Senior Director, Clinical Trial Management

Opportunity for Secondment to AskBio

Were 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 AskBios mission: to advance gene therapy and change the lives of patients around the world.

If youre 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 peoples lives.

Our principles:

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 KOLs 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 jobrelated 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 or sending us an email at .