Global Program Clinical Head, Hematology (M.D.)

Legend Biotech USA; East Hanover (NJ); Hybrid; USD 261,000 - 485,000; Full time

Job summary

An established industry player is seeking a Senior Global Program Clinical Head to lead clinical development strategies for innovative treatments. This pivotal role involves collaborating with cross-functional teams, driving clinical trials, and ensuring regulatory compliance. The ideal candidate will possess a strong background in Hematology and clinical research, demonstrating leadership in a dynamic environment. Join a mission-driven organization focused on transforming lives through cutting-edge medical solutions and be part of a team that values innovation and excellence.

Benefits

401(k) eligibility

Paid time off

Medical benefits

Discretionary awards

Sign-on bonus

Restricted stock units

Qualifications

• 6+ years experience in clinical research or drug development.
• Advanced expertise in Hematology and clinical study designs.
• Strong scientific partnership with key stakeholders.

Responsibilities

• Lead a cross-functional team for clinical document creation.
• Drive transition of pre-PoC projects to Development Decision Point.
• Ensure continuous evaluation of drug safety profiles.

Skills

Clinical Decision Making

Clinical Research

Clinical Trials

Disease Area Knowledge

Drug Development

Leadership

People Management

Risk Management

Strategy Development

Education

MD

Job description

Job Description Summary
Onsite
#LI-Onsite

Novartis is deeply committed to transforming the lives of people living with solid tumors, blood cancers and serious or life-threatening blood disorders. We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms and free from disease - this is our vision for the future.

As the Senior Global Program Clinical Head (GPCH), you are the clinical lead and will serve as a key member of the Global Program Team, contributing to the overall strategy in collaboration with relevant other functions such as Regulatory Affairs, Market Access and others. You will develop and ensuring the implementation of the Clinical Development plan and leading a cross functional team of specialists such as Medical Directors, Trial Directors, Safety Leaders, Biostatisticians and Regulatory Directors. In addition, you will lead the development and execution of the disease area strategy.

Job Description

Your Key Responsibilities:

• Responsible for clinical input to support Business Development & Licensing (BD&L) activities
• Serve as the Clinical Development Representative to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP)
• Contribute to 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 more treatment indications and/or multiple programs.
• Drive creation and implementation of Clinical Development to support decision analysis and optimal resource allocation in program(s).
• Lead a cross functional team through the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigators Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency.
• As the medical expert, lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcomes Research), and internal decision boards.
• Together with Patient Safety, ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance.
• Support 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)
• Plan and implement publication and clinical communication strategy in coordination with Global Medical Affairs and Medical Writing and provide input into key external presentations.

The ideal location for this role is the East Hanover site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover for periodic live meetings will be at the employees expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require X% travel.

Video Link https://www.youtube.com/watch?v=ggbnzRY9z8w

Role Requirements:
Essential Requirements:

• MD with 6+ years experience in clinical research or drug development in an industry environment spanning clinical activities in Phases I-III/IV, including submission dossiers.
• A passion for Hematology
• Advanced expertise in Hematology with ability to innovate in clinical development study designs, provide relevant evidence to decision-makers and to interpret, discuss and present clinical trial or section program level data
• Detailed knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
• 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
  Essential Preferred:
• CAR-T
• BD&L

Novartis Compensation and Benefit Summary:

The pay range for this position at commencement of employment is expected to be between: $261,100 and $484,900/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, 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.

Why Novartis:
Our purpose is to reimagine medicine to improve and extend peoples 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: https://www.novartis.com/about/strategy/people-and-culture

Youll receive:

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

https://www.novartis.com/careers/benefits-rewards

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 [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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: https://talentnetwork.novartis.com/network

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range
$261,100.00 - $484,900.00

Skills Desired
Clinical Decision Making, Clinical Research, Clinical Trials, Disease Area Knowledge, Drug Development, Leadership, People Management, Risk Management, Strategy Development