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Director, Clinical Pharmacology

3 months ago

Hamilton, Canada Allergan Full time
Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.

Job Description

The Director, Clinical Pharmacology in Local Delivery Translational Sciences (LDTS) is accountable for translational pharmacokinetic (PK) and clinical pharmacology strategies for assets primarily in the eye care, neurotoxin, and aesthetic portfolio at AbbVie. The incumbent will provide technical and strategic leadership on Therapeutic Area (TA) specific issues related to non-clinical, clinical and quantitative pharmacology from the discovery stage up to the post-marketing support (PMS) stage, ensuring implementation of a model informed drug development (MIDD) paradigm to R&D strategy at all stages. This role has multiple strategically important aspects that require the incumbent to provide strong cross-functional leadership across diverse stakeholders comprising Senior Leadership in Discovery, Development Sciences, Development, and Allergan Aesthetics.

Purpose:

  • Communicates/presents key Pharmacokinetic/Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers.
  • Leads strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives.
  • Utilizes scientific expertise to provide appropriate interpretation of data and relates implications of results to management.
  • Serves as liaison to other departments/divisions for any study/project needs.
  • Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions.
  • Serves as a matrix leader within LDTS on department initiatives and accountable for effective performance of the workstream teams.

Responsibilities:

  • Provides TA specific non-clinical, clinical and quantitative pharmacology leadership and oversight in designing and executing, within the regulatory framework, non-clinical, PK and toxicokinetic (TK) studies during the discovery phase, and FIH, POC, Phase 1 to 4 studies during the clinical development phase.
    • At the non-clinical stage, responsible for ensuring leadership on key milestones up to IND filing by collaborating with discovery, toxicology, clinical development, and clinical safety to enable selection of dose/regimen and patient population for FIH studies.
    • At the clinical stage, responsible for authoring and strategizing clinical pharmacology development plans and MIDD data analysis plans, identifying Phase 2/3 dose regimens, and providing strategic direction on writing reports and integrated summaries submitted to the regulatory authorities and interacting with the regulatory authorities.
  • Independently leads PK/PD/Clin Pharm activities and multiple major projects. Assists R&D senior management in the selection of action plans that best meets drug discovery and development business objectives at the R&D governance milestones.
  • Identifies issues impacting multiple complex projects and leads issue resolution. Conducts risk assessments and develops contingency plans. Assures project remains in alignment with strategic objectives.
  • Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/performance).
  • Provides expert scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans. Connects scientific, regulatory, and business implications from multiple teams. Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions.
  • Responsible for critically evaluating technical, scientific aspects of eye care, neurotoxin, and aesthetic projects along with LDTS management. Reviews study protocols and scientific reports for regulatory filings and anticipates regulatory questions. Leads regulatory documents writing, submission and response to Regulatory agency comments.
  • Independently conducts due diligence assessments, summarizes results and represents LDTS on business development teams.
  • Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship.
  • Manages personnel including development, mentoring, and effective delegation.
  • Leads teams within department, across LDTS and across functions. Responsible for leadership of cross-functional teams and accountable for effective performance of the team. Actively manages project team behaviors, mediates internal team disputes, and facilitates establishment of healthy and high performing teams.
Qualifications
  • PhD in pharmaceutical sciences or Pharm D with 10+ years of industry experience in a relevant field (includes experience with PK, PBPK, PK-PD, immunogenicity, Pharmacometrics or systems pharmacology)
  • Must have demonstrated strong leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple complex projects
  • Technical and practical knowledge of global regulations, regulatory guidances, ethical issues associated with clinical studies and drug development SOPs. Proven track record of representing PK/Clin Pharm function in interactions with global regulatory agencies (e.g. pre-IND, EOP2, pre-NDA, labeling and advisory committee and/or oral hearing meetings).
  • Knowledge of the current practices and issues in the bioanalytical, biopharmaceutics, nonclinical PK, safety pharmacology, and toxicology areas
  • Experience across range of discovery and development phases
  • Proven ownership of articulating and leading discussions at various governance meetings from FIH to submission-filing stages
  • Demonstrated leadership skills with broad scientific and business-related orientations
  • Proven track record of managing direct reports and developing staff
  • Demonstrated project management skills such as scope management, progress tracking/driving as well as people and time management
  • Excellent interpersonal skills
  • Excellent verbal articulation and technical writing communication skills
  • Advanced knowledge and experience with development of locally administered drug candidates preferred
  • Experience with development of novel therapeutic modalities including RNA, gene, and cell therapies preferred

Key Leadership Competencies:

  • Knows the business and the cross-functional contributions needed to deliver results
  • Manages conflict and difficult conversations in a constructive and transparent way
  • Develops junior colleagues through coaching, stretch assignments and learning opportunities
  • Respectfully provides transparent, accurate and timely feedback to help junior colleagues improve performance
  • Creates an inclusive environment where everyone can succeed
Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.
  • This job is eligible to participate in our long-term incentive programs.

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 and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.

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