What are the responsibilities and job description for the Vice President, Clinical Development position at BioBoston Consulting?
BioBoston Consulting- Recruitment is searching for a Vice President, Clinical Development for a leading Pharma company in Tucson, AZ.
Position Summary:
As Vice President of Clinical Development, you will play a pivotal role in leading and driving the clinical development strategy for our company's innovative pipeline of [mention specific therapeutic area, e.g., oncology, cardiovascular disease, etc.]. You will be responsible for all aspects of clinical trial design, execution, and management, ensuring the successful development and regulatory approval of our groundbreaking therapies.
Responsibilities:
Strategic Leadership:
Develop and implement a comprehensive clinical development strategy aligned with the company's overall business objectives.
Oversee the clinical development plan, including the selection and prioritization of clinical trials.
Collaborate with cross-functional teams, including research, regulatory affairs, and commercial, to ensure alignment and efficient execution of the clinical development plan. Clinical Trial Management:
Lead the design, initiation, and execution of all clinical trials, ensuring adherence to regulatory guidelines and ethical standards.
Oversee the selection and management of contract research organizations (CROs) and other clinical trial partners.
Manage the budget and resources for clinical development activities.
Monitor and manage clinical trial data, ensuring data integrity and accuracy.
Oversee the preparation of regulatory submissions, including INDs, NDAs, and MAAs.
Lead and mentor a team of experienced clinical professionals, including clinical trial managers, data managers, and statisticians.
Foster a collaborative and high-performing team culture.
Recruit, develop, and retain top talent in clinical development.
Stay abreast of industry trends and emerging technologies in clinical development.
Identify and implement innovative clinical development strategies to optimize trial design and execution.
Proactively contributes to the growth and expansion of the clinical development function.
Qualifications:
Advanced Degree: MD, PhD, PharmD, or equivalent degree in a relevant scientific field.
Significant Experience: 10 years of experience in clinical development, with at least 5 years in a leadership role.
Proven Track Record: Successful track record of leading and managing clinical trials from early phase to late-stage development.
Expertise in Therapeutic Area: Deep understanding of the specific therapeutic area of focus for the company.
Regulatory Knowledge: Thorough knowledge of global regulatory guidelines (e.g., FDA, EMA, PMDA).
Strong Leadership & Communication Skills: Excellent leadership, communication, and interpersonal skills with the ability to build strong relationships and collaborate effectively with cross-functional teams.
Strategic Thinking: Ability to think strategically and develop innovative solutions to complex clinical development challenges.
Data-Driven Decision Making: Strong analytical skills and data-driven decision-making capabilities.
Job Type: Full-time
Schedule:
- Monday to Friday
Work Location: In person
