Careers

Job Postings2018-10-25T04:22:35+00:00

Join Our Team.

We seek highly motivated professionals to join our team. We invite you to schedule a visit through Human Resources to learn more about our company and see our current open job postings below.

We participate in E-Verify, the US Government sponsored right-to-work verification process.

Administration

Responsibilities:

  • For the COO and CEO: managing an extremely active calendar of appointments; completing expense reports; preparing correspondence; arranging complex and detailed travel plans, itineraries, and agendas; and compiling documents for travel-related meetings
  • Keeps CEO/COO well informed of upcoming commitments
  • Successfully completes critical aspects of deliverables with a hands-on approach, including drafting acknowledgement letters, personal correspondence, and other tasks that facilitate the CEO/ COO’s ability to effectively lead the company
  • Assists board members with travel arrangements, lodging, and meal planning as needed
  • Assists in coordinating the agenda of senior management team meetings and off-sites, and all staff meetings
  • Edits and completes first drafts for written communications to internal/external stake holders
  • Follows up on contacts made by the CEO/COO and supports the cultivation of ongoing relationships

Qualifications:

  • Strong organizational skills that reflect ability to perform and prioritize multiple tasks seamlessly with excellent attention to detail
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast paced environment
  • Bachelor’s degree preferred not required.
  • Strong work tenure:10-20 years ears of experience supporting C-Level Executives, preferably in a fast paced organization
  • Proficient in Microsoft Office (Outlook, Word, Excel)

We participate in E-Verify, the US Government sponsored right-to-work verification process.

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Clinical

Responsibilities:

  • Responsible for study planning/start up and study feasibility assessments
  • Management of CROs and other third party vendors, including setting expectations, training, tracking timelines and deliverables, and issue management
  • Ensure that patient enrollment and data collection are completed
  • Oversee monitoring activities by the CROs are adequate and appropriate by reviewing visit reports, protocol deviations and CAPAs; Co-monitor sites to provide sponsor oversight
  • Work with CRO to revise scope of service agreements, budgets, plans
  • Perform review and QC central clinical files and trial master files
  • Collaborate with study management team to identify potential risks, recommend risk mitigating strategies and implement corrective and preventive actions
  • Serve as a liaison and resource for investigational sites; review investigator contracts and site payments
  • Participate in the development, review and implementation of departmental SOPs and processes

Qualifications:

  • Minimum 5-7 years of clinical trial management experience (CTM-4 & Sr. CTM – 6) including in house CTM experience in a small to mid-sized biotech/pharmaceutical company working on cross functional study teams in contributory or lead capacity with prior study monitoring experience, being knowledgeable in study site logistics
  • Working knowledge in all phases of study management from start-up through study close out, including protocol development, ICF creation, site feasibility/start up, contract/budget negotiation and tracking budget scope, safety reporting, data cleaning and generating CSR
  • Knowledge of basic data management, including working with EDC, biostatistics and pharmacovigilance activities
  • In depth knowledge and ability to interpret and implement FDA regulations, ICH GCP guidelines
  • Previous experience working in global studies is required
  • Experience in managing oncology clinical trials and/or orphan disease indications preferred
  • Baccalaureate or Master’s degree or equivalent in a scientific or health care field is required

We participate in E-Verify, the US Government sponsored right-to-work verification process.

Submit Resume

Responsibilities:

  • Oversees program plan development, tracks and updates milestones and key activities
  • Establishes and maintains integrated project schedules to ensure accurate project, financial and portfolio analyses
  • Collaborates with Clinical, Finance and Research and Development in the preparation of budgets
  • Documents and maintains project team outcomes, activities and decisions
  • Facilitates project team meetings, cross-functional information sharing and ensures alignment
  • Manages and can operationalize a set of alliance partnerships
  • Understands key interdependencies, drive decision-making, issue resolution and execution across collaborations, as well as keeping all stakeholders informed and on collaboration details

Qualifications:

  • BS or BA in Life Sciences. MS,MBA or Ph.D.is preferred; however experience and accomplishment will be considered in lieu of advanced degree
  • PhD in chemistry, biology or biomedical engineering with excellent working scientific knowledge of all areas. He/she would have several years’ experience in biotech industry project management, particularly at the early and Phase 3 development stage and would have worked within the context of an active industry alliance
  • 5 years-experience in project management in support of drug development
  • PMP certification preferred
  • Expertise and accomplishment in drug development methodology
  • Has financial acumen; can plan and manage budgets; metrics
  • Project management software to manage budgets, timelines and outcomes

We participate in E-Verify, the US Government sponsored right-to-work verification process.

Submit Resume