Senior Clinical Development Lead – Metabolic Therapeutics

Viking Therapeutics; San Diego (CA); On-site; USD 210,000 - 260,000; Full time

Job summary

Viking Therapeutics seeks an Associate Medical Director, Clinical Development to guide medical direction and review of trials in metabolic and endocrine disorders. You will help shape protocol development, safety monitoring, data analysis, and regulatory submissions, working with senior leadership.

The role emphasizes collaboration with cross-functional teams, CRO oversight, and medical input for trial design and reporting. Strong GCP knowledge and data interpretation skills are essential.

Qualifications

• MD/DO/PharmD or equivalent required.
• 2-4 years clinical or clinical research experience in academia, industry, or similar setting; direct biopharmaceutical industry experience preferred.
• Late-stage experience (Phase 2/Phase 3 trials) preferred.

Responsibilities

• Support protocol development in collaboration with Clinical Operations and other clinical sub-teams under senior medical leadership.
• Contribute to clinical development plans with cross-functional teams.
• Provide medical input and escalate complex questions to leadership as needed.
• Assist in regulatory document preparation (INDs, amendments, Investigator Brochures, DSURs).
• Contribute to CSR preparation and study document development (CRFs, ICFs).
• Develop study plans (MMPs, SMPs, DMPs, PD plans) and manage risk logs.
• Review AE/SAE reports and assess causality, escalating safety concerns.
• Support training of protocol, indications, and safety for investigators and site staff.
• Monitor data in ongoing studies and act as sponsor medical contact for clinical questions.
• Support communication among sponsor, investigators, sites, and safety committees.

Skills

Medical leadership

Clinical trial oversight

Regulatory knowledge

Data analysis

Scientific writing

Communication

Microsoft Office

Clinical trial software

Independent work

Team collaboration

Education

MD/DO/PharmD or equivalent

2-4 years clinical/research experience

Late-stage trial experience (Phase 2/3)

Tools

Medidata Rave

Medrio

Veeva Vault

Argus

Job description

Viking Therapeutics seeks an Associate Medical Director, Clinical Development to guide medical direction and review of trials in metabolic and endocrine disorders. You will help shape protocol development, safety monitoring, data analysis, and regulatory submissions, working with senior leadership.

The role emphasizes collaboration with cross-functional teams, CRO oversight, and medical input for trial design and reporting. Strong GCP knowledge and data interpretation skills are essential.