Under the leadership of the Head of Clinical Pharmacology, the Director/ Senior  Clinical Pharmacology Director is responsible for: Leading the Clinical Pharmacology program and strategy for defining and implementing the Early Development/Clinical Pharmacology Plan to support the registration dossier; Providing scientific and operational support to the Early Development studies (first-in-human, proof of concept) and late-phase Clinical Pharmacology studies (drug-drug interactions, special populations); Aligning plans and strategies with partner line functions and internal or external stakeholders; And interacting with Health Authorities. The Senior Clinical Pharmacology Director is accountable for the early drug development and translational strategy within the Project Team, and for the clinical study protocols and their operational implementation within the clinical Study Team.

 

Essential Duties & Responsibilities

Early Development/Clinical Pharmacology Strategy

  • In close collaboration with internal and external key stakeholders, define the Early Development/Clinical Pharmacology Plan and registration strategy for endocrinology and women’s health compounds
  • Provide input on study design for Early Development studies (first-in-human, proof of concept) as well as late-phase Clinical Pharmacology studies (drug-drug interactions, special populations),
  • Contribute to the appropriate use of biomarkers in Clinical Pharmacology studies with a focus on endocrinology
  • Contribute to the preparation of regulatory components Clinical Trial Applications (IND, IMPD, IB) and any other regulatory submissions (summary documents),
  • Attend meetings with external stakeholders (investigators, KOLs) and Health Authorities.

Project Team Member

  • Represent the Clinical Pharmacology function in Project Teams and endorse accountability for Clinical Pharmacology deliverables,
  • Liaise with key partner line functions to identify potential project hurdles, provide solutions and contribute to contingency plans,
  • Responsible for the timely and effective communication of strategy and results to the Project Team by efficient communication.

Clinical Study Team Member

  • As a core member of the Clinical Study Team, provide guidance for the design and successful execution of Early Development and Clinical Pharmacology studies,
  • Participate in the identification and the evaluation of clinical trial sites and CROs,
  • Contribute to the clinical study design, author clinical study protocols and clinical study reports,
  • Review and evaluate clinical study data, provide scientific input for their interpretation and adaptation of further development steps (data driven)
  • Prepare and attend meetings with investigators, external experts and Health Authorities.

Scientific expertise and organizational excellence

  • Contribute to the evaluation of licensing-in opportunities with a focus on endocrinology and women’s health
  • Contribute to the department working standards,
  • Strictly adhere to GxP guidelines, SOP and other working practices, as appropriate,
  • Actively participate in internal workstreams and cross-functional or cross-departmental initiatives.

 

Core Competencies, Knowledge and Skill Requirements

  • Working knowledge and experience with Word, PowerPoint and Excel
  • Effective time management and organization skills
  • Ability to multi-task under limited direction and on own initiative
  • Good interpersonal, written and verbal communication skills
  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
  • Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
  • Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
  • Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.

 

Significant Contacts

  • Employees across the Roivant companies, visitors

 

REQUIREMENTS

Education 

  • MD, and/or PhD in pharmaceutical sciences/pharmacology, or PharmD, with at least 10 years of industry experience in endocrinology or women’s health (early development translational studies and/or late phase development with a track record of Clinical Pharmacology contributions to projects or submissions). Demonstrated success in a matrix leadership role.

 

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:

  • Regularly required to operate standard office equipment
  • Ability to work on a computer for extended periods of time
  • Regularly required to sit for long periods of time, and occasionally stand and walk
  • Regularly required to use hands to operate computer and other office equipment
  • Close vision required for computer usage
  • Occasionally required to stoop, kneel, climb and lift up to 20 pounds

 

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

Apply for this Job

* Required
  
  
When autocomplete results are available use up and down arrows to review
+ Add Another Education


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Myovant Sciences are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 1/31/2020

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities1. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • HIV/AIDS
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.