Career
WANT TO MAKE A DIFFERENCE IN SOMEONE ELSE’S LIFE? JOIN US!

With a team of over 30 people from 10 countries across 3 continents, Moleac has brought to the market the first drug that addresses gaps in pharmacological modalities. Combined with rehabilitation programmes, we offer new hopes to patients to cope with their disabilities. Join us for a life changing career!

Current Openings Here Under:

  • Medical Advisor (Clinical Development)
    Medical Advisor (Clinical Development)
  • Singapore
  • Clinical Operations Manager
    Clinical Operations Manager
  • Singapore
  • Regulatory Affairs Specialist
    Regulatory Affairs Specialist
  • Singapore
  • 2 Junior and 1 Senior International Key Account Managers
    2 Junior and 1 Senior International Key Account Managers
  • Singapore
  • Clinical Research Associate
    Clinical Research Associate
  • Singapore
Medical Advisor (Clinical Development)
JOB DESCRIPTION:

1) The Medical Advisor (Clinical Development) primary responsibility is to oversee the design, implementation and conduct of some clinical studies for Moleac’s products. The responsibility may include local or international clinical trials for new registrations, new indications or line extensions  for new or existing products.

It is expected that the Medical Adviser, in collaboration with academic experts and KOLs  will contribute medical and scientific expertise needed to support state of the art development of Moleac’ products.

2) Additional responsibilities include, but are not limited to, driving publications, implementation and support of registry studies and other observational or real-world studies.

3) In addition, the Medical Advisor (Clinical Development), as part of the Medical Department Team, may be assigned to supporting Regulatory Affairs and Marketing teams as needed and in a timely manner, for specific projects.

The position is reporting to the Head of Medical Affairs.  It is mandatory that all activities be conducted with the highest ethical standards and scientific integrity, as well as compliance with applicable SOPs, guidelines, laws and regulations.

ESSENTIAL DUTIES & RESPONSIBILITIES

1) Clinical Trials under Moleac Drug Development Program (65%)

> Develops study concept, synopsis, full protocol, Investigator’s Brochure (IB), Informed Consent Form (ICF) and periodic safety report. Contributes medical expertise to CRF development, monitoring, data-management (DMP)and statistical analysis (SAP) plans
> Serves as Moleac liaison with KOLs, academic groups, advisory boards, investigators, etc. for study-related scientific and medical topics
> In liaison with Regulatory Affairs Department, ensure proper authorizations are obtained (Ethics Committee, IRB, Regulatory Authorities) to proceed with the assigned clinical studies
> Serves as scientific and medical advisor to provide guidance and support to Clinical Operations team, CRO/vendors and study sites personal on medical and scientific aspects of trials.
> Attends and/or presents at Kick-off meetings, Investigator’s Meeting, weekly team meetings, and vendor meetings, as needed or requested
> Performs medical review of collected data, and notably adverse events and concomitant medication coding, provide medical support for SAEs management. Performs review of Clinical Study Report (CSR) and patient narratives.
> Be available 24 hours per day, 7 days per week to respond to urgent protocol related issues at the investigative sites.

2) Additional responsibilities within Medical Affairs (20%)
As needed, and depending on workload, the incumbent will be assigned to contribute to some of the other activities pertaining to the Medical Affairs Department, and specifically:

> Provides in-depth perspective and support for existing and new registry platform. Ensures quality of data collection, produce reports from the registry in order to make presentations, publications, posters and promotional material
> Oversees and leads peer-reviewed publications activities at the level of an asset, ensuring robust planning and delivery as per marketing and commercial needs. Develops publication plans, develops publication materials, manuscripts and research articles for journal publication- Manages relationships with publishing houses.
> Responds to medical enquiries from Health Care Providers, partners, patients and other stakeholders

3) Support to Regulatory Affairs and Marketing teams (15%)

—– Assist and provide input and collaborate with the marketing team in:
> Reviewing of different collaterals and communication support – conducting literature research to develop written materials
> Providing support for marketing events, presentations, scientific activities, and collaborations with speakers – Contributing 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.
> Providing support in field intelligence and evaluation of data/publications to substantiate, update and improve the content of promotional messages and materials; and
> Reviewing accuracy of promotional messages and materials, including external communications materials such as scripts for marketing team, press releases, presentation during congresses, letters and positioning statements.

—– Assist Regulatory Affairs and Pharmacovigilance 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.
> Review, monitor and track adverse drug reaction events reported for all products.

REQUIREMENTS 

> Medical degree – Candidates with minimum 3 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 40 – 50% of the time including overnight travel and willingness to visit remote or small cities across countries.

Clinical Operations Manager
JOB DESCRIPTION:

The Clinical Operations Manager will be an active part of the Medical Affairs team contributing to Moleac’s drug development program to build scientific evidence of our products and introduce new product to the global market with the potential to address the needs of patients’ recovery from a loss of brain functions after a brain injury (Stroke, Traumatic Brain Injury). You will be reporting to the Associate Vice President, Clinical Operations and will be entrusted with a wide range of responsibilities, and have the opportunity to grow and develop with the company.

ESSENTIAL DUTIES & RESPONSIBILITIES

> Manages study operational plan and CRO activities, including project timelines & quality of deliverables, and managing approved trial budget(s) throughout the life of the assigned clinical trial(s)
> Participates in the selection of study vendors for assigned studies
Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed
> Develops, reviews and refines clinical protocols, statistical analysis plan, clinical study reports, study charters and clinical operational plans including the study monitoring plan and other plans as needed
> Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
> Develop and manage study timelines (including recruitment) and may develop and manage program timelines
> Participates in the selection of investigational sites with input from Clinical/Medical operations and vendors
> Assists with protocol design and medical issue resolution
> Proactively identifies project risks and resolution
> Participates in study data review and other review activities as assigned
> Oversees clinical trial sites’ adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, communications with investigators, study site personnel, CRAs, and other CRO/designee personnel
> Leads ongoing review of data to ensure GCP
> Oversees the submission of trial-related and essential documents to the Trial Master File
> Identifies and provides solutions to clinical trial issues and/or risks
> Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated
> Provide or facilitate training to clinical study teams on assigned protocol specific topics
> Work closely with other teams in the organization, e.g., quality, regulatory, etc.
> Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested.
> Provide guidance to Medical Affair team on Investigator Initiated Trials.


REQUIREMENTS

> BS or Master’s Degree in nursing, life science, or related field (or equivalent experience)
> Minimum of 3 years of clinical research experience (at least 1 of which are as a Project Manager) for clinical studies at a CRO and/or pharmaceutical/biotech organization
> Previous experience negotiating vendor/site contracts and managing the budget
> Thorough understanding of FDA, ICH and GCP guidelines
> Proven track record showing clear proficiency in clinical project management skills
> Proven complex problem-solving skills
> Solid vendor management skills, e.g., CRO, laboratory & clinical supply logistics
> Broad understanding of clinical operations related to clinical development functions
> Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
> Ability to effectively interface with medical personal at clinical site(s)
> Ability to lead multi-disciplinary, cross-functional team leadership and participation skills
> Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
> Proficiency with computer programs including Microsoft Office suite and Microsoft Project
> Ability and willingness to travel internationally

Other information:

> Location: Singapore
> Job Type: Full Time

Application process:

Please send the following to [email protected]

> Cover letter
> Resume
> Expectations: Salary
> Availability

We regret that only shortlisted candidates will be notified.

Regulatory Affairs Specialist
Summary of Job

The Regulatory Affairs (RA) Specialist contributes to all regulatory functions for Moleac products such as obtaining marketing authorisations and product life-cycle management for the global market, and assigned projects.

The candidate demonstrates consistent and excellent interpersonal and communication skills along with ability to thinking critically, problem-solve and collaborate effectively with internal stakeholders.

Key Responsibilities

–  Prepare and review registration/ variations dossiers for submission to regulatory authorities, ensuring scientific rigour, consistency and accuracy of product information, alongside good documentation practice.
– Coordinate with partners and regulatory consultants abroad to support overseas registration, in accordance to company strategy and timeline.
– Collaborate with stakeholders and contribute actively to all aspects of product life cycle management, ensuring compliance to applicable regulatory and quality requirements and continuity in commercialisation.
– Maintain and build on existing database of applicable health product regulations, standards, and guidance documents, interpreting emerging regulations and developments to assess impact on products.
– Review promotional material developed for commercial activities to ensure compliance to applicable regulatory guidelines.
– Participate in local and overseas regulatory inspections and internal audits when applicable.
– Develop and maintain effective relations with local authorities and industry associations Provide regulatory inputs and support to clinical trials and ethics committee submission.
– Assist in GDP and relevant quality assurance matters.

Personal Attributes/ Core Competencies

– Highly-organised and self-disciplined.
– Resourceful, with analytical and problem-solving skills.
– Able to prioritize and work well in fast-paced environment.
– A team player with excellent interpersonal skills.
– Proficiency in English (both written and spoken). Additional language such as Mandarin is a strong plus to liaise with external CMOs and partners.

Qualifications

– Degree in life sciences, with min. 1 – 5 years of relevant work experience.
– Knowledge in international regulatory guidelines such as ICH, ASEAN, USFDA, EU etc. Regulatory experience with food supplement/ herbal medicine in Europe, North America or Asia Pacific would be advantageous.
– Good understanding in GMP, GDP and relevant quality management systems desirable.

