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Associate Director, Clinical Development

Employer
Sumitomo Pharma America
Location
Brisbane, CA, United States
Start date
Oct 15, 2020

View more

Discipline
Clinical, Clinical Development
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
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 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.

We are currently seeking a qualified, highly motivated, experienced individual for the position of Associate Director, Clinical Development for the Prostate Cancer Program. The position reports to the Senior Vice President, Clinical Development. The location of the position is in Brisbane, CA, though remotely based candidates will be considered. Candidates should have an MD or equivalent medical degree.

Summary Description

The Associate Director, Clinical Development will provide medical and scientific expertise in collaboration with cross-functional teams to ensure successful execution of clinical trial activities, data analysis, and interpretation. May be responsible for the clinical and scientific strategy of assigned sections of a clinical development program, depending on the size and complexity.

Core Competencies, Knowledge and Skill Requirements
  • Support clinical study teams and provide appropriate medical monitoring for ongoing clinical studies
  • Manage medical/safety issues in the studies in collaboration with pharmacovigilance.
  • Conduct medical review and evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies
  • Contribute to the strategic development of clinical programs
  • Provide medical input into protocol design, study specific ICFs, investigator brochures, and clinical study reports.
  • Provide input into manuscripts, abstracts and presentations for scientific meetings and advisory boards.
  • Conduct literature reviews and prepare summaries to support clinical development programs
  • Serve as medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates
  • Travels periodically to conferences, investigator meetings. and individual sites as needed.
  • 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.
  • Daily demonstrates a positive, 'can do' and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
  • Ability to multi-task and shift priorities quickly while working under tight deadlines.
  • Skilled in developing collaborative internal and external relationships.
  • Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

Communication & Interpersonal Skills
  • Excellent verbal and written communication skills, as the position will interface potentially 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 Organization and visitors

REQUIREMENTS

Education
  • MD or equivalent medical degree required

Experience
  • Minimum of 3 years of involvement in clinical research or drug development in an academic or industry setting. Oncology background requested.
  • Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
  • Demonstrated ability to establish effective working relationship with key investigators
  • Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes

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


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 careers@myovant.com.

Equal Employment Opportunity

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