Medical Director - Merck - Singapore

Job description
The Medical Director manages the Medical department for a country and partners with Global Clinical Operations (GCO) in conducting clinical trials. The Medical Director is responsible for all aspects of local Medical Affairs (MA), including:
Focusing on local MA strategy, with a heavy emphasis on helping to develop global MA strategy.
Establishing and managing local Scientific Leader, investigator, and other key stakeholder relationships.
Building and managing relationships with regulatory health authorities.

Advising business units on medical and scientific matters.
Providing input to GCTO into local study feasibility and site selection.
Developing clinical trial strategy for the country
Implementing publication policy.
Giving medical input into market access/access alliance and policy as well as input into Health Economics.
Providing medical and scientific advice to business units, and others as required.
Providing medical and scientific training to the field force, Global Clinical Operations and others as required

The Medical Director is responsible for clinical/medical strategy, MA, Investigator relationships and serving as a medical and scientific advisor to his/her country’s business units.

Core responsibilities include:
Serving as a member of the country leadership team
Strengthening the Medical strategy.
Developing local clinical research programs and clinical trial strategies.
Designing local study protocols and implementing non-interventional local clinical evaluations
Providing input into global clinical research programs and trial/protocol design.
Managing the country Medical Affairs staff.
Advising business units on medical and scientific matters, including—but not limited to—scientific approval of promotional materials.
Building and managing relationships with local scientific leaders and other key stakeholders.
Training and scientific support for all parts of the company.
Providing scientific support for continuous medical education (CMEs).
Ensuring compliance with all applicable country regulations; developing relationships with regulatory authorities in collaboration with the local head of regulatory.
Overseeing all local MA activities.
Generating study concepts with KOLs.
Developing Protocol Concept Sheets (PCS) and obtaining Merck Investigator Study Programs – Review Committee (MISP-RC) approvals for new local studies, both Local Clinical Evaluations (LCE) & Investigator Initiated study Programs (IISP)
Overseeing inspections and answering inquiries by health authorities and ethical committees, in conjunction with Regulatory, PV and Clinical Operations, as applicable
Enhancing the company reputation and profile through an external focus, by representing the company on industry associations
.
Desired Skills and Experience
Education Level:
Graduate in Medical/Physician or a related discipline
Experience:
Minimum of 5 years of pharmaceutical experience.
Excellent planning and project management skills and knowledge of local pharmaceutical regulations.
Personal attributes sought include strong interpersonal effectiveness with good track record in performance and team player.

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