- Design and oversee execution of multi-layered clinical development strategies
- Maintain compliance with regulatory guidelines, that identify opportunities for breakthrough therapy designation and accelerated approval while identifying subsequent opportunities for label expansion
- Inform global registration strategy by providing expert medical review, assessment, and interpretation of clinical data and preparing results for presentation to regulatory authorities
- Manage drug safety and pharmacovigilance activities for ongoing trial(s)
- Prepare clinical portions of IND submissions and BLAs, including protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios
- Rapidly integrate new insights from on-going in-house or external clinical trials, translational science into development plans and clinical trial activities
- Create compelling data presentations for external disclosures
- Collaborate with research leadership and drug discovery teams to shape the company's drug discovery portfolio
- Develop and maintain key opinion leader relationships and serve as the clinical lead for advisory meetings
- Establish and maintain relationships with external companies (such as CROs), investigators and opinion leaders to optimize performance on clinical trial activities
- Prepare manuscripts for technical journals and make presentations at scientific meetings
- Work collaboratively with Research to provide input into design of preclinical studies to support drug products entering or in the clinic and by helping initiate IND submissions
- Provide input to evaluate products for in licensing/out licensing
- Participate in business development processes as needed
- Provide clinical portion of regulatory documents such as Investigator Brochure updates, and Drug Safety Update Reports
- Manage and be responsible for pharmacovigilance for clinical projects including review and reporting with support from the pharmacovigilance team
- Provide leadership and guidance for the clinical development team to ensure efficient execution to meet deliverables and timelines
- Oversee medical monitor activities for all phases of studies through direct execution of activities or supervision of a medical monitor
Education and Skills Requirements: - PhD, PharmD, or MD required
- 20+ years of progressive relevant experience within the biopharmaceutical/biotech industry in translational medicine/biology, clinical pharmacology or directly related discipline, preferably in the biopharmaceutical/biotech industry
- Experience in design and executing clinical trials; protocol development and design, development of case report forms, and statistical analysis plans; experience in rare disease drug development is preferred
- Demonstrated scientific and business acumen and the ability to influence senior leaders and stakeholders and lead complex partnership and alliance activities
- Provide clinical support and work with other members of the leadership team to develop and communicate the overall corporate strategy\
- Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trials
- Strong knowledge and experience across all phases of drug development
- Liaise with drug discovery, pharmacology, research and toxicology as necessary in order to finalize a pre-clinical program which will permit the most efficient clinical development of new chemical entities within the framework of the project team
- Propose upon consultation with clinical operations pragmatic solutions to ensure the efficient ethical & quality conduct of clinical trials
- Experience writing and reviewing clinical sections of study reports and regulatory documents (IND, BLA, MAA)
- Effective leadership, people management, communication skills and a team builder management style are essential; must be willing and able to be "hands on"
- Start-up/small company experience required, with willingness to be hands-on
- Demonstrated ability to manage multiple complex projects and programs simultaneously
- Excellent attention to details, critical thinking, and data interpretation
- Strong communication (oral and written) and interpersonal skills
- Excellent organizational, multi-tasking and collaboration abilities
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. -
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SVP, Head of Clinical Development - Waltham, United States - Dyne Therapeutics
Description
Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary:
The SVP, Head of Clinical Development will provide strategic direction and technical leadership to the clinical development team including clinical-regulatory development planning, clinical trial design, implementation and execution, clinical data analysis and management, and clinical competitive intelligence. This individual will provide strategic leadership for the clinical and medical aspects and will work closely with a cross-functional team to align the clinical development plan with the overall development strategy of the relevant products. The role is responsible for overseeing trials in clinical development and pharmacovigilance according to established timelines, for establishing and maintaining close working relationships with internal and external partners, and for providing the clinical regulatory landscape for each of the clinical programs. The Head of Development will act as a cross functional advisor and will work closely with the internal and/or external Clinical Development, Pharmacovigilance, biostatistics group(s), R&D, Regulatory, and the Commercial Development teams to execute clinical trial strategy and design.
This role is based in Waltham, MA without the possibility of being remote.
Primary Responsibilities Include:
