SENIOR DIRECTOR

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Date: Feb 27, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

The Senior Specialist – CDMA – Clinical Development – Medical Sciences is responsible for providing scientific and clinical expertise to support the design, execution, interpretation, and communication of clinical development programs across the product lifecycle. This role acts as a scientific bridge between early research, clinical development, regulatory strategy, and medical affairs. The Senior Specialist contributes to protocol development, clinical trial design, data analysis, and medical strategy, ensuring that clinical programs are scientifically rigorous, ethically sound, and aligned with patient and market needs. Working cross-functionally, the individual helps translate scientific insights into actionable development strategies and supports internal and external stakeholder engagement.

Academic Stream

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Work experience (in months)

0

Job Responsibility and key Decisions

Protocol and Study Design Support

Provide scientific input into the design of clinical trials, contribute to writing study protocols, amendments, and feasibility assessments.

Clinical Document Development

Draft and review investigator brochures, medical sections of regulatory dossiers, study reports, abstracts, and publications.

CrossFunctional Scientific Collaboration

Collaborate with clinical, regulatory, safety, and biometrics teams to ensure scientific consistency and integrity in study planning and execution.

Clinical Data Review and Interpretation

Participate in data review meetings, identify data trends, and support interpretation of clinical trial results with a focus on scientific accuracy.

Scientific Communication and Training

Develop training materials and scientific content for internal stakeholders e.g., MSLs, field medical teams and support external scientific communications.

KOL and Investigator Interaction

Support the engagement of KOLs for advisory boards, study input, and congress participation. Gather external insights to refine development strategy.

Regulatory and Submission Support

Assist in preparing and reviewing clinical sections of regulatory submissions, including INDs, CTAs, NDAs, MAAs, and responses to health authority queries.

Competitive Intelligence and Landscape Monitoring

Monitor scientific and clinical developments in relevant therapeutic areas and competitor pipelines to inform clinical strategy.

Internal Project Leadership

Lead or colead internal scientific workstreams, working groups, or task forces supporting study design, indication strategy, or evidence generation.

Key Decisions

Study Design and Endpoint Selection

Provide input on trial designs, inclusionexclusion criteria, and clinically meaningful endpoints based on scientific evidence and therapeutic landscape.

Content of Clinical Documents

Determine appropriate scientific and clinical content for study protocols, CSRs, and regulatory documents, ensuring accuracy and compliance.

Data Interpretation and Narrative Framing

Decide how to present study results and interpret efficacy and safety outcomes in a scientifically rigorous and transparent manner.

External Engagement Strategy

Identify when and how to engage external experts to validate or challenge clinical strategies and support development decisions.

Risk Identification and Mitigation

Identify scientific or operational risks related to trial design or execution and recommend appropriate mitigation strategies.

Support for Regulatory Interactions

Provide input on clinical responses to regulatory queries, ensuring clarity and scientific integrity in communication.