Medical Director - GPS | Medical Safety TA Oncology

Posted 16 Jun 2020

Darmstadt, Hesse - Germany

Req Id 207230

Details

A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Key Responsibilities

The role of the GPS Safety Strategy Lead is to ensure the delivery of integrated medical safety strategies for assigned development compound(s) and/or marketed product(s) including proactive safety surveillance and effective signal and benefit-risk management. 

 

For assigned product(s), either directly or through effective delegation to other members of the GPS Product Team:

  • set the medical safety strategic direction, in the context of delivering the benefit-risk profile, and provide clear, strong and visible safety scientific leadership, in partnership with R&D cross-functions
  • ensure oversight of the emerging safety profile of the product, including medical review of individual case safety reports as required, signal detection and evaluation, periodic safety reporting, risk-benefit evaluation and risk management throughout the lifecycle of the product
  • ensure that safety signals are identified promptly and communicated/escalated within the company appropriately
  • ensure high quality medical safety contributions to Pharmacovigilance Advisory Board (PVAB)
  • develop and leverage medical safety strategic contributions to other R&D governance bodies and review committees (e.g. DSC, MSEB, GMDB) 
  • represent GPS on cross-functional teams for the product, including e.g. the Global Program Team (GPT) and any Alert Action Teams, ensuring that all negotiated and agreed deliverables and deadlines for these teams are met
  • represent GPS at submission teams and provide safety strategic input into submission documents such as Integrated Summary of Safety, Clinical Summary of Safety (Module 2.7.4), Clinical Overview (Module 2.5) as well as safety update reports
  • chair the BRAT and SMCs as required
  • represent GPS on safety aspects for the product externally, e.g. engagement with external SMC/IDMC members
  • preparation for and attendance at regulatory authority meetings, interactions with external advisers or opinion leaders, effective collaboration with colleagues from partnership companies for co-development or co-marketing
  • act as a subject-matter expert on medical safety in interactions/discussion/negotiations with regulatory authorities
  • ensure effective communication of product-related aspects in audits and regulatory authority inspections
  • provide medical safety expertise for due diligence activities as required
  • provide efficient oversight for medical safety activities in support of outsourcing and offshoring models
  • maintain a profound level of knowledge about the product and the therapeutic area
  • provide product- or TA-specific training to GPS colleagues, and safety training to non-safety colleagues, as required
  • coach, support and help develop other GPS staff in relevant GPS Product Teams

 

Scope of people responsibility

Management of people

  • Scientific leadership of a team of Global Patient Safety team members working on the product (without line management responsibility)

 

Education

Required professional experience and necessary training

  • Physician with broad clinical experience; alternatively science or other healthcare related doctoral degree
  • Fluent in written and spoken English

 

Work experience

Necessary professional experience

  • Several years of medical experience as a physician, preferably clinical experience in the relevant therapeutic area
  • Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience; excellent knowledge of the pharmacovigilance regulations/guidelines and its application for activities related to assigned product/s
  • Excellent knowledge of product development process and experience of cross-functional teamwork
  • Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
  • First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good medical understanding of the relevant therapeutic area(s)
  • Expert knowledge of aggregate data analytics and understanding of related sciences such as predictive modelling, epidemiology, health outcomes and biostatistics
  • Professional experience in a global matrix environment across regions

 

Job specific competencies & skills

Required technical skills:

  • Excellent medical judgment in medical safety decision-making
  • Subject matter expert on all medical safety topics and demonstrated ability to drive the safety strategy on cross-functional discussions/deliberations
  • Proven ability to author complex benefit-risk related reports and other safety submission documents
  • Ability to engage with regulators in scientifically grounded discussions to support the safety strategy, in the course of clinical development interactions and submissions
  • Proven ability to chair/actively participate in high profile meetings effectively
  • Comfortably presents to governance and cross-functional boards
  • Proven ability to take calculated risks and scientifically leads by example.
     
    Required personal skills:
  • Strong team player with excellent networking skills
  • Entrepreneural thinking and ability to progress project(s), within prescribed budget and timelines
  • Strong, mature scientific leader with good decision making, negotiating and influencing skills
  • Sets the tone through own actions in creating an environment where ideas can be shared, questions can be asked, and individuals are accountable for their own actions
  • Self-motivated individual, who aspires to have updated knowledge of industry trends, latest scientific developments and applies them for the benefit of the team and/organization.
  • Makes efforts to improve team leadership skills (scientific leadership)
  • Anticipates and is equipped to cope with resistance and critical problems; demonstrated ability to provide relevant solutions to achieve desired outcomes
  • Excellent verbal and written communication skills (in English language).

 

 

  • Normal and routine office duties
  • Position requires both domestic and international travel up to 15% of time

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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