Clinical Development Unit Head job Princeton New Jersey
Clinical Development Unit Head job Princeton New Jersey
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Clinical Development Unit Head Job

Employer Name: SpiderID: 7727484
Location: Princeton, New Jersey Date Posted: 7/9/2018
Wage: Negotiable Category: Medical/Health
Job Code: 240411BR

Job Description:
Sandoz, a Novartis company and a global leader in generic pharmaceuticals and biosimilars, driving access to high-quality healthcare, is currently recruiting for a Clinical Development Unit Head.

The Clinical Development Unit Head is accountable for the functional excellence of the clinical/ medical team members within the Clinical Development Unit to deliver the portfolio and project priorities. He/she leads project clinical strategy in his area and oversees clinical contributions to regulatory submissions for marketing authorization. He/she may deputize for the Head, Biopharmaceutical Clinical Development (BCD) and act as BCD Medical Officer.

Major Accountabilities:
1. Assumes a leadership role within Biopharmaceutical Clinical Development (BCD)
* Leads one main area of clinical development (a CDU) and provides oversight and coaching to the sub-therapeutic area Heads and indirectly to Global Clinical Development Managers and Clinical Research Medical Advisors within that CDU
* May serve as deputy for the Head BCD, e.g. on decision boards (eg chair the Clinical Development Leadership Team (CDLT), attend the Development Committee (DC) and BPRB meetings) and key external meetings
* Is a core member of and may chair the Clinical Scientific Review Committee, may act as Medical Officer. Provides senior medical judgment in terms of safety and appropriateness of clinical study design elements
* Contributes to the overall development of BCD and Development organization to face the change in demand of projects approaching major submissions
* Orchestrates and supervises efficient use of resources to deliver optimal results, and contributes to department initiatives to streamline/enhance processes
* May act as Clinical Program Lead for high priority projects
* Develops and supports external contacts for Department and con- tributes to the Biosimilar education effort with key external audiences
* Maintains a close collaboration with partner functions in Biopharm Development and Marketing

2. Ensures clinical excellence and strategic oversight
* Guides and actively oversees the quality of clinical development plans, study designs and protocols, result interpretation, reports, clinical summaries for submission, and publications for projects in the CDU area
* Drives methodology development for programs with new indications
* Ensures strategic implementation of recommendations received from Health Authorities, and coherence of clinical contributions to submissions
* Anticipates internal and external drivers of changes to strategy, and guides teams to respond by making appropriate revisions to program/portfolio strategy
* Partners with the Head Biostatistics and Clinical Submission Management to develop submission experience within BCD and deliver high quality analysis plans and clinical components to dossiers
* Ensures state-of-the-art execution of clinical trials
* Provides medical input into Business Development & Licensing assessments

3. Responsible for developing medical and scientific talent within the CDU
* Drives recruitment of medical and clinical scientists
* Actively coaches direct reports and members of the CDU

MD; clinical specialty or additional scientific background such as PhD preferred

* Min 15 years of global drug development or clinical research experience with proven track record of R&D leadership and personnel management
* Advanced expertise in clinical trial designs and result analysis, strong biostatistic knowledge
* Experience in dossier submission/review and major Health Authority interactions required
* Clinical Background relevant to the Programs in the CDU is preferred
* Demonstrates the courage to assume personal accountability in challenging situations.
* Critical and strategic thinker. Able to develop and oversee implementation of a global strategy for the portfolio of programs.
* Strong communication skills essential, both oral and written to present to Health authorities.

Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:
Contact Name: Sandoz Company Type:
Company: Sandoz

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