Title:  Sr. Manager -Clinical Development

Job Title:

Sr. Manager, Clinical Development

Business Unit:

GDO

Job Grade

G9A/B

Location:

Mumbai/Gurgaon

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

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.

Position Description

Sun is seeking a Sr. Manager, Senior Clinical Development Study Lead (CDSL) within its Clinical Development organization in Princeton, NJ.  The Sr. CDSL will lead a cross-functional Study Team that is responsible for design and execution of one or more clinical studies and

serves as the primary source of medical accountability for the study.  Working with the functional study leads, the Sr. CDSL ensures there is a robust plan to drive Study Team deliverables that are aligned with the asset strategy, and creates a team environment that fosters strong collaboration, communication, and efficient decision-making.  The Sr. CDSL will report to a Clinical Development Project Lead who is responsible for deliverables for the entire Global Project Team or Asset Team. 

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Position Responsibilities

• Provides Clinical Development functional leadership and leads the Study Team which comprises members from Clinical Operations, Regulatory, Biostatistics, Quality Assurance, Data Management, Pharmacovigilance, Clinical Pharmacology, CMC, and other functions.
• Acts as a key point of accountability for study strategy, timelines, and execution.
• Serves as the primary source of medical accountability for one or multiple clinical studies, including performing or overseeing medical monitoring and data review.
• Creation of study plans that are aligned with business objectives to provide competitive differentiation and drive value for the company and benefit to patients.
• Drives execution of Study Team deliverables for clinical trials from inception, to design, through execution including protocol development, medical monitoring, data review and analysis, data presentations, preparation of study documents, and regulatory filings.
• Works closely with other Study Team functions to engage vendors and CROs in study design, planning, and execution, and provides oversight as appropriate.
• Leads and communicates Study Team progress at Project governance meetings
• Leads the Study Team to identify, manage, and mitigate risks and monitor progress of study and emerging data and proposes adjustments to Project leadership as needed.
• Responsible for ensuring cross-functional collaboration and communication to drive efficient and data-driven decision making and use of best practices
• Provides Clinical Development support for interactions with regulatory authorities and data monitoring boards including data analysis, document preparation, and presentations
• Serve as a key external spokesperson for the Study Team in interactions such as investigator meetings and advisory boards including collaborating with Medical Affairs and Commercial Teams as required for interactions with Key Opinion Leaders and external advisors
• Ability to be productive and successful in an intense, dynamic, fast-paced environment
• Contributes to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.

Qualifications:

• MD, MD/PhD, or MD + DM
• 3+ years of biotech and/or pharma drug experience
• Experience across multiple phases of drug development including hands-on experience managing clinical trials preferred.
• Experience developing robust study designs to meet regulatory and marketing needs in the face of an evolving landscape.
• Strong working understanding of compliance and global regulatory requirements (ICH) for drug development including GCP, ICH, US FDA and EMEA regulations.
• Effective written and verbal communications and interpersonal skills across all levels of the organization.
• Ability to lead in matrix environment, and motivate a dynamic group in a fast-paced and hands-on environment through influence and by fostering commitment in team members to build successful collaborations with internal and external partners.
• Strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making across various development functions.
• Strong analytical, problem-solving, and organizational skills to develop and execute drug development strategies aligned with business goals and navigate complex challenges.
• Works effectively under pressure and has rigorous work ethic and integrity with a focus on high-quality results and delivery of benefit to patients.

Travel Estimate

Job Requirements

Educational Qualification –

MD, MD/PhD, or MD + DM

Experience –

Tenure:  4+years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee 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 incumbent(s).