Senior Director, Clinical Trial Management

AskBio•Durham, NC

10h

About The Position

The Senior Director, Clinical Trial Management, is a strategic leadership role accountable for managing the overall execution of the assigned clinical programs. She/He will be responsible for multiple programs and will develop and recommend operational strategies and/or decisions in support of achieving clinical program objectives. The Senior Director, Clinical Trial Management also assumes a leadership role across Clinical Operations which includes recruiting and maintaining a high-quality team and serves as a subject matter expert on functional initiatives. The preferred location for this position is AskBio Headquaters in RTP, North Carolina, Philadelphia, Pennsylvania and Columbus, Ohio and will report to the Vice President, Head of Clinical Trial Management.

Requirements

B.S./B.A. degree in a related field
12+ years of relevant industry experience (including at least 10 years focused on clinical trial management)
Significant experience developing and implementing program-level plans including reporting tools, timelines, budgets; ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills
4+ years of experience leading clinical teams and/or direct line management and dotted line reporting
Proven experience directing and implementing clinical program strategy
Previous experience in Neurology clinical trials
Extensive knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials
Strong computer skills including knowledge of Excel, Word, PowerPoint, and Outlook
Proficient written and verbal communication skills
Approx. 25% domestic and/or international travel may be required (additional travel based on program needs)

Nice To Haves

Prior experience managing and/or supporting regulatory inspections
Experience with managing and demonstrating overseeing of CROs, vendors, and consultants

Responsibilities

Contributes to the development of Clinical Development Plans (CDPs) including scenario planning, high-level forecasting of timelines, assesses program level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategies
Oversees more than one clinical program and may have oversight of Director-level employees depending on program needs
Accountable for meeting all operational deliverables in accordance with the timeline, cost, and quality commitments
Maintains an overview of status, issues, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to relevant stakeholders
Ensures internal consistency across studies within a program and ensures alignment of operational program to the development team goals
Actively co-leads a highly performing Clinical Sub Team (CST) along with Clinical Development and ensures appropriate strategic topics are discussed and managed
Interfaces with key internal and external stakeholders (senior leadership, KOL’s, advocacy groups, external partner leadership teams, etc.)
Provides program leadership and trial subject matter expertise to the clinical trial teams
Mentors and coaches Clinical Operations program team (direct and dotted-line reports), provides timely feedback to Clinical Operations Department Head regarding staffing needs and individual performance feedback
Provides performance, talent and resource management, and succession planning
Identifies, recruits, hires, and develops Trial Management staff, as well as oversees their work to ensure all department goals, deliverables, and objectives are met
Ensures that employees are appropriately trained and comply with company and regulatory standards
Creates a positive work environment by encouraging mutual respect, creativity, and accountability
Serves as an escalation point for the study teams internally and with vendors
Actively participates in vendor/external partnership governance