Senior Director, Country Head, Poland SMM BP

The Senior Director, Country Head (SrDCH) is accountable for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

SrDCH who manages a large stand-alone country and/or several (≥3) country (ies) and reporting to Executive Director, Regional Head SMM (EDRH) acts as SrDCH for the country (ies) while combining line management and other responsibilities.

The SrDCH is accountable for line managing a dedicated group of staff and managing the local leadership team and is accountable for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up.

In partnership countries this role requires close cooperation with the Senior Director, Oncology Country Lead to maintain statutory country level oversight and maintain one SMM community

The SrDCH is a member of the Regional SMM Leadership team. 

Responsibilities:

• Leadership of a large stand-alone country or cluster of countries and building the team spirit, including developing team style and behaviour.

• Ensures adequate resources for the studies assigned to the country/ies.

• Ensures that the workload of the team(s) is adequate.

• Development and performance management of the team(s).

• Ensures that everyone in the team has development and training plans, according to IDP process.

• Coaches the team members and all direct reports on a regular basis, and plans/organises coaching with external providers if needed.

• Prepares salary and bonus proposals for all team members based on their performance, in close collaboration with responsible EDRH and local HRBPs.

• Delivers Country/ies budget(s) to plan with agreed RBU targets

• Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible EDRH

• Contributes to high quality feasibility work.

• Oversees successful delivery of SMM study delivery country/ies level targets to plan, with speed and quality.

• Delivers Country/ies budget to plan with agreed RBU targets

• Contributes to the quality improvement of the study processes and procedures.

• Ensures all systems are continuously updated.

• Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”.

• Assists Local Study Associate Directors (LSADs)/Local Study teams in forecasting study timelines, resources, recruitment, study materials and medication.

• Provides direction to LSADs/Local Study Teams on major study commitments resolving any key issues identified.

• Supports SMM region in initiatives/activities as agreed with EDRH.

• Ensures efficient communication to/from regional leadership team

• Ensures collaboration with local Medical Affairs Department.

• Ensures that study activities at country level comply with local policies and code of ethics.

Requirements:

Essential:

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).

• Minimum 10 years of experience in Development Operations (CRA/LSAD /DSMM) or other related fields.

• Previous line management experience (preferably >3 years).

• Proven team building and people/organizational development skills.

• Excellent interpersonal skills.

• Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.

• Excellent organisational, analytical, influencing and negotiation skills.

• Excellent presentation and communication skills, verbal and written.

• Excellent decision-making skills.

• Excellent team building skills also in cross-functional teams.

• Excellent resource management skills.

• Good financial management skills.

• Excellent ability to have attention to details and combining with delegation and prioritisation skills.

• Excellent knowledge of spoken and written English.

• Good ability to learn and to adapt to work with IT systems.

• Ability for national and international travel.

Desirable:

• International experience in role within Development Operations/ Clinical Research.

• Very good knowledge of the Clinical Study Process, Procedural Documents and international ICH-GCP guidelines.

• Excellent knowledge of the Monitoring Process.

• Good understanding of the Study Drug Handling Process and the Data Management Process. 

• Good knowledge of relevant local and international regulations.

• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.

• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Ability to work in an environment of remote collaborators.

• Integrity and high ethical standards.

• Good conflict management skills and ability to handle crisis.

• Good interviewing skills – responsibility for attracting, developing and retaining personnel.

• Good intercultural awareness.

• Excellent ability to work according to global standards.