Apply Now!

Please upload your resume (PDF or DOC):

Careers

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:

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

Travel Estimate: up to 20-30%

Primary Location: North America-United States-Princeton, NJ

Organization: Hengrui Therapeutics, Inc.

Job Function: Clinical Operations/Project Management

*Please include salary requirements when submitting CV/Resume

.

Medical Director/Executive Director of Clinical Development

Hengrui Therapeutics, Inc. is recruiting Medical Director/Executive Director of Clinical Development, 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, metabolic disorders, immunology and inflammation. 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 individual for the position will have a leadership role on a matrix team dedicated to early stage clinical development of multiple innovative compounds. 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 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 commercial functions.

Qualifications 

The position requires a minimum of an advanced degree in medicine.   Extended experience in clinical development, within the pharmaceutical industry is required. Significant knowledge of basic and clinical research and its application to 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. We have several medical lead positions available now, the title of the position will be dependent on the working experience of the candidates. 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

*Please include salary requirements when submitting CV/Resume to:info@hengruitherapeutics.com

.