Director Clinical Development Jobs in Maynard, MA

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington's disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to "Reimagine Possible", we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.
Description:
The Director, Clinical Development is responsible for providing clinical leadership for product(s) in development. This includes the design, planning, execution, scientific integrity, and medical oversight of clinical studies for all phases of development for various therapeutic areas (TA) including cardiometabolic, hepatology, and potentially additional TA programs from early clinical development through regulatory approval. The Director, Clinical Development will collaborate closely with cross-functional partners including Clinical Operations for study design and implementation, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biostats, Quality Assurance, Program Management, Preclinical Development and other functions to ensure aligned strategy and execution of all programs. This person will oversee medical monitors and provide medical input to relevant documents (e.g. IB, IMPD, DSUR, SUSAR, IND, NDA/BLA, PIP, etc.). The Director, Clinical Development will be responsible for interpretation and dissemination of study results, including clinical study reports and related publications as well as present data at conferences and other scientific or regulatory forums. This position serves as a core member of the clinical development team, will contribute to devising the overall clinical strategy and ensure all activities occur in compliance with the appropriate regulations. They will provide support to translational medicine efforts within assigned TA, working closely with research to define strategy and grow the discovery pipeline. The successful candidate will support the SVP, Clinical Development in providing medical input into the design of clinical development programs, and strategic and tactical plans for investigational products.
Experience:

• Board certified MD required
• Formal cardiometabolic and/or hepatology training is preferred
• 5+ years of industry experience or combined industry/academic experience
• Experience with all stages of clinical development
• Proficient in all aspects of management of clinical trials from inception to completion across all phases of development including study design
• Significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management

Responsibilities:

• Champion product(s) under development
• Serve as a subject matter expert (SME)
• Keep up to date on current literature, competitive environment, and regulatory guidelines
• Provide oversight and management of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Wave SOPs
• Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Wave SOPs
• Review clinical data from all phases of development and assist in generating study reports and publications
• Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Wave departments (e.g., Regulatory, PV, and Biometrics, etc.) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished
• Serve as study medical monitor, as needed
• Develop and maintain professional relationships with academic and community-based study sites, consultants, HCPs, and KOLs
• Represent Wave in interactions with regulatory agencies
• Provide input and support the SVP, Clinical Development in managing program budgeting and financial planning
• Deliver management personnel with timely updates on progress and changes in scope, schedule, and resources as required
• Develop and implement SOPs for clinical trials and related activities, as required
• Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians
• Interface with departments within and outside of R&D including Finance, Legal, etc.
• Analyze and present study data in conferences and scientific forums
• May mentor and manage matrix and direct reports (if applicable)

Key Skills:

• Strong scientific background in cardiometabolic diseases
• Expertise in project planning, leadership, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems
• Knowledge of FDA and ICH regulations
• Competence in clinical medicine and clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing)
• Familiarity of Good Clinical Practice (CGP)

Pay Range External Disclosure Statement
The annual base salary range for this position is $255,000 - $345,000.
The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees' and their families physical and financial health and overall well-being. These include, but are not limited to, company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), and 401K participation with matching contributions.
Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences' employees to perform their job duties may result in discipline up to and including discharge.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.