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.
- 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. Oversees project-related education of investigators, study site personnel and AbbVie study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
- 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 molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
- 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.
- Responsible, with limited supervision, for the proactive monitoring of clinical trial safety which is conducted in collaboration with the ABV CTPS (Clinical Trial Patient Safety). Evaluates all safety data generated in clinical trials and responds to safety questions from investigator sites and IRBs regarding safety issues and queries.
- 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 molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in 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.
- May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross- functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB) and/or other cross-functional teams and internal stakeholders.
- Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule 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 drug 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 (D.O.) and completion of an Oncology Residency, Board certification (or equivalent in ex-US countries) preferred
- 5-7 years of experience in medical monitoring of clinical trials is required or having relevant clinical development/pharma experience would be considered
- Track record of successful management of product safety matters (labeling negotiation, etc) preferred
- Experience in the clinical and drug development process in a global pharmaceutical/biotechnology company and preparation risk management plans, aggregate reports and company core safety information highly desirable
- Advanced analytical skills
- Basic leadership and decision-making skills
- Advanced communication skills
- Sound medical judgment and experience in medical safety interpretation of safety findings for clinical trials
- Basic clinical and/or drug development expertise
- Good organizational and prioritization skills
- Intermediate skill in strategic thinking and planning activities
- Basic negotiation skills and capabilities to influence
- Good interpersonal skills (i.e. team player)
- Intermediate computer skills (MS Office); knowledge of ARGUS and Business Objects is a plus
- Working knowledge of MedDRA
- Basic statistics and Pharmacoepidemiology
- Ability to work with limited supervision
- Ability to establish sound working relationships with people 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 20%
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.