Scientist/Sr Scientist, Nonclinical Pharmacology or Translational Biology
- Myovant Sciences
- Brisbane, CA
- Start date
- Mar 15, 2023
- Science/R&D, Biology, Biotechnology, Pharmacology
- Required Education
- Position Type
- Full time
- Biotech Bay
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 Scientist/Senior Scientist, with a focus in Nonclinical Pharmacology and/or Translational Biology, with level 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 discovery projects for Myovant Sciences. The individual will work closely with cross-functional team members (eg, other nonclinical disciplines, CMC, and clinical pharmacology) to advance early-stage research programs through preclinical development and into early clinical studies. Responsibilities include 1) providing subject matter expertise in biological pathways and pharmacology on cross-functional project teams for Myovant’s existing assets, 2) evaluation of promising new therapeutic mechanisms identified through industry partnerships and/or academic collaborators, 3) contribute to the development of early development plans, incorporating translational biology/pharmacology to inform milestone decisions, 4) serve as a project leader and/or provide functional oversight for early-stage programs, and 5) author regulatory documents (eg, INDs, IBs, NDAs) within subject area expertise, as necessary.
Essential Duties and Responsibilities
- Serve as a pharmacology/ translational biology functional representative on project teams
- Contribute to the evaluation of in-licensing opportunities with a focus on mechanisms, pharmacology and pharmacodynamics associated with programs in women’s health and oncology. Network with key academic and industry researchers and subject matter experts to establish research partnerships in areas of interest to Myovant.
- Serve as Project Lead and/or functional representative for strategic early-stage research partnerships. Responsible for establishing a core team (consisting of 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.
- Responsible for contribution to 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.
- 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
- Contribute to the research and development of biomarkers and translational aspects for appropriate use of biomarkers in early nonclinical and/or early clinical development
- 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.
- Excellent working knowledge of translational biology (pharmacological mechanisms, preclinical experimental models, pharmacodynamics, translational medicine) and/or nonclinical pharmacology as well as drug development principles
- 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 GCP requirements during study conduct
- 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
REQUIREMENTS (Education and Experience)
- PhD, PharmD, MD or equivalent degree in pharmacology, biology, translational biology, pharmaceutical sciences, or related discipline.
- Minimum 5+ years of relevant experience in biotech or pharmaceutical industry with a proven track record regarding contribution to discovery and 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
The well-being and safety of our employees is our top priority. Myovant Sciences strongly encourages all employee to get vaccinated, if eligible, however Myovant Sciences is not requiring employees to be fully vaccinated against COVID-19 as a condition of employment.
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 firstname.lastname@example.org.
Equal Employment Opportunity
We aspire to be the leading healthcare company focused on redefining care for women’s health and prostate cancer. Our experienced team brings significant breadth and depth of expertise in drug development, combined with a commitment to develop new treatments for women suffering from uterine fibroids, endometriosis, and infertility, and men suffering from prostate cancer. We strive to improve the lives of millions of people, while building an innovative, dynamic, and collaborative company where employees thrive.
2000 Sierra Point Parkway, Suite 900
Brisbane, CA 94005
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