Global Clinical Program Leader

243593BR
Global Clinical Program Leader
Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).
The Global Program Clinical Leader (GCPL) is responsible for one or more clinical programs across indications, involving one or multiple compounds. The GPCL owns the risk benefit assessment for the program(s), and as the leader of Global Clinical Team(s) (GCT) is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements and market access.

1) Leads the GCT, represents Clinical Development on the Global Program Team (GPT)
2) Contributes to overall development strategy as a member of the extended R&D leadership team
3) Leads the clinical development and execution of the clinical strategy.
Contributes to the Integrated Development Plan (IDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs
4) Leads the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with IDP and TPP. Supports registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical benefit-risk assessment for license renewals) for the compound(s)
5) Together with Patient Safety, ensures continuous evaluation of the benefit-risk profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance. Serves as a core member of the Safety Management Team (SMT)
6) As the medical expert, leads and contributes to interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Global Medical Affairs (GMA), Marketing, Health Economics & Outcomes Research), and internal decision boards
7) Serves as a core member on the Protocol Review Committee to support the Head of Clinical Development with the peer-review of IDPs, CTPs, and other clinical documents across various indications and programs; and with driving excellence across clinical trial strategy, design, and execution
8) May contribute to development of the overall development strategies

9) Plans and executes publication and clinical communication strategy in coordination with GMA and Medical Writing, and provides input into key external presentations
10) Drives scenario development for Clinical Development to support decision analysis and optimal resource allocation in program(s)
11) Ensures career development of program reports through active participation in the performance management, talent review, and succession planning processes. Provides on-boarding, coaching, and/or mentoring support; develops and fosters Clinical Development culture; and contributes to the performance evaluation of GCT members
12) Responsible for medical/scientific training of relevant AAA stakeholders on the disease area and compound/molecule. May serve as speaker for medical/ scientific training
13) Leads or serves on global process improvement work streams, act as Subject Matter Expert for standard operating procedures or trainings, and/or contributes to other cross-functional or Clinical Development functional initiatives
14) May serve as the Clinical Development Representative on Research project teams to drive transition of pre-PoC (Proof of Concept) projects to Development
15) May support Business Development & Licensing (BD&L) activities
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
MD or equivalent (preferred), PhD, or PharmD degree required. Specialization in a subspecialty may be needed. Advanced clinical training/knowledge in medical/scientific area aligned with TA required.
Medical Board certification preferred for MD or equivalent; Clinical practice experience ≥ 4 years (including residency) preferred for MD or equivalent

Fluent oral and written English

● ≥6 years (MD or equivalent)/ ≥ 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers
● Advanced knowledge of assigned therapeutic area required, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data
● Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
● Experience with submissions and health authorities required
● Demonstrated ability to establish strong scientific partnership with key stakeholders
● Demonstrated leadership and management skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry
● ≥ 5 years people management experience required, this may include management in a matrix environment
● Considerable organizational awareness including significant experience working cross-functionally and in global teams
● Excellent management, interpersonal, communication (both written and oral), and problem solving skills
● Excellent negotiation and diplomatic skills
ONCOLOGY
Advanced Accelerator Applications
USA
East Hanover, NJ
Advanced Accelerator Applications USA Inc.
Research & Development
Full Time
Regular