Senior Director, Clinical Development - Immunology

Sun Pharmaceutical Industries, Inc.; Princeton (NJ); On-site; USD 302,000 - 369,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc (USA) in Princeton, NJ seeks a Senior Director, Clinical Development to lead the overall clinical development strategy for deuruxolitinib. This role reports to the Vice President & Head of Clinical Development and will be based in Princeton, NJ.

You will design and oversee trials from phase 1 through registrational phase 3, provide scientific leadership for the portfolio, interact with regulatory authorities, and collaborate with cross-functional teams to drive

Qualifications

• MD or MD/PhD with 10+ years in biotech/pharma clinical development.
• Experience leading phase 1–3 trials and regulatory submissions.
• Strong leadership and cross-functional collaboration.
• Proven ability to work with regulatory agencies (FDA/EMA).
• Expertise in protocol design, data analysis, and trial management.
• Experience with platform trials and global programs.

Responsibilities

• Develop overall clinical development strategy for immunology programs.
• Design and oversee planning, execution, and management of trials to evaluate safety and efficacy of investigational products.
• Provide scientific leadership for the clinical portfolio including trial design and oversight.
• Collaborate with external stakeholders, investigators, patient advocacy groups, and advisory boards.
• Serve as external spokesperson for clinical programs in interactions with development partners and CROs.
• Support implementation of program-level initiatives and regulatory submissions.
• Foster cross-functional collaboration with medical affairs, regulatory, and commercial teams.
• Establish and maintain relationships with key opinion leaders and investigators.

Skills

Clinical development

Regulatory strategy

Trial design

Leadership

KOL engagement

Cross-functional collaboration

Education

MD or MD/PhD

Job description

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Title: Senior Director, Clinical Development - Immunology

Date: Oct 12, 2026

Location: Princeton, NJ

Company: Sun Pharmaceutical Industries, Inc (USA)

Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.

Description

Sun is seeking a Senior Director, Clinical Development to lead the overall clinical development strategy for deuruxolitinib. This role will report into the Vice President & Head of Clinical Development and be based in Princeton, NJ

Responsibilities

• Contribute to an overall clinical development strategy for clinical programs, ensuring alignment with the company’s overall goals and objectives.
• Design and oversee the planning, execution, and management of clinical trials to evaluate the safety and efficacy of investigational products.
• Provide scientific leadership for the clinical portfolio including direct responsibility for clinical development strategy, design and oversight of clinical trials
• Provides recommendations and insights study feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with key opinion leaders, potential investigators, patient advocacy groups, and advisory boards.
• Serve as a key external spokesperson of clinical programs in interactions with development partners, investigator meetings, and advisory boards.
• Support implementation of agreed-upon initiatives and program-level activities specific to the therapeutic area of focus.
• Collaborate across multiple internal multidisciplinary functions including prioritization of internal and external activities within the therapeutic area based on impact and strategic goals.
• Provide support to the VP of Clinical Development for interactions with regulatory authorities and data monitoring boards.
• Support the design and implementation of clinical protocols, data collection systems, digital tools, and data analysis including statistical analyses.
  • Will support and will be accountable for clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions.
• Implement best practices and standards for trial management in collaboration with other members of the clinical operations team.
• Collaborate with Medical Affairs and Commercial Teams to develop a strong group of Key Opinion Leaders.
• Foster collaboration with cross-functional teams, including research and development, regulatory affairs, medical affairs, and commercial teams.
• Establish and maintain relationships with key opinion leaders, clinical investigators, contract research organizations (CROs), and other external partners.

Qualifications

• MD, or MD/PhD
• 10+ years of biotech and/or pharma drug experience
• Successfully conducted clinical development from phase 1 through registrational Phase 3 studies
• Demonstrated ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
• Experience designing and developing smaller, yet robust and innovative platform trials, randomized phase 2 and registrational Phase 3 programs.
• Prior experience interacting effectively and successfully with regulatory agencies is essential, across the spectrum on FIH/IND, end of phase 2/ pre-phase 3 and (s)NDA/(s)BLA is a plus
• Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates / products is required. Has working knowledge of GCP, ICH, US FDA and EMEA regulations is a plus
• Effective written and verbal communications and interpersonal skills with all levels.
• Must have strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making across various development functions.
• Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions and understanding of pre-clinical development.
• Experience in working with external collaborators, including CROs, national institutes and multinational pharmaceutical companies is preferred.
• Strong analytical and problem-solving skills, is well organized has mastered complex medical/clinical development tasks
• Superior written and verbal communication skills within scientific presentation, corporate and clinical team and clinical trial environments
• Works effectively under pressure and has rigorous work ethics with focus on details and high-quality results

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provideequal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

The presently-anticipated base compensation pay range for this position is $302,000 to $369,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. 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.