Hiring for Clinical Domain Solutions & Presales Lead at Raritan, New Jersey - Hybrid

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Please find the Job Description (JD) below.

Role : Clinical Domain Solutions & Presales Lead

Location : Raritan, New Jersey - Hybrid

Life Sciences | Clinical R&D | Solution Consulting | RFPs & Proposals

Experience 15 16 years

Employment Type Full-time Function Clinical Domain Solutions & Presales

Role Summary

We are seeking a Clinical Domain Solutions & Presales Lead with 15 16 years of experience in Life Sciences and clinical technology consulting. The role will lead discovery, solution shaping, client presentations, RFP/RFI responses, proposals, effort estimation, and pursuit governance for clinical research and development opportunities. The successful candidate will combine deep clinical domain expertise, strong solution-consulting skills, commercial awareness, and executive presence to translate client priorities into differentiated, compliant, scalable, and deliverable solutions. The candidate must be from one of the SI partner organizations (and not from Product Pharma organizations) and should have expertise in liaison between business and IT.

Key Responsibilities

1. Clinical Domain & Solution Leadership

Act as the clinical domain lead and trusted solution advisor for pharmaceutical, biotechnology, medical device, and CRO clients.

Lead discovery workshops to understand business outcomes, clinical operating model, pain points, regulatory constraints, data landscape, and transformation priorities.

Define end-to-end solutions across Clinical Operations, Clinical Data Management, Study Start-up, EDC, CTMS, eCOA/ePRO, RTSM/IRT, Trial Master File, Safety/Pharmacovigilance, Regulatory, and clinical analytics.

Translate business and clinical needs into solution architecture, operating-model recommendations, implementation roadmaps, work packages, and measurable value propositions.

Ensure proposed solutions align with the clinical trial lifecycle, regulated processes, quality expectations, and enterprise technology standards.

Provide domain direction to solution architects, business analysts, data teams, validation/quality teams, and delivery leaders during pursuits and solution transitions.

2. Presales, RFPs & Proposal Management

Own or co-own responses to RFPs, RFIs, RFQs, proactive proposals, statements of work, and capability presentations for clinical-domain opportunities.

Analyze bid requirements, identify solution themes and win strategies, structure the response, coordinate contributors and ensure complete, accurate, and timely submissions.

Develop compelling executive summaries, solution narratives, delivery approaches, transition plans, governance models, assumptions, dependencies, risks, and differentiators.

Lead effort estimation with delivery, engineering, QA, data, cloud, platform, and commercial teams; validate staffing models, timelines, productivity assumptions, and pricing inputs.

Facilitate bid reviews, solution reviews, red-team reviews, and executive approvals, incorporating feedback while maintaining storyline consistency.

Maintain reusable proposal assets, case studies, reference architectures, accelerators, estimation models, and clinical-domain content for future pursuits.

3. Client Presentations & Pursuit Leadership

CLINICAL DOMAIN SOLUTIONS & PRESALES

Clinical Domain Solutions & Presales Lead | Job Description

Present proposed solutions, delivery models, transformation roadmaps, demonstrations, and business value to client stakeholders, including clinical, business, IT, quality, procurement, and executive leadership.

Lead solution defense sessions, workshops, orals, and follow-up discussions; respond confidently to functional, regulatory, technical, delivery, and commercial questions.

Tailor the value proposition and messaging to client priorities, clearly articulating differentiators, outcomes, risks and implementation considerations.

Partner with account, sales, and alliance teams to qualify opportunities, shape demand, build pursuit plans, and support pipeline conversion.

Establish credibility with senior stakeholders through consultative communication, structured problem solving, and a strong understanding of clinical R&D challenges.

4. Clinical Platforms, Data & Transformation

Shape solutions involving platforms such as Medidata, Veeva Vault Clinical, Oracle Clinical One/InForm, IQVIA technologies, and other clinical SaaS ecosystems.

Define solution approaches for implementation, configuration, integration, migration, validation, analytics, process harmonization, and application support.

Guide solutions involving clinical data ingestion, transformation, quality, reconciliation, lineage, reporting, and modern data platforms such as Snowflake, databricks and cloud services.

Identify opportunities for AI, GenAI, automation, advanced analytics, and reusable accelerators while ensuring appropriate controls for regulated clinical use cases.

Balance target-state vision with practical considerations such as legacy systems, data quality, validation, change readiness, rollout strategy, and adoption.

5. Compliance, Quality & Delivery Assurance

Ensure solution designs consider GxP, 21 CFR Part 11, data integrity, computer system validation/computer software assurance, privacy, security, audit readiness, and traceability.

Define a credible delivery model covering governance, Agile/Waterfall/hybrid execution, validation, UAT, cutover, go-live, hypercare, and transition to support.

Identify delivery and solution risks early, document assumptions and exclusions, and define practical mitigation plans.

Partner with delivery leadership to enable a structured handover from pursuit to execution and preserve commitments made during the sales cycle.

Required Experience & Skills

15 16 years of overall experience in Life Sciences consulting, clinical technology, domain advisory, delivery, solutioning or presales.

Demonstrated experience leading clinical-domain solution definition and presenting solutions to global clients and senior

stakeholders.

Proven ownership of RFP/RFI responses, proposals, solution documents, effort estimates, staffing models, and pursuit reviews.

Strong understanding of the clinical trial lifecycle, including study planning and start-up, study conduct, data capture, clinical data review/management, closeout, and reporting.

Experience across one or more clinical areas: Clinical Operations, Clinical Data Management, EDC, CTMS, eCOA/ePRO, RTSM/IRT, eTMF, Safety/Pharmacovigilance, Regulatory, or clinical analytics.

Working knowledge of regulated Life Sciences environments, including GxP, 21 CFR Part 11, data integrity, validation and audit readiness.

Experience shaping clinical SaaS/platform implementation, integration, migration, data, analytics, or managed-services solutions.

Ability to develop clear solution narratives, presentations, operating models, roadmaps, governance structures and implementation approaches.

Strong commercial acumen covering scope definition, assumptions, estimation, pricing inputs, change control, delivery risk and margin considerations.

Excellent executive communication, storytelling, facilitation, negotiation, stakeholder management, and written proposal

skills.

CLINICAL DOMAIN SOLUTIONS & PRESALES

Clinical Domain Solutions & Presales Lead | Job Description

Ability to lead cross-functional, geographically distributed teams under pursuit timelines and ambiguity.

Comfort with tools such as Microsoft PowerPoint, Word, Excel, Jira, Confluence, Azure DevOps, MS Project and collaboration platforms.

Preferred Experience

Experience with Medidata, Veeva Vault Clinical, Oracle Clinical One/InForm, IQVIA solutions, or comparable clinical platforms.

Exposure to Snowflake, modern cloud/data architectures, APIs, integrations, dbt-based transformations, and BI/reporting ecosystems.

Experience with Service implementation (SI) partners liaisoning with business and IT of global pharmaceutical, biotechnology, medical device, or CRO clients in onsite/offshore delivery models.

Experience developing AI/GenAI, automation, or analytics-led propositions for clinical R&D.

Prior responsibility for a clinical consulting practice, solution portfolio, center of excellence, or domain capability.

Education & Certifications

Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Medicine, Engineering, Computer Science, Information Technology, or a related discipline.

Relevant certifications such as PMP, PRINCE2, SAFe, CSM, cloud/data certifications, or vendor platform certifications are preferred.

Madhu Challa | Sr. Technical recruiter