Position Summary
This position will be primarily responsible for providing strategic and scientific leadership for the clinical programs as well as setting the clinical strategy for approved products and being involved with programs in all stages. This role will lead the design, plan and execution of clinical trials, and running of programs focused on assigned therapeutic areas, in accordance with applicable regulatory and quality standards, and company timelines and budgets. Activities are geared toward ensuring that all clinical activities related to clinical trials are managed effectively in support of regulatory submissions and subsequent approval. This role includes being more broadly a thought partner with the leadership team for clinical development strategies.
Essential Functions
- Lead the development and execution of clinical development plans to drive programs through clinical studies. Identify needs, contingencies and operational plans, while also ensuring strategic positioning is in line with company goals.
- Serves as the top representative for clinical development/medical strategy areas both internal and external facing.
- Lead the Clinical Development team, in close collaboration with all involved cross functional line functions such as Clinical Operations, Biostatistics, Regulatory etc., of designated clinical studies.
- Provide strategic input on new indications and/or opportunities for antibodies already in development as well as for novel antibodies entering the clinic
- Work closely with the Research team helping in the identification of novel targets
- Write and/or facilitate the writing of clinical project management documents such as project scope definition documents, project training materials, monitoring plans and monitoring tools, study protocols, safety plans, recruitment plans and closeout plans, etc.
- Coordinate with Clinical Operations – the execution of operational aspects of assigned clinical studies (including identification, selection, qualification and management of clinical investigators and third party vendors, test article release to sites, site monitoring activities, ongoing review of key study data, etc.).
- Facilitate and/or review and approve monitoring reports and follow-up letters prepared by the project CRAs for assigned studies.
- Plan and review the analysis of clinical data in collaboration with Data Science group, and determine the ultimate interpretation of results.
- Ensure, along with Clinical Operations and Regulatory team, the assigned trials are “audit ready” at all times (project team training records, current regulatory documents, appropriate IRB approvals, monitoring tools required for the trial). Ensure that any audit observations are addressed appropriately and in a timely manner.
- In collaboration with Clinical Operations develop and maintain project schedules, with key metrics, for clinical projects to ensure optimal study management. Identify and resolve issues that impact project scope, resources. or timelines and communicate to senior management.
- Develop and monitor overall clinical development budget for assigned projects; effectively manage resources, funding and expenses.
- Assist with tracking and forecasting resource capacity and utilization to ensure that required clinical development resources are available when needed and optimally utilized.
- Provide therapy area medical and scientific expertise to study teams and key stakeholders.
- Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning.
- Serve as principal medical monitor overseeing all aspects of the safety monitoring in the clinical development programs.
- Prepare clinical sections of regulatory documents such as investigator brochures, INDs, NDAs, BLAs, background packages for FDA meetings, etc. Provide medical review and approval of regulatory documents pertaining to the work of the clinical team.
- Cultivate and nurture strong collaborations with key opinion leaders, Investigators, research centers and corporate partners.
- Collaborate 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.
- Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision.
Supervisory Responsibilities
May manage other employees in the Clinical Development Department; would be responsible for the overall direction, coordination, and evaluation of these employees, carrying out supervisory responsibilities in accordance with the organization's policies and applicable laws. Duties would include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Requirements
Education and Experience:
- MD and US medical license, with 15+ years of clinical drug development related experience in the research and development of novel biologics.
- Expertise in preclinical, translational and early clinical development.
- Extensive academic and pharma collaborative network.
- Track record of program leadership and achievement of goals and deliverables, of effective collaboration, effectiveness in team settings, and team leadership
- Experience with Microsoft Word, Excel, PowerPoint, Outlook, Adobe, and Internet Explorer.
Knowledge Requirements:
- Firm understanding of the mechanistic basis of human inflammatory disorders
- Thorough understanding of clinical protocols and regulatory processes.
- Excellent understanding of the drug development process
- Thorough knowledge of FDA requirements, Good Clinical Practices, and pharmaceutical clinical development.
- Demonstrated success establishing, communicating and driving a vision and strategy for a therapeutic area/product, and develop an integrated plan of action including milestones and endpoints and ensure executional excellence.
- Viewed as a leader within 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.
Personal Competencies:
- Effective communication and interpersonal skills, with the ability to successfully articulate strategies, experimental results and analysis to various constituents such as governance committees, project teams, clinical sub-teams, and other senior management to build enthusiasm, passion and commitment, and to gain approval /sponsorship for projects. Speaks clearly and persuasively in positive or negative situations; Listens and seeks clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Ability to respond effectively to the most sensitive inquiries or complaints.
- Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well, with the additional ability of being able to build morale and group commitments to goals and objectives;
- Ability to garner support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change.
- Ability to work productively in a matrix team environment, as well as take ownership of multiple projects.
- Ability to define issues, collect and analyze complex data, and draw valid conclusions.
- Handle obstacles and roadblocks by anticipating challenges and preparing well thought out arguments and contingencies. Ability to develop strategies to achieve organizational goals; demonstrates an understanding of organization's situation and goals; analyzes market and competition; identifies threats and opportunities; adapts strategy to changing conditions.
- Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
- Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
Work Environment
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. May be required to travel by plane domestically and internationally about 20% of the time
