Wij zijn gespecialiseerd in functies binnen de farmaceutische industrie. Wij bemiddelen starters en ervaren kandidaten met een life science achtergrond.
alle vacatures
print vacature      e-mail vacature

Medical Science Director Internal Medicine 2 / Leiden


Deze vacature staat offline!
General
For the Global Medical Science Department of Astellas in Leiderdorp we are looking for an (Associate) Medical Science Director. Leiderdorp (the Netherlands) is home of Global Development-EU organization focusing on the development of medicines in the areas of Pain, Urology and DMCK. The therapeutic area Internal Medicine 2 comprises urological pain syndromes, pain syndromes and general internal medicine. We currently seek a physician experienced in pharmaceutical development to support the global team responsible for the development of new compounds for treatment of pain including pain syndromes in urology.
The job
Your main responsibilities are:
Assume the role of Global Medical Lead (GML) 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
Profile
  • Academic training and qualification as physician.
  • Registered MD with at least 2 years post graduation clinical experience, preferably certified specialist in internal medicine.
  • Extensive experience in global drug development evidenced by at least 5 years working experience within global pharma, preferably experience in the field of cardiovascular diseases, metabolic diseases and general internal medicine.
  • 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 general internal medicine, preferably metabolic diseases 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.
About Astellas
Astellas is an international pharmaceutical company employing over 15,000 people worldwide and with combined global sales of over 7 billion euro. The company’s European headquarters are based in London, with affiliates throughout Europe working in production, sales & marketing, and research & development. With over 3,500 employees, Europe is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Dermatology, Transplantation and Anti Infectives.
In the Netherlands Astellas has got approximately 850 professionals working within two locations, Leiderdorp and Meppel. Leiderdorp is home to the European R&D organization focusing on the development of medicines in the areas of Pain, Urology and Diabetes/Metabolic diseases.
An R&D investment budget of 15-20% is evidence of the company’s commitment to improving the health of people worldwide through the provision of innovative and reliable products.
Leiderdorp is also the head office for Supply Chain, Astellas Pharma Netherlands (the Dutch affiliate) and for Astellas Pharma International. Astellas Pharma International is present in Central and Eastern Europe, including the Baltic States and the Balkan countries, as well as the Near & Middle East, Africa and some other selected countries.
In Meppel (the Netherlands) Astellas has a production site. The Meppel plant produces 27 products, 90 formulations and 900 presentations. The production plant occupies an area of 40,000m2 in total. Products made at this plant are exported to over 40 countries worldwide.
The offer
  • A challenging and diversified job.
  • Good career opportunities.
  • Inspiring work climate.
  • Attractive remuneration.
  • Attractive relocation package.
Contact information
Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:

Dr. Arjan van den Wijngaard
Consultant Medical
Biltstraat 443
3572 AW Utrecht
tel 030 231 7350
mobiel 06 50650550
aanmelden



NL EN DE pharmamediar.nl