Senior Contracts Specialist

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, Germany, 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

The Senior Contracts Specialist, reporting to the Associate General Counsel, will work as part of the  AskBio legal team to create, review, negotiate and manage contracts and other documents, with a focus on clinical operations to support the conduct of clinical trials to help fulfill the Company’s mission of creating life-changing cures for patients. This position will be responsible from every phase of contract development from researching the legal regulations to negotiating the terms and preparing the document and may also collaborate with others on the legal team or work independently on a variety of contractual and legal operational needs.The location of this position could be in Durham (RTP), North Carolina or Philadelphia, PA, but other remote options will be considered for the right candidate.

Job Responsibilities

• Ensure adherence to AskBio’s contract management policies and procedures

• Review, revise, and negotiate clinical trial agreements for global clinical trials

• Conduct negotiations of terms and conditions per SOPs and AskBio preferred terms and playbooks, particularly in the clinical setting

• Utilize and complete contract templates for variety of agreements including confidentiality, consulting, clinical trial, HCP contracts and master services

• Identify key contract terms and conditions for categorization

• Collaborate with Clinical Operations teams and other contract requestors, other business units and the legal team when preparing and negotiating agreements, including clinical trial agreements

• Perform mark-ups of counter-party documents

• Proofread, edit and fact-check contract documents for completion, consistency, and accuracy

• Execute electronic and hard copy contract signature processes

• Explain contract terminology to key stakeholders and other interested parties in simple, clear, everyday language

• Self-monitor progress according to the schedule of completion to submit drafts and documents in a timely manner

• Utilize and help stakeholders to utilize a contract management software system, input and extract system information

• Assist in the tracking of the contract documents (agreements, amendments, notices, expirations) toward execution, finalization, and lifecycle management

• Log contract approvals and development activities according to established SOPs

• Perform regular monitoring of repository/common drive content to ensure accuracy and completeness

• Work with product and finance teams to answer and resolve contractual issues

• Serve as a point of contact for contract-related questions

• Monitor workflow, update any discrepant information and correct overdue items

• Develop, run and distribute contract information reports (weekly, monthly, quarterly)

• Oversee user access to contract management system

• Legal Department liaison to Information Technology (IT)

• Provide support and training to other team members on contract procedures

• Support entity/subsidiary formation and maintenance

About you

Required Education & Experience

• BS degree in science, accounting, business administration, economics, finance or related field and 5 years in-house law/contracting department or law firm experience

• Experience reviewing/revising clinical trial agreements, vendor contracts, services agreements, preferably both in the US and globally with a focus on EU and/or Canada

Preferred Experience & Skills

• Experience in the healthcare/life sciences industry, preferable with a pharmaceutical company or Contract Research Organization, or Institution clinical trial site

• Excellent verbal and written communication skills with substantial experience in document preparation, editing, and revision

• Paralegal certificate

• Experience in an in-house contracts management role

• Ability to work independently

• Ability to identify, analyze and suggest solutions for problems or process improvement

• Good organization skills and the ability to multitask on several projects simultaneously

• Knowledge of negotiation best practices, both in-person and in written form

• Ability to support multiple team members and functions

• Willingness to work virtually or in an office setting

• Beneficial prior experience:

  • Working with and/or managing a contract management software system

  • Working in a fast-paced growing environment

  • Familiarity with intellectual property issues

  • Corporate governance, subsidiary formation, and maintenance of corporate documents

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.