Director Clinical Research

Company:

An early stage medical device company headquartered in Watertown, MA. who develops innovative products to treat obesity.

Scope of the Job:

As an integral part of the Clinical Research team, the Director, Clinical Research reports to the Vice President of Regulatory, Quality and Clinical Affairs. The Director of Clinical Research will be responsible for the coordination of all activities associated with conduct of multiple clinical trials (develops study protocols, CRFs and Manuals of Operation; supervises study tasks and mentors other CRAs; assists in the generation and oversight of trial budgets and contracts; and communicates trial status to management).

Daily Responsibilities:

Management of CRO interactions for all operational aspects of study including sponsor oversight of relevant CRO/vendor functional activities (e.g., monitoring, site interactions, device re-supply).

Management of sponsor approval process for all relevant operational deliverables (e.g., regulatory documents, site initiation, device shipment).

Oversee development of key study documents: e.g., informed consent template, CRF, CRF instructions, Monitoring Plan, Data Management Plan and other study specific documents in collaboration with the appropriate functional areas, CRO and vendors (if applicable).

Coordinates the initial supply and re-supply of clinical supplies.

Oversight for compiling, mailing, collecting, tracking study related regulatory documents and all hardcopy or electronic study-related files maintained.

Writes protocol, amendments, and administrative letters.

Able to identify potential investigators.

Closely involved with the selection of a CRO for outsourced projects.

Manages progress of Investigator sites by maintaining close contact with site personnel or CRO staff (i.e., enrollment, IRB approvals, CRF and query return).

Manages interaction with other functional areas (statistics, data management,) as well as outside vendors (central labs etc…).

Demonstrates an understanding of overall protocol and corporate goals.

Identifies project issues and suggests resolutions - manages problem resolution through to remediation whether internal and external.

Resolves routine CRO or site-related questions.

Reviews the quality of data (listings/tables).

Conducts the initial and ongoing training of Investigators, site personnel, CRO staff and vendors.

Manages the study expenditures.

Oversight for all study close-out activities and transfer of Clinical Trial Master Files into archives.

Develops contracts and budget templates for sites, CROs and vendors.

Organizes project related meetings (teleconferences, Investigator Meetings Data Safety Monitoring Board meetings).

Candidate Requirements:

1. A minimum of 2 years of director level clinical development experience and 6+ years of industry experience. Device experience preferable.

2. A Health Science degree with additional license in health care (i.e.: RN, MT, PA, RPh,) or equivalent experience preferable.

3. Candidates with monitoring and, project management experience is highly desirable.

4. Must be extremely flexible and able to rapidly change priorities.

5. Must have the ability to develop solutions and solve problems for a wide variety of situations as they arise.

6. Must have medical and technical aptitude and technical writing skills.

7. Candidates should have the ability to interact effectively with others in our business, with our customers, and with others externally.

8. Must be computer literate and familiar with Windows, Word, and PowerPoint.

9. Travel as needed, including international (approximately 20% - 25%)

Compensation

A compensation package will be designed to attract outstanding talent and will include a base salary, stock options, and an attractive benefits package.