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Clinical Development Medical Director - Breast Cancer

Harvey Nash IT Recruitment Switzerland

Posted on Jan 29, 2021 by Harvey Nash IT Recruitment Switzerland

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



For our client in Basel we are searching for Clinical Development Medical Director for 5 months project


Job Title: Clinical Development Medical Director - Breast Cancer


Duration: 03/05/2021 to 30/09/2021


Location: Basel


Workload: 100%
Department: Clinical Development & Analytics

Job Purpose:
The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (eg submission activities, briefing books etc.), or a large, complex trial, under the 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:
1) 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
2) Leads development of clinical sections of trial and program level regulatory documents (eg, Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
3) 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
4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
5) May be the Program Manager of other associates (eg., CSE).
6) May act as study medical monitor
7) 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 (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
8) 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
9) As a medical expert, supports the (Sr.) GPCH or TAH 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
10) 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, & mentoring support
11) Contributes to medical/scientific training of relevant company's stakeholders on the
disease area and compound/molecule. May serve as speaker for franchise
medical/scientific training
12) May serve on or lead global initiatives (eg, process improvement, training, SOP
development, other Clinical Development line function initiatives)

KPIs:
Timely delivery of high quality IDP sections, CTPs, and other clinical deliverables aligned with IDP and TPP and endorsed by review committees and internal boards, with acceptance by key external and internal stakeholders
Applies effective clinical research methodology, including trial design/analyses,
efficacy endpoints, safety assessments, and risk management across disease
area and development phases
Strong evidence of quality medical review of trial data; support TA through high quality IDP and protocol reviews; timely development of quality disease/program clinical standards, publications, internal/external presentations, and other CD deliverables
Strong evidence of quality contributions to and acceptance of clinical sections of regulatory documents, Investigators' Brochures, briefing books, safety updates, and submission dossiers by key external and internal stakeholders
Clearly demonstrates company's Values and Behaviors

Job Dimensions:
Nr. of associates:
May lead team of up to 5 reports (dependent on the size of the programs and functional responsibilities)

Impact on Organization:
External:
Timely submission and delivery of high quality clinical program data supporting regulatory approval of key compounds (or new indications), as appropriate
Effective interaction with and influence on key external decision makers (eg, regulatory authorities, medical experts, pricing and reimbursement bodies)

Internal:
Medically and scientifically sound programs and trials resulting in the timely delivery of high quality analysis of trial data which enables strategic decisions within the clinical program
High quality clinical/scientific review of CTPs and CDPs, industry leading clinical processes
Identification and development of key talent

Ideal background:
Education: MD or equivalent medical degree required.
Advanced knowledge and clinical training in a medical/scientific area (eg, internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience = 4 years (including residency) preferred
Languages: Fluent English (oral and written)

Experience:
= 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. = 3 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 pharmaceutical industry
Advanced knowledge of assigned therapeutic area
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
Strong interpersonal skills
Excellent negotiation and conflict resolution skills




Reference: 1074598001

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