Clinical Development Director
2 days ago
Sun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company with a strong presence in the market. We are seeking a highly skilled and experienced Director, Clinical Development to join our team in Princeton, NJ.
Job Summary:
The Director, Clinical Development will be responsible for leading the clinical development strategy for our branded medicines. This includes designing and overseeing the planning, execution, and management of clinical trials to evaluate the safety and efficacy of investigational products.
Key Responsibilities:
- Contribute to the 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.
- Provide recommendations and insights on 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 the 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.
- 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.
What We Offer:
Sun Pharmaceutical Industries, Inc. offers a competitive compensation package, including base salary, annual performance bonus, and comprehensive benefits. Employees are eligible to participate in Company employee benefit programs, including 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.
Equal Employment Opportunities:
Sun Pharmaceutical Industries, Inc. provides equal 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.
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