced and self-motivated Licensed Mental Health Therapist to serve the behavioral healthcare needs of our members.

Reema is taking a value-based approach to care, so this role will work diligently to provide the right amount of care at the right time for each of our members. Rather than a volume-based approach, we believe this model of care delivery will produce the best clinical outcomes for our members and a sustainable and balanced job structure for our clinicians. The Licensed Mental Health Therapist is a key part of our Integrated Care Team, helping drive the creation and implementation of our tech-enabled psychotherapeutic care for our members. At Reema, we believe integrating social and clinical care is the most effective way to support member wellbeing. You’ll care for members in an outpatient clinical setting, primarily via telehealth, but also in the home and community as needed. You will be part of a multidisciplinary team made up of Psychiatric Nurse Practitioners and non-clinical Community Guides to collaboratively provide a holistic approach to member health, and support you to work at the top of your license. Together, this team is responsible for providing and coordinating member-centered quality care for a panel of members with complex health and social needs. 

Reema is expanding our service delivery into behavioral healthcare, so we are looking for someone who is comfortable helping create the details of our care model within the ambiguity of a fast-paced startup. For the right person, this position has the potential to grow into a leadership role.

Primary Responsibilities:

• Assess and diagnose behavioral health conditions, both chronic and acute.
• Formulate treatment plans for members in consultation with other members of the collaborative health team as the member’s condition warrants.
• Ensure a behavioral health perspective is incorporated into comprehensive care planning for complex patients.
• Complete initial intakes and assess patient risks and needs, delivering therapeutic interventions and therapy, and referring and navigating to community resources for access to the broader behavioral health continuum of care.
• Collaborate with primary care providers, psychiatrists, social workers, or other professionals to discuss treatment plans and progress.
• Provide psychoeducation to members, emphasizing mental health promotion and disease prevention
• Support referral for members who need additional specialty behavioral health care (e.g. to an in-patient facility) and advise on treatment plans until members are engaged in appropriate care.
• Establish and foster trusting relationships with patients and ensure care is aligned with the patient’s goals and values.
• Participate in multi-disciplinary case conferences to ensure holistic and appropriate care for patients.
• Provide formal and informal coaching and education to other clinical and non-clinical team members about supporting patients with behavioral health issues. 
• Support post-discharge planning to prevent readmissions.
• Timely and appropriate documentation in our EMR to manage member care and coordination with the multidisciplinary team.
• Contribute to the evolving design and implementation of clinical pathways and protocols for therapeutic treatment of behavioral health conditions in Reema’s care model to ensure we are providing the best patient care possible.

Job responsibilities to grow and change as business necessitates.

Experience and Skills:

• 3+ years of outpatient experience working with adults enrolled in Medicaid, Medicare, or are dual-eligible.
• 3+ years of experience in assessing, planning, and managing behavioral patient care as acquired through direct clinical experience, including direct therapy and care/case management work
• 3+ years of experience working with individuals who have significant mental and chemical health needs and believe that recovery is possible.
• 1+ years of experience practicing telemedicine
• Experience with underserved populations facing socioeconomic barriers to health care
• Excellent working knowledge of trauma-informed and evidence-based psychotherapy treatment for mental and chemical health conditions
• Awareness and comfort in participating in an integrated behavioral health model where you will work alongside Community Guide team members
• Comfort with electronic medical record documentation and excited about how technology can support your work and drive ongoing improvement towards new and better care
• Ability to make quick and accurate clinical assessments of mental and behavioral health conditions
• Ability to exercise balanced judgment in evaluating situations and making decisions, and to handle difficult or confrontational situations in a calm, consistent, and equitable manner
• Ability to work effectively as a team, interfacing with patients, primary care providers, consulting psychiatrists and mental health specialists, as well as with administrative and support staff
• Working knowledge of all related computer and software applications such as Microsoft Word, Outlook and Excel, telecommunication and Video Conferencing required; G-Suite preferred

Education, Qualifications & Position Requirements:

• LCSW, LMFT or LPC with an active license in the state New Jersey
• Ability to cross license in Ohio, Florida and Virginia
• 18 years of age or older
• Comply with federal, state and local regulations regarding patient confidentiality & HIPAA
• Proficiency with electronic medical records and other technology-based tools and systems

Benefits: 

• Competitive Salary 
• Medical, Dental, and Vision Insurance
• HSA and FSA Options
• 401(k) Retirement Savings with Company Match
• Employee Assistance Program
• Flexible Schedules and Remote Work
• Technology Stipend
• Accrued Paid Time Off
• Paid Family and Medical Leave

As an equal opportunity employer, Reema Health is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

All candidates who have received a written offer for this position will be required to undergo drug testing for commonly abused controlled substances in accordance with the company’s policy. Hires are contingent upon candidates producing satisfactory results from the pre-employment drug test.

Reema Health has reviewed this job description to ensure that essential functions and basic responsibilities have been included. It is intended to provide guidelines for job expectations and assess the prospective employee and/or current employees ability to perform the position described. It is not intended to be interpreted as an exhaustive list of all functions, responsibilities, skills, and abilities for this role. Additional functions and requirements may be assigned by supervisors as deemed appropriate.

Notice to all potential candidates

Reema Health has been made aware of fraudulent activities targeting job seekers. 

To ensure your safety and protect yourself from potential scams, we urge you to exercise caution and verify the authenticity of anyone claiming to represent Reema Health. 

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We appreciate your understanding and interest in a career with Reema Health.

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director will be responsible for the oversight of Translational Science preclinical safety assessment/toxicology deliverables, with a clear understanding of functional interdependence and critical path activities. The role will contribute to the research and/or development of the products, projects, and programs in support of the pipeline.  Collaborate cross‑functionally to conduct basic research and development, including designing and overseeing preclinical safety and toxicology studies in support of diverse projects and long-term company objectives.  Ensure timely and effective communication of project status and issues to drive alignment and successful completion of team goals and deliverables.

Primary Responsibilities

• Plans experimental safety assessment/toxicology programs to include design, logistics, resource allocation, schedules. Identifies critical support needs, and other necessary details to implement the program(s).

• Provides oversight on scientific management of preclinical safety assessment/toxicology studies supporting early drug development spanning lead optimization through IND and NDA submissions and nonclinical post marketing approval requirements.

• Monitors CROs for quality and compliance in the conduct of preclinical safety assessment/toxicology studies.

• Manages vendors and consultants, encompassing study design, detailed coordination of study execution, overview of quality compliance, and scientific rigor.

• Reviews and contributes to preparation of toxicology reports.

• Maintains oversight of test compound delivery, shipment and supply requirements.

• Works cross functionally on projects including an understanding of when broader discussion is required and the organization ad hoc working groups as needed to move project activities forward.

• Communicates project status and proactively identifies issues to ensure that project team goals and regulatory deliverables are met.

• Provides guidance to team members to objectively assess and resolve preclinical safety assessment/toxicology project issues to improve project effectiveness.

• Other duties as assigned.

Education/Experience/Skills

BS or MS in a relevant discipline or a related field. Targeting 8 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development within the pharmaceutical or biotech industry.  DABT Certification strongly preferred. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Understanding of the drug development process and the principles, concepts, practices, and standards of executing preclinical safety assessment/toxicology strategies.

• Knowledge in the tools and procedures of preclinical safety assessment/toxicology experimentation, including the various experimental designs, statistical tools of data analyses, software applications available for data manipulation and presentation, and instrumentation pertinent to the research and ability to evaluate the advantages and disadvantages of each, in terms of applicability to the research at hand.

• Knowledge of the preclinical study types necessary during drug development, including acute and chronic toxicology, safety pharmacology, developmental and reproductive toxicology, genotoxicity and carcinogenicity.

• Experience working in cross-functional project teams and in a semi-virtual environment including CROs and academic collaborations.

• Study monitoring experience on Good Laboratory Practices (GLP) safety assessment/toxicology studies at CROs.

• Experience in the composition and review of preclinical safety assessment/toxicology reports with respect to accuracy, quality and compliance.

• Knowledge and understanding of GLP, ICH and FDA guidance, and other relevant regulations and guidelines.

• Demonstrated skills and abilities in influencing, facilitation, development, and problem solving. Ability to elicit cooperation from a wide variety of sources and to be influential, encouraging and motivating.

• Excellent communication, presentation, consultative, partnership, and interpersonal skills. Self-motivated and able to work with limited supervision. 

• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.

• Must be able and willing to travel as needed.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#transmed

#LI-Hybrid #LI-SL1

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director in the Early Stage Drug Product Development organization at Acadia is responsible for the development of pharmaceutical formulations primarily intended for early-stage clinical trials and preclinical animal studies. This role also supports drug discovery teams by assisting in the selection of optimal drug candidates through detailed physicochemical characterization and assessment of compound properties. The incumbent will focus on formulation strategies tailored to early development phases, ensuring that candidates are suitably prepared for initial safety and efficacy evaluations. Additionally, collaboration with research scientists and external partners is essential to address technical challenges and advance promising compounds toward clinical readiness.

The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues The role will be critical in ensuring that we select developable drug candidates, reduce risk and accelerate the introduction of new chemical entities into the Acadia pipeline.

Primary Responsibilities
 

• Designs and develops pharmaceutical formulations to support early stage clinical trials, providing acceleration options such as on-site compounding and impromptu type of drug products.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, oversee operations at existing suppliers.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• With Translational Sciences teams, plans conduct of preclinical and toxicological studies and develops requisite formulations for the same considering developability of the new drug candidates.
• Develops phase appropriate formulations for new drug candidates in FIH, Phase 1 and POC studies employing resource sparing approaches such as compounded formulations and/or on-site preparations.
• Conduct physicochemical characterizations of the new drug candidates to support developability assessments.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with the CMC team, late-stage formulation team, and formulation development management to establish the development strategy for formulation of the new drug candidates.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Collaborates with regulatory teams in preparation of the health authority submissions for the early clinical trial applications (e.g. IND, CTA, IMPD)
• Other responsibilities as assigned.

Education/Experience/Skills

Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.  A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.  Demonstrated success in the field of formulations and dosage form development.   Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the physicochemical characterization of new drug candidates to assess developability, formulations for early stage clinical studies, and dosage form formulation and package development.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel to domestic and international locations is required.

#LI-HYBRID #NC1 

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

Responsible for the oversight of Translational Medicine preclinical safety assessment/toxicology deliverables, with a clear understanding of functional interdependencies and critical path activities.  The role will contribute to the research and/or development of the products, projects, and programs in support of the pipeline. Conducts and collaborates with others on basic research and development including preclinical safety assessment/toxicology studies supporting various projects relevant to long-term objectives of the company. Conducts and collaborates with others on basic research and development including designing and monitoring preclinical safety assessment/toxicology studies supporting various projects relevant to long-term objectives of the company. Responsible for the communication of project status and issues and develops strategies to ensure project team goals and deliverables are met.

Primary Responsibilities

• Plans experimental safety assessment/toxicology programs to include design, logistics, resource allocation, schedules.  Identifies critical support needs, and other necessary details to implement the program(s).

• Provides oversight on scientific management of preclinical safety assessment/toxicology studies supporting early drug development spanning lead optimization through IND and NDA submissions and nonclinical post marketing approval requirements.

• Monitors CROs for quality and compliance in the conduct of preclinical safety assessment/toxicology studies.

• Manages vendors and consultants to complete Translational Medicine safety assessment/toxicology studies for the various programs.

• Responsible for preparation and review of reports and regulatory documents for IND and NDA submissions. Explore innovative approaches to enhance efficiency of toxicology evaluations.

• Supports business development related nonclinical Tox/ADME assessments and due diligence projects by assessing available study data and regulatory submissions, identifying gaps, defining additional nonclinical study plans and test compound requirements, and developing overall project timelines and associated budgets.

