Clinical Trial Manager, Neuromuscular

AskBio Inc. a wholly owned and independently operated subsidiary of Bayer AG is a fully integrated gene therapy company dedicated to developing lifesaving 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 clinicalstage pipeline that includes investigational therapeutics for congestive heart failure limbgirdle muscular dystrophy multiple system atrophy Parkinsons disease and Pompe disease. AskBios gene therapy platform includes Pro10 an industryleading 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 preclinical and clinical testing.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform peoples 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 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 whats right in every situation. Make clear commitments and follow through.

Position Summary

The Clinical Trial Manager Neuromuscular reporting to the Senior/Director Clinical Operations will be responsible for the successful implementation of a clinical trial from startup to closeout and will represent the Clinical Operations Team at project meetings and professional events. The ideal candidate is required to have experience in managing crossfunctional teams the management of employee performance and development and strong knowledge of applicable regulatory requirements.

This hybrid role can be based in RTPNC or Philadelphia PA with approximately 10% travel.

Job Responsibilities

• Deliver on assigned clinical trial(s) budgets timelines and resource management with a focus on quality including making recommendations and decisions regarding operational strategies to support study and/or program objectives.
• Lead and manage daytoday execution of assigned clinical trials to ensure all trial deliverables are met according to established timelines goals budget and quality standards.
• Manage the cross functional study management team and CRO/vendor(s) related to all aspects of clinical trial operations and continuously assess operational performance through carefully designed performance and quality indicators.
• Effective management of issues and risks including escalation to Senior/Director Clinical Operations and senior leadership.
• Establish study timelines and ensure accurate tracking and reporting of study metrics.
• Develop and execute Study Operational and Vendor Management/Oversight plans.
• Lead identification RFP/bid defense and selection of CRO/third party vendors
• Develop manage and track clinical trial budget as well as the accuracy of trial information and provide ongoing reporting and forecasting to Finance.
• Manage and provide documented oversight of CRO and thirdparty vendors to ensure quality and adherence to ICH/GCP standards as well as established study timelines.
• Contribute to the development of documents including the clinical trial protocol Investigators Brochures Informed Consent Forms Case Report forms responses to questions from IRBs and Ethics Committees and to clinical sections of IND summary documents CTAs for initiation of studies exUS and responses to questions from regulatory authorities.
• Develop and maintain strong relationships with Investigators site staff and CRO partners.
• Contribute to Clinical Operations/organizational initiatives to build and optimize business procedures tools and guidance.
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs ICH/GCP and local regulations.
• Represent Clinical Operations team to internal and external stakeholders including key opinion/thought leaders.
• Champion continuous quality improvement by evaluating methods and approaches and recommending efficient and/or novel approaches.

Minimum Requirements

• BA/BS degree in health/life sciences or related field.
• 6years of drug development experience particularly in clinical trial management.
• Demonstrated experience developing clinical operations strategy and plans including site monitoring risk mitigation plans recruitment plans and CRO/vendor oversight plans.
• Prior experience managing and demonstrating oversight of CROs vendors and consultants.
• Proven knowledge and application of current FDA Regulations ICH/GCP guidelines in clinical trials.
• Demonstrated knowledge of clinical operations methodologies organizational project management and leadership capabilities as well as strategic insight decisiveness and strong judgment.
• Outstanding ability to communicate in an open and clear manner listening effectively and inviting response and discussion with internal partners and external service providers.
• Ability to collaborate effectively with the study team crossfunctional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
• Proficient in risk management to prevent and overcome complex safety and compliance related issues during clinical program implementation.
• Attention to detail highly organized and the ability to multitask and prioritize in a fastpaced highly interactive environment.
• Proficiency in Microsoft Office Suite (Word Outlook Excel Project) and Smartsheet.

Asklepios BioPharmaceutical 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 (919)or sending us an email at .

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.