Sr. Director – Clinical Development – Autoimmune – Cardiovascular – CV – Pulmonary and Rare Diseases
| Company | Moderna |
|---|---|
| Location | Cambridge, MA, USA, Princeton, NJ, USA, Bethesda, MD, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | PharmD, PhD, MD |
| Experience Level | Senior |
Requirements
- MD degree and 5 years’ experience or advanced degree (Ph.D, pharm D) with extensive experience in clinical development, preferably in rare disease
- Advanced medical training or experience in an internal medicine or pediatric-related field
- Ability to thrive in a fast-paced environment
- Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals
- Excellent analytical, problem-solving and strategic planning skills
- Extensive experience in clinical drug development with an understanding of multiple diseases, the underlying biology and potential therapeutic targets as well as current and future potential treatment options in all clinical trial phases.
- Extensive clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
- Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
- Proven ability to maximize and integrate genetic data to advance disease understanding and inform and guide clinical development plans
- Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
- Demonstrated experience using new learning and digital tools to create innovation in other areas
- Expertise in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content
- Embodies Moderna’s core values of Bold, Relentless, Curious and Collaborative.
Responsibilities
- Providing integrated and innovative clinical development strategy to lead the creation and management of the Clinical Development Plan (CDP) for an asset in development
- Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP
- Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
- Establishing expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP
- Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics
- Contributing to and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development
- Playing an active role in the technical and leadership development of Clinical Sciences staff via coaching and mentoring and potential direct line management
- Employs visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s). Leads selected clinical development projects for products/franchise of compounds
- Leading and positively interfacing with and influencing across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need
- Integrating inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Target Product Profile. Accountable for the clinical components of the Target Product Profile.
- Accountable for risk/benefit of the asset. Actively leads and makes decisions which balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; takes action to mitigate risk where appropriate
- Anticipating problems and proactively seeking input from other teams’ members/functional lines within R&D. Uses scientific/operational expertise to solve study and/or project related problems
- Accountable for the evaluation of clinical study/program probability of technical success
- Drives the end to end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management
- Leads clinical development discussions at regulatory interactions and clinical components of the submissions (e.g. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses
- Delivers value and access insights to inform medical strategy, expand market access and to address unmet patient need
- Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technology
- Champions implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions.
Preferred Qualifications
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No preferred qualifications provided.