• Supports Impurity/Degradant safety assessment reviews requested by Chemistry, Manufacturing, and Controls (CMC) groups, involving public domain literature reviews, evaluating structure activity relationships using in silico databases, and competitive intelligence sources.

• Works across functional areas on projects including lleading and participation in team and sub-team meetings and organizing ad hoc working groups as needed to move project activities forward. 

• Communicates project status and issues and ensures project team goals and regulatory deliverables are met. Clearly presents data, interpretation and recommendations to R&D leadership.

• Provides guidance to team members to objectively assess and resolve preclinical safety assessment/toxicology project issues to improve project effectiveness.

• Other duties as assigned.

Education/Experience/Skills

PhD or DVM in a relevant discipline or related field.  Targeting 10 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development experience within the pharmaceutical or biotech industry.  DABT Certification strongly preferred.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Advanced understanding of the drug development process and the principles, concepts, practices, and standards of executing preclinical safety assessment/toxicology strategies.

• Broad knowledge in the tools and procedures of preclinical safety assessment/toxicology experimentation, including the various experimental designs, statistical tools of data analyses, software applications available for data manipulation and presentation, and instrumentation pertinent to the research. Through a complete understanding of the tools and design methods, able to evaluate the advantages and disadvantages of each, in terms of applicability to the research at hand.

• In depth knowledge of the preclinical study types necessary during drug development, including acute and chronic toxicology, safety pharmacology, developmental and reproductive toxicology, genotoxicity and carcinogenicity.

• Experience managing cross-functional project teams and working in a semi-virtual environment including CROs and academic collaborations.

• Specific direct study monitoring experience on Good Laboratory Practices (GLP) safety assessment/toxicology studies at CROs.

• Experience in the composition and review of preclinical safety assessment/toxicology reports with respect to accuracy, quality and compliance.

• Knowledge and understanding of GLP, ICH and FDA guidance, and other relevant regulations and guidelines.

• Demonstrated skills and abilities in leading teams and sub-teams, coaching, influencing, facilitation, development, and problem solving. Passion for science and teamwork with self-motivation and ability to work with limited supervision.

• Excellent communication, presentation, consultative, partnership, and interpersonal skills. Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating.

• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.

• Willing and able to travel as needed.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#transmed

#LI-Hybrid #LI-SL1

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director of Drug Safety & Pharmacovigilance is a medical safety expert within the Drug Safety & Pharmacovigilance (PV) function, reporting to the Executive Director of Medical Safety. This role serves as the primary medical safety resource for assigned products across the Acadia portfolio, providing hands-on medical evaluation of safety data, signal detection and assessment, and clinical oversight of pharmacovigilance activities throughout the product lifecycle. The Director contributes product-level medical input to cross-functional safety governance, collaborates with the Executive Director of Medical Safety on complex or escalated safety issues, and supports regulatory submissions and health authority interactions for assigned products. 

Primary Responsibilities

• Serves as the primary medical safety resource for assigned Acadia products, providing product-level clinical safety and pharmacovigilance expertise across all stages of development and post-marketing surveillance
• Performs medical evaluation and interpretation of aggregate safety data for assigned products, including signal detection and evaluation, ad hoc safety assessments, and benefit-risk analyses; escalates complex or novel safety issues appropriately
• Assesses safety signals and trends for assigned products and proactively manages potential safety issues in collaboration with cross-functional stakeholders
• Contributes product-level medical input to the Medical Safety team and other cross-functional safety governance bodies
• Performs medical review of all serious adverse events from Acadia clinical trials for assigned products
• Performs retrospective medical review of adverse events for post-marketed products
• Authors Analysis of Similar Events (AOSE) and individual case narratives and comments for ICSRs for assigned products
• Provides oversight for the safety aspects of clinical studies for assigned products, including development and maintenance of product-specific core safety information
• Reviews and approves safety sections of clinical documents for assigned products, including protocols, DSURs, final study reports, and other documents as required
• Formulates response strategies and authors health authority responses for safety-related queries pertaining to assigned products, in collaboration with the Head of Medical Safety
• Provides medical input into Periodic Benefit Risk Evaluation Reports (PBRERs) for assigned products, including clinical interpretation of safety data
• Provides medical and scientific input into Risk Management Plans (RMPs/dRMPs) and REMS programs for assigned products
• Ensures all PV Medical Safety activities for assigned products are performed in compliance with applicable regulations and Acadia standards
• Maintains current knowledge of global regulatory authority regulations and guidance
• Other responsibilities as assigned

Education/Experience/Skills

• MD (Doctor of Medicine) or equivalent medical degree from an accredited institution, with relevant postgraduate clinical training and experience; candidates who are eligible for U.S. medical board certification are preferred. MPH or pharmacoepidemiology training is a plus. 
• 6 to 7 years of relevant drug safety experience, including expertise in safety signal management (signal detection, evaluation, aggregate data review, ICSRs), preferably in a pharmaceutical or biotech environment.  
• Neurology, psychiatry, rare disease, or CNS-related therapeutic area experience strongly preferred
• Advanced knowledge of FDA, EU, and ICH regulations and guidelines related to pharmacovigilance, including clinical trial safety monitoring, post-marketing surveillance, ICSR processing, aggregate reporting, and health authority reporting requirements
• Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data
• Demonstrated expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases
• Ability to author and critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses)
• Strong analytical and critical decision-making skills; ability to manage competing priorities and meet deadlines with minimal oversight
• Experience with pharmacovigilance safety databases (Argus) and signal detection tools
• Familiarity with pharmacoepidemiology concepts and study design
• Excellent interpersonal, written, and oral communication skills; ability to effectively communicate complex safety findings to internal and external stakeholders
• Proficiency in MS Office Suite (Word, PowerPoint, Excel)
• Ability to manage multiple priorities and work cross-functionally in a fast-paced environment
• Must be willing and able to travel both domestically and internationally

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID 

Position

We are seeking a physician with a strong clinical background and a passion for drug development to join our Clinical Development team to serve as a Study Responsible Physician, Senior Director, Clinical Research. In this role, you will play a pivotal part in advancing our oncology and/or non-oncology pipeline by providing medical expertise, leadership, and operational oversight for a clinical development study(ies).

