Senior Medical Director-Biotech Unit

Reporting to the Clinical Development Lead, Biotech Unit (BU), the position is a member of BU and contributes to clinical development strategy and supports successful execution of clinical development programs in BU.

Leveraging deep therapeutic and functional area expertise, the incumbent will play a key role in medical monitoring for pivotal stage studies, will be accountable to jointly develop clinical program strategy and help assure that activities are executed within expected scope, budget and timelines. The incumbent will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research to ensure successful deliveries by study team.

Essential Functions of the Job:

• Facilitate generation of, author, update, and/or review key documents, including, but not limited to:

• Protocol concepts, synopses, protocols, and amendments of Informed consent documents;

• Investigator Brochures, Clinical study reports;

• Abstracts, posters and manuscripts o 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.

• Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies.

• Provide scientific expertise for selection of investigator and vendors.

• Train BeOne colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol.

• Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CRO’s.

• Review, query, and analyze clinical trial data.

• Interpret, and present clinical trial data both internally and externally.

• Represent a clinical study or development program on one or more teams or subteams.

• Create clinical study or program-related slide decks for internal and external use.

• Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings.

• Contribute to or perform therapeutic area/indication research and competitor analysis.

• Build strong relationships with internal experts.

• Identify continuous process improvement opportunities.

• Identify incremental organizational resource needs – staff, budget, and systems.

• Develop, track, execute and report on goals and objectives.

• Support budget planning and management.

• Be accountable for compliant business practices.

Basic requirement and experience :

• 6+ plus years of experience and success within other biotech/pharmaceutical companies.

• MD or DO or international equivalent degree required.

• Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical development role.

• Minimum 3 years relevant work experience in oncology clinical development. Experience in conducting lung Cancer clinical trials strongly preferred.

• Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing.

• High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.

• Knowledge of GCP and ICH Guidelines

• Flexibility to work with colleagues in a global setting.

• Able to engage in work-related travel approximately 25%.

• Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred.

• Experience with the development and support of related SOPs and policies is expected.

• Knowledge of industry standard Clinical Development IT solutions expected.

Entrepreneurship & creativity:

· 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

Strategic thinking:

· Support strategic clinical development within Biotech Unit; integrate business case, mitigate risks and manage resources

Adaptability:

· Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Cross-functional knowledge & expertise:

· In-depth medical knowledge to drive operational excellence

· Sufficient experience and ability to work in an environment that requires seamless cross-function collaboration and handling complexity

Critical Competencies & Experience:

· 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

· Able to effectively communicate at multiple levels of the organization

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.