Troikaa - Clinical Research Physician - MD/DM

Job Purpose :

- Troikaa Pharmaceutical Ltd. is a research led organization with expertise in Novel Drug Delivery System (NDDS). This role seeks to hire qualified and experienced person with clinical research related expertise to drive the relevant activities.

- This individual will work in collaboration with internal and external stakeholders ensure robust clinical development,capturing safety reports, medical writing, scientific communications, documentation, audit/inspection-readiness, project management and strict adherence to the compliance and ethical guidelines.

Job responsibilities:

The primary job responsibilities include, but not limited to the activities mentioned below

1. Lead the Clinical Development Plans (CDPs)

a. Drive the clinical development strategy of pipeline and marketed products.

b. Lead the development of robust clinical study protocols design, and other relevant documents in line with the regulatory and ethical compliance.

c. Provide clinical input throughout clinical trial phases, from protocol concept to final study reports.

d. Interpret clinical data, integrate external scientific and competitive information, and engage with key external experts (KEEs), advisory boards, and collaborators.

e. Ensure patient safety and alignment with medical governance during clinical trial conduct.

2. Medical Monitoring

a. Act as the Medical Monitor for clinical trials, overseeing participant safety and ensuring compliance with study protocols, ICH-GCP standards, and relevant local regulatory frameworks.

b. Provide on-call medical oversight and decision-making for clinical trial and postmarketing safety issues.

c. Ensure ongoing benefit-risk evaluation across all development phases.

d. Responsible for the review and causality assessment of Serious Adverse Events (SAEs) reported during clinical trials, on behalf of the sponsor.

e. Monitoring study progress, timelines, budgets, and ensuring data quality and integrity.

3. Support the PV/regulatory/labelling activities

a. Lead preparation of regulatory submission documents including Investigators

Brochures, INDs, NDAs, and MAA dossiers. Support regulatory submissions

Department : Medical Services

Location : H.O.

- Contribute to the drafting and scientific validation of SmPC, PIL, CCDS, and product labels.

- Liaise with Contract Research Organizations (CROs) and third-party vendors to ensure effective execution of pharmacovigilance activities across the EU and EEA territories.

4. Scientific Communication Activities

a. Medical / scientific communication of the data to ensure robust impact on the healthcare professional, which includes but not limited to conference posters, abstracts, oral presentation, full manuscripts, and speaker slides.

5. Cross-functional Collaboration & medical leadership

a. Act as the medical-scientific subject matter expert across global clinical, regulatory, safety, and marketing teams.

b. Participate in periodic meetings with management.

c. Represent the medical department in internal governance bodies, regulatory meetings, and KOL interactions.

d. Mentor and guide junior medical staff, medical writers, PV associates, and clinical team members.

e. Liaise with Contract Research Organizations (CROs) and third-party vendors to ensure effective execution of the clinical projects.

6. Additional Duties

a. Carry out additional duties/responsibilities and ad-hoc assignments as delegated by the Head of the Medical Services Department or Senior MD with 5-10 years of relevant experience/DM clinical pharmacology with 1 2 years of experience in pharmaceutical/biotech/CRO clinical development

- Experience in pharmaceutical industry clinical development processes, regulatory strategy, and lifecycle management.

- Proven leadership skills, including team building, mentoring, and performance management.

- Excellent communication, strategic thinking, and project management capabilities.

- Knowledge of worldwide regulatory and safety requirements in drug development.

- Ability to manage complex collaborations internally and externally.

Location: Troikaa HO, Ahmedabad

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