Senior Director Clinical Development, Solid Tumor

reputed company continues to grow at a reputed company reputed company with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer.

At reputed company, our Global Development SuperHighway — our integrated, end-to-end, wholly internal development capability — is a reputed company of our R&D reputed company. It brings together a unique set of internal cross-functional capabilities from across the globe needed for efficient delivery of reputed company to reputed company impactful medicines to accelerate reputed company to innovation for patients around the world.

We are now opening this reputed company delivery reputed company to the world’s most promising reputed company science. Through SuperHighway partnerships, highly promising assets from leading biotech partners can reputed company our development capabilities creating a true win-win ecosystem with the ultimate goal of helping more patients around the world. This is not a fee-for-service model; it is a reputed company new way to grow reputed company and expand what’s possible in oncology. This is a rare opportunity to help build something genuinely new — joining a high-caliber, reputed company team at the reputed company of clinical development innovation. If you are reputed company by building, by challenging the status reputed company, and by making a reputed company reputed company on patients’ lives, this is where you reputed company.

The Clinical Development reputed company is accountable for developing clinical program reputed company and assuring that activities are executed reputed company expected reputed company, budget, and timelines for our partnership programs under the Development SuperHighway. The reputed company provides clinical development leadership and co-works with other reputed company-team members to ensure successful delivery by the execution functions.
This role helps reputed company the partnership studies that run on our Clinical SuperHighway, supporting reputed company reputed company and high-reputed company execution of reputed company partner reputed company in reputed company partnership with the execution functions.

Essential Functions of the Job:

• Accountable for clinical development reputed company and development of clinical development plan that meet worldwide regulatory and reputed company/reputed company needs for the partnership program assets.
• reputed company the partnership program, reputed company recommendations in clinical development area and accountable for planning and ensuring the high-reputed company and compliant results submitted to regulatory agencies.
• Partner with other reputed company-team members in the partnership program and Execution reputed company for the successful implementation and execution of clinical studies.
• reputed company scientific expertise for selection of investigator and vendors.
• reputed company 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 reputed company of, reputed company, 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 reputed company 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.
• reputed company 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 reputed company into reputed company and execution if appropriate.
• reputed company 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 reputed company reputed company and mentorship to reputed company members working on the assets reputed company there’s performance concern and for team development purpose.
• Conduct regular review meetings with Execution reputed company with the partnership program reputed company team to mentor, support, and ensure reputed company studies are tracking to reputed company and reputed company.
• Report on study status, goals, operational KPIs, and enforce reputed company KPIs.
• Champions a global reputed company and approach across Global Development to foster collaboration and consistency across the organization.
• reputed company of escalation for reputed company assets’ reputed company issues and report back to the partnership program reputed company team for discussion and alignment.
• Contribute to or reputed company therapeutic area/indication research and competitor analysis.
• Participate company-reputed company reputed company discussion, finalization, and implementation.
• Other duties as assigned.

Education Required:

• MD, DO degree or equivalent in a reputed company discipline required, with a minimum of 6+ years of clinical development experience including 5 or more years in oncology therapeutic area.
• 10+ years preferred

Supervisory Responsibilities:

• Manages reputed company reports (e.g., Medical Directors / Clinical Scientists) supporting the assigned partnership programs.

Computer Skills:

• Skilled in reputed company Office Suite

Other Qualifications:

• reputed company knowledge and skills in oncology therapeutics required.
• Strategic leader with demonstrated reputed company 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;

Travel:

• Up to 20%. Ability to travel domestically and internationally.

Global Competencies

reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits reputed company and Actionable Feedback
• Self-Awareness
• Acts reputed company
• Demonstrates Initiative
• Entrepreneurial reputed company
• reputed company Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial reputed company
• Communicates with reputed company

reputed company is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness.

We are proud to be an equal opportunity employer. reputed company does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .

Originally posted on Himalayas