About You

You are a highly accomplished professional who excels in the development and execution of clinical projects. As a key member of the cross-functional Development Teams and the Clinical Study Teams, you will employ your expertise in clinical development to advance new therapies to patients in need. Your dedication to scientific rigor and meticulous attention to detail is evident in all your work. With a deep passion for creating important new medicines, you are committed to advancing the field of medical research and improving patient outcomes.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey or California offices to ensure effective collaboration and high-quality execution of your clinical work.

What You’ll Do in partnership with your Manager

• Design and conduct early-stage or late-stage clinical development trials as needed, including, but not limited to assessing clinical safety and efficacy data, performing medical monitoring, and be responsible for other study-related clinical activities.
• Interpret reports, and prepare oral and written results of product research.
• Be proactive in fulfilling your responsibilities and pay particular attention to quality and accuracy of work as well as timeliness of deliverables.
• Collaborate closely with relevant functions within Eikon including discovery, translational and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, and regulatory personnel.
• Work closely with functional partners (Clinical Science, Data Management, Clinical Operations, Biostatistics) to ensure an integrated approach to flawless execution and systematic oversight of study protocol(s) in clinical development.
• Work closely with functional partners to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.

Qualifications

• MD or DO degree with significant experience in Oncology.
• Minimum of 5-7 years of clinical experience, including 3+ years in drug development.
• Experience in clinical practice with direct patient care.
• Proven track record in leading clinical trials, including medical monitoring of early and late stage clinical trials.
• In-depth knowledge of clinical research methodologies, GCP, and regulatory requirements.
• Ability to work effectively in a matrixed environment.
• Strong analytical, organizational, and problem-solving skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Passion for clinical trials and improving patient outcomes.
• Experience with IND and/or NDA/BLA filings is preferred.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $270,000 to $294,500 depending on skills, competency, and the market demand for your expertise.

Position 

We are seeking a highly experienced, collaborative, and detail-oriented Contract Senior Manager capable of helping Eikon optimize its clinical Site Engagement and Monitoring function to support delivery of world class clinical drug development. The successful candidate will work closely with the Eikon Site Engagement and Monitoring Excellence (SEME) team, global Clinical Research Associates (CRAs) and internal study teams across therapeutic areas to oversee clinical site engagement and monitoring activities.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You have significant monitoring experience and a passion for leading, training, and mentoring CRAs. You are adept at developing and maintaining relationships with clinical trial sites and demonstrate the ability to oversee monitoring with a strong knowledge of Good Clinical Practice and clinical trial regulations to ensure subject safety, data integrity and inspection readiness. You have experience developing systems, resources, and tools to support high-quality monitoring and forecast CRA resourcing. You also have experience utilizing a Functional Service Provider (FSP) monitoring model embedded within a sponsor study team to execute major data collection and study milestones. You are a strong collaborator across clinical functional areas with a demonstrated ability to creatively and independently resolve complex issues that impact sites and CRAs.

What You’ll Do 

• Establish and foster effective relationships with internal and external stakeholders, such as the CRO and study team members.
• Promote awareness of Eikon’s clinical pipeline and programs to trial sites, investigators, and networks.
• Complete or oversee the qualification of sites and promptly facilitate site selection to support study milestone goals.
• Develop and maintain strong site relationships to support the site/patient experience and drive study team goals such as enrollment and major study milestones.
• Onboard and train CRAs to conduct high quality site qualification, initiation, and monitoring visits.
• Review and approve monitoring trip reports in the Clinical Trial Management System (CTMS).
• Perform and document monitoring oversight activities to assess monitoring quality and CRA performance.
• At times, perform the CRA role as needed, to support prompt site qualification, initiation, monitoring and close-out visits at key sites to meet urgent study milestones.
• Regularly review site and monitoring Key Risk Indicator (KRI) metrics to detect issues and ensure prompt resolution.
• Serve as an escalation point for CRAs and as a Subject Matter Expert (SME) to resolve site management and monitoring quality issues and develop/ensure implementation of Corrective and Preventive Action (CAPA) Plans as needed.
• Support CRAs to ensure sites are inspection-ready and support Eikon Clinical Quality Assurance during site inspections.
• Effectively utilize the CTMS and Trial Master File (TMF) to ensure SEME documents are promptly filed and site data is accurate.
• Contribute to monitoring process improvement initiatives by developing functional area Standard Operating Procedures (SOPs), Work Instructions (WIs), job aids, and tools.
• Contribute to improving site selection, monitoring, and monitoring oversight trip report templates in Veeva CTMS by identifying gaps, suggesting updates, testing and implementing change controls.

Qualifications

• 8+ years of experience with a Bachelor's degree, or 6+ years with a post graduate degree
• Experience utilizing Veeva CTMS and TMF is required.
• Experience supporting site and/or sponsor inspections is required.
• Working on-site from an Eikon office location (Jersey City, NJ or Millbrae, CA) 3 days per week is required during non-travel weeks.​

The expected hourly range for this role is $77.40 to $84.50 depending on skills, competency, and the market demand for your expertise.

Position

The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology.

What You’ll Do

• Team leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans
• Works with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams
• Demonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions 
• Provide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted  following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents
• Oversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity
• Responsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial.
• Oversee the preparation and maintenance of detailed clinical trial project timelines
• Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed following contract specifications of time, cost and quality.
• Work with finance, legal, and external vendors to ensure the assigned studies are meeting the target milestones
• Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research)
• Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.
• Responsible for hiring, performance management, career development, and providing mentorship to Clinical Study Management personnel.
• Contribute to initiatives and projects adding value to Eikon Therapeutics

Qualifications

• Minimum of 10 years of related experience with a Bachelor’s degree or 8 years and a post-graduate degree.
• Experience leading large, global clinical trials, preferably in oncology
• In-depth knowledge of ICH-GCP, EMA guidelines and other relevant regulations and guidelines.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
• High sense of accountability and urgency to prioritize deliverables.
• Growth mindset and capable of working independently.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $183,000 to $199,500 depending on skills, competency, and the market demand for your expertise.

