Global Head Clinical Development Program Excellence and Capability - UnitedStates, United States - Novartis

Description

This position is based on site in East Hanover, New Jersey.

In this role, you will ensure consistent and excellent clinical standards in the Novartis Global Drug Development pipeline. You will directly support Clinical Developments key objective to provide world-class expertise and external input into the clinical trial designs for Novartis' priority programs by bringing the patient's voice systematically into programs to enhance value and clinical applicability of our programs. You will also ensure the clinical therapeutic area expertise in our Development Units by growing and fostering world class talent and development of our clinical development associates in the programs.

What you'll be doing:

• Strengthen and oversee protocol design rigor for Novartis GDD
Improve and embed the protocol development and review (ISRC) (Study Review Committee) process
Chair protocol review across all Novartis global drug development units as a key clinical development methods expert
Partner with core experts, including Analytics leadership for best-in-class design considerations. E.g. when to leverage external data or surrogate endpoint development to provide efficient and valuable protocol science.
Bring in regulatory perspective consistently into protocols, including latest trends in FDA, EMA and Asia e.g. regulatory level of evidence, use of AI to generate data in submission dossiers
Build a mechanism for systematic incorporation of external world class ex-pert input into our IEPs (Integrated Evidence Plans) and CDPs (Clinical Development Plans)
Build a mechanism and embed the incorporation of systematic patient in-put into our IEPs and CDPs
Review critical Phase 3b/4 interventional studies in collaboration with Glob-al Medical Affairs through co-Chairing Scientific Review Committee

• Sponsor work aimed at improving Clinical program level best in class ways of working, skills and capabilities
Ensure rigorous Clinical Development processes by providing timely, high-quality input into our industry leading portfolio of clinical trial protocols, and maintaining up to date and rigorous Clinical Development led standard operating procedures.- People and capability: Ensure streamlined and clear ways of working to optimize CD in the program teams and grow talent
Responsible for the Clinical Scientific Experts Function ensure continued development of talent and build of capabilities to attain and remain best in industry. Ensure the group is fit for purpose as well as for the future.
Responsible for the CDFH (Clinical Development Function Heads ) as senior clinical scientists who drive program level clinical capability in teams
Responsible for CRMA (Clinical Research Medical Advisor) Strategically leverage our in country scientific execution of protocols with CRMA and CRMD resource to maximize execution of global clinical trials
Leverage unique global capability centers strategically i.e Dublin and Hyderabad
Responsible for clinical business operations to enable program work and initiatives to improve CD

• Attract, build and develop talent to ensure success of the team and function. Coach and share expertise to develop the team

• Ensure career development through the clinical program axis

• Create a Learning culture across CD
o Assess and create unified learning opportunities and forums for CD

Diversity & Inclusion / EEO

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

• Novartis: e-mail [email protected] or call
• Sandoz: e-mail [email protected] or call:

Role Requirements

What you will bring to the role:

MD/PhD, with experience in drug and diagnostic development with a minimum of 10 years of experience

Min 10 years of drug development and clinical research experience including experience leading Global Teams in dossier submissions. Blend of Pharma and Biotech experience is a plus

• Hands on Clinical Trial experience throughout the total cycle from protocol to registration

• Strong command of the drug development process, medical affairs, regulatory environment, safety risk management, pharma business, and strategic portfolio management. Proven track record of R&D leadership and personnel management and in leading multidisciplinary scientific, medical and technical staff and teams

• Strong communication skills in representing Development functions and issues to Senior Management and Executive Committees and with external stakeholders

• Ability to lead, inspire and engage teams

• Adept and navigating complexity and ambiguity

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here:

You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $270,400-$405,600/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

View or Apply

To help us track our recruitment effort, please indicate in your email – cover/motivation letter where ) you saw this job posting.