Vacancy for Head, Clinical Data Review and Reporting in Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Head, Clinical Data Review and Reporting

Job Description
Job Purpose:
Build and operationally, functionally manage a global team of statistical programmers who provide support for a portfolio of major drug projects in Oncology Therapeutic area. CDRR deliverables must satisfy regulatory requirements, be of high quality, and be prepared in the shortest time possible to gain regulatory approval or meet other critical business needs. Is an independent CDRR representative on major Novartis initiatives and represent the CDRR group outside the function..

Major Accountabilities:
1. Operational and functional leadership globally of one Unit within the Clinical Data Review and Reporting (CDRR) group. One Unit usually represents a multiple drugs portfolio.
2. Recruit, develop, mentor, coach people managers responsible for managing individual drug projects within the Unit and in CDRR Hyderabad. Appraise the performance of direct and indirect reporting associates. Ensure high quality performance management and associates development within his/her unit and in CDRR Hyderabad.
3. Lead and implement the CDRR strategy for his/her Unit and the Hyd site.
4. Contribute to the development of the CDRR and BDM organization. Define / Contribute to the developement of long-term goals and operating policies for the CDRR and BDM organization through his/her leadership role on the management teams.
5. Manage quality, timeliness, efficiency, and implementation of standards within his/her Unit and CDRR Hyd. Ensure implementation of global state of the art programming practices and quality guidelines in compliance with regulatory requirements and Novartis quality standards, to ensure CDRR deliverables of high quality, on time, and within budget.
6. Manage timelines, quality and preparation of statistical reporting deliverables and ensure that they comply with BDM, Oncology TA and regulatory guidelines globally.
7. Build and maintain strong partnerships within Novartis Statistical Programming groups and across functions within BDM, OGD&GMA and Oncology Translational Medicine.
8. Coordinate with Novartis GenMeds Statistical Programming and Development Informatics to ensure implementation of reporting systems
9. Lead all external and internal resource management activities in the assigned Unit, as well as contribute to the overall resource planning globally for CDRR.
10. Lead independently improvement initiatives and/or non-clinical projects for Global CDRR and within BDM and/or cross-functionally
11. Ensure that relevant SOPs/BGs/Working practices are in place and followed.
12. Review the planned contents of tables / listings / figures for SCS/SCE and project level documents (within assigned Unit) to ensure efficient production and usefulness of output.
13. Represent Oncology CDRR regarding requirements, selection, and evaluation of reporting tools and systems (hardware and/or software) that directly relate to statistical programming activities.
14. If located on a different site than CDRR, Global Head, own the local CDRR cost center
15. Lead/participate in external industry/statistical programming activities.

KPI:
1. Timeliness and quality of deliverables.
2. Efficiency of resource usage. Adequacy of resource estimation.
3. Quality of the submission programming package as measured by Health Authority feedback.
4. Recruitment, retention and development of talent in the Unit and across the Hyderabad site
5. Compliance with internal and external guidelines and processes, as measured by internal audit.

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Candidate Profile
Education (minimum/desirable):
Post-graduate university or college degree in Life Sciences, Statistics, Mathematics, Computer Science, Medical Informatics or equivalent.

Experience/Professional requirement:
1.Significant relevant experience in the Pharmaceutical Industry, including some relevant experience in Oncology.
2. At least 8-10 years of experience in global drug development, including at least 8 years in a senior programming/statistical role within the pharmaceutical industry.
3. Strong leadership skills including leading people, operations, and innovation globally in complex matrix structures and business models.
4. Superior interpersonal skills.
5. At least 5 years of Global management experience of staff across multiple sites, preferably in multi-national locations.
6. Proven ability to proactively identify issues, recommend and implement solutions
7. Strong global project management skills / Track record in successful project management.
8. Good knowledge of statistical programming languages
9. Strong communication skills. Builds positive departmental and inter-departmental relationships.
10. Strong Health Authority experience / knowledge of HA guidelines.
11. Evidence of external focus with involvement in external industry activities.

Additional Information:
Experience: 8-10 years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 147386BR
End Date: 28^th August, 2014