For the Global Medical Science Department of R&D in Leiderdorp, the Netherlands, we are looking for a Medical Director Global Medical Science Urology. Leiderdorp (the Netherlands) is home to the Astellas Pharma Global Development-EU organization focusing on the development of medicines in the areas of Pain, Urology and DMCK. The therapeutic area Urology comprises Urology, Uro-Oncology and Prosatate cancer in particular. We currently seek an experienced physician to support the global teams responsible for development of new compounds in this therapeutic area.

The job:

For the Global Medical Science Department of APGD-EU in Leiderdorp, the Netherlands, we are looking for a Medical Director Global Medical Science. Your main responsibilities are:

Assume the role of Global Medical Lead within the Global Development Core Teams and attends the core team meetings. Takes responsibility for the medical strategy and safety management. Writes the medical and clinical strategy sections of the GMAP/CDP in close cooperation with the Global Development Project Leader. Responsible for the set up and management/leadership of medical extended teams and safety management teams. Assumes a global perspective in development of global projects.

1. Responsible for medical/scientific strategic input and/or writes the target product profile, key go/no-go criteria and risk management (developmental and safety). Is accountable for inclusion of HEOR/PRO strategies/endpoints into the GMAP/CDP/Protocol in close collaboration with the HEOR group within GDO/Medical Affairs.
2. The GML is (co-)author of the IB, RMP, clinical study protocols, CSR's, sections of NDA/IND/MAA. In conjunction with study team, designs rigorous clinical protocols that address key strategic objectives.  Provides medical/scientific input in study objectives, selection of study populations, variables, data analysis, interpretation and completion of study reports.  Facilitates meaningful interpretation and assessment of trial data, and decision making.  Responsibilities may include programs at both early and late-stages of development. Provides input and leadership in development of budgets, resource estimations and allocation, establishment and management of necessary external committees required for state of the art execution of clinical studies (such as SC, AC, DSMB etc).
3. The GML has final responsibility/ accountability for overall safety oversight and development risk management of the development project (including but not limited to safety of subjects within clinical trials). Manages program and protocol risk based on target product profile, MOA, clinical pharmacology and preclinical data.  Reviews and assesses safety data for subjects in clinical studies and from post-marketing reports in close collaboration with the Drug Safety Department and Safety Lead (member of the SMT) and GCPL for early phase clinical studies. 

Provide medical and scientific leadership to the relevant therapeutic area for optimal understanding of the indications, drug development planning and high quality clinical trial design

Your professional qualifications and experience:

• Academic training and qualification as physician
• registered MD with at least 2 years post graduation clinical experience, preferably certified specialist in Urology
• extensive experience in global drug development evidenced by at least 5 years working experience within global pharma, preferably experience in the field of Urology, Uro-Oncology and/or prostate cancer.
• Extensive medical-scientific experience in drug development from preclinical stage until and after registration.
• Experience with submission and approval of NDA/MAA is highly desirable
• In-dept knowledge of Urology and Uro-Oncology/Prostate cancer and clinical and basic research
• Being able to quickly review and interpret scientific publications on content and strategic relevance

General Competencies

Understand current treatment standards and impact on pending development programs to ensure delivered product meets patients/providers needs

Ability to identify key safety issues and address these in development strategy

Ability to take medical/scientific leadership role within global team and medical committees and bodies within the company

Can articulate the strategy and position to senior management and external experts/regulators

Demonstrated leadership in a matrix organization, able to motivate and inspire team members to high performance

Good communication, people management and social skills with a good sense of diplomacy in a scientific, business and global environment

Capable of managing teams and meetings within a multidisciplinary, multicultural and multiregional environment

Capable of identifying issues of strategic importance for project and portfolio

Excellent understanding of the interdependencies of the various disciplines (e.g. CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing)

Excellent managerial and communication skills in a multicultural global team

Proven managerial qualities and experience and ability to lead professional teams

Excellent communicator both verbally and written

Fluent in English

We offer:

• A challenging and diversified job
• Good career opportunities
• Inspiring work climate
• Attractive remuneration.
• Attractive relocation package