Therapeutic Area Head

2 weeks ago

Midrand, Gauteng, South Africa MSD Full time
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.

Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.


Brief Description of Position
This role will be key to further develop the country capabilities in clinical research.

Under the oversight of the country or cluster Clinical Research Director, the person will be responsible for the end to end performance of clinical trials in one or several Therapeutic Areas, from feasibility to close out in one or several countries.


The role should be responsible for 30 to 50 clinical trials and will ensure excellent study performance with strict adherence to local regulations, company standard operating procedures and ICH Good Clinical Practice.

The role is responsible for oversight of all the employees working in the Therapeutic Areas, with line management for Clinical Research Managers and functional oversight of other roles in his studies.

As line manager the role is critical to develop key talents in the organization to ensure a pool of successors in critical roles.


The role will work at country level with other local stakeholder like Global Medical Affairs, Global Human Health, Pharmacovigilance and Regulatory Affairs to ensure alignment and development of the country capabilities and can represent the Clinical Research Director of cluster in local management if required.


Responsibilities include, but are not limited to:

  • Will lead one or several Therapeutic Areas of the growing portfolio in the country.
  • Accountable for the successful execution, enrolment and quality of their clinical trial portfolio.
  • Accountable to ensure timelines and key milestones are met.
  • Accountable for performance metrics.
  • Accountable to develop operational strategies and quality plans for the conduct of all programs and studies in the Therapeutic Area portfolio.
  • Collaborates with other Therapeutic Area directors, local and regional stakeholder in Global Clinical Trial Organisation in order to develop and build territory of principal investigators and sites.
  • Ensures oversight and line management of Clinical Research Manager (CRM) team within the therapeutic are.
  • Leads team independently with supervision from Clinical Research Director to high performance.
  • Accountable for Clinical Research Manager performance reviews, including addressing low performance situations, and taking appropriate actions.
  • Ensures key talent development and retention.
  • Collaborates and works closely with other stakeholders in the Therapeutic Area in Global Clinical Trial Organisation & Global Clinical Development regional and headquarter teams, quality, finance, IT and HR.
  • Collaborates externally with investigators, regulators and vendors.
  • Member of the Global Clinical Trial Organisation country leadership team.
  • Supports strategic initiatives across Global Clinical Development and Global Clinical Trial Organisation.
  • Supports local strategy development consistent with longterm corporate needs in conjunction with Clinical Research Director.
  • Together with direct reports contributes significantly to effective conduct of clinical studies and to develop the pipeline, while maintaining regulatory requirements and compliance.
  • This position impacts directly the country ́s ability to reach business targets and objectives and ensures that productive collaboration with internal and external business partners are built.

Qualifications, Skills & Experience

CORE Competency Expectations:

  • Business and financial acumen
  • Strategic thinking
  • Ability to think crossfunctionally and working across boundaries internationally
  • Ability to identify problems, conflicts and opportunities early and lead, analyse mitigation plans and drive conflict resolution is critical
  • Fluent in Local Language and business proficient in English (verbal and written) and
excellent communication skills

  • Sound ICH-GCP knowledge and knowledge of Good Documentation Practices
  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

Behavioural Competency Expectations:

  • High emotional intelligence
  • Strong leadership and negotiation skills
  • Positive proven success in people management
  • Demonstrated ability to build relationships with senior business executives
  • Influencing skills
  • Excellent interpersonal and communication skills, conflict management
  • Relationship management and networking: strong integration into local and Headquarters Therapeutic Area network and ability to build productive relationships with all parties
  • Effective time management
  • Effective communication with external customers (e.g. sites and investigators)

Experience Requirements:

Required:

  • Minimum of 10 years ́ experience in clinical trial organization
  • Minimum of 2 yea

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