Associate Director, Clinical Research

Responsibilities

• Plan, implement, manage and report for regional or global clinical studies.
• Manage and Lead selection process of CROs for regional or global clinical studies.
• Manage the performance of study vendors (e.g. CROs and central labs).
• Cook up and coordinate with the Clinical Lead to achieve project objectives.
• Manage and resolve project performance issues (issue management) if they arise.
• Manage activities for clinical site selection and activation, investigator meetings and study initiation.
• Manage, provide guidance and direction to Sr. Manager(s).
• Oversight of patient recruitment and development of recruitment strategies and plans.
• Responsible for the creation of study related documentation (protocol, ICF, CRF, operations manuals etc.).
• Track of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans.
• Affirm compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols.
• Coordinate negotiation of clinical trial contracts between investigational sites and CROs.
• Coordinate data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan.
• Responsible for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites.
• Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes.
• Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.).
• Supervise at least one (1) Sr. Manager in Clinical Research. Responsible for their performance management including professional development.

Qualifications

• Experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets.
• Good cross-functional team leader who fosters team spirit and team motivation (teamwork).
• Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies.
• Ability to anticipate and timely escalate issues and to define appropriate action plans.
• Decision-making and problem-solving skills.
• Strong organizational, communication and presentation skills.
• Team player, flexible, ability to adapt to change.

Education And Experience

• Bachelor’s Degree in sciences or related field with 8 + years of pharmaceuticals/biotech experience.
• Minimum of 8 + years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials.
• Hematology - oncology clinical trial experience is preferred.
• Rare Disease experience preferred.
• Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc.).
• Program and project management experience preferred.

Pay

The annualized target salary range for this role is $175,000 to $205,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit.

Benefits

• Medical, Dental & Vision Insurance.
• Basic and Voluntary Life and AD&D Insurance.
• Short- and Long-Term Disability Insurance.
• Flexible Spending Account, Health Savings Account.
• Employee Assistance Programs.
• Discretionary Bonus Programs and Long-term Incentive Plan.
• Retirement Savings 401k with company match.
• Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown.
• Career Development, Progression and Training.
• Flexible Work Arrangement Programs.