Position

The Clinical Program Manager, Oncology, Clinical Study Management, will plan and oversee the execution of clinical trials in oncology and other therapeutic areas, as needed. This role  works in close partnership with cross-functional teams to ensure studies are delivered on time and within budget, with a strong focus on quality,  operational excellence, and best-in-class clinical study management. The successful candidate will play a key role in driving study execution, managing risks, and enabling high-performance collaboration across functions and regions.

This role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. 

About You

You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology or neuroscience.

What You’ll Do

• Develop and own the operational strategy, timelines, and operational plans for clinical trials, ensuring alignment with program objectives and overall business goals.
• Oversee and lead cross-functional clinical trial execution, leading proactive risk identification, assessment, management, and driving alignment on mitigation strategies.
• Ensure high standards of quality by overseeing that clinical studies are conducted in accordance with approved protocols, company SOPs, applicable regulations, and maintain ongoing inspection readiness across the program lifecycle.
• Serve as central point of contact to facilitate cross functional team effectiveness, drive operational efficiency, and provide clear direction and guidance to ensure successful study execution.
• Work with minimal oversight from the Clinical Study Management Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development, Finance, and Legal functions.
• Oversee and manage vendor relationships and performance to ensure that clinical studies are completed in accordance with contractual specifications for quality, timelines, and cost.
• Provide regular, clear updates on study progress, risks, and mitigation plans to stakeholders and executive management (e.g., Clinical Study Management, Project & Portfolio Management, Clinical Research).
• Ensure that all study-related documents are accurate, complete, and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems in a timely manner.
• Lead, manage, hire, develop, and mentor global and regional Clinical Study Management personnel.
• Contribute to improvement initiatives, operational excellence efforts, and cross-functional projects that add value to Eikon Therapeutics.

Qualifications

• Bachelor’s degree with 8 years, a Master’s degree with 6 years, or a PhD with 3 years of relevant experience in life sciences, healthcare, or related field preferred. 
• Fluency in English (strong reading, writing, and speaking skills with the ability to effectively communicate with colleagues and stakeholders at all levels) is required.
• In-depth knowledge of ICH-GCP, regulations, directives, and guidelines.
• Proficiency in clinical trial management systems (CTMS, RTSM (IRT), Veeva Vault suite) and electronic data capture (EDC) systems.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience managing budgets, resources, processes and controls, productivity, quality, and project delivery.
• High sense of accountability and urgency to prioritize deliverables effectively.
• Growth mindset and ability to independently.
• PMP certification preferred.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.

About Schumacher

Schumacher & Co. is an innovative interior design company that is disrupting the $150 billion-dollar global interior design industry. We are a technological leader on the design frontier, constantly pushing boundaries and striving for excellence. With over 500+ employees and growing, we are driven by a shared belief that design transforms life. We are dedicated to the mission of helping our customers “celebrate the feeling of home”. Schumacher designs and produces some of the most beautiful fabrics, wallcoverings, trims, furniture, and accessories in the world. Our portfolio of products is broad, but they are united by a passion for design, a thirst for what is next, an appreciation for what’s come before, a drive to make our products with enormous care and attention for detail. Schumacher is a globally recognized company with a myriad of showrooms both domestically and internationally.

Our competitive advantage in the industry is the people. We believe that our employees are our most important assets. F. Schumacher & Co is deeply anchored in our company core values which are as follows:

• Preserve Our Entrepreneurial Spirit
• Take Ownership & Accountability
• Be Solutions-Oriented
• Demonstrate Courage
• Practice Adaptability
• Embrace Collaboration

We empower our employees to live these values daily because we understand how it will positively impact the customer's journey. F. Schumacher & Co., also known as FSCO, is the parent company to many brands within our portfolio. This role is part of Schumacher North America, which is the largest division of the company.

About Paramount Prints

Since F. Schumacher & Co. was founded in 1889, our family-owned design house has been synonymous with style, taste, and innovation—and always ahead of the pack. We’re driven by a shared belief that design transforms life. It challenges convention. It brings a unique point of view into the world. It sets trends. And it leaves a mark.

We champion individual style and the collective practice of transformational interior design. We create it. We supply it. We support it. We celebrate it. We also partner with the most brilliant trendsetters in design and fashion to advance it. And we want to bring it to as many people and into as many homes as possible. Paramount is an independently operating business unit of F. Schumacher & Co., functioning as a growth-stage startup with the resources of an established organization and serving both direct-to-consumer and bulk/volume channels.

Role Overview

The Shipping and Receiving Lead position is an exciting and highly visible role that plays an important role in shaping, supporting, and monitoring the future of Schumacher’s manufacturing operation. 

