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Senior Manager Global Clinical Development

Date: 27-Aug-2021

Location: Gothenburg, SE Helsinki, FI Milton Keynes, GB Warszawa, PL Prague, CZ Allerod, DK Gallarate, IT Berchem, BE Matosinhos, PT Oslo, NO Düsseldorf, DE Vilnius, LT Tallin, LV Vienna, AT Tallin, EE Zagreb, HR Lille, FR Madrid, ES Schlieren, CH Breda, NL

Company: Mölnlycke Health Care

Are you looking for a great career and want to make your mark?  

Please keep on reading but don’t just take our word for it. We’ve interviewed colleagues around the world about their jobs, the Mölnlycke unique culture and Mölnlycke people and it is simply A great company to work for! Could you help improve healthcare outcomes around the world? 

If the answer is yes, you think just like us and should apply for this exciting opportunity that we have below. 

 

Currently we are recruiting for a Senior Manager Global Clinical Development. Preferably you will work from HQ in Gothenburg, Sweden or from Europe. If you are working from Europe this will mean regular travels to HQ. The purpose of the position is:

 

  • To strategically and operationally lead the team of Global Clinical Development Managers (CD)
  • Accountable for creating the Market Access and Evidence Plans (MAEP) and for the resulting Clinical Evidence Strategy
  • Accountable for creating the Post-Market Clinical Follow-up (PMCF) plans and for the resulting  Clinical Evidence Strategy
  • Accountable for Clinical Study Outline for Clinical Investigations in collaboration with applicable internal and external stakeholders. Assure that the study will have scientifically appropriate methods, have a high economic impact, be of a competitive nature and follow applicable regulations
  • Accountable for PMCF surveys and Registry studies
  • Act as project sounding board, providing a high level of support regarding clinical evidence
  • Accountable for being the M&E project leader within Clinical Affairs for the dedicated Business Area

 

KEY ACCOUNTABILITIES

  • Manage a team of CD managers responsible for creating and updating the MAEP for products/solutions/projects/ and create evidence strategies to close identified gaps
  • Resource utilization and competence development
  • Budget and time line adherence
  • Monitoring and reporting of team activities/progress
  • Responsible for setting up MAEPs for new products/solutions/projects and update the MAEPs continuously during product life-cycle together with applicable functions (i.e. Business Area marketing and R&D leads, Health Economics, clinical evaluation manager,) depending on the customer need to value process
  • Responsible for setting up Post Market Follow-up Plans as an output from the corresponding Clinical Evaluation Report
  • Accountable for Post Market Clinical Follow-up  surveys as well as Registry studies
  • Accountable for writing clinical study outlines, according to the output from the MAEP, to secure the quality of Clinical Investigation for various Mölnlycke sponsored study formats (Interventional, observational studies, etc)
  • Accountable for being the M&E project lead within Clinical Affairs for the dedicated Business Area
  • Provide training and support to applicable functions to be Involved in the work of the MAEP
  • Responsible to provide input on Investigator Initiated Studies (IIS) as requested by the IIS Committee, e.g. design and strategies
  • Close interaction and networking outside the group to maintain a broad network and act as an ambassador of the Clinical Development Team

 

KEY DECISIONS

  • Management of the CD team and the resource utilization
  • Budget and time line adherence
  • Responsible for development of clinical strategies and programs to secure successful early development projects as well as business development projects
  • Provide training opportunities related to the MAEP when needed
  • All decisions related to dedicated MAEPs

 

QUALIFICATIONS AND EXPERIENCE

  • Relevant medical/scientific education on MSc/PhD level or equivalent
  • Proven leadership experience
  • Approx. 10 years Clinical research experience from medical device, pharmaceutical or from a CRO giving a seniority level of experience
  • Solid training in clinical research methodology and/or biostatistics
  • Good networking skills
  • Problem solver and solution oriented mindset, able to handling challenges and changes
  • Team player and natural leader in driving cross-functional teams
  • Commercial mindset and ability to create evidence strategies
  • Leading with impact and prestige less personality as the team leader, will also function as CD in dedicated area
  • Fluent in English (written and spoken)

 

About Mölnlycke

 

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day.

We specialise in:

  • Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®
  • Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn    and re-position patients
  • Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves

 

Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.