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Clinical Development Medical Director – Melanoma Program (m/f/d)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Engineering, Design

Projektbeschreibung

REFERENCE NUMBER:

537189/1

MY DUTIES:

- Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
- Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
- Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
- Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
- May be the Program Manager of other associates (e.g.., CSE)
- May act as study medical monitor
- Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
- Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
- As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
- May work other department to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other

medical matters, as needed - Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training,
- Profound experience regarding the involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. Some years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
- Advanced knowledge of melanoma
- Demonstrated ability to establish strong scientific partnership with key stakeholders
- Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
- People management experience preferred, this may include management in a matrix environment. Global people management experience desirable
- Excellent communication skills, written and oral

MY BENEFITS:

- You will work in an international environment

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Emina Mustafic

Reference number
537189/1

Contact
E-Mail: emina.mustafic@hays.ch

Projektdetails

  • Einsatzort:

    Basel Stadt, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 MM++

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland