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Hengrui Therapeutics, Inc. is dedicated to providing a supportive and entrepreneurial environment that encourages innovation, team work, and professional growth. We offer competitive compensation and incentives.

Available Positions:

Associate Manager, Clinical Project Management

Hengrui Therapeutics, Inc. (HTI) is recruiting for an Associate Manager, Clinical Project Management, located in Princeton, NJ.

 

HTI is a biotechnology startup, focusing on early stage clinical development of innovative therapeutic solutions in areas of major unmet medical needs, such as oncology, cardiovascular/metabolic disorders, immunology and neuroscience. We offer abundant opportunities for motivated pharmaceutical professionals to pursue their scientific/clinical interests, make an impact and maximize their growth potential.

 

Job Description

The Associate Manager, Clinical Project Management (referred to herein as “Project Manager”) will provide support to HTI’s clinical development operations, trial strategy and project management. This individual will facilitate the cross functional preparation, implementation and facilitation of HTI’s clinical trials in the US and around the world.

 

The Project Manager will also assist with various project activities, supporting phase 1-4 global clinical trial initiation, budgeting, planning, execution and completion, which may include clinical project schedules, process development and budgets, tracking, status reporting, project communication, information gathering, coordination and facilitation of meetings, tracking and resolution of issues, and tracking risks and resources. The Project Manager will plan and manage projects or sub-projects under the general direction of the department director.

 

Essential Functions

  • Responsible for leading global cross functional teams in the initiation, planning, execution and closeout of assigned clinical studies to scope, quality, budget, time, managing resource and risk, and in compliance with SOPs, applicable global regulations and ICH/GCP guidelines.
  • Chair study team meetings ensuring goals and deliverables are clearly defined, and issues, decisions and action items are appropriately tracked.
  • Provide leadership, guidance, global clinical trial expertise and direction to internal and external study teams to ensure process consistency and knowledge sharing.
  • Develop and manage study budgets and timelines based on project and global business needs.
  • Participate in and facilitate vendor selection for assigned studies. Oversee vendor management for assigned studies, including negotiation of scope of work, budgets, performance management and issue resolution.
  • Assess current and projected demands of clinical studies, and partners with department head and leadership to identify and secure resources.
  • Analyze and develop action plans for investigational site, vendor and administrative issues.
  • In collaboration with the Medical Director or Clinical Scientist, analyze, develop action plans and escalate safety issues, patient care issues, and study design and/or conduct issues.
  • Plan, prepare and present at investigator meetings.
  • Lead internal and external development of key study documents including, but not limited to study protocols, study plans and procedure manuals, project tools, informed consent forms and clinical study reports.
  • Evaluate, manage and facilitate the timely flow of clinical data to support project objectives.
  • Oversee forecasts to maintain sufficient clinical and non-clinical supplies.
  • Prepare and present study specific updates.
  • May represent Project Management & Clinical Operations in partnered development programs.
  • Participate in or lead process development initiatives, as required.
  • Mentor and oversee day-to-day study related activities for junior staff members, as applicable.
  • Other duties as assigned.

 

Basic Qualifications

  • Bachelor’s Degree required (scientific or medical discipline preferred). Graduate degree is a plus.
  • A minimum of at least 6 years of relevant experience with at least 2 years of project management in the pharmaceutical industry.

Preferred Qualifications

  • Experience in drug/biologic development, managing clinical trials and a strong track record of delivering results in strategic planning, project management, and operational excellence
  • Working knowledge of FDA regulations and ICH GCP guidelines is required
  • Proven ability to lead a study team
  • Strong vendor oversight experience required
  • Ability to think the “big picture,” think strategically, work in a matrix, cross functional environment on both a local and global basis
  • Ability to manage projects with minimal supervision, deal with ambiguity, multitask and maintain tight timelines and priorities in a highly professional manner
  • Experience developing study and program execution strategies and risk mitigation
  • Strong leadership, negotiation, interpersonal and communication skills
  • Ability to work cross-culturally
  • Excellent skills in MS Project, Excel, PowerPoint and Word
  • Certificate or training in Project Management a plus

*Please include Salary requirements when submitting your CV/Resume

Travel Estimate: up to 20-30%

Primary Location North America-United States-Princeton, NJ

Organization Hengrui Therapeutics, Inc.

Job Function Clinical Operations/Project Management

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Manager, Clinical Project Management

Hengrui Therapeutics, Inc. (HTI) is recruiting for a Manager, Clinical Project Management, located in Princeton, NJ.

 

HTI is a biotechnology startup, focusing on early stage clinical development of innovative therapeutic solutions in areas of major unmet medical needs, such as oncology, cardiovascular/metabolic disorders, immunology and neuroscience. We offer abundant opportunities for motivated pharmaceutical professionals to pursue their scientific/clinical interests, make an impact and maximize their growth potential.

 

Job Description

The Manager, Clinical Project Management (referred to herein as “Project Manager”) will provide support to HTI’s clinical development operations, trial strategy and project management. This individual will facilitate the cross functional preparation, implementation and facilitation of projects related to HTI’s clinical trials in the US and around the world.

 

The Project Manager will also assist with various project activities, supporting phase 1-4 global clinical trial initiation, budgeting, planning, execution and completion, which may include clinical project schedules, process development and budgets, tracking, status reporting, project communication, information gathering, coordination and facilitation of meetings, tracking and resolution of issues, and tracking risks and resources. The Project Manager will plan and manage projects or sub-projects under the general direction of the department director.

 

Essential Functions

  • Responsible for leading global cross functional teams in the initiation, planning, execution and closeout of assigned clinical studies or projects to scope, quality, budget, time, managing resource and risk, and in compliance with SOPs, applicable global regulations and ICH/GCP guidelines.
  • Chair study team meetings ensuring goals and deliverables are clearly defined, and issues, decisions and action items are appropriately tracked. May chair team meetings at the compound/project level.
  • Provide leadership, guidance, global clinical trial expertise and direction to internal and external study teams to ensure process consistency and knowledge sharing.
  • Prepare and manage study budgets and timelines based on project and global business needs. May assist in preparing and managing compound/project level budgets and timelines.
  • Participate in and facilitate vendor selection for assigned studies or projects. Oversee vendor management for assigned studies/projects, including negotiation of scope of work, budgets, performance management and issue resolution.
  • Assess current and projected demands of clinical studies, and partners with department head and leadership to identify and secure resources.
  • Analyze and develop action plans for investigational site, vendor and administrative issues.
  • In collaboration with the Medical Director or Clinical Scientist, analyze, develop action plans and escalate safety issues, patient care issues, and study design and/or conduct issues.
  • Plan, prepare and present at investigator meetings.
  • Lead internal and external development of key study documents including, but not limited to study protocols, study plans and procedure manuals, project tools, informed consent forms and clinical study reports. May contribute to the development of the compound/project clinical development plan.
  • Evaluate, manage and facilitate the timely flow of clinical data to support project objectives.
  • Oversee forecasts to maintain sufficient clinical and non-clinical supplies.
  • Prepare and present study or project specific updates.
  • May represent Project Management & Clinical Operations in partnered development programs.
  • Participate in or lead process development initiatives, as required.
  • Mentor and oversee day-to-day study related activities for junior staff members, as applicable.
  • May have direct line management responsibilities.
  • Other duties as assigned.

 

Basic Qualifications

  • Bachelor’s Degree required (scientific or medical discipline preferred). Graduate degree is a plus.
  • A minimum of at least 7 years of relevant experience with at least 4 years of project management in the pharmaceutical

Preferred Qualifications

  • Experience in drug/biologic development, managing clinical trials and a strong track record of delivering results in strategic planning, project management, and operational excellence
  • Working knowledge of FDA regulations and ICH GCP guidelines is required
  • Proven ability to lead a study team
  • Strong vendor oversight experience required
  • Ability to think the “big picture,” think strategically, work in a matrix, cross functional environment on both a local and global basis
  • Ability to manage projects with minimum supervision, deal with ambiguity, multitask and maintain tight timelines and priorities in a highly professional manner
  • Experience developing study and program execution strategies and risk mitigation
  • Strong leadership, negotiation, interpersonal and communication skills
  • Ability to work cross-culturally
  • Excellent skills in MS Project, Excel, PowerPoint and Word
  • Certificate or training in Project Management a plus

*Please include Salary requirements when submitting your CV/Resume

Travel Estimate: up to 20-30%

Primary Location North America-United States-Princeton, NJ

Organization Hengrui Therapeutics, Inc.

Job Function Clinical Operations/Project Management

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Senior Manager, Clinical Project Management

Hengrui Therapeutics, Inc. (HTI) is recruiting for a Senior Manager, Clinical Project Management, located in Princeton, NJ.

 

HTI is a biotechnology startup, focusing on early stage clinical development of innovative therapeutic solutions in areas of major unmet medical needs, such as oncology, cardiovascular/metabolic disorders, immunology and neuroscience. We offer abundant opportunities for motivated pharmaceutical professionals to pursue their scientific/clinical interests, make an impact and maximize their growth potential.

