Brine SA is looking for a Clinical Development Director for our Client in Basel.
The Clinical Development Director (CDD) in oncology/haematology is the clinical leader of defined program level activities (e.g. submission activities, briefing books, etc.), and/ or indication related clinical trial(s), 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 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), clincal 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) with appropriate oversight from Medical Lead
5) May be the Program Manager of other associates (e.g., CSE).
6) 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.
7) 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.
8) As a clinical 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.
9) May work with our client’s Institute of Biomedical Researc)/ 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 CDD.
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 stakeholders on the
disease area and compound/molecule. May serve as speaker for franchise
12) May serve on or lead global initiatives (e.g., process improvement, training, SOP
development, other Clinical Development line function initiatives).
– Advanced degree in life sciences/healthcare (or clinically relevant degree) is required.
– PharmD, or PhD strongly preferred
– 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.
– ≥ 3-5 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
Work location: Basel
Duration: 15/2/2021 to 14/02/2022
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