Sr Manager/ Assoc Director/ Director of Clinical Operations

Location
San Mateo, CA
Salary
Based on qualifications
Posted
Nov 14, 2020
Required Education
Bachelors Degree
Position Type
Full time

Senior Manager/ Associate Director/ Director of Clinical Operations

Company Overview:

Innovent Biologics (USA), Inc. is the US Office of one of the largest and well-known biotechnology companies based in China focused on developing innovative therapeutics in oncology, autoimmune, metabolic and other major diseases.  We have a small start-up team environment situated within a ~$11 billion dollar Market Cap parent company with almost 3000 employees.

Established in 2011, Innovent has developed a fully-integrated platform which includes research & development, manufacturing, clinical development, and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 23 innovative assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas, with sixteen in clinical development, five in Phase 3 clinical trials, and will have 3 biologics approved this year, plus a PD-1 inhibitor, Tyvyt®, officially approved for marketing in China late 2018. 

On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong.  The company has strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi, Coherus, Alector, and other international pharmaceutical companies.

Job description:
The candidate works with CROs in the execution and management of primarily Phase 1 & 2 clinical trials in the U.S.

The successful candidate is provided with a lot of opportunity to be a manager and leader in clinical operations.  The candidate must understand the drivers of study timelines, and offering solutions that can help the CRO execute trials efficiently, and “rolling up his/her sleeves” to drive results regardless of what is needed.  

Responsibilities:

  • Manage US clinical trials through clinical study teams and through the use of CROs and internal resources.
  • Ability to risk-assess study goals, timelines and other study assumptions and compare CRO plans against company goals.
  • Planning, starting, and completing Phase 1 and 2 studies with aggressive timelines and goals.
  • Responsible for high-level oversight of 1-3 compounds/programs within clinical development.
  • Oversee the tactical implementation of clinical development plan for all assigned clinical programs by managing the site contracts, budgets, timelines, clinical trial vendors, CRO resources, patient enrollment and site activities.
  • Responsible for oversight and strategic direction and implementation across projects to ensure clinical programs are conducted to meet corporate goals, milestones, and budgets through close partnership with parties involved both inside and outside of the company.
  • Compile and maintain regular status reports of study progress and study specific timelines and ensure information is provided to project team leadership and senior management.
  • Maintains awareness of industry trends and developments to help define the future strategic direction for clinical trials design and execution.
  • Ensure clinical programs meet GCP and will pass corporate and regulatory authority audits.
  • Manage adverse event reporting, data clean up and study close out.

Knowledge, Experience and Skills:

  • Must be independent, a self-starter, and have the ability to “roll-up sleeves” to produce work-products.
  • Experience in oncology clinical development a must.
  • Must be aggressive (but have sufficient “soft skills”) to maintain relationships to accelerate timelines for achieving clinical operational milestones.
  • Must have experience dealing with academic IRBs and study ramp-ups to ensure timely “first-patient-in.”
  • Ability to prioritize and handle multiple tasks simultaneously

Specific Education and Experience:

  • BS degree in Biological Sciences, health care, or relevant scientific discipline required.
  • Minimum 3-5 years of relevant clinical operations experience, and at least 2-3 years proven experience leading a clinical study.
  • Skilled user in Microsoft Office (Word, Excel, Powerpoint) including creating Powerpoint presentations
  • Smart, high-energy and positive people
  • Local candidates only