Senior Director, Clinical Trial Management

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

2d • Hybrid

About The Position

AskBio Inc., a subsidiary of Bayer AG, is a gene therapy company focused on developing life-saving medicines. The company has a pipeline of clinical programs for various diseases, including neuromuscular, central nervous system, cardiovascular, and metabolic indications. AskBio utilizes a proprietary cell line manufacturing process and has developed a wide range of capsids and promoters. The Senior Director, Clinical Trial Management, is a strategic leadership role responsible for the overall execution of assigned clinical programs. This role involves managing multiple programs, developing operational strategies, and leading the Clinical Operations team. The position requires recruiting and maintaining a high-quality team and serving as a subject matter expert. The preferred locations are Research Triangle Park, North Carolina, Philadelphia, Pennsylvania, and Columbus, Ohio. The role reports 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.

Benefits

• 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 [phone] or sending us an email at [email protected].

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree