Director - Clinical Pharmacology - Cubist Pharmaceuticals - Lexington

Job description
Position Summary:
The director, clinical pharmacology, will provide expertise in the area of clinical pharmacology and pharmacokinetic/pharmacodynamics leadership to the project teams and will be responsible for the clinical pharmacology components (including protocols, analysis plans, study reports, etc) of all relevant clinical studies and regulatory documents.

Responsibilities include, but not limited to:
Development and execution of the Clinical Pharmacology strategy for a given program(s) from candidate selection through registration.

Plan, design and oversee clinical pharmacology development plans and represent the clinical pharmacology function in the design, analysis and interpretation of clinical pharmacokinetic and pharmacodynamic studies.
Lead/contribute to the planning of studies that generate PK-PD data and lead the integration of analyses involving PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.
Lead clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings, NDA/MAA.
Provide clinical pharmacology expertise to Discovery and Pharmaceutical Development as appropriate through collaborating with internal team members to define and generate in vitro and in vivo data to support clinical pharmacology studies.
May participate in multidisciplinary teams in assessing potential in-licensing opportunities as requested by senior management

Minimum Basic Qualifications:

PharmD or PhD in an area relevant to clinical pharmacology and pharmacokinetics with minimum 10 years of relevant industry experience in multiple therapeutic areas including infectious diseases
Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required
Candidate must demonstrate an through understanding of principals of PK, PK/PD and pharmacology, clinical pharmacology including study design, analysis, and interpretation, quantitative modeling and simulation and application of these approaches to drug development, guidelines in the design of clinical trials and development plans.

Preferred Qualifications and Experience: (Include technical and functional qualifications)

10+ years industry experience, including direct experience with clinical pharmacology summary documents required for NDA and MAA.
Candidates must demonstrate strong communication skills; verbal, written and presentation. Medical scientific writing skills must be strong. Must be a creative thinker and a problem solver.
Experience building personal collaborations, networks and teams inside and outside of the organization.
Team player/builder with the ability and desire to grow and assume greater responsibility.

Competencies:

Supports the success of a group being led by providing clarity, support and tools needed to excel as things change
Sets standards and holds others accountable for their performance and behavior in order to support high quality outcomes
Leverages a deep understanding of oneself on both a cognitive and an emotional level to increase one’s effectiveness
Maintains a functional, perspective and acts on the belief that solutions and plans are stronger when appropriate collaboration occurs across and beyond the organization
Consistently acts to ensure that Cubist’s people have the requisite skills and behaviors to meet strategic goals.
Actively builds relationships and networks with others across and beyond Cubist, working constructively across organizational boundaries despite differences in interests, perspectives and needs

Enter your email address:

Refer This Job To Your Friends And Help Them To Find Jobs!