Hours are 6:30am to 3:00pm Monday - Friday with potential for Overtime

YOU WILL

• Receive and process incoming orders for the production team
• Process and prepare Fedex and UPS shipments for daily pickups before the end of day
• Ship and confirm all orders to ensure proper delivery to customers for consolidated pallets and made to order drop-ships
• Access and pallet completed orders to Schumacher’s processing facility in Fort Mill, SC
• Receive orders and accurately input quantities to ensure they match inventory in ERP
• Measure quantities of each order to ensure they match what was ordered
• Communicate with internal logistics at Schumacher to ensure timely pickups
• Ensure products are packed securely to ensure the safety of the product
• Pick orders and prepare them for small package or freight shipment by the ship date
• Generate packing lists
• Create bills of lading using MS Excel and Word
• Prepare fabric and wallpaper grounds in advance for printers at the end of each day
• Break down and re-palletize products
• Coordinating customs, brokers and clearance for overseas incoming and outgoing shipments
• Receive raw material shipments and accurately input received quantities into the ERP
• Be instrumental in implementing new tracking and inventory systems with operations and production teams
• Shrink wrapping, labeling and recording pallets and wallpaper orders
• Inspect all outgoing orders for damage or other quality control issues
• Track inventory related to shipping and general floor organization, submit replenishment numbers for ordering on a weekly basis
• Track weekly shipping targets and proactively communicate regarding deadlines, issues with orders and other flags
• Achieve proficiency across all other dept. functions and sub in as needed
• Dispose of trash and recyclable materials
• Assist in other operational functions as needed

YOU HAVE/ARE:

• Excellent communication and interpersonal skills
• Bi-lingual (Spanish-speaking capability preferred)
• Proficiency in MS Office (including Excel, Outlook, Word and Access)
• Experience in receiving, counting materials and stocking materials (preferred)
• Experience working with ERP systems (preferred)
• Able to respond quickly to shifting order priorities and stay focused while working on multiple projects at once
• Able to thrive in target driven environment and proactive in meeting deadlines
• Resourceful, a creative problem solver with a high level of ownership, accountability, and initiative
• Willing to pick up additional shifts as needed (overtime pay)
• Highly organized and detail oriented with an ability to keep your workstation clean and tidy
• Able to attend phone calls and email requests from inter-company and third-party customers
• Able to handle product with care
• Able to utilize ladders and other small equipment
• Able to lift a minimum of 60lbs, bend, squat, kneel, reach overhead, push and pull heavy boxes and containers, stand for long periods of time; this is a largely active role

Benefits Package

Your well-being is our top priority. Our benefits and total compensation are designed for the whole person, caring for both you and your family.

Wealth Benefit:

• Monthly Production Incentive

Health Benefits:

• Dental Coverage
• Medical Coverage
• Prescription Drug Plan
• Vision Coverage
• Health Savings Account (HSA)
• TELADOC

 Other Benefits:

• 15 Days Paid Time Off (PTO)
• 10 Company Holidays
  • Mid-year & Year-End Closures
• Bereavement Leave
• Life Insurance
• Flexible Spending Accounts (FSA)
• AFLAC Plans (Accident and Critical Illness Plans)
• Pet Insurance
• Short-Term Disability (STD)
• Long Term Disability (LTD)
• Parental Medical Leave
• Child Bonding Leave
• Employee Discount

We are an Equal Opportunity Employer committed to diversity, inclusion, and equality in the workplace. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, physical and mental disability, genetic information, marital status, sexual orientation, gender identity/assignment, citizenship, pregnancy or maternity, protected veteran status, or any other status prohibited by applicable national, federal, state or local law.

About Schumacher

Schumacher & Co. is an innovative interior design company that is disrupting the $150 billion-dollar global interior design industry. We are a technological leader on the design frontier, constantly pushing boundaries and striving for excellence. With over 500+ employees and growing, we are driven by a shared belief that design transforms life. We are dedicated to the mission of helping our customers “celebrate the feeling of home”. Schumacher designs and produces some of the most beautiful fabrics, wallcoverings, trims, furniture, and accessories in the world. Our portfolio of products is broad, but they are united by a passion for design, a thirst for what is next, an appreciation for what’s come before, a drive to make our products with enormous care and attention for detail. Schumacher is a globally recognized company with a myriad of showrooms both domestically and internationally.

Our competitive advantage in the industry is the people. We believe that our employees are our most important assets. F. Schumacher & Co is deeply anchored in our company core values which are as follows:

• Preserve Our Entrepreneurial Spirit
• Take Ownership & Accountability
• Be Solutions-Oriented
• Demonstrate Courage
• Practice Adaptability
• Embrace Collaboration

We empower our employees to live these values daily because we understand how it will positively impact the customer's journey. F. Schumacher & Co., also known as FSCO, is the parent company to many brands within our portfolio. Paramount is an independently operating business unit of F. Schumacher & Co., functioning as a growth-stage startup with the resources of an established organization and serving both direct-to-consumer and bulk / volume channels. This is an exciting and highly visible position that plays an important role in shaping, supporting, and monitoring the future of Schumacher’s manufacturing operation.

Role Overview

The Warehouse Associate is responsible for the overall efficiency, accuracy, and organization of all warehouse activities, including inventory receiving, storage, and order fulfillment. This role is critical in ensuring a seamless flow of materials between vendors, the warehouse, and the production/shipping departments, directly impacting timely order completion. The Lead will be responsible for inventory accuracy through rigorous counting procedures and will play a key role in system and process implementation.

Hours are 6:30am to 3:00pm Monday - Friday with potential for Overtime

YOU WILL:

Inventory Support & Accuracy

• Assist with the receiving, labeling, storage, and organization of raw materials and finished wallpaper products.
• Support daily and weekly cycle counts to help maintain inventory accuracy.
• Participate in end-of-month and end-of-year physical inventory counts as directed.
• Accurately record inventory movements in the Monday Board and related tracking tools.
• Report inventory discrepancies, damaged goods, or data errors to the Warehouse Lead promptly.
• Assist with inbound quality control (QC) checks to ensure materials meet specifications before being accepted into inventory.

Warehouse Operations & Fulfillment

• Pick, stage, and prepare materials and finished goods for production or outbound shipping.
• Ensure orders are fulfilled accurately and efficiently according to production schedules and shipping timelines.
• Maintain clean, organized, and safe warehouse areas to support efficient workflows.
• Support coordination between Warehouse, Production, and Shipping teams to prevent delays due to material availability or handling issues.
• Assist with loading, unloading, and internal movement of materials using appropriate equipment.

Process Support & Continuous Improvement

• Follow established SOPs for inventory handling, safety, and system usage.
• Assist with the implementation of new tools or processes (e.g., barcoding, improved labeling, layout changes).
• Provide feedback to the Warehouse Lead on workflow challenges or improvement opportunities.

