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Head of Department - Therapeutic Areas

Type of position:  Temporary agent
Shift Type:  2 November 2021, 23:59 CEST

Job grade: AD10 

Interagency Job grade: AD09-AD14

Type of position: Temporary agent 

Selection procedure reference: EMA/AD/6566 

Job title: Head of Department - Therapeutic Areas 

Deadline for applications: 2 November 2021, 23:59 CEST 

 

 

About this role

The Agency is looking to recruit a Head of Department to manage operations, people and overall resources for the life-cycle management of medicines as part of the Human Medicines Division. As member of the Division’s leadership team, you will lead and manage a department responsible for the integrated knowledge and continuous benefit-risk assessment of a medicinal product throughout its lifecycle. The department fosters the generation and utilisation of scientific evidence in the therapeutic context to enable regulatory and scientifically robust decision-making. It also supports scientific committees and other expert groups and working parties to ensure consistent and high-quality scientific and regulatory opinions and guidance It also contributes to the implementation of the Agency’s Regulatory Science Strategy in collaboration with internal and external stakeholders.

As Head of Department you will be responsible for managing a newly created Department of about 100 staff organised in 6 therapeutic area offices each managed by a head of office. Offices have about 10-20 staff composed of scientific and administrative staff and are organised by therapeutic area (e.g. oncology). The Division’s departments actively collaborate with each other and with other functions of the Agency for the management of human medicines.

The Head of Department implements and manages the department-specific capabilities of the Human Medicines Division to achieve Agency results, and ensures the department delivers objectives effectively and efficiently. The Head of Department ensures that activities are conducted in accordance with organisational policies, processes and standards. The Head of Department anticipates and leads necessary changes according to the Agency’s strategy and division objectives. The Head of Department prevents risks and issues with human medicines and manages them when they arise.

As a Head of Department, you will be expected to set quality and professional standards, be accountable for the quality of department outputs and support the Division’s effective matrix collaboration.

Among your responsibilities, you will develop department work, human resource and budget plans and activity reports. As member of the Division’s leadership team, you will contribute to division work, budget plans, and activity reports, and more broadly to the Agency’s strategy.

Job description

In this role and in the context of the department’s mission and objectives, you will:

  • Provide scientific, technical and operational leadership for the department through a comprehensive and integrative approach to regulatory activities along the medicine’s lifecycle
  • Lead the development and delivery of the Agency’s strategy for human medicines for the areas falling under the responsibilities of the department
  • Foster collaboration and communicate across offices in the division and the Agency
  • Ensure team communication across the Agency, vertically and horizontally
  • Lead, coordinate and manage the department’s management team
  • Ensure that the department’s internal organisation is fit-for-purpose
  • Ensure the offices contribute to matrix activities (e.g. product teams, communities, ad-hoc task forces, etc.) thereby promoting a collaborative working culture
  • Ensure continuous improvement of quality of outputs and the optimal use of talent
  • Set and monitor objectives and performance indicators for the department and offices
  • Direct, organise, plan and monitor activities of the offices
  • Coach, mentor and develop office heads and manage their performance and ensure development of competencies and skills of staff in the department
  • Ensure that resource needs are clearly identified, justified and planned in concertation with other functions of the division and Agency
  • Manage the department’s budget, as applicable
  • Establish, monitor and report management information
  • Manage risks and the implementation and monitoring of quality assurance
  • Manage external engagement of the department and foster collaboration with EU and international partners (e.g. European Commission and other European agencies, national competent authorities and other decision makers such as notified bodies and health technology assessment bodies).

Eligibility Criteria

To be eligible for consideration for this position, you are required to:

General conditions

  1. Enjoy full rights as a citizen of an EU Member State or Iceland, Lichtenstein and Norway.
  2. Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2).
  3. Have fulfilled any obligations imposed by applicable laws concerning military service.

Specific conditions

  1. Possess a university degree of a minimum of four years that must have been obtained by the closing date of this vacancy notice or possess a university degree of three years and relevant professional experience of at least one year obtained after the university degree;
  2. Have at least 12 years’ relevant professional experience in the domain of the Agency’s activities after obtaining the relevant degree, that must have been obtained by the closing date.

For general condition 1 and for specific conditions 1 and 2, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.

Essential Criteria

Technical knowledge:

  • Proficient level of expertise evidenced by 9 years of professional experience working in the area of the development of medicines and/or the management of medicine lifecycle from a clinical and regulatory perspective, at the level required to assist, consult with or lead other professionals in the area in question;
  • At least 5 years of recent (acquired in the last 10 years) professional experience of working in the pharmaceutical industry;
  • Good understanding of the evolving landscape of the pharmaceutical field and the EU regulatory system.

Management and/or leadership experience:

  • Proven track record of at least 5 years experience in leading collaboration across teams and managing or leading people as teams to undertake activities or deliver initiatives or projects in human or veterinary medicines, with concrete deliverables requiring setting objectives and monitoring;

Desirable criteria

  • Experience gained in European or global regulatory affairs in a regulatory agency or the pharmaceutical industry;
  • Experience gained in research and development of medicines for the purpose of regulatory submissions.

