Senior Scientist, Non-Clinical Pharmacology

Brisbane, CA
Nov 10, 2021
Biotech Bay
Required Education
Position Type
Full time

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, Non-Clinical Pharmacology. 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 biologist/pharmacologist functional representative on project teams
  • Contribute to the evaluation of licensing-in opportunities with a focus on mechanisms and pharmacology associated with endocrinology and women’s health as well as 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 (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 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.
  • 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 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.

Core Competencies

  • 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, pharmaceutical sciences, or related discipline.
  • Minimum 10+ 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

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.

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Equal Employment Opportunity