 

Job Description

The Manager, Clinical Project Management (referred to herein as “Project Manager”) will provide support to HTI’s clinical development operations, trial strategy and project management. This individual will facilitate the cross functional preparation, implementation and facilitation of projects related to HTI’s clinical trials in the US and around the world.

 

The Project Manager will also assist with various project activities, supporting clinical project (phase 1-4 clinical trial programs) initiation, budgeting, planning, execution and completion, which may include clinical project schedules, process development and budgets, tracking, status reporting, project communication, information gathering, coordination and facilitation of meetings, tracking and resolution of issues, and tracking risks and resources. The Project Manager will plan and manage projects or sub-projects under the general direction of the department director.

Essential Functions

  • Responsible for leading global cross functional project level teams in the planning and delivery of all clinical studies within a program to scope, quality, budget, time, managing resource and risk, and in compliance with SOPs, applicable global regulations and ICH/GCP guidelines.
  • Chair team meetings for assigned compounds/projects ensuring goals and deliverables are clearly defined, and issues, decisions and action items are appropriately tracked.
  • Provide leadership, guidance, global clinical trial expertise and direction to internal and external project teams to ensure process consistency and knowledge sharing.
  • Develop study and compound/project level budgets and timelines based on project and global business needs.
  • Lead vendor selection for assigned projects. Oversee vendor management for assigned projects, including negotiation of scope of work, budgets, performance management and issue resolution.
  • Assess current and projected demands of a clinical study or program, and partners with department head and leadership to identify and secure resources.
  • Analyze and develop action plans for investigational site, vendor and administrative issues.
  • In collaboration with the Medical Director or Clinical Scientist, analyze, develop action plans and escalate safety issues, patient care issues, and study design and/or conduct issues.
  • Plan, prepare and present at investigator meetings.
  • Oversee internal and external development of key study documents including, but not limited to study protocols, study plans and procedure manuals, project tools, informed consent forms and clinical study reports. Contribute to development of the compound/project clinical development plan.
  • Evaluate, manage and facilitate the timely flow of clinical data to support project objectives.
  • Oversee forecasts to maintain sufficient clinical and non-clinical supplies.
  • Prepare and present study or project specific updates.
  • Represent Project Management & Clinical Operations in partnered development programs.
  • Participate in or lead process development initiatives, as required.
  • Mentor and oversee day-to-day study related activities for junior staff members.
  • May have direct line management responsibilities.
  • Other duties as assigned.

 

Basic Qualifications

  • Bachelor’s Degree required (scientific or medical discipline preferred). Graduate degree is a plus.
  • A minimum of at least 9 years of relevant experience including at least 5 years of project management in the pharmaceutical

Preferred Qualifications

  • Experience managing clinical trials and a strong track record of delivering results in strategic planning, project management, and operational excellence
  • Working knowledge of FDA regulations and ICH GCP guidelines is required
  • Proven ability to lead a study team
  • Strong vendor oversight experience required
  • Ability to think the “big picture,” think strategically, work in a matrix, cross functional environment on both a local and global basis
  • Ability to manage projects with minimum supervision, deal with ambiguity, multitask and maintain tight timelines and priorities in a highly professional manner
  • Experience developing study and program execution strategies and risk mitigation
  • Strong leadership, negotiation, interpersonal and communication skills
  • Ability to work cross-culturally
  • Excellent skills in MS Project, Excel, PowerPoint and Word tools
  • Certificate or training in Project Management a plus

*Please include salary requirements when submitting CV/Resume

Travel Estimate: up to 20-30%

Primary Location North America-United States-Princeton, NJ

Organization Hengrui Therapeutics, Inc.

Job Function Clinical Operations/Project Management

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Director, Regulatory Affairs (Early Development)

Hengrui Therapeutics, Inc. is recruiting a Director, Regulatory Affairs (Early Development), located in Princeton, NJ.

Hengrui Therapeutics, Inc. (HTI) is a biotechnology startup, focusing on early stage clinical development of innovative therapeutic solutions in areas of major unmet medical needs, such as oncology, cardiovascular/metabolic disorders, immunology and neuroscience. We offer abundant opportunities for motivated pharmaceutical professionals to pursue their scientific/clinical interests, make an impact and maximize their growth potential.

The Director, Regulatory Affairs (Early Development) will be responsible for managing all regulatory aspects (Nonclinical, Clinical, CMC) of early stage clinical development of multiple innovative drugs in different therapeutic areas. The position level is dependent on experience and qualifications.

