Company Profile
Trinity Partners LLC is a leading life sciences consulting firm that provides strategic and tactical insights to clients worldwide. Our clients include a mix of pharmaceutical, biotechnology, medical device, and diagnostic companies. Blending consulting services with research capabilities, we specialize in corporate strategy, pipeline & portfolio optimization, brand planning, market analytics, promotional effectiveness, and licensing & acquisition. Based just outside Boston, MA, with offices across the globe.
Position Summary
The Associate Director, Commercial Legal & Life Science Regulatory serves as Trinity’s lead legal counsel for life sciences regulatory support, regulated data and product use analysis, and regulated contracting frameworks across consulting and product offerings. The role partners closely with the General Counsel, the Associate Director responsible for commercial legal infrastructure, Contract Operations, Compliance & Pharmacovigilance, business leaders, and product/data stakeholders to maintain a consistent risk posture as Trinity expands its life sciences consulting, productized data, and AI-enabled offerings.
This role is initially an individual contributor position, with an expectation to assume increasing subject matter leadership and cross-functional influence over time as the legal and compliance model matures. In the near term, the role will also handle a meaningful volume of commercial contract drafting and negotiation, particularly where life sciences regulatory, privacy, data-governance, or clinical-trial issues are implicated.
Reporting Line & Key Stakeholders
• Reports to: General Counsel.
• Key partners: Associate Director, Commercial Legal; Associate Director, Commercial Legal & Contracting Operations; Senior Manager Compliance & Pharmacovigilance; business leaders in India/APAC, the United States, and other regions as applicable; product, data, and analytics stakeholders.
Responsibilities
• Handle a defined portion of U.S. overflow and global commercial contracts, especially where the agreement includes life sciences regulatory, privacy, data-use, or product counseling issues.
• Own legal support for life sciences regulatory matters arising in Trinity’s consulting and product offerings, including pharmacovigilance, transparency, FMV, anti-gift/HCP interactions, safety data exchange, clinical-trial consulting, regulated market research, and related compliance-sensitive activities.
• Own the substantive legal frameworks, template overlays, annexes, and playbooks for regulated contracting issues embedded within customer agreements, statements of work, data licenses, and product terms.
• Serve as primary legal owner for privacy-by-design, regulated data-governance analysis, and higher-risk data use questions where life sciences regulatory, privacy, and ethics issues intersect.
• Lead legal analysis of whether Trinity may use, reuse, anonymize, aggregate, license, or productize datasets, including third-party licensed data, public or internet-sourced data, and client engagement data, within approved legal and business guardrails.
• Serve as primary legal counsel for higher-risk clinical-trial consulting, pharmacovigilance-related, safety data, and other regulated engagements, escalating material exceptions, novel issues, and policy decisions to the General Counsel.
• Co-develop negotiation playbooks, templates, and guardrails with the Associate Directors responsible for commercial legal infrastructure and Contracting Operations so that regulated overlays can be implemented consistently by the broader legal and contracting team.
• Partner closely with Compliance & Pharmacovigilance to strengthen Trinity’s legal frameworks for PV, transparency, FMV, anti-gift, investigations support, and related regulated-business matters.
• Participate in product, data, and AI review cadences; provide practical legal guidance on intended use, data provenance, permissible outputs, privacy assumptions, and regulated-risk boundaries for new
offerings and features.
Tertiary Responsibilities (As Needed -- ~10%)
• Support APAC and other regional business teams on regulated commercial models, launches, strategic initiatives, and life sciences legal questions that require subject matter judgment.
• Provide support on litigation, investigations, remediation, disputes, or employment-related matters where compliance and regulated-business considerations materially intersect with the legal analysis.
• Assist on acquisition diligence or strategic transactions where life sciences regulatory, privacy, data-use,
or compliance risk is material to the deal.
Governance & Decision Rights
• Owns legal interpretation and approved drafting positions for regulated overlays in Trinity customer agreements, data-license arrangements, and product-related documents within the approved Trinity risk framework.
• Owns legal judgment on whether specific data uses, product features, AI-enabled use cases, and regulated-business workflows are supportable within approved guardrails, escalating material exceptions and policy decisions to the General Counsel.
• Partners with Contracting Operations to operationalize regulated templates, clause packs, playbooks, and escalation workflows; Contracting Operations owns routing and prioritization.
First 6--12 Months: Success Measures
1. Operationalize a repeatable legal review model for life sciences regulatory issues embedded in Trinity’s consulting and product work, including clear escalation thresholds.
2. Publish and socialize template overlays, fallback positions, and playbooks for PV, transparency, FMV, anti-gift/HCP interactions, safety data exchange, and clinical-trial consulting arrangements.
3. Implement a practical privacy-by-design and regulated data-use review framework for productized data, AI-enabled offerings, and higher-risk datasets.
4. Establish a legal framework for data-license and third-party data use decisions, including use, reuse, derivation, anonymization/aggregation, and productization guardrails.
5. Deliver stakeholder training for Legal, Compliance, Contracting Operations, and relevant business teams
on regulated contract guardrails and issue spotting.
6. Provide regular reporting to the General Counsel on issue volume, escalation patterns, high-risk themes, and areas requiring policy or process refinement.
Qualifications
• Law degree (LL.B./J.D.) and eligibility to practice in India.
• 10+ years of legal experience with a strong background in commercial contracts, life sciences regulatory counseling, privacy, compliance, and data governance.
• Proven ability to draft, redline, and negotiate commercial contracts independently in regulated and cross-functional business environments.
• Strong familiarity with applicable life sciences, compliance, and privacy laws, rules, and frameworks, including pharmacovigilance, transparency, anti-bribery/anti-gift concerns, data protection, and related healthcare industry requirements.
• Demonstrated ability to advise on product and commercial strategy in regulated markets, including risk- based decision making and practical stakeholder partnership.
• Strong organizational skills and ability to manage workload across multiple time zones and business functions.
• Ability to work independently while collaborating effectively with commercial, compliance, product, data, and operational stakeholders.
• Preferred: meaningful experience with privacy-by-design, data ethics, or regulated data-governance frameworks.
• Preferred: playbook, template, or CLM experience and comfort translating legal positions into
operational workflows.
Skills Required
- Law degree (LL.B./J.D.) and eligibility to practice in India
- 10+ years of legal experience with commercial contracts, life sciences regulatory counseling, privacy, compliance, and data governance
- Proven ability to draft, redline, and negotiate commercial contracts independently in regulated environments
- Strong familiarity with life sciences compliance frameworks including pharmacovigilance, transparency, anti-bribery/anti-gift, and healthcare data protection
- Demonstrated ability to advise on product and commercial strategy in regulated markets and perform risk-based decision making
- Strong organizational skills and ability to manage workload across multiple time zones
- Ability to work independently while collaborating with commercial, compliance, product, data, and operational stakeholders
- Experience with privacy-by-design, data ethics, or regulated data-governance frameworks
- Playbook, template, or CLM experience and comfort translating legal positions into operational workflows
What We Do
Trinity Life Sciences is a modern partner to companies in the life sciences industry with nearly 30 years of expertise. The firm combines strategy, insights, and analytics to help life science executives with clinical and commercial decision-making. Serving over 300 pharmaceutical, biotech, and medical device clients, Trinity helps them develop the right drugs and devices for today’s market and optimize them once in market.
