Assertio Therapeutics, Inc.

Clinical Scientist/Sr. Clinical Scientist

Location
Northern Chicago
Posted
Feb 25, 2018
Ref
1073XX
Required Education
Doctorate/PHD/MD
Position Type
Full time
Description The Clinical Scientist will work under the supervision of the Sr. Director, Clinical Affairs to participate in diverse drug development activities. The position is intended to provide broad exposure and participation across drug development to allow individual to refine their future career interests. Some of the activities are likely to include preparation of INDs, Clinical Development Plans (CDPs), protocols, and Clinical Study Reports (CSRs), execution of clinical trials, organizing scientific advisory committee meetings and evaluation of new business development opportunities. The Clinical Scientist may serve in various roles including membership on a clinical team and clinical project sub-teams ESSENTIAL JOB FUNCTIONS
  • Become familiar with the latest thinking regarding mechanism of disease, diagnostic tests, treatment, drug development trends, and regulatory requirements in assigned disease and therapeutic areas.
  • Conduct literatures searches relevant to the therapeutic area, disease state or prior clinical trials and develop presentations and summaries that will inform clinical development plans or clinical study protocols
  • Participate in the design and implementation of applicable clinical protocols, data collection systems, and final reports.
  • Develop and assist in the preparation of documents to support the components of a regulatory submission (i.e. IND Annual reports, Briefing book for pediatric investigational plan
  • Review and interpret study results as appropriate and dissemination of the results to study investigators, etc).
  • Prepare clinical publications or provide input into communication and publication development
  • Participate in due diligence activities in evaluating new opportunities
  • Collaborate with the medical director and other experts to understand prior research and related studies to inform clinical protocol development and/or assessment of business development opportunities
  • Coordinate across experts in relevant departments, including regulatory, clinical, pharmacovigilance to initiate and expedite clinical studies.
  • Collaborate with R&D and other stakeholders to assess requirements for emerging products.
  • Assist with the management of and input into Scientific Advisory Boards convened to develop drug development strategies as appropriate.
  • Assist in conducting efforts to obtain external scientific and clinical validation of clinical research protocols.
  • Assist in establishing links with outside experts to initiate and expedite clinical studies. May include seeking advice from key external experts, regulatory, pricing/reimbursement, and market access experts.
  • Additional Responsibilities/Duties

    May participate in the tactical execution of the clinical development protocols by providing guidance, input, and implementation support as appropriate. This may include:

  • Study Management Plan.
  • Review study budgets and expenses, ensure study related contractual and budgeting issues are upheld and performed
  • Identification and selection of clinical research centers and investigators. Assist with contract negotiations when necessary
  • Investigator meetings, advisory boards and other scientific committees
  • Study risk mitigation and highlight of potential issues and solutions.
  • EDUCATION AND EXPERIENCE
  • Pharm.D. or PhD in health sciences with preference for Pharm.D. candidates
  • 2 years of clinical research experience, or demonstrated ability to develop clinical research protocols and effectively manage clinical trials and protocol development plans, preferably in the therapeutic area of the position. Recently graduating Pharm.D. candidates with research background will also be considered
  • SKILLS AND ABILITIES

  • Demonstrated ability to work in cross-functional teams and with individuals.
  • Effective verbal and written communication skills in relating to colleagues and associates at all levels both inside and outside the organization.
  • Evidence of ability to rapidly learn clinical development role and performance of its associated tasks is required.
  • DEPOMED COMPETENCIES INCLUDE

  • Integrity
  • Decisions & Judgment
  • Ownership & Initiative
  • Adaptability & Change Readiness
  • Teamwork & Collaboration
  • PHYSICAL/MENTAL DEMANDS

  • Sitting
  • Standing/ walking
  • Repetitive motion
  • Visual Requirements