Director I, Clinical Development - Plastics & Regenerative Medicine

Purpose

Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities

• Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues.
• Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the device. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
• Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents.
• May oversee the work of Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
• Provides in-house clinical expertise for the device and disease/condition, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects.
• May serve on an Asset Strategy Team or chair an Integrated Evidence Strategy Team (IEST), with responsibility for development of a rigorous, cross-functionally aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
• Acts as a clinical interface and actively solicits external expert interactions related to the device and disease area; 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.
• Responsible for understanding the regulatory requirements related to the clinical studies and global device development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

• M.D. or equivalent, PharmD, PhD, or Masters in a relevant area
• Experience in the clinical and device development process in a global pharmaceutical/biotechnology company essential
• Advanced analytical skills
• Strong leadership and decision-making skills
• Advanced communication skills
• Good organizational and prioritization skills
• Skilled in strategic thinking and planning activities
• Sound negotiation skills and capabilities to influence
• Strong interpersonal skills
• Intermediate computer skills (MS Office)
• Basic statistics and Pharmacoepidemiology
• Ability to work with limited supervision
• Ability to establish sound working relationships with colleagues globally, in various functions with a wide variety disciplines and backgrounds
• Flexibility and ability to adapt and learn quickly
• Ability to work under pressure and to tight deadlines
• Must possess excellent oral and written English communication skills
• Willing to travel 25%

Applicable to California Applicants Only 

The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California.

· This job is eligible to participate in our short-term incentive program 

· This job is eligible to participate in our long-term incentive programs 

· We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 

• • Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. 

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.