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Director / Senior Director, Clinical Development

Brisbane, CA, USA | Myovant Sciences Ltd.

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
    5-7 years
Job Description:
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The Director/Senior Director, Clinical Development, as clinical lead, will be responsible for the advancement of multiple late stage clinical development programs (CDPs) for our women’s health programs.The individual must have the ability to work independently and also as an effective and engaged member of a cross-functional team in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.


 Essential Duties and Responsibilities


Assist in the design of strategic clinical development programs (CDPs)

Develop clinical protocols that align with the CDP and that meet ethical and regulatory standards

Lead the cross functional teams (including, but not limited to, clinical operations, safety, regulatory, PK and statistics) in the management and execution of the strategic CDP

Work with clinical operations, safety, assigned CROs and study vendors to assure the execution of clinical trials, consistent with GCP guidelines

Serve as medical monitor of clinical studies

Manage and develop other medical directors

Review, summarize and present clinical data at key meetings across various venues

Draft and/or edit clinical study reports, update investigator brochures and other required annual updates to regulatory documents (US and exUS)

Assist in the development of INDs as appropriate

Participate in and prep for strategic interactions with regulatory agencies (US and exUS)

Establish and maintain key working relationships with clinical trial investigators, expert leaders in the field (e.g., KOLs, academicians, etc.) as per ethical guidelines

Assess project/program needs and resources and address in a timely fashion to maintain program timelines and deliverables

Ensure adherence to agreed-upon timelines/budgets, while maintaining regulatory compliance

Participate in due diligence activities for other potential BD opportunities from a clinical perspective

Perform other duties as assigned



Core Competencies, Knowledge, and Skill Requirements


Requisite skill set to carry-out above noted “essential duties and responsibilities”

Ability to think analytically and strategically to formulate, develop, and execute clinical plans

Strong leadership skills with an ability to set vision, lead change, and mentor others

Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving

Demonstrated ability to review, interpret and present complex scientific data

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)

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 



REQUIREMENTS


Education 


MD or equivalent required

Oncology training preferred



Experience

Minimum of 5 years of pharmaceutical industry drug development experience


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