What are the responsibilities and job description for the Functional Lead - Clinical Domain position at Modak?
Functional Lead – Clinical Domain
About Modak
Modak is a fast-growing data engineering firm that enables enterprises manage and utilize their data landscape effectively. Modak provides a mix of services and software and are technology and cloud agnostic to customer datafication initiatives. Modak uses advanced software techniques to transform how structured and unstructured data is prepared, consumed, and shared. Modak’s Nabu™ is an enterprise ready modern data platform and has been covered in Gartner’s “Market Guide to Data preparation 2020.”
Job Description:
The Domain Lead provides deep functional expertise across Safety, R&D Quality, Data & Statistical Sciences, Phase 1 Unit, Clinical Data Strategy & Operations, Clinical Operations, R&D Financial Operations, Medical Affairs, Real-World Data, CMC & Drug Supply, Clinical PMO, and Regulatory Affairs. The role guides domain-specific solution design while driving responsible adoption of AI/ML to enable data-driven decision-making, compliance, and innovation.
Key Responsibilities
- Act as SME for assigned domains (Safety, R&D, Clinical, etc.), interpreting business, scientific, and regulatory requirements.
- Guide design of technical and data solutions aligned with GxP, FDA/EMA, GDPR, and organizational governance.
- Translate complex domain requirements into actionable work for technical and analytics teams.
- AI/ML Guidance & Adoption
- Identify, assess, and prioritize AI/ML use cases across R&D and clinical workflows.
- Evaluate data readiness, quality, and suitability for machine learning applications.
- Partner with data science teams to shape AI/ML models supporting prediction, automation, insights, and continuous improvement.
- Promote responsible AI practices including transparency, fairness, explainability, and regulatory compliance.
- Cross-Functional Collaboration
- Work with data, engineering, analytics, and governance teams to ensure solutions meet domain needs.
- Support development of scalable data architectures, standards, and domain-specific data models.
- Recommend improvements and optimization opportunities leveraging data-driven and AI-enabled approaches.
- Stakeholder Engagement
- Engage domain stakeholders to gather requirements and align on solution priorities.
- Communicate technical and domain concepts clearly to clinical, regulatory, operational, and executive audiences.
- Represent domain needs in workshops, governance forums, and review sessions.
Qualifications -
- Advanced degree in Life Sciences, Medicine, Pharmacy, Biotechnology, Data Science, or related field.
- 6 years of experience in Safety, Clinical, R&D Quality, CMC, Regulatory Affairs, Medical Affairs, or related domains.
- Demonstrated experience advising on or delivering data, analytics, or AI/ML initiatives in regulated environments.
- Strong understanding of R&D processes, data standards (CDISC, SDTM, ADaM, MedDRA, WHODrug), and compliance frameworks.
- Ability to collaborate across cross-functional teams and influence stakeholders.
- Experience applying AI/ML in clinical, safety, or R&D workflows.
- Familiarity with FAIR data principles and modern data platforms.
- Strong communication and stakeholder management skills.
Note: Modak will only consider applicants for this position who are legally authorized to work in the United States and do not require company sponsorship.