Clinical Development Lead in Cambridge, MA

Cambridge Crossing - MA - US • Madison - Giralda Farms • Princeton - NJ - US

Clinical Development Lead - Neuroscience/Psychiatry

Client cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters

Job Description

Position Summary

• CDLs are matrix leaders and managers who lead, develop, motivate and achieve results through teams; demonstrate a commitment to the development of a resilient attitude, embrace change and have an unwavering commitment to our People Strategy
• Serves as the clinical point of accountability for the Development Team and is responsible for navigating the overall clinical development plan for complex programs that have a large impact on the business. Ensures clinical studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals
• Serves as a matrix leader to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs)

Position Responsibilities

• Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication
• Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
• May serve as CTP as necessary
• Accountable in partnership with the Clinical Scientist and Statistician for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles
• Accountable for clinical content for CSRs, regulatory reports, briefing books, submission documents, and periodic updadates
• Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
• Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
• Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
• Serves as the (co-)leader of the cross-functional Clinical Development Team
• Provides clinical leadership and disease area expertise into integrated disease area strategies
• Partners closely with KOLs, to seek input into the design, execution, analysis and reporting of studies.
• Serves as Primary Clinical Representative in Regulatory interactions
• Evaluates strategic options against a given Target Product Profile (TPP)
• Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed
• Sets executional priorities and partners with CTP and CS to support executional delivery of studies
• Accountable for top line data with support of CTP, CS, and Statisticians
• Other clinical development responsibilities as assigned by Head of Late Development for Neuroscience

Degree Requirements

• MD preferably with appropriate sub-specialty training as appropriate
• At least 11years of relevant experience

Experience Requirements

• The Senior Director CDL has demonstrated leadership in the design and execution of multiple clinical trials having had significant experience as a senior clinical leader and exhibits all of the following attributes:
• Able to synthesize internal and external data to produce a clinical strategy.
• Demonstrated success in formulating clinical development strategy across increasingly complex clinical programs with large impact on the business.
• Able to ensure that the clinical program will result in a viable registrational strategy
• Demonstrated success in designing and executing multiple clinical trials, with significant experience as a clinical leader.
• Has achieved the knowledge base to serve as a a trusted internal expert in the therapeutic area, asset, indication, and clinical development, and is viewed as a peer by external academic collaborators and other KOLs.
• Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts
• Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio
• CDL has demonstrated sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent
• Verifiable track record of successful people management and development or leadership in a matrix team (e.g. mentoring junior colleagues)
• Interface across multiple functions to mediate conflict resolution, and champion an organizational culture to promote behaviors that lead to meaningful synergies and superior performance.

In addition, the CDL should have all the following experiences and capabilities:

• Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results
• Ability to recognize, articulate, and accept calculated risks to make informed decisions
• Deep understanding of the fundamentals of protocol development and follow up, including but not limited to study monitoring, data collection and analysis, database cleaning and database lock
• Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements
• Comfortable working in a fast-paced environment; ability to support multiple, complex, studies in parallel
• Willing to work outside of a traditional functional environment, in a team unified around serving the assets
• Willingness and ability to form strong, productive partnerships with external providers/thought leaders
• Possess excellent communication skills and experience delivering effective presentations on both technical and non-technical subjects.

Key Competency Requirements

• CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s)
• External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of Client
• Partner and interact with colleagues from Early Development who design and implement first in human through proof-of-concept trials and will to assure a seamless transition into late-stage development (Phase II-III trials)
• Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables
• Minimum 3 years’ experience as a medical monitor with proven track record designing and overseeing clinical trials, ideally both early and late stage
• Experience supervising CRO-driven studies
• Experience with health authorities and regulatory submissions
• Understanding of the clinical development process, and the role of non-R&D functions: commercial, health outcomes, access, medical
• Proven ability to partner effectively with key internal and external stakeholders
• Excellent communication skills for conveying scientific data and for internal and external interactions

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