Scientific Head of Assets, Oncology Early Development

Purpose:

Manages Medical and/or Scientific Directors and leads the direction planning execution and interpretation of clinical trials or research activities of one or more clinical development programs.  Participates in and may lead cross-functional teams to generate deliver and disseminate high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities:

Provides leadership to the Oncology Early Development (OED) Clinical Sciences team by managing one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists.  This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects.  Responsible for hiring onboarding mentoring training and supporting career development of these individuals.

Shapes the vision mission and culture of the Clinical Sciences team while driving innovation in early phase clinical studies. As a member of the Oncology Early Development Leadership Team the incumbent supports clinical research excellence through high-quality delivery of protocols and data packages; champions clinical trial innovation digital applications and patient centricity; fosters cross-functional collaboration and establishes best practices to support portfolio success. Develops metrics to track output trends associated with continuous improvement.

Personally or through a direct report leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large complex program) in support of the overall product development plan based on strong medical and scientific principles knowledge of compliance and regulatory requirements AbbVies customers markets business operations and emerging issues.

Oversees project-related education of investigators study site personnel and AbbVie study staff.  Responsibility may extend from early translational development activities to clinical programs for internal and/or partnered programs.

Overall responsibility for leading and mentoring clinical study teams monitoring overall study integrity and review interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule.  Along with Clinical Operations is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables.

Primary responsibility for and ownership of overseeing design analysis interpretation and reporting of scientific content of protocols Investigator Brochures Clinical Study reports regulatory submissions and responses and other program documents.

May chair Clinical Strategy Team(s) with responsibility for development of a rigorous cross-functionally-aligned vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.

In this capacity responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs) and/or other cross-functional teams and internal stakeholders.

May participate in or lead clinical development contributions to due diligence or other business development activity.  As required by program needs contributes in partnership with Discovery colleagues to design and implementation of translational strategies.

Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs Commercial and other functions in these activities as required consistent with corporate policies to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.

Stays abreast of professional information and technology through conferences medical literature and other available training to augment expertise in the therapeutic area.  May represent AbbVie at key external meetings.

Qualifications :

Bachelors degree in the sciences; advanced degree (e.g. MS PhD) preferred

At least 8 years of clinical trial experience in the pharmaceutical industry academia or equivalent.

Extensive knowledge of clinical trial methodology regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.

Proven leadership skills and ability to bring out the best in others on a cross-functional global team.  Must be able to lead and manage through influence.

Demonstrated commitment to training and development of junior-level staff using best judgment to assure that they work with an appropriate level of autonomy.

Ability to interact externally and internally to support a global scientific and business strategy.

Ability to run a complex clinical research program independently.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time