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Medical Director Translational Biomarker Research

Eingestellt von Bio Careers

Gesuchte Skills: Support, Marketing

Projektbeschreibung

EMD Serono, Inc., a leader in the US biopharmaceutical industry, is a subsidiary of Merck KGaA, Darmstadt , Germany, a global pharmaceutical and chemical group with 40,000 people world wide.

DESCRIPTION

PURPOSE OF THE ROLE

- Provide medical and scientific expertise and to lead the translational / biomarker function supporting early development from discovery through early clinical development to PoC
- Provide leadership in biomarker strategy, development of companion diagnostics, and relevant regulatory guidance
- May act as a member of either a Global Project Team (GPT) or Clinical Development Team (CDT) as appropriate
- Provide medical and scientific expertise/input to Business Development activities, to launch/post launch activities and Marketing strategies, to Medical Communications, Stratified Medicine, Preclinical Pharmacology, MS research, quality assurance, global clinical operations, biostatistics, global regulatory affairs and Global Drug Safety
- Support business development activities by providing medical-scientific expertise for evaluation of in/out-licensing opportunities as appropriate

KEY TASKS & RESPONSIBILITIES

- Act as medical-scientific director:
- - Provide medical/scientific input and drive/contribute to the creation of relevant clinical documents or parts thereof to ensure high quality of e.g. biomarker strategy documents, study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
- Review and sign off all clinical documents related to the clinical studies (e.g. study protocols and study reports) within area of responsibility
- Oversees relevant translational / biomarker aspects of trials and provides respective guidance to the trial team
- Oversee relevant aspects related to the scientific and medical risks in collaboration with the safety representative
- Contribute to the review, analysis and interpretation of study data
- Support communication of study results as assigned
- Act as member of the Global Project Team and Clinical Development Team:
- - Propose biomarker / translational development strategies for assigned indication(s)/product(s) in order to establish its safety and efficacy and support registration in the shortest possible time worldwide
- Contribute to the development and preparation of clinical development plans, study concept sheets, and study protocols in collaboration with clinical and project team members for assigned indication(s)/products()
- Liaise with (principal) investigators, consultants, opinion/thought leaders, health authorities, IEC/IRB, and academic institutions in area of responsibility
- Participate in cross-functional development project team activities to provide medical/scientific input into e.g. business plan, project strategy, in-/out-licensing activities as assigned
- Act as a liaison between TA MS and relevant pre-clinical scientists
- - Participate in DPT meetings of selected projects and provide relevant medical and clinical expertise and input into the pre-clinical development activities
- Support business development activities
- - Participate in Due Diligence activities and contribute to the Due Diligence Report in collaboration with the Senior Medical Director and other team members
- Strategic Biomarker Development
- - Collaborate with team to produce translational / biomarker strategy for MS platform and for individual trial programs
- Lead the strategy for stratified medicine and development of companion diagnostics
- Together with colleagues from regulatory functions, advise on regulatory strategy as related to biomarker use in registration trials and development of companion diagnostics
- External collaborations
- - Contribute to and / or lead the development of external collaborations in translational medicine and biomarker development

MANAGEMENT OF PEOPLE

- Supervise the work of two translational / biomarker scientists

MANAGEMENT MAIN INTERFACES WITH OTHER INTERNAL DEPARTMENTS/FUNCTIONS:

- Biostatistics, Business Development, Business Unit/Marketing, TA MS, Chief Medical Officer, Clinical Trial Management & Monitoring, Data Management, Drug Safety, Exploratory Medicine, Legal, Medical Information, Medical Writing, Project Management, Regulatory Affairs, R&D Quality Assurance
- Main External Interfaces:
- - Health Authorities, Opinion/Thought Leaders, Clinical Investigators, Academic Institutions, Scientific and Patients' Organizations

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Bio Careers