Novan
  • 09-Aug-2018 to 01-Oct-2018 (CST)
  • Morrisville, NC, USA
  • Full Time

Purpose:

The Head of Clinical Outsourcing is responsible for the leadership and strategic direction of all aspects of performance related to clinical outsourcing across multiple clinical programs.  This individual will direct vendor selection and the oversight of partner delivery.  The Head of Clinical Outsourcing will ensure external budgets, resources and systems are adequate and meet the company's objectives in terms of financials and milestones.  This position is expected to provide leadership across project teams to facilitate vendor relations and contribute to the wider Company direction and management.  This position shall adhere to the Company's quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.

 

Principal Responsibilities and Accountabilities:

  1. Responsible for coordinating the vendor selection for clinical development programs incorporating input from the Study Manager and the broader development team as appropriate. This effort includes input into the planning of clinical trials, resourcing, and providing oversight to vendors to achieve program objectives with high quality deliverables within established timelines and budgets.
  2. Implement and execute processes to issue RFPs, receive bids, coordinate bid defenses and make final decision with the Chief Development Officer or VP, Clinical Operations and the Study Manager. Effectively oversee CROs/vendors to ensure expectations relative to quality, budgets and timelines are met.
  3. Effectively communicating a vision for the success of our programs with potential CRO partners, fostering team work to ensure timely and high-quality deliverables, demonstrating efficient and clear decision making, fostering principles and values that place subjects and quality first.
  4. Oversee external clinical trial budgets, resources and timelines and identify risk factors, risk mitigation strategies to ensure successful achievement of corporate objectives.
  5. Identify gaps in existing SOPs related to clinical outsourcing and develop and implement SOPs for clinical trials related to such outsourcing activities.
  6. Provide updates and status reports to the Chief Development Officer or VP, Clinical Operations on a regular basis; report on performance against plan.

 

Qualifications:

  1. Education
    • Bachelor's degree required, Master's in health care related profession viewed favorably.
  2. Experience
    • 10+ years' experience in drug development outsourcing with experience across all phases of clinical trial execution.
    • Knowledge of GCP regulations.
    • Expertise in dermatology highly desirable.
    • Knowledge in clinical trial protocols for Phase 1 through Phase 3, and NDA submission experience preferred.
    • Experience effectively managing CRO relationships, and international trials preferred.
    • Start-up or early stage company development experience preferred.
  3. Skills
    • Demonstrated leadership skills; ability to establish excellent collaborative internal and external relationships; ability to motivate and lead high performing teams.
    • Excellent analytical skills and scientific writing skills.
    • Strong interpersonal skills, effective written and verbal communication, and oral presentation skills.
    • Effective problem solving and decision making skills and ability to interact with all levels of management.
    • Ability to anticipate future trends and engage in new, forward-thinking approaches. A challenger of "status quo."
    • Proficiency utilizing standard business tools to manage resources and projects (e.g. MS Project, Excel and PowerPoint)

 

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

In the typical office environment requirements include:  reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds.  Occasional travel up to 20%.

 

Novan, Inc. maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.

 

EEOC Statement:

Novan, Inc. is an equal opportunity employer and actively seeks candidates from diverse backgrounds including women, communities of color, the LGBT community, and people with disabilities.

Novan
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