Senior Director Clinical Development, Solid Tumor

BeiGene

2d•$299,800 - $369,800•Remote

About The Position

BeOne is experiencing rapid growth and is seeking experienced professionals who are highly motivated, collaborative, and passionate about fighting cancer. The company's Global Development SuperHighway is an integrated, end-to-end internal development capability designed for efficient clinical trial delivery and the development of impactful medicines. This capability is now being extended to external science through SuperHighway partnerships, allowing promising assets from biotech partners to access BeOne's development expertise. This role offers a unique opportunity to build something new within a high-caliber, agile team at the forefront of clinical development innovation, with a focus on making a real impact on patients' lives. The Clinical Development Lead is accountable for developing clinical program strategy and ensuring the execution of activities within scope, budget, and timelines for partnership programs under the Development SuperHighway. This role provides clinical development leadership and collaborates with core-team members to ensure successful delivery by execution functions. The position supports the seamless onboarding and high-quality execution of external partner projects within the Clinical SuperHighway.

Requirements

MD, DO degree or equivalent in a related discipline required, with a minimum of 6+ years of clinical development experience including 5 or more years in oncology therapeutic area.
Skilled in Microsoft Office Suite
Professional knowledge and skills in oncology therapeutics required.
Strategic leader with demonstrated success building, managing, and developing teams.
Working knowledge of applicable international compliance guidelines and regulations.
Experience working in a global environment required; deep understanding of immuno-oncology strongly desired.
Fluent in written and verbal English;

Nice To Haves

10+ years preferred
deep understanding of immuno-oncology strongly desired

Responsibilities

Accountable for clinical development strategy and development of clinical development plan that meet worldwide regulatory and commercial/access needs for the partnership program assets.
Make recommendations in clinical development area within the partnership program and accountable for planning and ensuring the high-quality and compliant results submitted to regulatory agencies.
Partner with other core-team members in the partnership program and Execution Units for the successful implementation and execution of clinical studies.
Provide scientific expertise for selection of investigator and vendors.
Provide scientific and medical guidance/support throughout conduct of a clinical trial.
Review, query, and analyze clinical trial data.
Interpret, and present clinical trial data both internally and externally.
Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings.
Facilitate generation of, author, update, and/or review key documents, including, but not limited to protocol concepts, synopses, protocols, and amendments, informed consent documents, Investigator Brochures, Clinical study reports, abstracts, posters and manuscripts, as well as clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports, Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports, risks / benefits analysis for applicable documents, Clinical Development Plans etc.
Provide responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, investigators, and CROs etc.
Consult with Advisory Committee for relevant topics and incorporate the ideas into strategy and execution if appropriate.
Provide guidance/training to function team in Execution Unit, CRO staff and study site staff on the therapeutical area, molecule, and/or clinical protocol and may provide coach and mentorship to the team members working on the assets when there’s performance concern and for team development purpose.
Conduct regular review meetings with Execution Units with the partnership program core team to mentor, support, and ensure all studies are tracking to quality and timeline.
Report on study status, goals, operational KPIs, and enforce quality KPIs.
Champions a global mindset and approach across Global Development to foster collaboration and consistency across the organization.
Point of escalation for all assets’ related issues and report back to the partnership program core team for discussion and alignment.
Contribute to or perform therapeutic area/indication research and competitor analysis.
Participate company-wise standard discussion, finalization, and implementation.
Other duties as assigned.