US-NJ, Head, Clinical Development (Sandoz) 218475BR_1501770916-MZ
|•Lead clinical due diligence activities and provide expertise and support to Business Development & Licensing (BD&L); represent Clinical Development in cross-functional and cross-divisional due diligence teams. |
•Implement and lead the US Clinical Development function that will oversee efficacy and safety studies (and Phase 1 studies in patients) for 505(b)(2) clinical development programs, in close collaboration and alignment with US Development & Registration (D&R), Regulatory Affairs (RA), Quality Assurance (QA), and other functions
•Provide clinical and medical support and oversight for 3rd party/partner clinical development programs for assets that will be incorporated into the Sandoz Inc. portfolio.
•Represent Clinical Development in cross-functional and cross-divisional due diligence teams, and lead clinical due diligence activities; provide clinical development expertise and support to Business Development & Licensing;
•Implement the US Clinical Development function that will oversee efficacy and safety studies and clinical programs for 505(b)(2) clinical development programs. This function will also oversee phase 1 studies in patients (not healthy volunteers).
•Directly lead or oversee all aspects of medical and clinical support of assigned clinical programs and trials within the US.
a. Medical support to investigative sites and program staff for protocol-and study-related issues such as protocol clarifications, inclusion/exclusion determinations, and issues related to patient safety and/or eligibility, among others.
b. Review and assessment of clinical trial Adverse Events (AEs).
c. Medical case review of Serious Adverse Events (SAE) including review of case documentation and patient narrative.
d. Medical support for data trend analysis as needed.
e. Medical and safety monitoring during the study.
f. Medical advisory expertise and guidance to all internal stakeholders supporting assigned clinical trials.
g. Medical expertise to CROs supporting assigned clinical trials.
h. Input into the development of clinical trial protocols, and associated documents (e.g., Case Report Forms, Informed Consent Forms, Study Analysis Plans) for studies that have a US component.
i. Input into clinical interpretation of study results and defining and interpreting data driven analyses, as needed.
•Closely collaborate and align with US D&R, RA, QA, and other functions, in the implementation of 505(b)(2) clinical development programs.
•Provide medical and clinical expertise to all US internal functions, stakeholders, and CROs supporting the assigned clinical trials.
•Ensure timely, quality planning and execution of assigned clinical programs.
•Provide clinical and medical expertise, oversight, and advice for clinical development programs implemented by 3rd parties and partners identified through BD&L initiatives, for assets that will be incorporated into the Sandoz Inc. portfolio.
•Provide clinical and medical expertise to US D&R as needed.
•Lead and/or contribute to multifunction task forces designed to support continuous improvement in US CDMA.
•Clinical review of third party sponsored studies.
Key Performance Indicators:
•Achieve agreed targets in terms of quality and time.
•Provide high quality clinical and medical input to BD&L due diligence activities
•Achieve high level of medical quality for all programs implemented and supervised (low number of questions/requests for change asked by internal or external review committees) thus allowing timely completion of related activities.
•Establish sound and trustful relationship with D&R, DRA, QA, and other internal stakeholders, as well as with all external partners and stakeholders.
•Adapt activities to the ever changing regulatory and operational requirements and environment.
•Allow fast decision making by adequately gathering and presenting relevant facts.
•Contribute to the development, innovation and improvement of US CDMA’s working standards and basic values.
Position will be filled at level commensurate with experience.
•MD, preferably with specialization in Oncology, Immunology, Rheumatology or Dermatology, or as required by new programs preferred
•Excellent English (oral and written)
•7 years of experience, including 5+ years of experience in clinical research, including Phase IIb - IV clinical development; industry experience preferred.
•Experience in due diligence activities.
•High-level clinical and scientific knowledge of assigned therapeutic area.
•General knowledge of all aspects of the drug development process.
•Knowledge of clinical trial design and statistics.
•Proven ability to interpret, discuss and represent efficacy and safety data in the as-signed therapeutic area.
•Deep understanding of GCP, regulatory requirements and data privacy laws.
•Proven learning agility: comfortable with complexity and able to explain complexity in simple words. Curious, find solutions to tough problems. Can deliver results under first time conditions. Interested in continuous improvement. Self-aware and comfortable with diversity of people and opinion.
Helpful even in disagreements. Clear in presenting both their viewpoints and explaining the thinking of others.
•Experience working in a matrix organization.
•Regulatory agency filing experience a plus.
•Phase IIb - IV experience important.
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