Clinical Development Leader

Job Title: Clinical Development Leader

Job Summary:

We are seeking a highly skilled Clinical Development Leader to join our team at Sun Pharmaceutical Industries. As a Clinical Development Leader, you will be responsible for leading clinical development strategies and activities for our portfolio programs. You will oversee and contribute to clinical development strategy and activities to ensure alignment with the company's overall goals and objectives.

Responsibilities:

• Functional leadership and guidance of a team of clinical professionals
• Oversee and contribute to clinical development strategy and activities for all portfolio programs
• Oversee and participate in the design and planning, execution, and management of clinical trials
• Provide broad drug development and functional knowledge and experience
• Provide recommendations and insights regarding study feasibility and operational risks and challenges
• Support the design and implementation of clinical protocols, data collection systems, digital tools, and data analysis
• Oversee the analysis and interpretation of clinical trial data
• Provide support for interactions with external development partners, investigator meetings, and advisory boards
• Collaborate with Medical Affairs and Commercial Teams
• Provide support for internal cross-functional interactions with study teams
• Support study team and Asset Lead presentations to Global Development leadership and governance
• Support study teams to manage clinical development budgets and resources effectively
• Support, review, and be accountable for clinical sections of regulatory documents
• Collaborate across multiple internal multidisciplinary functions
• Support implementation of initiatives and program-level activities
• Ability to be productive and successful and serve as an effective change agent in an intense, fast-paced, and dynamic environment
• Foster a team culture that promotes continuous improvement, ownership, professional growth, and inclusion
• 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
• Experience designing and developing smaller, yet robust and innovative platform trials
• Prior experience interacting effectively and successfully with regulatory agencies
• Solid knowledge of compliance and global regulatory requirements
• Has working knowledge of GCP, ICH, US FDA and EMEA regulations
• Proven ability to represent the Company's interests effectively in interactions with external partners, investigators, and regulatory agencies
• Ability to lead a dynamic group in a fast-paced and hands-on environment
• Strong consensus-building skills and the ability to lead multi-disciplinary teams
• Outstanding leadership and management capabilities to motivate and guide a strong Clinical Development team
• Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions
• Experience in working with external collaborators, including CROs, national institutes, and multinational pharmaceutical companies
• Strong analytical and problem-solving skills, is well organized and has mastered complex medical/clinical development tasks
• Superior written and verbal communication skills within scientific presentation, corporate presentation, and clinical team and clinical trial environments
• Works effectively under pressure and has a rigorous work ethic with a focus on details and high-quality results
• Able to assess human resource needs and suggest appropriate prioritizations
• Clinical Development Experience: Extensive experience in clinical research and drug development
• Leadership Skills: Strong leadership and team management skills
• Regulatory Knowledge: In-depth understanding of global regulatory requirements for clinical trials and drug development
• Strategic Thinking: Ability to develop and execute clinical development strategies aligned with business goals
• Analytical Skills: Proficiency in analyzing clinical trial data and making data-driven decisions
• Problem-Solving: Strong problem-solving and decision-making capabilities
• Industry Awareness: Stay current with industry trends, emerging therapies, and advancements in clinical trial methodologies
• Interpersonal Skills: Collaborative and able to build strong relationships with internal teams and external partners
• 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
• 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 provide 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
• Job Requirements:
• 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
• Experience designing and developing smaller, yet robust and innovative platform trials
• Prior experience interacting effectively and successfully with regulatory agencies
• Solid knowledge of compliance and global regulatory requirements
• Has working knowledge of GCP, ICH, US FDA and EMEA regulations
• Proven ability to represent the Company's interests effectively in interactions with external partners, investigators, and regulatory agencies
• Ability to lead a dynamic group in a fast-paced and hands-on environment
• Strong consensus-building skills and the ability to lead multi-disciplinary teams
• Outstanding leadership and management capabilities to motivate and guide a strong Clinical Development team
• Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions
• Experience in working with external collaborators, including CROs, national institutes, and multinational pharmaceutical companies
• Strong analytical and problem-solving skills, is well organized and has mastered complex medical/clinical development tasks
• Superior written and verbal communication skills within scientific presentation, corporate presentation, and clinical team and clinical trial environments
• Works effectively under pressure and has a rigorous work ethic with a focus on details and high-quality results
• Able to assess human resource needs and suggest appropriate prioritizations
• Clinical Development Experience: Extensive experience in clinical research and drug development
• Leadership Skills: Strong leadership and team management skills
• Regulatory Knowledge: In-depth understanding of global regulatory requirements for clinical trials and drug development
• Strategic Thinking: Ability to develop and execute clinical development strategies aligned with business goals
• Analytical Skills: Proficiency in analyzing clinical trial data and making data-driven decisions
• Problem-Solving: Strong problem-solving and decision-making capabilities
• Industry Awareness: Stay current with industry trends, emerging therapies, and advancements in clinical trial methodologies
• Interpersonal Skills: Collaborative and able to build strong relationships with internal teams and external partners
• What We Offer:
• 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
• We provide 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

How to Apply:

Please submit your application through our website or email your resume and cover letter to [insert contact information].

We look forward to hearing from you

Equal Employment Opportunity:

We provide 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.

Disclaimer:

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).