Major Responsibilities

  • Develop and implement global regulatory strategies for IND/NDA applications.
  • Provide regulatory guidance and scientific advice to cross-functional international project teams to ensure early consideration of regulatory and clinical requirements, as well as alignment on regulatory plans and strategies.
  • Interface with cross-functional teams (CMC, Nonclinical, Clinical) to define contributions of required documents for regulatory submissions.
  • Collect, review and revise study reports and documentation to ensure high-quality preparation of investigational applications (IND, CTA, etc.) in compliance with FDA and other global health authority requirements.
  • Interact with regulatory agencies, coordinate the preparation of responses to questions and inquiries from FDA and other health authorities.
  • Serve as primary liaison with regulatory authorities, including overseeing the writing of meeting materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow-up.
  • Monitor and maintain all regulatory activities to ensure compliance with relevant regulatory requirements, including but not limited to, protocol and information amendments, clinical study reports (CSRs), annual reports and safety reports to support clinical development in the US, EU, Canada, and other countries as necessary.
  • Ensure relevant US and international regulatory laws, regulations and guidance, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.

Qualifications

  • Requires advanced degree in life science related discipline, i.e. MD, PhD, PharmD or equivalent.
  • 10+ years of pharmaceutical industry experience required. At least 3 years of regulatory affairs with experience associated with global submissions.
  • Experience with the research and development of oncology drugs is highly desirable.

Required Knowledge and Abilities

  • Excellent knowledge of global regulatory requirements and processes and filing experience (IND, CTA).
  • Strong verbal and written communication skills are essential.
  • Excellent organizational and analytical skills. Detail oriented and a great ability to support multiple projects in a timeline-driven environment.
  • Exceptional interpersonal skills with the ability to influence others in a positive and effective manner.
  • Demonstrated leadership and people management skills in a matrix organization.*
  • Please include salary requirements when submitting CV/Resume

Primary Location North America-United States-Princeton, NJ

Organization Hengrui Therapeutics, Inc.

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Executive Director/Vice President of Clinical Development/Oncology

Hengrui Therapeutics, Inc. is recruiting an Executive Director/Vice President of Clinical Development/Oncology, located in Princeton, NJ.

Hengrui Therapeutics is a biotechnology startup, focusing on early stage clinical development of innovative therapeutic solutions in areas of major unmet medical needs, such as oncology, cardiovascular/metabolic disorders, immunology and neuroscience. We offer abundant opportunities for motivated pharmaceutical professionals to pursue their scientific/clinical interests, make an impact and maximize their growth potential.

The individual for the position will have a leadership role on a matrix team dedicated to early stage clinical development of multiple innovative compounds to treat cancer. He or she will lead the development of clinical strategies for the innovative new drug candidates and drive successful implementation of such strategies.

The individual will be responsible for drafting clinical development plans, clinical trial protocol synopses and protocols, and leading discussions and revisions of study design with internal stakeholders and external experts/consultants. He/she will be the key physician contact for sites and investigators during site start-up and study execution, act as a liaison between the company and clinical investigators, develop credible relationships with opinion leaders and participate in the medical review, interpretation and reporting of the results of the research, including submission to health authorities.The person will be one of the main contributors of INDs, IMPDs and other regulatory submissions, and play an important role in the required regulatory interactions with the FDA, EMEA and other regulatory authorities. He/She will also evaluate scientific information and new ideas to assist in identifying new research opportunities.

The role requires a motivated, energetic and highly entrepreneurial individual who demonstrates outstanding scientific and clinical development knowledge applicable to oncology clinical development and the highest personal and ethical standards.  The successful candidate must be equally comfortable among the team as well as working independently.

Other functional groups represented on the team include project management, regulatory affairs, global clinical operations, data management, medical writing, biostatistics, medical affairs, clinical pharmacology, and possibly commercial functions.

Qualifications 

The position requires a minimum of an advanced degree in medicine.  A trained Oncologist (Board certified or Board Eligible or equivalent) is strongly preferred.   Extended experience in oncology clinical development, within the pharmaceutical industry is required, 7 years for Executive Director, and 10 or more years for Vice President.  Significant knowledge of basic and clinical cancer research and its application to cancer drug development is important.  Good oral, written communication and presentation skills are essential.  Successful work experience in a matrix team environment with cross-functional teams is required.  Able to lead and manage matrix and cross-culture teams to deliver desired results. Travel required may be up to 20-30% annually (international, as well as domestic).

  • Primary Location North America-United States-Princeton, NJ
  • Organization Hengrui Therapeutics, Inc.
  • Job Function Clinical Development, MD

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