INC Research is a top-tier therapeutically focused global clinical research organization (CRO) providing a complete range of Phase I - Phase IV clinical development services for the world’s biopharmaceutical companies. We proudly boast 43 of the world’s top 50 pharmaceutical companies as our customers. With approximately 5,000 employees across six continents and experience spanning more than 100 countries, we provide significant scale, scope and expertise to deliver innovative clinical development approaches and strategic alliances that meet the needs of our customers.
Medical Director (APAC)
jobsDB Ref. JSG400003003188713
Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do.
We are currently looking to strengthen our Medical Affairs team in Asia Pacific and are seeking a Medical Director to be based in one of our offices in the region according to wherever the successful candidate is based.
Interacts with senior management, customers, and project teams to ensure the safety of subjects in clinical trials; ensures the scientific integrity of the clinical portions of clinical trials; provides medical input to clinical programs; provides clinical development and regulatory consulting advice as needed. Performs the duties of a Medical Monitor.
- Manages subject safety and the scientific integrity of clinical trials.
- Responsible for subject-safety and the scientific integrity of clinical trials.
- Performs the duties of a Medical Monitor.
- Provides 24-hour coverage for clinical trials.
- Participates in bids, bid-defenses & feasibility assessments when requested.
- Provides project-specific and therapeutic training to sponsors and Company staff as needed.
- Works with the Drug Safety Department by providing medical input and oversight.
- Works with Medical Writing/Regulatory in the preparation of a variety of documents as required.
- Maintains in-depth knowledge of worldwide drug development regulations and Good Clinical Practice (GCP) guidelines.
- Interacts with senior management, project management, and other departments as appropriate.
- Provides clinical development and regulatory consulting advice both within Company and to clients as requested.
- Locates and interacts with outside experts as necessary.
- Provides feedback to management on quality issues within the clinical trial team
- Represents Company at scientific meetings as required.
- Primary senior-level contact for customers.
- Assumes line-management duties as needed.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
A doctoral-level degree in medicine and must have practiced medicine and have clinical research experience. In-depth knowledge of FDA and worldwide drug-development regulations. Strong understanding of the use of medical terminology and of drug-names in multiple nations, cultures and environments. In-depth knowledge of national and ICH Good Clinical Practice (GCP) guidelines. Basic computer and word-processing skills, including the use of spreadsheets, e-mails and smart-phones. Experience working in matrix-teams. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Effective organizational and interpersonal skills. Skilled at presenting data to groups, and in the creation of effective documentary communication. Customer-focused with a disciplined approach to work with excellent verbal communication and language skills. Fluency in written and spoken English.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“We were ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.