Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Global Clinical Leader Rheumatology / Autoimmune Diseases (m/f/d)

Your tasks and responsibilities

  • Lead the Clinical Team, a cross-functional, multi-national team of internal experts
  • Set project-related objectives with clinical team members and provide input to their annual performance evaluation (completed by the functional line manager)
  • Request clinical team members and clarify resource availability with global functional heads
  • Be a member (m/f/d) of the Global Project Team representing the Clinical Development Group
  • In consultation with relevant key disciplines, prepare the Clinical Development Plan (CDP), including an operational plan with high level resource planning (timelines, budget and manpower)
  • Responsible for planning and managing the clinical timelines, managing clinical budget (external clinical grants and CRO management fees) and manpower against the approved CDP and approved resources, proactively initiates corrective action as needed
  • Responsibility for the ongoing risk-benefit assessment of a compound until approval in a main country, analyze incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate
  • Accountable for communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities)
  • Prepare assessments and recommendations at decision points, and presents them together with the Global Project Head (GPH) to the Development Management Committee
  • Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (ISE, ISS, expert report, Benefit-Risk Assessment). Compiles and maintains Investigators' Brochures (IB)
  • Provide medical expertise to Strategic Marketing (for marketed products) and New Product Commercialization Strategy (for development projects) and defines together with the Global Medical Affairs Physician the publication strategy
  • Establish and maintain appropriate external scientific consultancy and committees and assists in advocacy development
  • Provide medical assessment of in- and out-licensing opportunities of development projects
  • Explore and integrates Digital Health technology solutions into the clinical development and study designs as appropriate
  • Foster patient-centric trial designs and considers patient involvement in clinical development and trial design planning

 

 

 

Who you are

  • University medical degree (MD) with broad and proven extensive professional and academic track record
  • Board certification in rheumatology or a closely related medical specialty is preferred
  • In-depth understanding of the drug development and commercialization process with long-term experience in Clinical Research / Medical Science and drug development (from protocol writing to data analysis and reporting)
  • Experience in conduct of late stage clinical program (Phase IIb/III) in therapeutic area of inflammatory and autoimmune diseases incl. related dossier compilation, and submission / registration activities is preferred
  • Strategic thinker (m/f/d) who takes delight in tapping into new fields, while executing responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively
  • Proven leadership, motivational and interpersonal skills
  • Decisive and well developed practical judgment
  • Excellent networking abilities with internal and external stakeholders
  • Ability to paint a compelling picture of the vision and strategy that motivates others to action
  • Ability to achieve results even under tough circumstances
  • High degree of self-initiative as well as ability to work in an international and multi-cultural team
  • Fluent in English, both written and spoken

 

 

Your application

Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.

 

 

 

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. 

Country: Germany
Location: Berlin, Basel
Reference Code: 48914
Functional Area: [sap_fa_16]
Entry Level: 5