BeOne Medicines · 6 days ago
Senior Director, Clinical Operations Lead, Biotech Unit
United States
Full-time
Hybrid
Director/Executive
$206K/yr - $276K/yr
8+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer, looking for a Senior Director to lead Clinical Operations in their Biotech Unit. The role involves overseeing clinical studies, managing budgets, and ensuring compliance with regulatory standards while driving the overall strategy of the unit.
Pharmaceuticals
Responsibilities
Accountable for driving clinical operations strategy in line with Biotech Unit asset development strategy
Within Biotech Unit, make recommendations in clinical operations area and accountable for clinical operations performance
Consult with Advisory Committee for relevant topics and incorporate the ideas into strategy and execution if appropriate
Accountable for resource planning and allocation and alignment with Execution Unit
Create and be accountable for annual budget and resource forecasts, as well as lead to define CST goals for the assets
Create and maintain compound level documents such as IB, ICF, DSUR
Ensure timely clinical drug supply
Oversee and ensure feasibility, study start-up, site management, drug supply and other clinical studies’ activities operating according to GCP and Health Authorities’ requirements
Provide guidance to Execution Unit at regional and global level and ensure timely, quality, and efficient study planning and execution of associated clinical programs/studies
Conduct regular review meetings with Execution Unit to mentor, support, and ensure all studies are tracking to budget and timeline
Report on study status, goals, operational KPIs, and enforce quality KPIs with support from Compliance team
Provide guidance to function team in Execution Unit and may provide coach and mentorship to the team members working on the assets when there’s performance concern and for team development purpose
Champions a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization
Provide expert knowledge on the execution of clinical trials through deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements
Point of escalation for all assets’ related issues and report back to Biotech Unit core team for discussion and alignment
Identify and drive process improvement initiatives in collaboration with GCPL team
Collaborates with other function leads within Biotech Unit to provide operational perspectives to enable effective and efficient delivery of clinical development goals
Understand and monitor assets’ landscape and competitors’ actions and progresses, and translate market intelligence into clinical strategy
Manage risks, opportunities, and issues effectively and transparently at strategic, tactical, and operational levels
Other duties as assigned
Qualification
Required
Strong project management skills, including ability to work independently, lead multiple projects simultaneously and consistently meet or exceed project deadlines in a fast-paced environment
Ability to seek and utilize benchmark data to monitor and champion opportunities to accelerate project timelines without compromising quality
Strong working knowledge of ICH Guidelines, Good Clinical Practices, and Regulatory Agency requirements
Proven ability to make sound judgement and decisions. Possess the ability to quickly assess problems/situations and provide effective resolution/solution
Excellent interpersonal skills and the ability to build and maintain positive work relationships to effectively interface at all levels across the organization
Detail-oriented without losing sight of the big picture
Ability to travel 20%
Have the ambition and passion to drive value and impact with a 'can-do' attitude, willing to take calculated risk
Adopt an open and creative mindset to pilot new concepts and overcome challenges
High learning agility
Drive strategic clinical operations within Biotech unit; integrate business case, mitigate risks and manage resources
Make operation-level decisions under set thresholds
Accountable for decisions even facing uncertainties and for implementation of development strategy
In-depth clinical operations knowledge to drive operational excellence
Sufficient experience and ability to work in an environment that requires seamless cross-function collaboration and handling complexity
Proven ability to effectively work in a cross-region, cross-function matrix; able to work effectively in diverse cultures, showing aptitude in modifying style
Business acumen - understand unmet market needs; provide clear path to win; demonstrated track record in driving innovation through to the global commercialization of assets
Strategic and Decisive Leader - leadership skills that demonstrate energy, passion, courage, vision and demonstrated competence in thinking strategically, analytically and innovatively; able to quickly and creatively analyze and provide solutions to complex challenges; proven experience as a successful decisive leader in a strategic multifunctional environment
Able to effectively communicate at multiple levels of the organization
Strong change management experience and experience with building new teams preferred
Bachelors degree and 12+ years or Masters degree and 8+ years in clinical or drug development in the biotech/pharmaceutical/CRO industry or the relevant clinical research field
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase