Associate Director/Director, Clinical Operations

Clinical Operations Cambridge, Massachusetts


Description

What’s in it for you?

We have an exciting opportunity for a highly motivated individual to guide the operationalization of the clinical strategy for Mersana’s drug development programs. You will mentor colleagues with less experience and ensure processes are optimized for maximum efficiency and GCP compliance. This is an opportunity to make a visible impact through your strategic and scientific input as you use your knowledge of and experience with executional excellence to help build clinical expertise on the team and help driving the development of our assets. This position reports to our Executive Director, Clinical Operations.

How do you know if you’re the right fit?

Excellent and timely communication skills are essential elements of success in this position. The ability to track and hold groups and individuals accountable to their incremental and program- level deliverables, goals, and objectives is a key performance expectation for this position.

Established skills to negotiate conflicting differences and opinions in a way that ensures all study deliverables are met on-time and in accord with Mersana expectations are of critical importance. Your leadership style should be strongly oriented to leading by example and influence Your past experience and current skill set will contribute to the following:

  • Playing a leadership role in facilitating the clinical development process
  • Leading cross-functional teams from various external partners and internal departments in the development and execution of clinical
  • Developing cross-functional study plans for use with external partners and internal teams
  • Contributing to the design of clinical studies in close collaboration with the Medical Lead and the clinical development team
  • In collaboration with clinical and other cross-functional groups, participate in creating materials for investigator meetings, scientific advisory boards, DMCs, and steering committees, such as preparing abstracts, posters, presentations, and publications
  • Tracking study timelines and running different scenarios based on development plan contingencies
  • Review protocols and work with internal and external teams to ensure Mersana’s research requirements can be met by clinical research personnel
  • Providing input on CRF design, statistical analysis plan and drug supply planning
  • Providing opportunities for on-the-job and didactic training in clinical strategy and execution
  • Participating on periodic patient safety and efficacy reviews
  • Extensive experience monitoring the throughput and quality of work conducted by the external parties conducting SEVs, SIVs, PMVs, and COVs is required
  • Ability to organize and manage multiple priorities: your own and those of work teams you oversee and support

The other stuff

This is typically a role best suited for Masters’ degree candidates with a scientific background and at least 10 years’ experience in clinical research.

In addition, the successful candidate will possess:

  • A thorough understanding of and the ability to operationalize FDA, GCP, ICH, and eCTD compliance standards, and relevant regulatory requirements
  • Experience communicating with research site personnel
  • Expertise in authoring clinical documents
  • Expertise with PowerPoint and MS Project
  • Experience preparing regulatory documents for submission
  • Experience in vendor identification, RFP development and review, and the development and use of balanced score cards for proposal and performance evaluation
  • Experience as a program manager ensuring program timelines are met
  • Demonstrated strong analytical and strategic thinking skills

 

Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation and paid holidays.

Successful candidate must be authorized to work in the United States.

Mersana Therapeutics, Inc. is an equal opportunity employer.