Apac Regional Clinical Director Lead Quality Growth
Our client, a groundbreaking biopharmaceutical company focused on rare disease therapies, is seeking a visionary and experienced Director of Clinical Operations to lead their global clinical development efforts. This is a fully remote position, allowing you to contribute from anywhere within Makassar, South Sulawesi, Indonesia. You will be responsible for the strategic planning, execution, and oversight of all clinical trial operations, ensuring adherence to timelines, budgets, and regulatory standards. We are looking for a dynamic leader with a proven track record in managing complex clinical programs, building and mentoring high‑performing teams, and fostering strong relationships with CROs and investigative sites. This is an unparalleled opportunity to drive the development of transformative treatments and significantly impact the lives of patients with unmet medical needs.
Key Responsibilities
- Develop and implement global clinical operations strategies aligned with company objectives.
- Oversee the planning, execution, and monitoring of all clinical trials from initiation to close‑out.
- Manage clinical operations budgets and ensure adherence to financial targets.
- Select, negotiate with, and manage Contract Research Organizations (CROs) and other vendors.
- Develop and implement departmental SOPs, ensuring compliance with GCP and other relevant regulations.
- Lead, mentor, and develop a high‑performing global clinical operations team.
- Establish and maintain strong relationships with clinical investigators and site personnel.
- Oversee the development of clinical trial protocols, informed consent forms, and other trial‑related documents.
- Ensure the timely collection, management, and reporting of clinical trial data.
- Contribute to regulatory submissions and respond to regulatory agency inquiries.
Requirements
- M.S. or Ph.D. in a life science, healthcare, or related field.
- Minimum of 10 years of progressive experience in clinical operations within the pharmaceutical or biotechnology industry, with at least 5 years in a leadership or management role.
- Extensive experience in managing global clinical trials across various therapeutic areas, particularly rare diseases.
- Proven ability to manage CROs, vendors, and investigative sites effectively.
- Strong understanding of GCP, ICH guidelines, and other relevant regulatory requirements.
- Demonstrated success in developing and implementing clinical operations strategies.
- Excellent leadership, strategic thinking, decision‑making, and problem‑solving skills.
- Exceptional communication, interpersonal, and negotiation skills.
- Ability to thrive in a fast‑paced, dynamic, and remote work environment.
- Experience in drug development for rare diseases is highly preferred.
Benefits
- Exceptional salary competitiveness with executive-level bonus potential.
- Comprehensive benefits package including top‑tier health insurance.
- Stock options.
- Robust retirement savings plan.
- Continuous learning opportunities and leadership development programs.
- Access to prestigious industry events.
- Fully remote role offering significant flexibility.
- Highly collaborative, innovative, and mission‑driven culture.