Our client, a leading Life Sciences company, is hiring a Director of Clinical Development.

Work Location: Somerset County, New Jersey

Summary:

• Plans and designs studies consistently with product development and clinical development plans, embracing innovation. Studies the literature and consults with internal experts, external advisors, and advisory boards, contributing to identifying these experts and assembling these boards. Identifies the desired study population by delineating subject eligibility criteria for study participation and pursues the demonstration of drug activity by selecting clinical and mechanistic endpoints. Act as clinical study leader.
• May lead the Global Development Team for assigned molecules; providing scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
• Build the innovation strategy and partner with the head of marketing to define a differentiated pipeline.
• May assist in the clinical evaluation of business development opportunities.
• Oversee the vendor medical monitor, including addressing questions related to protocol execution, subject eligibility, safety reporting, and safety coding, or may serve as medical monitor.
• Play a leading strategic role in translating customer needs into product requirements, design targets, and specifications that guide the development of products and cooperate with other equities to develop design targets and product briefs. Ensures the constant flow of information to incorporate -whenever possible- local/regional insights into design targets and optimize future leverages or geographic expansion.
• As the Clinical Development Lead, be responsible and accountable for the scientific validity and integrity of the Clinical Development Plan and all clinical content, including, but not limited to protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions, and publications associated with the clinical trials.
• Provides leadership for the creation of all regulatory-related documents and ensures compliance with FDA/ICH guidelines and corporate SOPs and budgets.

Qualifications:

• Medical Degree (MD or DO) strongly preferred; a PharmD, or Ph.D. will be considered if accompanied by strong directly relevant experience within clinical trial management and medical monitoring.
• At least 10 years of clinical development experience in the pharmaceutical/biotech Industry.
• Demonstrated experience successfully managing clinical trials in multiple phases, including the selection, management, and oversight of key third-party vendors and CROs.
• Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders.
• The ability to communicate effectively verbally and in writing to internal and external KOLs and stakeholders, as well as partners is essential.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Intellectual curiosity, innovation, and creative problem solving with an entrepreneurial spirit.
• Demonstrated ability to successfully work within a nimble and matrixed organization where mental agility and emotional intelligence can be key to delivering successful outcomes.
• Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve.
• Highly organized and detail-oriented with a passion to deliver quality results.
• Highest levels of professionalism, confidence, personal values, and ethical standards.
• MD, Ph.D., or PharmD. (Preferred)
• At least 10 years in all phases of clinical development gained working for pharmaceutical, biotechnology, or CRO company.

Benefits:

• Competitive compensation
• 401(k)
• 401(k) matching
• Dental Insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8-hour shift

Supplemental Pay:

• Bonus pays

Published Category: Clinical Operations & Development