BRINE SA has been placing top 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 Medical Director for our Client in Basel.
The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e.g. 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 (e.g., 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 (e.g., 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 (e.g.., 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 (e.g., 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 (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
10) May work with an Institute of Biomedical Research/ 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
13) May serve on or lead global initiatives (e.g., 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
• 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 our client`s Values and Behaviors
Nr. of associates:
May lead team of up to 5 reports (dependent on the size of the programs and functional responsibilities)
Overall lifetime clinical budget of program which can vary and be in excess of $10 – 20 million.
Impact on Organization:
• 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 (e.g., regulatory
authorities, medical experts, pricing and reimbursement bodies)
• 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
MD or equivalent medical degree required.
Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience ≥ 4 years (including residency) preferred
Fluent English (oral and written)
• ≥ 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 (e.g., 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
ADDITIONAL INFORMATION FROM INTAKE CALL:
CDMD will ideally have ≥3 years as a clinical research physician in the pharma/biotech industry.
The candidate would have protocol/clinical study report writing, data review, and strong verbal and written communication.
Ideally, the candidate should be proactive and have experience working within a global, cross-functional clinical trial team experience.
The candidate would work with clinical scientific experts in data review and train/mentor them in data review for assigned study(ies).
Work location: Basel
Duration: 3/5/2021 to 30/9/2021 (Possibility of Extention)
Salary: to be discussed
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA. firstname.lastname@example.org