Associate Director, Clinical Trial Lead

Work Location:  Billerica, Massachusetts

Shift:  No

Department:  HC-RD-DT Clinical Trial Management

Recruiter:  Shelby Elizabeth Briggs

This information is for internals only. Please do not share outside of the organization.

Your Role:

Manage multiple studies, projects, and work streams with

high complexity, risk, impact and reach, typically Phase III and registrational/sourcing models.

Demonstrates skills in successfully leading large-sized global project teams in a matrix organization and directs, influences and motivates stakeholders from closely related areas and beyond, creating a positive working climate.

Leads the development of the clinical trial strategy while accountable for successful project execution and delivery of clinical operational budget, timelines and quality standards agreed upon by Governance Committees.

As a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals, Clinical Operations Team, and/or Global Program  Strategy Team.

Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to operational and organizational challenges in a holistic manner to mitigate risks.

Exhibits Subject Matter Expert level understanding of multiple functions and functional processes. Familiar with and considers overall company strategy.

Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical functional teams or projects.

Ensure all study management activities will be completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP; audit leadership- interviewee & responses.

Contribute to non-study -related initiatives in addition to study assignments. Provide reports to senior management, including updates and timelines independently.

Demonstrates creativity and innovation to support projects from a strategic perspective, able to predict the result of action in advance and achieve goals.

Who You Are

Minimum Qualifications:

Bachelors degree with minimum 8 or more years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment

Minimum 7 years of in-depth experience in clinical trial management

Demonstrated experience in managerial responsibility

Preferred Qualifications:

Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM cPMP) desirable.

Proven experience in all aspects of clinical study planning and startup (including budget and resource planning) and in executing study activities, from startup through final study report.

Experience in multiple Therapeutic Areas (oncology and immunology preferred)

Requires substantial to extensive professional experience in relevant disciplines and substantial project management experience. Required and experience in own discipline and beyond which may also require good market and competitor knowledge.

Strong leadership competencies and influencing skills.

Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.

Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other nonclinical & pharmaceutical development, regulatory, commercial/marketing)

Location: Billerica MA, Onsite

Travel:

Pay range for this position: $122,200 - $202,900

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click  here .

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.