job description
Join Allied Search Pte. Ltd. as a Clinical Affairs Manager and lead transformative healthcare initiatives in Bali’s dynamic medical landscape. This executive role offers a unique opportunity to shape clinical strategies, drive regulatory compliance, and foster innovation in patient care across Southeast Asia’s growing healthcare sector.
As a key leader in Medical Affairs, you will collaborate with cross-functional teams to ensure the highest standards of clinical excellence, while aligning business objectives with ethical medical practices. Your expertise will be pivotal in bridging the gap between scientific rigor and operational efficiency, positioning our organization at the forefront of healthcare advancement.
Based in the vibrant regions of Bali (Canggu, Ubud, Denpasar, or surrounding areas), this role combines professional growth with an unparalleled quality of life, offering a competitive salary package and the chance to make a lasting impact in the healthcare industry.
Responsibility
- Develop and implement clinical strategies to support product launches, regulatory submissions, and post-market surveillance in compliance with global and local healthcare regulations.
- Lead cross-functional teams (R&D, Regulatory, Marketing) to ensure alignment between clinical data, medical insights, and business goals.
- Oversee clinical trials and studies, including protocol design, site selection, and data analysis to ensure scientific integrity and timeliness.
- Serve as the primary medical liaison for key stakeholders, including healthcare professionals, regulatory bodies, and internal teams.
- Drive medical education initiatives, including training programs, advisory boards, and KOL (Key Opinion Leader) engagements.
- Monitor and report on clinical performance metrics, identifying trends and recommending improvements to enhance patient outcomes.
- Ensure adherence to GCP (Good Clinical Practice) and other ethical standards in all clinical activities.
- Represent the company at industry conferences, symposia, and regulatory meetings to promote thought leadership.
Qualifications
- Bachelor’s degree in Medicine, Pharmacy, or Life Sciences (Master’s or PhD preferred).
- Minimum 8+ years of experience in Clinical Affairs, Medical Affairs, or Regulatory Affairs within the healthcare/pharmaceutical industry.
- Proven track record in clinical trial management, including Phase I-IV studies and regulatory submissions (e.g., FDA, EMA, or local authorities).
- Strong understanding of GCP, ICH guidelines, and regional healthcare regulations (ASEAN experience is a plus).
- Exceptional communication and stakeholder management skills, with the ability to influence senior leadership and external partners.
- Experience in medical writing (e.g., protocols, investigator brochures, clinical study reports).
- Fluency in English; additional languages (e.g., Indonesian, Mandarin) are advantageous.
- Willingness to travel regionally (20-30%) and relocate to Bali, Indonesia.