Allergan Exec Dir, Clinical Trial Management in Madison, New Jersey
Exec Dir, Clinical Trial Management
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/5165/other-jobs-matching/location-only
▾ ▸ 1 additional location
Irvine, California, United States
May 02, 2018Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
The Executive Director, Global Clinical Trial Management (GCTM) leads and drives all operational and administrative functions in the GI therapeutic area clinical programs by ensuring the execution of clinical studies to successfully register new products/indications. This individual exercises a high degree of quality, productivity and communication to the department and therapeutic area for the timely completion of all clinical studies. Hires, develops and motivates staff to ensure scientifically valid studies conducted according to Good Clinical Practices. Contributes at the Core Team level to rapidly deliver studies, which meet minimum and desired requirements in an efficient manner using high quality scientific rationale. Provides project and resource management across therapeutic area portfolio. Serve as a member of therapeutic area management team with focus on project and resource management for clinical projects and participates in therapeutic area teams to provide input to ensure studies are executable. Contributes to GCTM strategic and operational development by active participation in the GCTM executive leadership team.
The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Main Areas of Responsibility
Works collaboratively with other Therapeutic Operations Leads to agree upon processes, systems and procedures to lead GCTM. Direct and leads the operations for multiple global therapeutic area clinical programs which includes implementation study protocol ensuring patient enrollment has met study goals.
Provides feedback to TA on operational aspects of protocol design. Acts as a resource for operational process improvement ideas and targets. Serves as content expert in execution of clinical operations. Provides guidance in development and modification of clinical timelines and resource requirements.
Ensures appropriate number of staff with appropriate skills, knowledge and experience are assigned to study. Ensures proper metrics and diagnostics are utilized to ensure staffing levels meet study requirements and also reallocates staff to priority projects within Global Development Operations.
Works collaboratively with Therapeutic Areas to ensure study design and critical study decisions are made collaboratively to ensure study success. Performs other duties as assigned.
Ensures operations team, locally and/or globally as appropriate, follow any and all SOP’s, policies and regulatory requirements. Also works in tandem with other Global Development Operations.
Leads to ensure consistent processes are collectively agreed upon and followed by all GCTM team members. Ensures timely communication and problem resolution occurs when study progress may not be meeting study goals. Ensures documentation and reporting occur in a timely manner. Ensures appropriate global tracking and management of study is occurring.
Provides operations services to Therapeutic Area Head, Clinical Leads and Project Team Leaders.
Operationally leads clinical research teams to rapidly deliver operational excellence for new projects or indications that meet minimum and desired characteristics for worldwide registration.
Ensures all regulatory requirements are adhered to when applicable. Proactively plans study prioritization, budgetary requirements and goal attainment. Ensures consistency with processes and procedures.
Assists in the development of operations budgets ensuring program needs are identified in budget. Ensures study budgets are managed without overages or discrepancies.
GI therapeutic Area experience strongly preferred
Minimum 15 years’ experience working in a clinical operations organization, preferably within pharma or CRO.
Minimum of 15 years’ experience working in clinical research with a strong understanding of the clinical and drug development process.
Minimum 8 years leading and managing highly diverse and educated teams.
Demonstrated strong networking both internally and externally.
Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences.
Strong interpersonal skills and ability to confront issues with CROs and Allergan staff for a win-win outcome.
Proactive and critical evaluation of varied and multiple aspects of trial implementation to ensure timely completion and with requisite quality.
Demonstrated understanding of risks to CROs’ businesses and how they might be impacted by Allergan.
Advanced computer skills (word processing, spreadsheets, graphics, PowerPoint).
Ability to travel (domestic and international) on short notice, up to 20%.
Strong financial business acumen and analytical skills.
Cross Cultural sensitivity.
Bachelor’s degree with experience in a relevant field:
BS degree with 15 years’ experience, MS degree with 12 years’ experience
An MBA or MPH is highly desirable.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.