Exec Med Dir, Program Ld GCR&D
Other Locations:US- NJ- Summit East
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Clinical Program Lead is a senior medical leader within the Global Clinical R & D function and is responsible for leading clinical program(s) for one or more compounds in multiple indications and high complexity. Accountable, as a leader within assigned global therapeutic area, for the design, implementation, execution and submission/approval of clinical development program(s) to support decision milestones, regulatory requirements and commercial and financial targets. May have people management responsibilities for study level medical directors with responsibility for designing and executing clinical trials, and running programs focused in assigned therapeutic areas for Phases 1 through 3, including biomarkers, proof-of-concept and full development.
Responsibilities will include, but are not limited to, the following:
- Provide therapy area medical and scientific expertise to study teams and key stakeholders.
- Lead the development of the clinical strategic plan for program/therapy area. Identify what is needed to drive the program/therapy area and the specific operational plan to get there.
- Ensure that the strategic positioning is in line with company goals and anticipate and plan for problems/challenges and establish contingency plans and course corrections.
- Manages, forecasts, and allocates resources for the clinical program with support from Therapeutic Area Head (TAH). Accountable for timely execution of clinical deliverables within approved budget
- Member of the Clinical R&D extended leadership team
- Ensures career development of functional reports (Medical Directors) through active participation in the performance management and talent planning processes. Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of team members as appropriate.
- Attracts and develops talent, coaches and mentors others to higher levels of performance. Creates an atmosphere of innovation and continual improvement.
- Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning.
- Engage and inspire the program/clinical development teams through communicating the strategic vision and the operational plan to achieve the vision.
- Oversee quality, coordination and timeless of clinical sections of IND's, Investigator Brochures, CTA's , ISS', ISE's and clinical expert reports.
- Represent the team with internal and external leaders and instill confidence in stakeholders by possessing a broad knowledge of the pharmaceutical industry and business environment and their impact on the product/therapy area.
- Work with Therapeutic Area Head and other team members to prepare abstract, manuscripts and presentation for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
- Lead the development of a significant clinical development budget and effectively manage resources, funding and expenses across assigned programs.
- Cultivate and nurture strong collaborations, relationships and support with Investigators, Academic partners and KOL's.
- Collaborate extensively with Business Development, Senior R&D and Commercial leadership to identify, recommend and develop strategic alliances, partnership and licensing opportunities requiring due diligence work and strategic input.
- The ability to establish, communicate and drive a vision and strategy for the therapy area/program and develop and integrated plan of action including milestones and endpoints and ensure executional excellence.
- Viewed as a global leader with the therapeutic area/disease state and considered a scientific contributor and innovator within internal and external spheres of influence.
- The ability to think globally, strategically and innovatively about the future of the disease state and company's therapeutic agents and possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business, including Marketing and Sales, Market Access, Pricing/Reimbursement, Business Development, Medical Affairs and Supply Chain.
- 8 years of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through IV.
- 8 years of demonstrated leadership and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing), or section of clinical programs in a global/matrix environment (including remote) in pharmaceutical or biotech industry.
- People management experience preferred, this may include management in a matrix environment. Global people management experience desirable.
- Excellent leadership, management, interpersonal, communication, and problem solving skills.
- Excellent negotiation and diplomatic skills, experience with health authorities required
- Considerable organizational awareness (e.g., inter-relationship of departments, business priorities), including significant experience working cross-functionally and in global teams.
- In-depth Medical/scientific and operational expertise in hematology/oncology. Demonstrated technical knowledge and innovation in clinical development study designs that provide relevant evidence to decision-makers.
- Create complex strategies to develop the franchise or product and successfully articulate this to various constituents such as governance committees, project teams, clinical sub-teams, and other senior management to build enthusiasm, passion and commitment.
- Build teams by understanding the skills and capabilities needed to effectively meet goals and objections and align them with the talents and capabilities of team members.
- Reinforce open-mindedness, diversity of thought, collaboration, best practice sharing and risk taking among team members and stakeholder groups.
- Make significant decisions and recommendations and persuasively present data and support materials to gain approval and sponsorship for projects from senior management.
- Optimize extensive knowledge of the clinical development process and strong relationships with team members, colleagues and internal and external stakeholders to achieve results.
- Foster innovation and informed risk taking among staff members and study team colleagues.
- Act as an agent for change when new projects are launched or priorities change by creating and communicating value proposition or business rationale.
- Present opinions and recommendations persuasively and authoritatively utilizing compelling information, strong influencing skills, personal credibility and strength of one's convictions and commitment.
- Handle obstacles and roadblocks by anticipating challenges and preparing well thought out arguments and contingencies.
Garner support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change.Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.