Associate Director, Clinical Pharmacology (Immunology)

BioSpace; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Paid time off

Job summary

AbbVie is seeking a leader in Clinical Pharmacology to conceive, execute, and manage multidiscipline development plans, generating PK/PD study proposals and guiding regulatory strategies across Phase 1-4 projects.

The role requires driving strategy, leading cross-functional teams, authoring pivotal documents, and presenting at conferences while collaborating with external stakeholders and KOLs.

Qualifications

• PhD with typically 4+ years of experience in a relevant field (PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology) or PharmD with typically 6+ years of experience.
• Excellent interpersonal skills.
• Ability to interact with functional representatives and KOLs externally and internally and lead team(s).
• Strategic thinking and enterprise view.
• Proven scientific track record and technical skills to perform the role.
• Key Leadership Competencies: drives results, perseverance, accountability, collaboration and influence.

Responsibilities

• Accountable for Phase 1-4 studies design and clinical pharmacology strategy; acts as the representative for project(s).
• Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses, CTDs and related sections.
• Leads clinical pharmacology and biopharmaceutics meetings; represents the function in strategy teams and study teams.
• Drives small teams with members from clinical pharmacology to provide a unified position to clinical, CMC and regulatory teams.
• Authors scientific publications and presents at national/international conferences; interacts with KOLs and external stakeholders.
• Conducts due diligence assessments, summarizes results and represents clinical pharmacology on BD teams.
• Represents Clinical Pharmacology at regulatory meetings.

Skills

PK/PD

Leadership

Strategic thinking

Interpersonal skills

Education

PhD in Pharmacology

PharmD

Masters Degree

Bachelors Degree

Job description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

Conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology, PK/PD or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies. Consistently demonstrates excellent record of accomplishment of Clinical Pharmacology and business objectives. Leads Clinical Pharmacology/PK/PD aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management.

Responsibilities

Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s).

• Executes strategy, lead teams and various data analyses and interpretation by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation and discussion of model results in the context of research question).


• Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, relevant section of investigator brochures, white papers, and other similar documents.


• Leads clinical pharmacology and biopharmaceutics meetings, serve as CLINICAL PHARMACOLOGY representative at Clinical Strategy Team/Asset Development Team and present at various departmental and cross functional teams such as study teams, CLINICAL PHARMACOLOGY leadership team, Journal club.


• Drives small teams with members from CLINICAL PHARMACOLOGY functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.


• Authors scientific publications and present at national and international conferences and interact with KOLs/external stakeholders.


• Conducts due diligence assessments, summarizes results and represents CLINICAL PHARMACOLOGY on business development teams.


• Represents Clinical Pharmacology at regulatory meetings.

Qualifications

• PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field, Masters Degree or equivalent education and typically 12+ years of experience, Bachelors Degree or equivalent education and typically 14+ years of experience;(*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)


• Excellent interpersonal skills


• Ability to interact with functional representatives and KOLs externally and internally and lead team(s)


• Strategic thinking and enterprise view


• Proven scientific track record and technical skills to perform the role


• Key Leadership Competencies: Delivers business results while also positioning AbbVie for long-term success Persistent and resilient finds the way to move good ideas forward Acts respectfully yet courageously Connects unrelated concepts, generates original or unique ideas Influences colleagues to achieve cross-functional alignment Gives full accountability when delegating and accepts full accountability when delegated to by others

Additional Information

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

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html