Director, Medical Affairs

Merck Gruppe - MSD Sharp & Dohme; Singapore; On-site; USD 120,000 - 180,000; Full time

Job summary

An innovative global leader in healthcare seeks a Cluster Medical Director to oversee Medical Affairs in Southeast Asia. This pivotal role involves strategic planning, compliance oversight, and collaboration with diverse teams to enhance patient care and advance medical knowledge. The ideal candidate will possess extensive experience in the biopharmaceutical industry, a strong understanding of regulatory environments, and exceptional leadership skills. Join a forward-thinking organization where your expertise will directly impact the future of healthcare and improve lives across the region.

Qualifications

• Minimum 5 years in global biopharmaceutical industry.
• Experience in Clinical Development and/or Medical Affairs.
• Strong organizational skills and compliance understanding.

Responsibilities

• Oversight of Cluster Medical Affairs strategy and execution.
• Manage medical aspects of submissions for reimbursement.
• Enhance company reputation through external representation.

Skills

Leadership

Medical Affairs

Clinical Development

Strategic Planning

Regulatory Compliance

Oncology

Infectious Diseases

Vaccines

Health Economics

Communication

Education

M.D. or equivalent degree

Advanced degrees (MPH, Ph.D., MBA)

Job description

Job Description

Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.

Role Overview:
The Cluster Medical Director is the Senior Medical Leader for the SEA Cluster comprising of Singapore, Malaysia and Hong Kong. (S)he will be the primary cluster level contact for medical affairs. (S)he is responsible for:

• Oversight of the development and execution of the Medical Affairs (MA) strategy for the cluster, based on understanding of global, regional and cluster opportunities and requirements;

• Creating and maintaining a high performing, highly compliant MA organization for the cluster;

• Representing cluster opportunities, requirements and needs at the regional and/or global levels, as appropriate; Representing medical affairs in the Cluster Leadership Team; representing the company in external activities requiring the presence of the cluster’s Senior Medical Leader;

• Coordinating with the cluster GCTO, Pharmacovigilance, RA and OR, BARDS staff to ensure well-functioning interactions between the company and external in-country stakeholders

• Managing the entire portfolio for our company, allocating resources balancing global and cluster priorities. (S)he builds on existing capabilities through internal development and external hiring, analyzes and fills gaps by reallocating resources and creates an empowering, compliant, collaborative, and innovation-focused work environment.

• Managing the medical aspects of submissions for reimbursement or tenders for the entire portfolio of medicines and vaccines (collaboration with OR, BARDS, market access, and commercial colleagues).

As part of the Leadership of V&I (Value & Implementation), the Cluster Medical Director will assist in maintaining GMSA as a leading research-based MA organization. As such (s)he will help create and execute a strategy for the future evolution of GMSA building on existing strengths while identifying key areas for improvement and implementing plans to address these elements.

What will you do:

The Medical Director is responsible for oversight of all aspects of Cluster Medical Affairs (MA), including:

• Cluster MA team focus on cluster MA strategy, with a heavy emphasis on helping to develop global MA strategy, support of strategic planning for medical support of Company objectives.

• Strategic planning and support of structured and consistent Continuous Medical Education (CME) activities.

• Strategic planning and support of Company interactions with Authorities and relevant Organizations at all levels.

• Building of close relationships with regulatory, GCTO departments.

• Consulting Business Units on medical and scientific matters.

• Providing input into study feasibilities and sites in countries within the cluster, selection and implementing publication policy.

• Providing medical and scientific advice to business units, market access functions and others as required, as well as input into Health Economics. Also serving as a member of the respective country leadership teams. S/he may delegate the responsibility to a qualified in-country representative.

• Managing the developed Protocol Concept Sheets (PCS) and obtaining regional and global) approvals for new studies.

• Review and approval of study protocols and IISPs.

• Advising business units on medical and scientific matters, including—but not limited to—scientific approval of promotional materials.

• Ensuring compliance with all applicable country regulations; developing relationships with regulatory authorities in collaboration with the local heads of regulatory.

• Overseeing all activities of Cluster Medical Department employees.

• Overseeing inspections and answering inquiries by health authorities and ethical committees, in conjunction with Regulatory, PV and GCTO. S/he may delegate the responsibility to a qualified in-country representative.

• Enhancing the company reputation and profile through an external focus, by representing the company on cross-company boards and industry associations, represents the Company in mass-media (in collaboration with PR Manager).

• Orchestrate regional input for medical priority setting and co-sponsor the regional medical affairs planning teams to have bi-directional communication with HQ.

• May serve as subject matter expert for one therapeutic area for the cluster.
  

Cluster Medical cross functional Management:

• Successfully collaborating with the Affiliate/Cluster LT, Regulatory, Pharmacovigilance, Reputational (ie Public Relations), Legal, Compliance and other risk issues in the

• Leading Cluster Medical Governance Council ensuring that functional (Clinical, Regulatory, Safety and Medical Affairs) collaborate on planning and execution of clinical activities with an emphasis on the external stakeholder, company reputation, and compliance.

• Participating in and contributing significantly to internal policy and external trade or regulatory working teams on matters that impact the cluster affiliates

What should you have:

• M.D. or equivalent degree from a recognized medical school. Additional advanced degrees, entry on a Specialist Register (Pharmaceutical Medicine or a relevant clinical specialty) and a current ‘license to practice’ are a strong plus.

• Minimum 5 years of experience in global biopharmaceutical industry in Clinical Development and/or Medical Affairs.

• Minimum of 3 years of people management experience running a large organization of healthcare professionals.

• Demonstrated effective organizational skills, including ability to set goals and align priorities.

• Experience in one of the following fields: Oncology, Infectious Diseases Treatment, Vaccines, or Specialty care.

• As noted above, an advanced degree (MPH, Ph.D., MBA, Degree in Health Administration or Economics)

• Leadership experience across geographies and diverse cultures.

• Strong understanding of the compliance environment in which Medical Affairs functions.

• Business acumen, ethics and credible reputation with the external scientific community.

• Successful leadership and expertise in management of a Medical Affairs team.

• Experience in the development or field management of interventional/non interventional clinical studies.

• Ability to simplify and convey complex concepts and strategies, orally and in writing. Effectively conducts/facilitates meetings. Strong presentation skills.

• Demonstrated creativity and effectiveness in addressing strategic challenges. Possesses an entrepreneurial mindset; capable of thinking out of the box and taking measured risks.

• Experience working in global and regional medical affairs functions.

• Able to understand issues across a global affiliate network and contribute relevant insights as appropriate.

• Comfortable managing a matrix organization
  

Who we are:

We are known asMerck & Co., Inc., Rahway, New Jersey, USA in the United States and Canadaand MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's mostchallenging diseases. Today, our company continues to be at the forefront ofresearch to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration witha diverse group of colleagues who pursue and bring hope to countless peoplewho are battling some of the most challenging diseases of our time. Our teamis constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/30/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R347118