Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne has a broad portfolio of programs for serious muscle diseases, including candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.
The Associate Director, Contracts Attorney, provides a wide range of contracting and administration support for the R&D organization, with particular focus on drafting and negotiating contracts and other documents related to global clinical studies (clinical trial agreements, LOAs, etc.). This role is responsible for drafting and negotiating contracts for a variety of investigator sites, universities and hospitals participating in Dyne’s clinical trials as well as more routine contracts including MSAs, Consulting Agreements, and CDAs related to the pharma/biotech space. The person in this role must be able to juggle multiple priorities and work in a matrix environment with multiple stakeholders. This individual needs to be able to work independently, interacting with the Head of Contracts.
Primary Responsibilities Include:
- Assist in developing template agreements as well as alternative terms and negotiation practices
- Assist with identifying and implementing improvements to contract processes and cycle time
- Help to prepare and negotiate agreements, including master service agreements, clinical trial agreements, development and manufacturing agreements, sponsored research agreements, consulting agreements, confidential disclosure agreements, material transfer agreements, and license and collaboration agreements
- Help to integrate the contracting function with company stakeholders, including educating colleagues on contract policies and processes
- Interface with the finance and other internal groups on contract matters
- Provide, as needed, legal support relating to business development, compliance, employment law, GDPR policies, and public company work
- Help to establish, manage and update in collaboration with Head of Contracts, external parties and client group(s)) regional and global contract templates, such as clinical trial site agreements and informed consents
- Apply effective risk management techniques and offer proactive advice on possible legal issues
- Collaborate on continuous review and updates of Dyne’s contracting standards
- Consult with subject matter experts (e.g., IP, Regulatory, country legal specialists) on contract terms
- Coordinate with, and escalate issues to, other legal team members as needed to ensure alignment with Dyne’s contracting standards and timeliness of established contracting activities
- Collaborate on special projects as needed, including development and implementation of contract process changes, compliance initiatives, development of contracting standards, and contract project management
- Maintain current knowledge of changes in relevant legal frameworks
Education & Skill Requirements:
- JD from accredited law school and license to practice in at least one US jurisdiction
- 6+ years’ experience in contracts negotiation and administration in the biotech or pharmaceutical industry required with additional experience in business development, compliance, employment law, GDPR policies, and public company work a plus
- Knowledge in the conduct of global clinical trials in the pharma/biotech industry
- Experience working within a contracts management system, prior experience with Conga contracts management system a plus
- Highly organized and ability to manage large volume of contracts for multiple studies, simultaneously
- Experience with ex-US privacy laws, such as GDPR
- A dedicated, interactive, proactive, and practical individual with the ability to counsel clients at all levels of the company with clear and concise advice
- An ability to help streamline contracting procedures to create efficiencies
- A proven multi-tasker in a fast-paced environment
- Hands-on experience in contract drafting, administration, negotiations, management within the pharma/biotech industry
- Experience drafting and negotiating Master Services Agreements, Clinical Trial Agreements, Statements of Work, letters of agreement, Consulting Agreements, and other key biotech contracts
- Experience in global clinical trials and well versed in the pharma/biotech industry
- Experience working with clinical study investigator sites and large institutions (universities and hospitals)
- Ability to collaborate and negotiate large volumes of work in an efficient manner
- Excellent communication, writing and computer skills
- Ability to collaborate well with internal and external stake holders
- Ability to provide strategic insights to negotiations with difficult contract situations.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.