Director of Clinical Development

Director of Clinical Development

About the Company

Chipscreen Biosciences (stock symbol 688321. SH) is a leading China-based biotech company, founded in 2001, that specializes in the discovery and development of novel small molecule treatments. The company has successfully utilized its proprietary chemical genomics-based discovery platform to develop a portfolio of different drug products in oncology, metabolic disease, and autoimmune diseases. The company currently has over 1000 employees working in drug discovery, clinic development, product development and commercial manufacture (both DS and DP), regulatory, pharmacovigilance, IP, sales and marketing, and commerce and market access. The company’s business strategy is to generate first-in-class drug candidates internally in China, then partner at different stages for further co-development and commercialization in and outside China, and license-in products at different stages of development from outside partners for China market.

Chipscreen Biosciences (United States) Limited, based in Somerset, NJ area, is a fully owned subsidiary of Shenzhen Chipscreen. Company website: https://www.chipscreen.com/en/

This is an on-site position.

Essential Responsibility

Include (but are not limited to) the following:

• 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 Chipscreen’s 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.

Education and Professional Experience

• 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).

Other Essentials and Key Success Factors

· 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

Additional Requirement

To safeguard the health of our employees and their families, partners, visitors, and communities, Chipscreen requires that all employees be fully vaccinated against COVID-19 and provide proof of vaccination before beginning employment, except where prohibited by law. Requests for exemption will be considered and Chipscreen will provide reasonable accommodations unless doing so would pose an undue hardship.

Job Type: Full-time

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

Education:

• MD, Ph.D., or PharmD. (Preferred)

Experience:

• At least 10 years in all phases of clinical development gained working for pharmaceutical, biotechnology, or CRO company.

Job Type: Full-time

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus opportunities

Work Location: In person