- Manage and maintain the lifecycle of the contract process to ensure workflows occur in a timely manner for all contracting activities.
- Negotiate clinical trial agreements, master service agreements, scope of work documentation and other business critical agreements.
- Host weekly/monthly meetings with internal and external teams to ensure all activities are progressing in an orderly manner.
- Participate in regular check-ins with FSP's Senior Counsel, Contracts to discuss contract issues and updates.
- Provide training to relevant business units on contracts processes to ensure approvals and contract requirements are met.
- Ensure contractual obligations are tracked and relevant stakeholders apprised of obligation deadlines in a timely manner.
- Format documents for finalization and execution, including the use of e-signature platforms.
- Develop and optimize contracts templates and develop internal positions on key provisions.
- Buildout technical infrastructure to support legal operations in an efficient and effective manner, including building and maintaining an internal contract management system.
- Some knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
- JD required with a minimum of 5 years' experience, with 3 years prior experience in a biotech/pharma company or university setting.
- Prior experience negotiating with Academic and Non-Profit institutions.
- Knowledge of the current global and regional trends in clinical contracting as well as legal and regulatory environment as it relates to the pharmaceutical/biotech industry.
- Familiarity with Cobblestone or other contract management systems required.
- Knowledge of the drug development process with understanding of the operational aspects of clinical development.
- Strong interpersonal skills to maintain positive working relationship with internal and external stakeholders.
- Detail-oriented mindset with excellent verbal and written communication skills.
- Ability to work independently and thrive in a fast-paced environment; good time-management and prioritization skills, be detail oriented, manage multiple contracts and projects simultaneously under tight deadlines.
- Ability to efficiently manage time to balance the business needs of multiple business partners.
- Positive outlook, willingness to learn and contribute, commit to personal growth and a team-oriented attitude; the ability to adapt to new/evolving processes will be key.
- Local candidates preferred as this is a hybrid role, with an expectation of 2-3 days in the office (Cambridge, MA).
- Relocation assistance will not be offered for this position.
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Contracts Counsel - Cambridge, United States - Flagship Pioneering, Inc.
Description
Who we are
Alltrna, a Flagship-founded company, has mapped tRNA biology to systematically design tRNA medicines and encode a completely new, unifying approach to treating both rare and common human diseases driven by shared genetic mutations.
We have an unprecedented opportunity to advance a single tRNA medicine to restore disrupted protein production, regardless of target, for thousands of diseases with the same underlying genetic mutation.
Flagship Pioneering (FSP) conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability.Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $200 billion in aggregate value.
To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions.
The current Flagship ecosystem comprises 42 transformative companies, including Denali Therapeutics (Nasdaq:DNLI), Foghorn Therapeutics (Nasdaq: FHTX), Indigo Ag,, Moderna (Nasdaq: MRNA), Omega Therapeutics (Nasdaq: OMGA), , Sana Biotechnology (Nasdaq: SANA), and Seres Therapeutics (Nasdaq: MCRB).
Position Summary
For this unique opportunity, Alltrna is looking for a shared-resource Contracts Counsel, able to spend a portion of time assisting FSP's legal needs.
The individual will spend the majority of time (at least 60%) working with the Alltrna team to draft, negotiate and manage a broad variety of contracts related to Alltrna's business needs, including confidentiality agreements, services agreements, clinical trial agreements, ICF review, consulting agreements and others.
This role will require close collaboration with Alltrna business stakeholders, including clinical development, operations, IT, HR and finance.The individual will also have the opportunity to draft a variety of contracts related to the business needs of FSP or its other FSP companies.
As an Alltrna employee, the Contracts Counsel will report to the leadership at Alltrna, but will have a dotted line to, and work closely with, to FSP's Senior Contracts Counsel, and will also work directly with other members of the FSP Legal Team with respect to his/her responsibilities.
FSP and its ecosystem companies, including Alltrna are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies:
FSP and Alltrna do not accept unsolicited resumes from any source other than candidates.
The submission of unsolicited resumes by recruitment or staffing agencies to FSP or Alltrna or its employees is strictly prohibited unless contacted directly by FSP's and Alltrna's internal Talent Acquisition team.
Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP/Alltrna, and FSP/Alltrna will not owe any referral or other fees with respect thereto.
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