Senior Scientific Director, Oncology Clinical Development (Non-Hodgkin Lymphoma)

About the role

The Senior Scientific Director, Oncology Clinical Development (Non-Hodgkin Lymphoma) leads the direction, planning, and interpretation of clinical trials or research activities of one or more clinical development programs. They participate in and may lead cross-functional teams to generate, deliver and disseminate high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities

• 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, AbbVie’s customers, markets, business operations and emerging issues.
• Oversees project-related education of investigators, study site personnel and AbbVie study staff.
• May have responsibility for leading 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 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 Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
• Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. 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.
• 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.

Requirements

• Bachelor's degree in the sciences; advanced degree (e.g., MS, PhD) preferred. Hematology experience preferred. Non-Hodgkin Lymphoma (NHL) experience strongly preferred.
• At least 8 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run a complex clinical research program independently.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
• Ability to interact externally and internally to support a global scientific and business strategy.
• 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.
• Excellent oral and written English communication skills.
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.

Qualifications

• Pharmacology, Immunology, Hematology, Oncology, or related field.
• Experience in non-Hodgkin lymphoma clinical development.
• Experience in managing clinical development programs.
• Experience in regulatory affairs and compliance.
• Experience in leading cross-functional teams.
• Experience in designing and implementing translational strategies.
• Experience in interacting with opinion leaders and other stakeholders.

Skills

• Strong scientific and medical background.
• Leadership and team management skills.
• Excellent communication and interpersonal skills.
• Knowledge of Good Clinical Practices and regulatory requirements.
• Ability to manage multiple projects simultaneously.
• Ability to work independently and make decisions.

Benefits

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

Pay

Pay Range: $206,500 - $393,000 USD

Schedule

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.