1+ months

Clinical Science Director

Roche
Tucson, AZ

Works cross-functionally within the organization, collaborating with other Medical and Scientific Affairs functions (Clinical Operations, Medical Affairs and Biostatistics) as well as Research & Development, Regulatory, Quality, Marketing and Business Development. Serves as the scientific and medical/clinical liaison between internal teams and external groups such as Clinical Research Organizations (CROs), external pharma partners, regulatory authorities, professional and public health organizations, key opinion leaders, and advisory boards. Drives the clinical registration strategy with a focus on intended use statements, clinical trial design and sampling strategy for cancer diagnostics projects. Contributes to the clinical section(s) of health authority submissions and defends the companyâs position in discussions with health authorities. Works collaboratively with internal/external pharma partners as part of the Joint Project Team and actively engages pharma counterparts to ensure adequate consideration of diagnostic requirements and current clinical practices. Contributes to portfolio strategy and planning discussions within the LifeCycles.
 

ESSENTIAL RESPONSIBILITIES:

  • Creates, implements and manages clinical validation and registration plans for cancer diagnostics as part of the project team. Works with the Clinical Operations, Biostatistics and Data Management teams to design, implement, interpret, report and publish clinical research studies to support product registrations.

  • Defines potential clinical utility claims for cancer diagnostics products. Reviews and guides the development of product specifications to ensure that suitable attention is given to designing products that will be both safe and efficacious. Identifies areas of unmet medical need for diagnostics while devising medical strategy for new products and articulates their potential medical value.

  • Provides medical/scientific input into and assists with the preparation of PMA and 510(k) regulatory submissions. Prepares and provides responses to questions or requests for from regulatory agencies.

  • Engages in peer to peer discussions with pharma partners as the clinical subject matter expert throughout product development to educate pharma partners on the diagnostics requirements and current clinical practice.  Ensures pharma partners are aware of diagnostic needs and discusses consideration of these needs in pharmaâs clinical strategy. 

  • Scientific/clinical advisor to LifeCycle for portfolio strategy. Maintains medical, clinical, and scientific expertise in the cancer diagnostics domain area; keeps abreast of the current literature, collects and communicates medical and scientific insights and intelligence relevant to Lifecycle and product portfolio.

  • Establishes and maintains ongoing long-term collaborative peer-to-peer relationships with global key thought leaders in Oncology and Pathology and leads Global Key Opinion Leader activities including Medical Advisory Boards; aligns with Lifecycle/International Business Team and Regions to ensure transparency regarding KOL activities.

Miscellaneous duties and special projects as assigned, including a) assisting Research and Development groups with the design of analytical performance verification and validation studies; b) Works in collaboration with Medical Affairs group to generate and/or review medical and scientific information materials including scientific publications, abstracts, posters, and whitepapers relating to cancer diagnostics registration study program; and c) Participates in Scientific Exchange activities, including responding to relevant unsolicited requests for information from healthcare professionals in accordance with all compliance regulations and policies.

 

MINIMUM QUALIFICATIONS:

Formal Training/Education:

  • PhD in a related field, or MD.

 

Experience:

  • Minimum of 5 years related clinical experience

  • 3+ years (preferably 5+ years) of clinical research experience with a proven ability to design clinical trials, and critically evaluate study results

  • Experience in interfacing with key opinion leaders including physicians and clinical laboratorians

  • Experience in contributing to regulatory submissions and interactions

  • Experience within the diagnostics, medical device or pharmaceutical industry, with a track record of FDA clearance or approval based on clinical trials preferred

  • Thorough understanding of companion diagnostics development and regulation preferred

  • Experience in design control processes is preferred

  • IVD and Oncology experience is preferred.

Knowledge, Skills, and Abilities:

  • Demonstrated ability to write and review the study reports and publications.

  • Excellent and proven leadership skills, team skills, written and oral communication skills.  Ability to build and foster global relationships.

  • Ability to develop a sound scientific and strategic position in regards to Intended Use and Clinical Validation of IVD devices and to explain and defend the Companyâs position in interactions with health authorities (i.e. FDA), pharma partners and KOLs.

  • Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought.

  • Expert knowledge and application of scientific principles and concepts.

  • Ability to apply creativity and ingenuity to strategic issues by developing effective solutions for clinical study design, validation and registration strategy related questions.

  • Ability to implement strategic projects, act as a catalyst to remove organizational barriers and drive direct process improvements.

  • Strong ability to handle multiple projects simultaneously.

  • Ability to drive activities for publication and/or patent applications.

TRAVEL REQUIREMENTS:

Domestic and International travel required approximately 10-15%.

Posted: 2018-11-08 Expires: 2018-12-20

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Clinical Science Director

Roche
Tucson, AZ

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