This Job Vacancy has Expired!

Clinical Development (Medical) Director

Harvey Nash IT Recruitment Switzerland

Posted on Feb 6, 2021 by Harvey Nash IT Recruitment Switzerland

Basel, Switzerland
Health Care
Immediate Start
Annual Salary
Contract/Project



For our client in Basel we are looking for a Clinical Development (Medical) Director for a 12-months project


Job title: Clinical Development (Medical) Director


Start date: Asap


Duration: 12 months

Job Purpose:
The Clinical Development Director (CDD) in oncology/haematology is the clinical leader of defined program level activities (eg submission activities, briefing books, etc.), and/or indication related clinical trial(s), under thne leadership of the (Sr.) GPCH. May lead a section of a clinical program (eg, an indication, a new formulation, or a specific development phase)

Major Activities:


  • Drives the 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 Clinical Scientific Expert(s) with appropriate oversight from Medical Lead

  • Leads the development of clinical sections of trial and program level regulatory documents (eg, Investigator's Brochures, briefing books, safety updates, submission dossiers, and may be involved with responses to Health Authorities)

  • May be the Program Manager of other associates (eg, CSE) in the context of clinical/medical data review

  • Provides clinical leadership and 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 or substudies consistent with the Integrated Development Plans (IDP), clinical data review, program-specific standards, clinical components of regulatory documents/registration dossiers, and publications

  • Supports (Sr.) GPCH in ensuring the 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 (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety-related documents) in collaboration with Patient Safety

  • May supports the Clinical Development Head (CDH) by providing medical input into IDP and CTP reviews and contributing/driving the development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the CD

  • As a clinical expert, may support the (Sr.) GPCH or CD in interactions with external stakeholders (eg, regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (eg CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards

  • May serve on or lead global initiatives (eg, process improvement, training, SOP development, other Clinical Development line function initiatives)


Ideal Background:

Education (minimum/desirable):


  • Advanced degree in life sciences/healthcare (or clinically relevant degree) is required

  • PharmD, MD, or Ph.D. strongly preferred

  • Preferred experience in benign or malignant hematology; or oncology 


Languages:


  • Fluent oral and written English 


Preferred experience/Professional requirement:


  • = 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV preferred.

  • = 3-5 years of contribution to and accomplishment in all aspects of conducting clinical trials (eg, planning, executing, reporting, and publishing) in a global/Matrix environment in the pharmaceutical industry

  • Advanced knowledge of the assigned therapeutic area

  • Demonstrated ability to establish a 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

  • Strong interpersonal skills

  • Excellent negotiation and conflict resolution skills



Reference: 1086415077

Set up alerts to get notified of new vacancies.