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.
> 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.