Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women's health and prostate cancer designed to improve the lives of millions. We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and enthusiastic individuals who share our excitement for this mission. Summary Description
We are currently seeking a dynamic, highly motivated, experienced individual for the position of Senior Scientist, Toxicology
(Nonclinical Safety Assessment) commensurate with academic and/or industry experience. The position reports to the Senior Director, DMPK & Toxicology
within the Early Clinical Development (ECD) department at Myovant. The location of the position is in Brisbane, CA
but flexibility for a remote work plan is possible for the right candidate.
The position will serve an important role in the growth of early-stage Research and Development programs for Myovant Sciences. The individual will work closely with cross-functional team members to advance early-stage programs through preclinical development. Responsibilities include 1) providing subject matter expertise in toxicology/nonclinical safety assessment on cross-functional project teams for Myovant's existing assets, 2) evaluation of promising new therapeutic opportunities identified through industry partnerships and/or academic collaborators, 3) contribute to the development of nonclinical development plans, 4) serve as a project leader on early-stage programs, and 5) author regulatory documents (eg, INDs, IBs, NDAs) within subject area expertise, as necessary.Essential Duties and Responsibilities
- Serve as nonclinical functional representative on project teams (toxicology/nonclinical safety assessment)
- Responsible for preparation of nonclinical development plans (program-level) and effectively liaise with key partner line functions to identify potential challenges and risks, develop solutions and/or devise mitigation strategies.
- Serve as Project Lead and/or functional representative for strategic early-stage research partnerships. Responsible for establishing a core team (internal and/or external experts) to identify, evaluate, and advance preclinical projects and research partnerships. The candidate will integrate with ECD team to effectively transition early-stage projects into development as appropriate.
- Conduct diligence activities on nonclinical aspects of external programs through the evaluation of licensing-in opportunities with a focus on endocrinology and women's health as well as oncology.
- Contributor to the preparation of regulatory documents, including INDs, IMPDs, CTAs, Investigator Brochures, Briefing packages and responsible for authoring and finalization of nonclinical modules and subsections of other modules, as appropriate, of NDA and MAA submissions.
- Participate in the identification and the evaluation of CROs and other research partners
- Serve as Study Sponsor/Sponsor Monitor for outsourced studies. Conduct or oversee outsourced preclinical studies (eg, via CRO or partners) and ensure all studies are conducted with the utmost scientific integrity
- Attend meetings with external stakeholders (investigators, KOLs) and health authorities, as necessary.
- Actively participate in internal workstreams and cross-functional or cross-departmental initiatives to improve department working standards.
- Participate in publication of key data or findings in peer-reviewed scientific journals and presentations at external industry conferences.
REQUIREMENTS (Education and Experience)
- Excellent working knowledge of preclinical drug development as well as drug development principles with experience and subject area expertise toxicology/nonclinical safety assessment.
- Ability to interpret and communicate complex scientific concepts in a concise and clear manner to an audience with various levels of expertise to ensure scientific input is incorporated into strategic decision-making
- Good working knowledge of FDA, EMA and ICH regulations and ability to incorporate relevant regulatory requirements into development plans, study design and ensure adherence to regulations, including GLP requirements
- Strong oral and written communicator. Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
- Exercise good judgment and make decision that is appropriate for the organization
- Results-driven, take initiative and ownership to accomplish work
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
- Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables.
- High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
- Effective time management and prioritization skills
- MS, PhD, PharmD, or equivalent degree in pharmacology, drug metabolism, toxicology, pharmaceutical sciences, or related discipline.
- Minimum 7+ years of relevant experience in biotech or pharmaceutical industry with a proven track record regarding contribution to early development programs, development and execution of project plans, accountability for the scientific and operational aspects of preclinical studies and contribution to regulatory interactions, documents and/or submissions is preferred
- Board certification in toxicology (eg, DABT and/or ERT) is preferred but not required.
The well-being and safety of our employees is our top priority. Myovant Sciences requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based). Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.If you require any accommodations, please email email@example.com.
Equal Employment Opportunity#LI-AR1