Clinical Development Medical Director (Ref. Nr. RE2745)
Posted on Nov 22, 2020 by BRINE SA
BRINE SA has been placing top IT specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.
Brine SA is looking for a Clinical Development Medical Director for our Client in Basel.
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)
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) May work with NIBR/Translational Medical Sciences) 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
11) 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
12) Contributes to medical/scientific training of relevant stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
13) May serve on or lead global initiatives (eg, process improvement, training, SOP development, other Clinical Development line function initiatives)
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 Novartis Values and Behaviours.
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
= 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
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA.
Work location: Basel
Duration: till 31.05.2022
Salary: to be discussed
Language: Fluent English (oral and written)
BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:
Financial services sector, especially banks and insurance companies
Government and services sectors
BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.
IT - Resources
We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:
Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.
Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA
Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.
BRINE SA is ISO 9001:2008 certified since 2014