2 Junior and 1 Senior International Key Account Managers
Job description

The Key Account Manager is assigned a portfolio of countries on which he/she works in team guided by a more senior member of the commercial team. The commercial team is currently directly reporting to the CEO of the company

In existing markets:

> Drive sales development in a portfolio of countries to reach corporate sales objectives
> With the support of Global Marketing and Medical teams, drive product knowledge in the market; train partner’s marketing team and salesforce; build positive dynamics with key prescribers in each market.
> Orchestrate local events and participation of markets to international events
>Monitor and execute required sales and marketing initiatives
> Build and manage yearly OPEX and sales forecasts

 

In new markets:

> Identify candidate affiliate partners for the marketing of Moleac products in a portfolio of geographies, conduct discussion up to formalization of distribution agreement
> Working with the Regulatory Affairs Team to drive listing of NeuroAiD in new countries

 

Training – travel requirements and expectations

Initial training the new recruit will be trained in the company procedures and tools as well as on the product clinical and scientific data. We expect significant personal efforts to ensure a rapid learning curve to enable him/her to be credible and relevant when driving product development or disseminating medical information in the export markets with a variety of counterparts (Affiliates Management, sales force, health professionals, …)

Profile of candidate:

The ideal candidate would

> Have graduated from a first-tier business, engineering, pharmaceutical/biology school
> Have years of relevant experience ideally in pharmaceutical, B2B or B2P model
> 1-3 years experience for a Junior Key Account Manager positions
> 4-8 years experience for a Senior Key Account Manager
> Be Fluent in English (spoken, written), additional language (Russian, Turkish…)
> Be stimulated by commercial targets
> Show high motivation to be given operational responsibilities and exposure

Possess:

> Strong adaptability to be able to work with different positions / cultures
> Excellent communication skills, at ease with public speaking
> Pre-existing international exposure / having lived or worked in several countries
> Easy going and curious
> Ability to work independently
> Values team work and multi-cultural environment
> Relevant prior experience / being familiar with the medical sector would be a strong plus

 

Motivation

> Junior Candidate should be prepared to be based in Spore for at least 1-2 years of initial training
> Travel can represent two to three weeks per month.

 

Other Information:

> Job Type: Full Time

 

Application process:

Please send the following to [email protected]

> Cover letter
> Resume
> Expectations: Salary
> Availability

Clinical Research Associate
JOB DESCRIPTION:

Here at Moleac, we are a company aiming to address the needs of patient’s recovery from a loss of brain functions after a brain injury as well as cognitive deficits. In our small and dynamic Medical Affairs Department, you will play an important role in supporting the clinical studies we undertake and will have abundant opportunities to learn the entire clinical study process. The Department runs Moleac’s international drug development programs with two focus areas: extension of indications for our main marketed products and conduct of clinical studies aiming at the regulatory approval of our new products in major markets.

ESSENTIAL DUTIES & RESPONSIBILITIES

> Support the investigators in implementing clinical trials protocols:
• Liaise with the study site personal to implement the study per global and local requirements.
• Ensure compliance with all ethical, regulatory and contractual requirements.
• Training of study site personal (protocol, use of IP, SOPs, etc.).

> Ensuring data quality and integrity of clinical study data:
• Conducts site monitoring visits and follow-up to identify deviations & issues and to ensure that all clinical aspects of studies are being carried out in accordance with the protocol, regulations, guidelines and policies.
• Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance.
• Identifies deficiencies and discrepancies, and provides remedial training and/or implement corrective and preventive actions as required.
• Liaise with data management, reviews case report form queries, clarifies and/or obtains changes to data as appropriate.

> Create, update, track, and maintain study-specific trial management files. Ensure study documents are audit ready.
• Co-ordinate and track meetings with CROs, vendors, investigators and internal teams.
• Update and maintain clinical department management tools and systems, as required.
• Provide administrative support as required.


REQUIREMENTS

> Bachelor’s Degree in Science or a related field preferred.
> Minimum of 2 years’ CRA experience is preferred, however, other relevant experience and skills may be considered.
> Good understanding of GCPs (Good Clinical Practices).
> Advanced analytical thinking skills and numeracy grasp.
> Strong in using project management tools and Microsoft Office.
> High sense of accountability and urgency. Ability to set priorities and handle multiple tasks simultaneously.
> Meticulous, highly organized and effective in time management.
> Establishes and maintains good working relationships with internal and external stakeholders (e.g., investigators, trial coordinators and other site staff).
> Fluent in English (verbal and written) and excellent communication skills.

Other information:

> Location: Singapore
> Job Type: Full Time

Application process:

Please send the following to [email protected]

> Cover letter
> Resume
> Expectations: Salary
> Availability

We regret that only shortlisted candidates will be notified.