Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain. 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. About the role Askbio is seeking an experienced translational leader to lead the design and execution of biomarker strategies to support our early and late-stage therapeutics programs. The candidate will be responsible for the development of translational biomarker approaches that measure target engagement, circulating biomarkers, and development of qualified biomarkers. As a strategic leader the candidate will ensure that biomarker strategies align with the most current understanding of CNS and Muscle biology to enable early clinical proof-of-concept and contribute to the clinical strategy for rare diseases with potential for accelerated pathways. The candidate is expected to take a hands-on approach and a collaborative approach with relevant functional groups and clinical teams to inform strategic design. This is a unique opportunity to work at the interface of discovery/development while championing biomarker-initiatives that have a direct impact on novel clinical study design. Responsibilities: Lead efforts to develop and implement translational biomarker strategies that assess proof of mechanism, establish early signs of efficacy and enable proof of concept studies Develop and implement global clinical biomarker strategies for our clinical programs (Parkinson’s disease, CHF, Pompe, LGMD2i, etc), with a primary focus on rare disease LGMD2i and Pompe for accelerated approval Experience in the identification and validation of pharmacodynamic and disease biomarkers, as well as their clinical implementation Act as biomarker project leader for the CNS development programs and support the other therapeutic areas (cardiovascular, neuromuscular, etc) as needed Ability to drive and influence projects from discovery through early clinical development with a focus on the identification of indications and development of biomarker strategies that enable early proof-of-concept Lead the development and validation of biomarker assays for clinical use, including proficiency testing, analytical validation, and clinical validation Analyze biomarker data and generate reports to support clinical decision-making Outstanding analytical, research and organizational skills Strong interpersonal, influencing, and collaboration skills Ability to prioritize, and be highly productive and flexible in a fast-paced, team-oriented environment Ability to communicate scientific results to diverse audiences, in a clear and concise manner About you Minimum Requirements: PhD or equivalent in life sciences, chemistry, engineering or related discipline Minimum 8 years of experience in the pharmaceutical or biotechnology industry with a focus on biomarker sciences Minimum of 3 years of technical team leadership experience Experience with biomarkers in gene therapy, oncology (solid tumor) and/or rare disease Ability to drive and influence projects from discovery through early clinical development with a focus on the development of biomarker strategies that enable early proof-of-concept and inform the clinical strategy for rare and neurodegenerative diseases Outstanding analytical, research and organizational skills Ability to prioritize, and be highly productive and flexible in a fast-paced, team-oriented environment Effective communicator fluent in English, both written and spoken Preferred Experience and Qualifications: Experience with cell or gene therapy Experience with fluid biomarkers Familiarity with regulatory guidelines for accelerated pathways 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 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. Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.