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The Position

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 nonGLP 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 nonGLP) for inclusion in regulatory submissions including but not limited to pharmacology toxicology and biodistribution studies.

Ability to onboard 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: biweekly/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 prescreening 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 qualityrelated 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 multitask and work in both an individual and teambased environment.
• Excellent interpersonal organizational and problemsolving 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 problemsolving 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 $112600.00 $209200.00 USD Annual. Actual pay will be determined based on experience qualifications geographic location and other jobrelated 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

Who we are

A healthier future drives us to innovate. Together more than 100000 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 lifechanging healthcare solutions that make a global impact.

Lets 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 companys 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.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.