Safety & Compliance

• Adhere to all safety protocols, including proper use of PPE and equipment.
• Participate in required safety and operational training.
• Report safety hazards or incidents immediately.

JOB QUALITIES:

• Able to respond quickly to shifting order priorities and stay focused while working on multiple projects at once
• Thrive in target driven environment and willing to do what it takes to meet deadlines
• A great communicator and active contributor to larger team goals and processes
• Enjoys the small team environment, high energy and scrappy
• Resourceful, a creative problem solver
• Willing to pick up additional shifts as needed (overtime pay)
• Highly organized, ability to keep your workstation clean and tidy
• Able to handle product with care
• Able to utilize ladders and other small equipment
• Able to lift a minimum of 60lbs, bend, squat, kneel, reach overhead, push and pull heavy boxes and containers, stand for long periods of time; this is a largely active role
• Experience in receiving, counting materials and stocking materials is preferred
• Experience working with ERP systems is preferred
• Able to attend phone calls and email requests from inter-company and third-party customers

YOU HAVE/ARE:

• Excellent communication and interpersonal skills – Bi-lingual, Spanish-speaking capability preferred
• High school diploma or equivalent required.
• 1–2 years of warehouse, manufacturing, or inventory-related experience preferred.
• Basic familiarity with inventory systems or Monday software is a plus.
• Ability to perform physical tasks, including lifting, standing, and repetitive movement.
• Strong attention to detail and ability to follow procedures accurately.
• Reliable, punctual, and able to work well in a team-oriented environment.
• A team player, cooperative, a person who easily gains trust and supports peers
• Has an all hands on deck mentality, and is willing to pitch in with multiple team members
• Able to work well with others in a fast-paced environment

Wealth Benefits:

• Competitive Salary
• Corporate Annual Profit Sharing
• 401K Plan

Health Benefits:

• Dental Coverage
• Medical Coverage
• Prescription Drug Plan
• Vision Coverage
• Health Savings Account (HSA)
• TELADOC

Other Benefits:

• 15 Days Paid Time Off (PTO)
• 10 Company Holidays
• Bereavement Leave
• Life Insurance
• Flexible Spending Accounts (FSA)
• AFLAC Plans (Accident and Critical Illness Plans)
• Pet Insurance
• Short-Term Disability (STD)
• Long Term Disability (LTD)
• Parental Medical Leave
• Child Bonding Leave
• Employee Discount

We are an Equal Opportunity Employer committed to diversity, inclusion, and equality in the workplace. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, physical and mental disability, genetic information, marital status, sexual orientation, gender identity/assignment, citizenship, pregnancy or maternity, protected veteran status, or any other status prohibited by applicable national, federal, state or local law.

About Schumacher

Schumacher & Co. is an innovative interior design company that is disrupting the $150 billion-dollar global interior design industry. We are a technological leader on the design frontier, constantly pushing boundaries and striving for excellence. With over 500+ employees and growing, we are driven by a shared belief that design transforms life. We are dedicated to the mission of helping our customers “celebrate the feeling of home”. Schumacher designs and produces some of the most beautiful fabrics, wallcoverings, trims, furniture, and accessories in the world. Our portfolio of products is broad, but they are united by a passion for design, a thirst for what is next, an appreciation for what’s come before, a drive to make our products with enormous care and attention for detail. Schumacher is a globally recognized company with a myriad of showrooms both domestically and internationally.

Our competitive advantage in the industry is the people. We believe that our employees are our most important assets. F. Schumacher & Co is deeply anchored in our company core values which are as follows:

• Preserve Our Entrepreneurial Spirit
• Take Ownership & Accountability
• Be Solutions-Oriented
• Demonstrate Courage
• Practice Adaptability
• Embrace Collaboration

We empower our employees to live these values daily because we understand how it will positively impact the customer's journey. F. Schumacher & Co., also known as FSCO, is the parent company to many brands within our portfolio. Paramount is an independently operating business unit of F. Schumacher & Co., functioning as a growth-stage startup with the resources of an established organization and serving both direct-to-consumer and bulk / volume channels. This is an exciting and highly visible position that plays an important role in shaping, supporting, and monitoring the future of Schumacher’s manufacturing operation.

Role Overview

YOU WILL:

• Help receive and process incoming orders for the production team
• Process and prepare Fedex and UPS shipments for daily pickups before the end of day.
• Ship and confirm all orders to ensure proper delivery to customers for consolidated pallets and made to order dropships.
• Able to access and pallet completed orders to Schumacher’s processing facility in Fort Mill, SC
• Receive orders and accurately input quantities to ensure they match inventory in ERP.
• Measure quantities of each order to ensure they match what was ordered.
• Communicating with internal logistics at Schumacher to ensure timely pickups.
• Ensure products are packed securely to ensure the safety of the product.
• Pick orders and prepare them for small package or freight shipment by the ship date.
• Generate packing lists.
• Prepare fabric and wallpaper grounds in advance for printers at the end of each day.
• Break down and re-palletize products.
• Coordinating customs, brokers and clearance for overseas incoming and outgoing shipments.
• Receive raw material shipments and accurately input received quantities into the ERP.
• Be instrumental in implementing new tracking and inventory systems with operations and production teams.
• Shrink wrapping, labeling and recording pallets and wallpaper orders.
• Inspect all outgoing orders for damage or other quality control issues.
• Track inventory related to shipping and general floor organization, submit replenishment numbers for ordering on a weekly basis.
• Track weekly shipping targets and proactively communicate regarding deadlines, issues with orders and other flags.
• Achieve proficiency across all other dept. functions and sub in as needed.
• Dispose of trash and recyclable materials.
• Assist in other operational functions as needed.

