Medical Director

Company:Pharmacyclics, LLC
Location:Sunnyvale, California
Health Care
Job Category:
Health Care
Full time
Employment Type:Full time

Job Description:

General Position Summary/Purpose:
The Medical Director, Clinical Science develops the strategies, designs, implements, monitors and evaluates clinical trials and other associated clinical development programs for assigned molecules or drugs. Medical Director will be assigned responsibilities for Ph II and Ph III clinical trials, programs and/or other projects. As such, the Medical Director will work closely with internal cross-functional stakeholders, external investigators, various corporate partners and regulatory authorities.
Key Accountabilities/Core Job Responsibilities:
Plays a lead role in providing clinical input into the assigned therapeutic areas(s) scientific strategy. Helps Research and to ensure consistency of scientific and development strategies with target label claims and corporate goals. May be called upon to perform clinical assessments on relevant drug discovery projects
May also consult to Business Development on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic area(s) product pipeline and portfolio
Is responsible for creating the clinical development plan for assigned molecules, drugs and/or other programs
Is responsible for regular review of data collected for assigned programs and works closely with biometrics on data analysis plans.
Regularly called upon to act as an internal consultant to various internal partners, stakeholders, teams and review or decision-making committees; providing clinical development expertise in relation to assigned therapeutic area(s)
Develops and delivers key presentations, both internally and externally, to convey the clinical development perspective and provide updates on activities. Includes playing a key role in the organization and delivery of successful expert advisory boards
Participates in FDA or other health authority interactions with little or no supervision from his/her manager
Works with Regulatory and other partners/stakeholders in the completion and submission of IND (investigational new drug) applications and filings. Supports Regulatory Affairs on clinical development aspects of filings; plays a central role in developing language in a drug's Package Insert. Acts as the clinical lead on Filing Teams. Monitors IND filings for all assigned molecules and programs
Provides clinical oversight for a variety of projects:
o Works with a host of internal and external partners and stakeholders in the design and implementation of clinical trials for assigned molecules and drugs
o Designs and develops trial protocols; including effectively incorporating cross-functional strategies and input into programs
o Develops the product safety profile
o Gains alignment with various internal partners and stakeholders on goals and resource needs. Includes working with core team project teams to establish appropriate budgets and other resource plans
o Develops key clinical sections of Investigator brochures
o Plays a key role in the identification of appropriate external investigators
o Produces clinical components of presentations at clinical trial investigator meetings; delivering high-quality presentations at such meetings
Converts clinical development plans into project implementation plans and leads clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators, Clinical Operations and others internally and externally. Measures project progress, monitors variances and is expected to proactively identify any issues or challenges and develop, recommend and implement strategies to effectively resolve such
Plays an important role in the development of disease and/or treatment registries. Includes developing strategies or plans to enable appropriate registry recruitment
Keeps all partners abreast of developments throughout all applicable intervals
Contributes to safety and/or other relevant sections of IND annual reports, as these sections and reports relate to assigned molecules and/or drugs
May interact with Board of Directors and Investor Relations
Works closely with Clinical Operations to close-out clinical trials and complete internal reporting of trial status and results; including associated publications
Biotech/pharmaceutical industry experience preferred OR be a recognized expert in the field
Strong background/experience with clinical trials (as typically measured by 2 or more years' experience)
Strong, relevant therapeutic experience (as typically measured by 3 or more years' relevant clinical experience)
In-depth understanding and firsthand knowledge of Phase I-III drug development.
Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
Demonstrate ever-increasing competence and abilities in leading disease strategy planning and reviews. Expected to provide important, strategic inputs in Clinical Development decision-making
Create targeted and executable clinical development plans for multiple molecules and or drugs
Deliver multiple projects and programs on-time, on-target and within-budget
Develop and cultivate important relationships with internal and external partners and stakeholders. Includes developing and cultivating important relationships with thought leaders and KOLs (key opinion leaders)
Competently and collaboratively interact with a host of internal and external partners and stakeholders
Effectively represent Clinical Development on multi-disciplinary teams.
Stay informed and abreast of the external landscape as it relates to assigned molecules, drugs and/or programs and the associated therapeutic area(s)
Lead in clinical development contributions and insights into strategies, plans and objectives
Comprehensive understanding of product and safety profiles
Well-versed in medical aspects of FDA regulations
Previous people management experience is a plus
Education Requirements (degree, certifications, etc.):
M.D. Board eligible or boarded in hematology; although those with significant oncology industry experience are also of keen interest.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

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