Senior Director, Clinical Development - Oncology

The Role:Moderna is seeking a board-certified medical hematologist/oncologist with pharmaceutical experience (or M.D. with oncology drug development experience) to lead Clinical Development for one or more of their immuno-oncology-based development programs. This role will report to the Head of Clinical Development Oncology, for Moderna and have direct medical responsibility for the clinical development programs including creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring all in close collaboration with relevant internal and external pharmaceutical partners and Clinical Research Organizations.The successful candidate will thrive in a proactive can-do culture and enjoy working across the full range of clinical development activities for the ground-breaking, mRNA-based immuno-oncology-based new drug candidates in addition to being a highly-effective internal and external team player and terrific communicator and collaborator.Here’s What You’ll Do:Providing integrated and innovative clinical development strategy to support 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.Scientific Leadership, Direction and Strategy: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.Assessing and predicting when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit.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.Study & Program Design and Evidence Generation: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.Creating Innovative Scientific and Technical Solutions: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.Here’s What You’ll Bring to the Table:Board Certification in medical hematology and/or oncology with 5 years’ experience in clinical development with at least 3 years in the biopharmaceutical industry, or M.D. with 5 years of experience in oncology drug development in biopharmaceutical industry.Experience in immune-oncology or oncology clinical drug development, preferably in a pharmaceutical or biotechnology company, as well as significant knowledge and experience in the design and execution of clinical trials. Background working in development programs that heavily integrate translational medical approaches a must.Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).Outstanding verbal and written communication skills, in addition to excellent organizational skills.Understanding of the entire drug development process, including clinical and non-clinical study design and execution.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.Oversee activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct.Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world.Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication.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.Excellent analytical, problem-solving and strategic planning skills.Ability to thrive in a fast-paced environment.Embodies Moderna’s core values of Bold, Relentless, Curious and Collaborative.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.Moderna is a smoke-free, alcohol-free and drug-free work environment.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

#J-18808-Ljbffr