Job Summary:
The senior Manager, Clinical Supply will be responsible for overseeing the end-to-end supply chain operations for clinical trials, ensuring accurate inventory and delivery of clinical trial materials. This role is responsible for planning, execution, and oversight of clinical supply operations. Incumbents in this role will work cross-functionally to ensure efficient communication with internal teams, vendors, and Contract Research Organizations.
Essential Duties & Responsibilities:
- Forecasting clinical supply needs for clinical studies, ensuring adequate inventory levels for Clinical Trial Material (CTM).
- Perform Product inventory checks and maintains proper inventory levels at depots and clinical sites.
- Procuring concomitant and comparator drugs for clinical trials conducted in the in United States and globally.
- Coordinates and facilitate the distribution of investigational product and ancillary supplies. Tracks shipments of investigational product and ancillary supplies to and from all clinical sites, including investigational product recalls.
- Facilitate the import and export of investigational products globally in compliance with local regulations, in coordination with Contract Research Organizations (CROs). Author and review label text and label designs for investigational products, ensuring compliance with regulatory standards.
- Manages the packaging, labeling, distribution, return or destruction of investigational product at depots and clinical sites.
- Author and reviews Clinical Trial Supplies sections of all relevant clinical documents.
- Develop and maintains a pharmacy manual for clinical trials.
- Tracks expiry dates of investigational product at distribution centers and sites, providing expiry extension documents as needed.
- Initiates vendor selection, reviews proposals, and negotiates contracts for packaging, labeling, and distribution of investigational product.
- Works with study teams to establish plans for investigational product and ancillary supplies for global clinical studies.
- Collaborates with study teams to set up Interactive Response Technology (IRT) and coordinate investigational product aspects of the system.
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:
- Bachelor's Degree in life sciences or health-related field with a minimum of six years of relevant experience working in a clinical, pharmaceutical, or clinical trial environment.
- Experience with investigational drug product primary/secondary packaging and labeling processes.
- Experience with labeling, distribution, and recall processes for investigational products.
- Clinical study site interaction skills: previous training in GMP/GCP is preferred.
- Contracts and vendor management experience.
- Detail orientated and process focused.
- Excellent communication (written and oral) and interpersonal skills.
- Able to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines.
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 $120,000 to $144,000. 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.
Limitations and Disclaimer:
The above job description is meant to describe the general nature and level of work performed; it is not intended as an exhaustive list of all duties, responsibilities, and required skills for the position. Employees will be required to follow any other job-related instructions and to perform other duties requested by their supervisor in compliance with Federal and State laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities necessary to perform each duty proficiently. Continued employment remains on an "at-will" basis.
Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.
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.