Director of Health Outcomes CRF

Position Summary:
The Director of Health Outcomes will guide the organization providing strategic insight and understanding of our
clients needs and possess comprehensive knowledge of the regulatory requirements in the European Union and
United States for patient reported outcomes (PRO). This position will develop important relationships with
instrument authors and key opinion leaders and make recommendations on instrument selection and validation.
The Director of Health Outcomes will support the Sales and Operation streams and participate in bid defenses.
This position will have a broad and diverse understanding of many different therapeutic areas and will represent
the company at scientific conferences, webinars and be recognized as an authority in our industry.
Responsibilities:
Establish relationships with instrument authors across multiple therapeutic areas gaining an understanding of their
instruments
Providing and gathering recommendations on instrument selection
Provide training on instrument development and validation internally and externally
Support the Sales and Operations teams efforts
Participation in bid defenses
Active participation in conferences, delivering speeches webinars and papers on selected topics
Acquiring appropriate licenses to use various instruments
Selection and coordination of third party organizations for instrument validation
Other responsibilities will be assigned as required.
Requirements:
Degree in a Science or other appropriate subject
Seven years experience in Pharmaceutical/Patient Reported Outcomes field.
Must have experience in instrument development or validation
Strong experience in compiling Dossier of evidence for PRO instrument selection and validation
In depth understanding of EU and US regulatory requirements for PRO used in clinical trials
Have strong interpersonal skills along with excellent verbal and written skills
Need to be a high energy, enthusiastic team player who can easily communicate with clients and all levels within
the organization
Travel will be required in this position.

Location:	504 Totten Pond Road Waltham, MA 02451 United States