Executive Director, Contracts, Regulatory & Compliance (Counsel)

Soufflé Therapeutics; Watertown (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Soufflé Therapeutics, a Watertown-based biotech company, seeks an experienced life sciences attorney to lead contracting and privacy initiatives as the company scales its pipeline.

You will own end-to-end R&D contracting, align privacy controls with GDPR and HIPAA, and build scalable processes to support rapid growth across internal units.

Qualifications

• 10+ years of relevant legal experience (mix of law firm and in-house), including 7+ years in a similar role and at least 4 years in biotech
• J.D. from an accredited law school; active bar membership in at least one U.S. jurisdiction in good standing
• Strong contract drafting, redlining, and negotiation skills, with strong working knowledge of GDPR, HIPAA, and comparable global privacy frameworks as applied to clinical research and patient data
• CIPP/E, CIPP/US, or equivalent privacy certification
• Experience with contract lifecycle management (CLM) or CTMS platforms; prior in-house experience at a clinical-stage biotech company; broader contracting experience; later-phase clinical trial experience

Responsibilities

• Own Soufflé's contracting function by leading end-to-end negotiation and risk review of all R&D contracting, with immediate priority on clinical and development agreements and expanding to cover commercial and general business contracts as the company scales
• Serve as the internal subject-matter expert on global data privacy law (GDPR, HIPAA) as applied to clinical trial operations, owning the creation and enforcement of privacy policies and internal controls
• Ensure contracts comply with applicable regulatory requirements, including EU CTR/CTIS, ICH-GCP, and data privacy law; build and maintain template agreements, fallback positions, and negotiation playbooks across contract types
• Lead privacy and data protection impact assessments (DPIAs) for clinical data flows, including genomic and biospecimen data, in partnership with the General Counsel and IT
• Build scalable contracting processes and playbooks that support Soufflé's growth and align with company strategy

Skills

Contract drafting

Negotiation

Data privacy

Regulatory compliance

Education

J.D. from law school

Tools

CLM platforms

CTMS platforms

Job description

Soufflé Therapeutics is a biotech company focusing on the cell-type specific delivery of genetic medicines. Its team of driven scientists is making a mark in delivery of oligonucleotides to extrahepatic tissues. We thrive in a purpose-building lab and office space in Watertown. Come and join us in our quest!

Position Summary:

As Soufflé grows, we need a dedicated attorney to lead tour contracting function across all internal business units, while owning global data privacy compliance (GDPR, HIPAA) for multi-regional studies involving patient, genomic, and biospecimen data. The immediate focus will be development and clinical agreements as our pipeline advances, with scope expanding to cover the full breadth of business contracting. This is a high-visibility, high-ownership role for an experienced life sciences attorney who wants to build the contracting and privacy function from the ground up as our company and pipeline scales.

Key Responsibilities

• Own Soufflé's contracting function by leading end-to-end negotiation and risk review of all R&D contracting, with immediate priority on clinical and development agreements (CTAs, CDMO and CRO agreements, clinical vendor agreements, site clinical trial agreements, ICFs, and patient advocacy agreements) and expanding to cover commercial and general business contracts as the company scales
• Serve as the internal subject-matter expert on global data privacy law (GDPR, HIPAA, and comparable frameworks) as applied to clinical trial operations, owning the creation and enforcement of privacy policies and internal controls
• Ensure contracts comply with applicable regulatory requirements, including international clinical trial regulations (e.g., EU CTR/CTIS, ICH-GCP) and data privacy law; build and maintain template agreements, fallback positions, and negotiation playbooks across contract types
• Lead privacy and data protection impact assessments (DPIAs) for clinical data flows, including genomic and biospecimen data, in partnership with the General Counsel and IT
• Build scalable contracting processes and playbooks that support Soufflé's growth and align with company strategy

What Success Looks Like

• In 3 months: You've completed an audit of all in-flight clinical agreements, triaged initial contract and DPA templates, and built trusted relationships with Clinical Operations and CMC leads
• In 6 months: You're independently managing the full contracting pipeline with no material backlog, and you've drafted and circulated solutions for identified privacy and internal control gaps and build a framework to enable prioritization.
• In 12 months: Contract turnaround time is down at least 30%, the privacy program is fully operational, and you're recognized as the go-to legal partner by Clinical Operations, CMC, and R&D

Qualifications — Required

• 10+ years of relevant legal experience (mix of law firm and in-house), including 7+ years in a similar role and at least 4 years in the biotech industry
• J.D. from an accredited law school; active bar membership in at least one U.S. jurisdiction in good standing
• Strong contract drafting, redlining, and negotiation skills, with strong working knowledge of GDPR, HIPAA, and comparable global privacy frameworks as applied to clinical research and patient data

Qualifications — Preferred

• CIPP/E, CIPP/US, or equivalent privacy certification
• Experience with contract lifecycle management (CLM) or CTMS platforms; prior in-house experience at a clinical-stage biotech company; broader contracting experience (partnership and licensing agreements); later-phase (Phase II/III) clinical trial experience

Education

• J.D.

At Soufflé Therapeutics, we are intentional about building an equitable culture. How we treat our people is reflective of this focus. We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

This is an onsite position in Watertown, MA (US) with flexibility as needed for collaboration and external engagements.