AVP CDMA

Hetero; Hyderabad; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Hetero is seeking a senior leader to drive Global Clinical Development, Medical Affairs, Pharmacovigilance, and related functions. You will guide biostatistics, data management, medical writing, and project management as part of a cross-functional global team.

The role requires an MD/MBBS with extensive experience in biologics, generics, or specialty pharma, and a proven track record of leading diverse teams across regions.

Qualifications

• MD/MBBS required.
• Experience across Clinical Development, Medical Affairs, Pharmacovigilance and Clinical Research.
• Strong leadership of cross-functional global teams.

Responsibilities

• Lead global Clinical Development, Medical Affairs, Pharmacovigilance, Clinical Data Management, Medical Writing, and Biostatistics.
• Coordinate Phase I–IV trials, post-marketing studies, investigator-initiated studies, and real-world evidence programs.
• Ensure ICH-GCP and regulatory compliance.
• Build and maintain relationships with investigators and trial sites.
• Oversee Clinical Project Management, budgeting, vendor management, and governance.

Skills

Clinical development

Medical affairs

Pharmacovigilance

Cross-functional leadership

Education

MD / MBBS

Job description

Job Description Clinical Development Medical Affairs

Job Purpose

Lead Global Clinical Development, Medical Affairs, Pharmacovigilance, Clinical Project Management, Clinical Data Management, Medical Writing, and Biostatistics. Drive global clinical and medical strategies, ensure regulatory compliance, and support clinical development across the product lifecycle.

Key Responsibilities

Strategic Leadership

Lead and guide the Clinical Development, Medical Affairs, Pharmacovigilance, Clinical Data Management, Medical Writing, Biostatistics, and Clinical Project Management teams.

Work closely with senior leadership to achieve business and organizational goals.

Clinical Development

Oversee global clinical development activities for biologics, generics, and discovery programs (as applicable).

Coordinate Phase IIV clinical trials, post-marketing studies, investigator-initiated studies, and real-world evidence programs.

Ensure compliance with ICH-GCP and global regulatory requirements.

Build and maintain strong relationships with investigators and clinical trial sites.

Medical Affairs

Lead Medical Affairs, Scientific Communications, Medical Information, Medical Writing, Clinical Data Management, and Biostatistics activities.

Review and approve clinical protocols, study reports, publications, and scientific documents.

Pharmacovigilance

Oversee global pharmacovigilance activities across regulated and emerging markets.

Ensure compliance with global drug safety regulations, signal detection, risk management, aggregate reporting, and inspection readiness.

Review safety data and support regulatory inspections and audits.

Clinical Project Management

Oversee clinical project planning, budgeting, resource allocation, vendor management, clinical quality, and project governance.

Monitor project timelines, quality, risks, and deliverables to ensure projects are completed on time and within budget.

Qualification

MD / MBBS

Experience

1825+ years of experience in Clinical Development, Medical Affairs, Pharmacovigilance, and Clinical Research.

Experience in biologics, biosimilars, generics, or specialty pharmaceuticals.

Strong leadership experience in managing cross-functional global teams.

Location

#L1-Onsite