Rockville, Maryland, USA
5 days ago
Senior Director Clinical Pharmacology

Job Summary:  

 

The Senior Director of Clinical Pharmacology provides leadership and oversight of all clinical pharmacology activities across drug development programs, from preclinical stages throughout late -phase clinical trials and regulatory submissions. Incumbents in this role are responsible for the implantation, and execution of clinical pharmacology plans to optimize drug development strategies, assess drug safety and efficacy, and support regulatory approvals.

 

Essential Duties & Responsibilities:

Provide leadership for the Clinical Pharmacology group and drives clinical pharmacology strategy for all assets in development. Collaborates with Preclinical and Toxicology groups to inform development of phase 1 programs for all assets in development. Collaborates with Clinical Development to develop phase 2 and 3 programs for all assets in development. Designs, implements, and oversees the execution of clinical protocols, internal strategy and planning documents, final reports, and peer-reviews publications with commercial, biostatistics, medical affairs, and clinical operational input. Monitors clinical and scientific adherence to protocols, ethical and good clinical practices. Cooperates with academics, government officials, professional consultants, and other external resources, including CROs, to facilitate clinical trials research. Serves as a clinical and scientific consultant to management, research project teams, business development, commercial teams, and government regulatory agencies. Monitors and interprets results of clinical investigations in preparation for potential commercial partnerships and / or new-drug applications. Identifies and evaluates compounds or technologies as pipeline opportunities are identified. Monitors changes in the scientific/regulatory/medical environment, which may impact the global drug development process and pharmaceutical marketplace and communicates findings appropriately within the organization. Other responsibilities and projects as assigned.

Supervisory Responsibilities:

Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives. Understands Company Policy and procedure to be able to guide direct reports appropriately.

Knowledge & Other Qualifications:

MD, PharmD, or PhD in a scientific discipline and a minimum of nine years of experience is required, MD is preferred. Prior successful experience in leading a team highly preferred. Scientific background and strong understanding of scientific, clinical, pharmacokinetics, and operational aspects of the drug development process. Proven ability to manage teams and projects. Ability to clearly communicate clinical, scientific and operational benefits and risks to team members and management. Ability to attain confidence of team and company through personifying professionalism and clinical/scientific knowledge. Ability to maintain and eventually build appropriate relationships with academics, government officials, professional consultants and other external resources including CROs, and any other entities necessary. Ability to initiate project efforts in a self-motivated way, including acquiring certain resources (e.g. prospective investigators, publicly available information, etc). Ability to work in a project team and lead or co-lead projects with operational counterparts.

Other Characteristics:

Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. Ability of having an innovative and dynamic approach to work. A self-starter able to work independently but comfortable working in a team environment. Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. Capable of performing other duties as assigned by Management. Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading The worker is not substantially exposed to adverse environmental conditions

Compensation:

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions.  The expected salary range for fully qualified candidates applying for this role is $250,000 to $287,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.  

Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs.

 

Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.

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