Medical Advisor

  • Department: Medical Affairs
  • Reports To: Head of Medical Affairs
  • Location: Singapore

Job description

The Medical Advisor is accountable to initiate, develop, deliver and contribute medical and scientific input and activities for Moleac’s products to address the needs of patients’ recovery from a loss of brain functions after a brain injury. These include, but not limited to, driving of clinical trials and registries and contributing to Regulatory Affairs and Marketing teams as needed and in a timely manner. You will be reporting to the Head of Medical Affairs and have the opportunity to grow and develop with the company.

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Clinical Trials under Moleac Drug Development Program (40%)
    • Develops study concept, synopsis, full protocol, Investigator’s Brochure (IB), Informed Consent Form (ICF) and periodic safety report.
    • Performs review and clarification of trial-related adverse events (AEs) and medical case review of serious adverse events (SAEs), including review of case documentation and patient narratives.
    • Provides medical support for Analysis of Similar Events (AOSE).
    • Performs medical review of adverse event and concomitant medication coding.
    • Performs review of Clinical Study Report (CSR) and patient narratives.
    • Serves as scientific and medical advisor to provide guidance and support to Clinical Operations team on medical and scientific aspects of trials.
    • Participates in study data review and other review activities as assigned.
    • Collaborates with Clinical Operations to perform review and refine Medical/Safety monitoring plan, Statistical Analysis Plan (SAP) and other study plans as needed.
    • Participates in and/or lead advisory boards to gain further insights for Moleac’s drug development program strategies and tactics.
    • Provides medical support to CRO/vendor or investigative sites for protocol-related issues including protocol clarification, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
    • Attends and/or presents at Kick-off meetings, Investigator’s Meeting, weekly team meetings, and vendor meetings, as needed or requested.
    • Provides therapeutic and protocol training to Clinical Operations team, CRO/vendor and investigative sites.
    • Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
    • Performs medical review of Case Report Forms (CRFs).

 

  • Trials/Registries for marketed Products (30%)
    • Provides in-depth perspective and input in evaluating needs and proposals for clinical studies (mainly Phase IV), Post-Marketing Surveillance (PMS) studies, Observational studies, registries, Externally Sponsored Studies (ESS), and Investigator-initiated Studies (IIS).
    • Maintains a network of academic cooperation as a platform for Moleac to implement initiatives.
    • Writes the study concept, synopsis, and full protocol; supervising the operational conduct of the studies (monitoring, compliance including GCP/ICH, reporting of adverse events, etc); performing the medical review of the data; assisting the investigator(s) in the preparation of study publications
    • Acts as primary driver of trials and registries.
    • Manages relationships with publishing houses.
    • Writes IB and periodic safety reports.

 

  • International Operations (20%)
    • Assists and provides input and collaborate with the marketing team in:
      • Providing support for marketing events, presentations, scientific activities, and collaborations with speakers;
    • Assists Regulatory Affairs team in:
      • Gathering, evaluation, medical assessments, and follow-up of adverse drug reaction events reported and of possible product complaints.
      • Creating, maintaining, and updating of standard product response messages, medical information requests and responses.
    • Pharmacovigilance:
      • Reviews, monitors, and tracks adverse drug reaction events reported for all products.

 

  • Training (10%)
    • Contributes to the development and implementation of briefings, trainings, and updates for the sales and marketing forces on products, diseases, and competition to enhance the overall understanding of the products, market environment as well as the regulations and guidelines that affect the products and services of the company.
    • Design medical training according to the different needs of Moleac, partners, and external institutions.

Profile of candidate:

The ideal candidate would

  • Medical degree or Advanced Scientific degree in appropriate biological sciences with clear relationship to human medicinal products; or PhD qualification in neuroscience.
  • Candidates with minimum 3 – 5 years’ experience with medical affairs roles and experience in neurology/neuroscience preferred.
  • Strong scientific analytical and problem-solving skills, strategic capabilities, project management, planning and organizational skills with excellent communication, writing and presentation skills.
  • Ability to interpret, evaluate and present clinical data to internal and external stakeholders.
  • Ability to develop medical/scientific data into clear, teaching programs and plenary presentations.
  • Ability to write and edit technical documents, such as protocols, informed consent, and other trial-related documents.
  • Excellent verbal and written communications and presentation skills; fluent in written and verbal business English.
  • Outstanding interpersonal and networking skills within and outside the organization.
  • Ability to travel 30 – 40% of the time including overnight travel and willingness to visit remote or small cities across countries.

Other information:

  • Location: Singapore (2)
  • Job Type: Full Time

Application process:

Please send the followings to emily.lim@moleac.com

  • Cover letter
  • Resume
  • Expectations: Salary
  • Availability

We regret that only shortlisted candidates will be notified.