Senior Director, Clinical Trial Management

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

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.

Job 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

Minimum 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)

Preferred Experience

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

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.

Agencies:  Please do not contact any employee at AskBio about this requisition.  Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position.  All agencies must have a prior executed service agreement with AskBio prior to any search engagement.  If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.