Director Clinical Pharmacology

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jan 27, 2021
Ref
R-129238
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Purpose

The position of Director of Clinical Pharmacology, Therapeutic Area Scientific Director leads the Clinical Pharmacology and Pharmacometrics strategy aligned with the Therapeutic Area Leadership Teams strategic vision. The incumbent develops and drives clinical pharmacology opportunities/ requirements and innovation for a particular therapeutic area. The incumbent would have deep therapeutic area knowledge, focus on clinical pharmacology, translational science and bioanalytical assay, pulling these aspects together to develop Translational and Clinical Pharmacology plans. This position will lead a Clinical Pharmacology sub-team to drive innovation and strategy to answer key translational and clinical questions using quantitative tools.

RESPONSIBILITIES AND ACCOUNTABILITIES

1 . Leader in clinical pharmacology; representing CPAT on Project Strategy Teams within a specific Therapeutic Area .

2 . Leader in imp lementation of clinical pharmacology strategy across projects within a specific Therapeutic Area .

3 . Leads the plan ning and oversees the implementation / integration of all relevant PK/PD analyses: non - compartmental, PK, PKPD analyses, population PK and PKPD modeling and simulations methods .

4 . Oversees/ manages clinical pharmacology deliverables for projects within a particular the Therapeutic Area. This includes major contributions to clinical development documents (e.g. Clinical Development Plan), commercial deliverables (e.g . pricing related input), medical affairs (publications), and regulatory documents including labelling and those required for regulatory meetings and submissions.

5 . Provides input for, or leads derivation of, standard operating procedures and best practices in clinical and translational pharmacology .

6 . Provides le adership and support to early R& D in the establishing a translational pharmacology plan required for early clinical development strategy and utilizes innovative methods to translate preclinical pharmacology data to the early clinical studies.

7 . Key interactions with Therapeutic Area leadership across disciplines including Clinical Development, Commercial, Medical Affairs, and key stakeholders including Safety and Statistics.

8 . Provides solutions with substantial direct operational and financial impact

9 . Critical and thorough input towards in-licensing and due diligence assessments as needed

REPORTING RELATIONSHIP

Reports To:

Senior Director, Therapeutic Area Clinical Pharmacology Lead

Direct Reports:

None

JOB SPECIFICATIONS

Education

  • PhD or PharmD /PhD with a clinical pharmacology related major (e.g. clinical pharmacology, pharmacokinetics, PKPD).


Experience ( Minimum years of experience and knowledge required to perform the job.)

  • Minimum of 8 years of pharmaceutical industry (or relevant) experience, specifically leading and contributing to clinical pharmacology aspects of clinical drug development
  • Minimum of 2 years clinical pharmacology and multifunctional team leadership.
  • Thorough understanding of general clinical pharmacology (including the design and conduct of clinical trials), interpretation of PK, PK/PD, population PK methodologies and related data interpretation, and the use of biomarkers in clinical development
  • Demonstrated technical understanding/application of PK/PD/ pharmacometrics methodologies which provide values clinical pharmacology solutions
  • In-depth knowledge and experience in clinical pharmacology and pharmacometric components of regulatory submission
  • Extensive understanding of the role of clinical pharmacology in drug development and FDA/ICH requirements for drug registration
  • Clinical trial design experience across all stages of drug development
  • Ability to understand, lead , and implement all aspects of clinical pharmacology needs across a variety of disease areas/ programs
  • Experience in leading representation of clinical pharmacology/ pharmacometrics at critical submission-related regulatory authority meetings
  • Broad experience in the following clinical pharmacology deliverables/areas


  • IND, CTA, IB, Orphan drug applications, CTDs/submissions, regulatory agencies responses
  • ICH Good Clinical Practice and Good Laboratory Practice
  • Related EMA and FDA drug development guidelines
  • Quality Control systems and processes for data analytical work to meet Regulatory requirement
  • In-depth knowledge of and experience with global clinical pharmacology and pharmacometrics regulatory requirement
  • Global bridging strategy


Competencies

  • Excellent communication skills with demonstrated ability to effectively present any aspect of clinical pharmacology, as well as its plans/strategies, aligned various audience in both verbal and written form.
  • Provide ability to lead matrix teams and influence across disciplines, including negotiation and influential skills.
  • Excellent oral presentation skills including examples at major Clinical Pharmacology related scientific/ clinical meetings.
  • Excellent ability to create and communicate Clinical Pharmacology plans/ strategies and analyses and tailor presentation based on different audiences
  • Provision of leadership in this discipline within the organization
  • Proven ability to create high quality publications according to international and scientific standards
  • Established and excellent interpersonal skills, including a positive and constructive attitude and ability to work in a team matrix environment that fosters collaboration.