Director/Senior Director, Clinical Pharmacology

Location
Brisbane, CA, United States
Posted
Aug 01, 2021
Ref
5244591002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
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 develop and deliver empowering medicines for women's health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.

Summary Description

We are currently seeking a dynamic, highly motivated, experienced individual for the position of Director/Senior Director, Clinical Pharmacology. The position reports to the Vice President, Early Clinical Development. The location of the position is in Brisbane, CA but flexibility is possible for the right candidate.

The Clinical Pharmacology Director/Senior Director will be responsible for the development of the strategic, scientific, translational and clinical aspects of a clinical pharmacology development plan, including defining key milestones and decisions, identifying risks and mitigation strategies, study planning and execution, providing input to modeling and simulation plans and the interpretation of pharmacokinetic, pharmacokinetic and safety data from phase 1 studies and ensure alignment and seek input from cross-functional partners, consultants, experts and vendors as necessary; lead author and contributor to relevant sections of regulatory documents including IND or IMPD submissions, briefing packages or background documents and NDA or MAA submissions; serve as the study director and/or medical monitor for all phase 1 to phase 2a studies, as necessary, including first-in-man, biopharmaceutics, drug-interaction, special populations and proof-of-pharmacology/concept studies; and provide functional representation at project team meetings and during regulatory interactions.

Essential Duties & Responsibilities

Early Development/Clinical Pharmacology Studies:
  • Act as Medical Monitor/ Study Director to collaborate with internal and external cross-functional study team members, provide scientific and clinical/medical input into the rationale and design, procedures and safety assessment requirements for early development/clinical pharmacology (phase 1 to phase 2a) studies and phase 3 studies
  • Contribute to the appropriate use of biomarkers in early development studies with a focus on endocrinology
  • Collaborate with the operations lead, provide oversight of early development studies during study execution and serve as the study medical monitor to ensure all studies are safely conducted with the utmost scientific integrity
  • Participate in the identification and the evaluation of clinical trial sites and CROs,
  • Provide subject matter expertise to the interpretation of pharmacokinetic and pharmacodynamic data for proper data interpretation and reporting, including co-authoring, review and finalization of clinical study reports

Early Development functional expertise and organizational excellence:
  • Responsible for preparation of early clinical development plans (program-level) and effectively liaise with key partner line functions to identify potential project hurdles, provide solutions and contribute to contingency plans,
  • Contributor to the preparation of early clinical development components of regulatory documents, including INDs, IMPDs, CTAs, Investigator Brochures and responsible for authoring and finalization of biopharmaceutics and clinical pharmacology modules and subsections of other modules, as appropriate, of NDA and MAA submissions,
  • Attend meetings with external stakeholders (investigators, KOLs) and health authorities, as necessary,
  • Serve as early development functional representative on project teams
  • Contribute to the evaluation of licensing-in opportunities with a focus on endocrinology and women's health
  • Actively participate in internal workstreams and cross-functional or cross-departmental initiatives to improve department working standards.

Core Competencies, Knowledge and Skill Requirements
  • Excellent working knowledge of clinical pharmacology (pharmacokinetics, pharmacodynamics, translational medicine) and 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
  • Direct experience leveraging modeling and simulation to facilitate compound development and registration with a good understanding of the technical aspects of modeling and available software used for analysis
  • 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

REQUIREMENTS

Education, Experience and Training
  • MD, PharmD, and/or PhD in clinical pharmacology.
  • Minimum 15+ years of previous industry experience in early clinical development and/or clinical pharmacology with a proven track record regarding the development and/or contribution to an early clinical development/clinical pharmacology development plan, accountability for the scientific, clinical and operational aspects of phase 1 studies including completion of the CSR and contribution to regulatory interactions, documents and/or submissions is preferred.
  • A completed residency program (clinical pharmacology program) and/or a post-doctoral fellowship is desired.

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.

Equal Employment Opportunity