Senior Director, Clinical Trial Management

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

About The Position

Opportunity for Secondment to AskBio We’re pleased to share an exciting secondment opportunity at AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement. This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio’s mission: to advance gene therapy and change the lives of patients around the world. If you’re interested in exploring this opportunity, we encourage you to: Speak with your direct manager to discuss your interest and alignment with your development goals. Apply directly using the link provided in the posting. We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through. 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