JOB QUALITIES:

• Able to respond quickly to shifting order priorities and stay focused while working on multiple projects at once
• Thrive in target driven environment and willing to do what it takes to meet deadlines
• A great communicator and active contributor to larger team goals and processes
• Enjoys the small team environment, high energy and scrappy
• Resourceful, a creative problem solver
• Willing to pick up additional shifts as needed (overtime pay)
• Highly organized, ability to keep your workstation clean and tidy
• Able to handle product with care
• Able to utilize ladders and other small equipment
• Able to lift a minimum of 60lbs, bend, squat, kneel, reach overhead, push and pull heavy boxes and containers, stand for long periods of time; this is a largely active role
• Experience in receiving, counting materials and stocking materials is preferred
• Experience working with ERP systems is preferred
• Able to attend phone calls and email requests from inter-company and third-party customers

YOU HAVE/ARE:

• Excellent communication and interpersonal skills – Bi-lingual, Spanish-speaking capability preferred
• High level of ownership, accountability and initiative
• Proficiency in MS Office (including Excel, Outlook, Word and Access) Create bills of lading using MS Excel and word
• Ability to handle multiple tasks and change direction based on business needs
• Extremely detail oriented with strong organizational skills
• Action oriented and enjoys working hard/smart
• A team player, cooperative, a person who easily gains trust and supports peers
• Has an all hands on deck mentality, and is willing to pitch in with multiple team members
• Able to work well with others in a fast-paced environment

Benefits Package

Your well-being is our top priority. Our benefits and total compensation are designed for the whole person, caring for both you and your family.

Wealth Benefits:

• Competitive Salary
• Corporate Annual Profit Sharing
• 401K Plan

Health Benefits:

• Dental Coverage
• Medical Coverage
• Prescription Drug Plan
• Vision Coverage
• Health Savings Account (HSA)
• TELADOC

Other Benefits:

• 15 Days Paid Time Off (PTO)
• 10 Company Holidays
• Bereavement Leave
• Life Insurance
• Flexible Spending Accounts (FSA)
• AFLAC Plans (Accident and Critical Illness Plans)
• Pet Insurance
• Short-Term Disability (STD)
• Long Term Disability (LTD)
• Parental Medical Leave
• Child Bonding Leave
• Employee Discount

We are an Equal Opportunity Employer committed to diversity, inclusion, and equality in the workplace. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, physical and mental disability, genetic information, marital status, sexual orientation, gender identity/assignment, citizenship, pregnancy or maternity, protected veteran status, or any other status prohibited by applicable national, federal, state or local law.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Director, Clinical Science (non-hemato-oncology) is a vital position in our growing global organization. As part of the Clinical Science group, this person is a key member of multi-disciplinary project teams responsible for the achievement of milestones (e.g., IND, FIH, POC, EOP2, NDA) for development programs. It is expected for this role to exercise leadership in the scientific discussion in project teams from the clinical perspective, diving deeply into the science of her/his assigned program(s), and perform the role of a subject matter expert for the program(s). He/she will play an active role in the creation of regulatory documents (e.g., BB, IND), study protocols, and clinical development plans for new and/or launched products, including lifecycle management.  He/she will be responsible for establishing and maintaining KOL relationships.

Essential Functions:

•    Serve as leading voice on clinical matters as Clinical Science representative on assigned project team(s), based on firm understanding of given disease area(s) and of clinical development processes, especially in the US and Europe
•    Lead in the formulation of clinical development strategies, in collaboration with related functions, and create clinical development plans, accordingly
•    Lead in the formulation of clinical trial protocols with sufficient feasibility and high probability of success, based on significant expertise in new drug development
•    Lead in the development of written material for clinical sections of key regulatory submissions; work closely with Regulatory in the process of preparing these submissions and ensure compliance with local regulatory requirements and standards throughout the course of clinical trials.
•    Work closely with cross-functional teams, including Regulatory, Marketing, and Quality to support clinical trial design and execution, regulatory submissions, and launch-related activities.
•    Provide input from the clinical perspective to the formulation of Target Product Profiles.
•    Analyze safety and efficacy findings from clinical studies; participate in inter-disciplinary team meetings, as required
•    Support required safety evaluations for clinical studies, e.g. AE assessment, as needed.
•    Create and maintain good relationships with clinical investigators and relevant Key Opinion Leaders; identify physicians with potential to serve as strong investigators for clinical studies
•    Attend relevant scientific meetings to strengthen competency in assigned field(s) and to gain awareness of research activities underway and activities of competitors
•    Serve as an author and lead in the preparation of review articles and conference presentations, relating to assigned clinical trial(s)
•    Support business development, as needed, in due diligence efforts of new in-licensing opportunities (or other topics).
•    Foster and contribute to collaborative environment that seeks to encourage innovation, strengthen scientific understanding among team members, and enhance professional development for all.
•    Perform other duties, as required.

Requirements:

Education
MD (or equivalent), PharmD, PhD in life sciences or related field; applicable R&D experience may also be considered.

Experience
•    Minimum 10 years of relevant clinical research experience with at least 5 years in clinical development role
•    Authorship and review of clinical development plans, clinical study protocols, briefing books, IBs, SAPs, and CSRs
•    Significant experience and ability to work effectively with external partners, including physicians and vendors
•    Preferred experience: leadership role in large, late-stage, global outcomes trials; background in Bone & Mineral or Rare Disease trials

Technical Skills
•    Strong scientific background with good understanding of drug development process
•    Good leadership skills, highly motivated, great attention to detail, ability to work in complex and changing situations, excellent problem-solving skills
•    Broad level of interpersonal skills and flexibility; cultural sensitivity and ability to develop consensus within matrix structure of a multinational organization
•    Excellent written and oral communication skills
•    Good project management skills; able to organize and prioritize multiple activities
•    Proficient in MS Office Suite, relevant software applications, using templates, and other electronic formats
•    Ability to think analytically (in terms of both strategy and tactics) and simultaneously consider scientific, medical, and business aspects of projects

Working Conditions:

Requires up to 15% domestic and international travel

The anticipated salary for this position will be $225,000 to $285,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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