Associate Director, Nonclinical Outsourcing and Operations

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The Department of Pharmacology and Toxicology is seeking an experienced individual with nonclinical business operations and outsourcing experience to support contracting and outsourcing of various non-GLP and GLP studies to Contract Research Organizations (CROs). The successful candidate will use their expertise to play an important role in the development of gene therapies and rapidly advance early assets through the pipeline. To this extent, the individual will effectively perform the duties of the outsourcing lead across the portfolio, but not limited to: outsourcing of studies, maintaining and managing CRO partners and relationships, tracking and forecasting budgets and timelines, and maintaining a master study schedule, etc.

Responsibilities

Manage outsourcing of preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including but not limited to pharmacology, toxicology, and biodistribution studies.

Ability to on-board CROs, manage consultants and negotiate contracts on behalf of Spark.

Maintain and initiate relationships with established and new CROs based on business needs. Conduct feasibility assessments and participate in the selection of new CROs.

Generate and submit study designs to CROs, obtain competitive bids and timelines, and negotiate as appropriate.

Generate and manage CRO KPIs and governance as it relates to Spark needs. Track CRO issues and work with CROs to resolve them.

Participate in regular teleconferences with CROs including but not limited to: bi-weekly/monthly CRO program meetings, operational meeting, and governance

Effectively manage and track project timelines of nonclinical outsourced studies. Mange a Master Schedule.

Effectively manage budget across multiple departments as it relates to outsourced studies.

Facilitate discussions with CRO personnel and Spark SMEs as needed.

Manage CDC and CITIES permits. Track sample shipping and internal sample registries. Track animal procurement and pre-screening activities.

Effectively negotiate and facilitate open communication across all departments at Spark and maintain close relationship and communications with finance.

Independently support multiple programs with strong communication skills and ability to multitask.

Interface effectively with CMC and Supply Chain to manage test article supplies, orders and shipping.

Education and Experience Requirements

• Bachelor or higher degree in business, management, scientific or quality-related field.
  At least 15 years of industry experience preferably working at a pharmaceutical company and/or CRO in procurement, finance, nonclinical/clinical outsourcing or study monitoring.
• Solid understanding of procurement and finance tracking tools, data management systems, procedures and documentation practices.
• Effective communicator both verbally and in writing.
• Must be detail oriented, with ability to multi-task and work in both an individual and team-based environment.
• Excellent interpersonal, organizational and problem-solving skills required.
• Ability to influence and negotiate effective solutions.
• Proficient with MS Office and Acrobat Reader in PC/Mac. Good understanding of other computer systems a plus.
• Travel required up to 10% of the time.

Complexity and Problem Solving

• The successful candidate must also demonstrate excellent interpersonal, organizational and problem-solving skills required.

• Organized and skilled in managing and prioritizing multiple responsibilities, tasks, and projects.

The expected salary range for this position based on the primary location of Pennsylvania is $112,600.00 - $209,200.00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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