You lead clinical strategy and regulatory documentation for cardiovascular projects, ensuring safety and scientific integrity while collaborating with various stakeholders and providing training on relevant topics.
Anforderungen
- •Advanced degree in life sciences required
- •PharmD or PhD strongly preferred
- •Minimum 3 years experience in clinical research
- •7 years experience in drug development
- •Working knowledge of assigned disease area desired
- •Ability to interpret and present clinical data
- •Demonstrated ability to establish relationships
- •Working knowledge of GCP and clinical trial design
- •Knowledge of regulatory and clinical development processes
- •Strong communication skills in global organization
Deine Aufgaben
- •Provide clinical leadership for project deliverables.
- •Lead development of regulatory document sections.
- •Drive execution of clinical program sections.
- •Conduct ongoing medical review of trial data.
- •Support safety management for assigned sections.
- •Assist in stakeholder interactions and decision boards.
- •Contribute to scientific training for stakeholders.
Original Beschreibung
# Associate* Clinical Development Director - Cardiovascular
**Basel (City)** | **Full time**
**Band**
Level 6
**Job Description Summary**
The Associate\* Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As a CDD in the CV TA, you will have oversight of the clinical development for the assigned programs and drive the execution of the clinical development plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
**Job Description**
**Major accountabilities:**
• Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program. Clinical deliverables may include clinical sections of individual protocols or sub studies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
• Leading development of clinical sections of trial and program level regulatory documents
• Driving 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
• Overseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
• Supporting (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section and may be a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety
• As a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
• Contributing to scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training and may be the Program Manager of other associates
**Minimum Requirements:**
• Advanced degree in life sciences / healthcare (or clinically relevant degree) is required. PharmD or PhD is strongly preferred\*\*\*
• Minimum > 3 years (Associate) or 7 years experience (CDD) in clinical research or drug development
• Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
• Demonstrated ability to establish effective working relationship with key investigators
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Strong communication skills with the ability to work in a cross functional and global organization
\* *Final job title (Associate Clinical Development Director, Level 5/ Clinical Development Director, Level 6 and associated responsibilities will be commensurate with the successful candidates’ level of expertise.*
**Skills Desired**
Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring