Director – Drug Development Consulting (DDC)
Location: Australia
Job Type: Full-Time
Industry: Clinical Research | Drug Development | Life Sciences Consulting
Experience Required: 12+ Years
Job Overview
We are seeking an experienced Director – Drug Development Consulting (DDC) to join a high-caliber global consulting team supporting biotech and pharmaceutical sponsors across integrated drug development programs. This senior leadership role combines strategic client advisory, hands-on development plan authorship, and cross-functional program leadership, aligned with best-in-class life sciences consulting models.
The Director will play a pivotal role in shaping global development strategies spanning preclinical research through regulatory approval and lifecycle management, with a strong focus on clinical pharmacology, regulatory submissions, and translational science.
Key Responsibilities
Lead high-impact client engagements focused on integrated drug development strategies, from preclinical stages through approval and post-marketing lifecycle management.
Interpret preclinical PK/PD and ADME data to design robust clinical pharmacology plans, including dose selection and dose escalation strategies.
Author, review, and defend clinical pharmacology and regulatory strategy documents, including IND, CTA, MAA, NDA, and BLA submissions and responses to global health authorities.
Design clinical pharmacology programs and contribute to protocol development, ensuring alignment across statistical, PK/PD, safety, and operational considerations.
Provide expert guidance on first-in-human studies, nonclinical-to-clinical translation, and exposure-response strategies.
Mentor and develop junior consultants while building long-term client partnerships and contributing to business development initiatives.
Support thought leadership activities by delivering evidence-based, high-value recommendations consistent with top-tier life sciences consulting standards.
Lead and collaborate with multidisciplinary, cross-geography teams in a global consulting environment.
Required Qualifications and Experience
Advanced degree in Medicine, Pharmacy, or Life Sciences (MD, PharmD, or PhD).
Minimum 12 years of experience in drug development, clinical pharmacology, or pharmacokinetics across multiple therapeutic areas.
Proven track record in directing and executing clinical pharmacology programs within biotech, pharmaceutical, CRO, or consulting environments.
Strong expertise in global regulatory submissions, including IND, CTA, MAA, NDA, and BLA pathways.
Excellent written and verbal communication skills, with demonstrated experience presenting to senior leadership teams and regulatory authorities.
Prior experience working in or with leading life sciences consultancies or global CROs is highly desirable.
Willingness and ability to travel as required to support global client engagements.
Preferred Technical Expertise
Clinical Pharmacology and Pharmacometrics: PK/PD modeling, exposure-response analysis, dose optimization, and DDI strategies.
Global Regulatory Strategy: End-to-end regulatory submissions and agency interactions.
Clinical Development Design: Adaptive trials, seamless phase designs, pediatric and rare disease programs.
Why Join Novotech
Novotech is a globally recognized, full-service Contract Research Organization headquartered in Sydney, Australia, with a presence across Asia-Pacific, North America, and Europe. With over 3,000 employees and 5,000+ site partnerships worldwide, Novotech offers the scale, expertise, and infrastructure to support complex global development programs.
The organization is committed to fostering an inclusive, flexible, and collaborative work environment, offering benefits such as flexible working arrangements, paid parental leave, wellness initiatives, and continuous professional development opportunities.
About the Team
At Novotech, you will work alongside empowered, high-performing teams with deep therapeutic and regulatory expertise. The culture emphasizes strategic thinking, proactive decision-making, collaboration, and strong leadership support—providing an ideal environment for senior professionals to grow their impact and career.
Job ID: 3668
Posting Date: 12 January 2026
Work Schedule: Full-Time
Primary Location: Australia
Apply now through thepharmadaily.com to explore this senior leadership opportunity in global drug development consulting.
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