Behavioural competencies

Translating strategies (Advanced*) - Ability to set and revise objectives for one's area of responsibilities within the overall strategic framework and priorities. 

Organising and managing operations (Advanced) - Ability to organise and manage the department’s work, assign work among team members, determine priorities, and monitor and evaluate the progress made towards achieving the set objectives.

Guiding and building high performance teams (Advanced) - Ability to ensure team members understand what is expected of them and how their work contributes to the team’s objectives; ability to build strong teams with complementary strengths suited to the efficient pursuit of the team’s objectives.

Motivating and developing staff (Advanced) - Ability to motivate and empower team members to achieve the desired result; ability to support their development by providing regular feedback on their strengths and successes as well as learning opportunities for them to achieve their greatest potential.

Communication and negotiation skills (Advanced) - Ability to communicate clearly, to present complex subjects simply, to solicit inputs from and listen to staff and stakeholders, and to effectively steer discussions in order to generate the best possible results.

Fostering cooperative relations (Advanced) - Ability to deal with people effectively, respectfully and courteously; ability to build productive and cooperative working relationships across the organisation.

 

*Advanced - Demonstrates in-depth proficiency level sufficient to assist, consult with or lead others in the application of this competency. Has in-depth knowledge in the subject matter area. 

Provisional selection procedure timelines

Deadline for applications

2 November 2021 at 23:59 CEST

Preliminary Assessments (if required)

Week of 15 November 2021

Final Assessments

Week of 29 November 2021

Assessment Centre and interview with the Executive Director

Week of 13 December 2021

Selection Process

The selection process for these positions will be executed in accordance with the EMA decision on middle management staff (EMA/MB/299672/2018).
Suitability and qualifications of eligible candidates will be assessed against the assessment criteria in different steps of the selection procedure. Before the start of the selection procedure, the selection committee decides which assessment criteria will be used at each stage of the process. Certain criteria will be assessed/scored only for shortlisted candidates during interviews (and/or tests).

Shortlisting
According to Article 9(1)(a) of the IR on middle management, the pre-selection committee using assessment checklists shall consider all applications received having regard to the vacancy notice.
In order to allow the pre-selection committee to carry out an objective assessment of all candidates in a structured way, all candidates must answer the pre-defined set of questions as part of their application.
The questions are based on the essential and desirable assessment criteria, as well as on behavioural competencies included in this vacancy notice. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form. The pre-selection committee will assess whether you meet all the eligibility criteria, including your suitability for the position, using the information provided in the responses to those questions.
To carry out this assessment, the pre-selection committee will first assign each question a weighting that reflects its relative importance, and each of your responses will be awarded points (1 to 10). The points are multiplied by the weighting factor and added up to identify those candidates whose profiles best match the duties to be performed.

Preliminary and Final Assessments
The pre-selection committee will draw up a shortlist of the applicants who best match the profile sought, giving reasons for its choices. On this basis, shortlisted candidates will be invited to an interview with the pre-selection committee. The procedure may include a written test. 
As a result of those assessments, the pre-selection committee will recommend the most suitable candidate(s) to be interviewed by the Executive Director and at least one member of a grade and management function equal or superior to that of the function to be filled. Those candidates shall also take part in the evaluation conducted by the Assessment Centre.
Please note that due to current travel restrictions, assessments may be conducted remotely. 
Qualified and suitable candidates not recruited will normally be included in a reserve list (valid until 31 December 2022, with possibility of extension), which may also be used for future recruitments for head of department positions. Each interviewed candidate will be notified in writing whether they has been placed on the reserve list. Candidates should note that the placement on the reserve list does not guarantee an appointment offer in the future.

More about careers at the EMA (including administrative appeal procedure), you will find at: Careers at EMA (europa.eu)

Conditions of employment

In principle, the Agency offers a five-year renewable contract.
The monthly basic salary, including the local weighting* which adjusts salaries to the cost of living in the Netherlands compared to Brussels, is €10,193.54. Note this salary is subject to deductions of community tax, health insurance and pension contribution. 

EMA offers a final salary pension scheme and a world-wide medical insurance.

In addition to the basic salary, the jobholder may be entitled to various additional allowances, including family allowances, such as education allowance for dependent children of school age, and expatriation allowance. Relocation and/or resettlement allowances may also be available upon entry into employment.

More detailed overview of various allowances and entitlements is available at our website.

 

*The current weighting for the EMA's location in Amsterdam, the Netherlands, is 113.9. Please consult the Eurostat and Commission websites for more information on weightings.

Eligibility criteria for interagency candidates:

Interagency applicants must, on the closing date for the receipt of applications:

  • be established temporary staff referred to in Article 2(f) CEOS. As regards inter-agency publication, Article 9 of the GIPs on temporary staff 2(f) shall apply;
  • be in grade: AD09, AD10, AD11, AD12, AD13 or AD14,

Appointment:
a) The selected candidate shall be appointed in his/her current grade.
b) Article 6(2) of the GIPs on temporary staff 2(f) shall apply.

______________________________________________________________________________________________________

 

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu

 

© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.

 


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