Director, Clinical Development
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 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 Director, Clinical Development within its Clinical Development organization in Princeton, NJ. The Director will report into the Vice President & Head of Clinical Development and contribute to the overall clinical development strategy for clinical programs for branded medicines.
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
- 3+ 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
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