AD / Senior AD, Clinical Pharmacology Lead - Remote

Duties & Responsibilities

• Delivering results: Under the supervision of senior clinical pharmacologist in the group, ensures timely delivery of state-of-the-art CP scientific concepts for decision making throughout clinical drug development and registration including all necessary processes and documentation
• Supports the CP of not only small molecules (new chemical entities) but also large molecules (for instance, monoclonal antibodies) or newer therapeutic concepts such as ADC, oligonucleotides, gene therapy, etc.
• Ensures timely delivery of state-of-the-art CP strategy development and implementation
• Defines the CP strategy (e.g., defining the drug-drug interaction liability, formulation development strategy, strategy development to evaluate the impact of Antidrug Antibodies (ADA) on pharmacokinetics (PK), efficacy and safety of drugs, QT prolongation) of assigned project
• Refines the CP strategy in a timely manner as new data become available during drug development. As part of the strategy, may define CP aspects in a clinical trial protocol and for an eventual submission and further phase IV activities
• Contributes to the Clin Pharm section of official documents (e.g., Investigators Brochure (IB), Company Core Data Sheet (CCDS), label); engages with regulatory agencies on matters pertaining to CP during drug development (e.g., Investigational New Drug (IND), end of Phase II (EoPhII) meeting, NDA/BLA submission) and are responsible for supporting global submission and post-submission activities with Clin Pharm and BioPharma expertise
• Acts as Clin Pharm representative in trial and project teams and regulatory meetings, Clinical development project representative
• Serves as Clin Pharm representative within various teams (ECI, Drug & Device, Evidence Team, etc.) in support of early development milestones such as Start of Development (SoD) and Proof of Clinical Principle (PoCP)
• Post PoCP, by default will be the CPS integrators representing the various functions in TMCP in various clinical project teams until submission and launch
• Serves as main CPS representatives in PMO projects
• When delegating a trial to TCP, ensures that adequate amount of information on the project and trial are provided to the TCP
• May function as a TCP in certain studies or projects

Driving science and innovation

• Involved in clinical development of trial and project overarching topics from CPS (e.g., via focus group)
• Represents Clinical Pharmacology or CPS in internal and external initiatives/working groups
• Scouts, evaluates (incl. piloting), and implements new methods and strategies around Clinical Pharmacology
• Develops and refines further functional processes and infrastructure
• Is a CP (CP and BioPharma) expert and may offer this expertise to other interface functions (e.g., Toxicology, Pharmacovigilance, Customer Information, Marketing, Regulatory Affairs, etc.) or to support internal or external working groups
• Presents results internally and externally as well as contributed to scientific publications

Requirements

• Doctoral degree (MD or PhD) in Medicine, Pharmaceutical Sciences or CP. Prior experience in the pharmaceutical industry, regulatory agencies, or academia preferred OR Master’s Degree in Medicine, Pharmaceutics, CP, or equivalent area of focus with at least three to five (3-5) years of relevant experience in CP in the pharmaceutical industry, regulatory agencies, or academia could be considered for this position
• Requirements for the Senior Associate Director: Masters Degree in Medicine, Pharmaceutical sciences, CP or equivalent area of focus with preferably 5-7 years of relevant experience in CP in the pharmaceutical industry, regulatory agencies, or academia could be considered for this position OR Doctoral degree (MD or PhD) in Medicine, Pharmaceutical sciences or CP. Prior CP experience (around 3-5 years) in the pharmaceutical industry, regulatory agencies, or academia preferred

Eligibility Requirements

• Must be legally authorized to work in the United States without restriction
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older

Compensation

The base salary range for the Associate Director position is $140,000.00 to $222,000.00 USD. The base salary range for the Senior Associate Director position is $170,000.00 to $269,000.00 USD. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here.