- Accountable for implementation and execution of bioanalytical plans for preclinical and clinical programs.
- Manage the bioanalytical operations and logistics within Translational Sciences by creating/managing the bioanalytical plans, timelines, budget, risks assessment and quality metrics.
- Partner with lead bioanalytical scientists and study directors to manage external contract research organizations, including managing contract execution, creating statement of work, assay development or transfer, and overseeing sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases.
- Provide PM support for the Translational Sciences team including cross functional initiatives. Actively manage the execution of the project plan with team members, including internal and external and preclinical activities, to ensure projects are delivered on-time and within budget.
- Create and maintain project and department documentation including agenda, minutes, action items, dashboards, goals and milestones. Participate in study team, cross-functional and Translational Sciences meetings.
- Collaborate with Quality to establish fit-for-purpose processes for documentations, sample and data management.
- Develop presentations to update stakeholders on scenarios, progress and timelines.
- Manage and oversee documentation of sample/data management and archival on nonclinical studies.
- Contribute to the preparation of regulatory and clinical documents when required.
- Help with logistics and facilitate smooth cross functional operations
- Facilitate reviewing and writing documents and reports as needed.
- Foster a driven, fast-paced, dynamic, and fun environment in which to do rigorous science.
- Have a strong scientific background, minimum of a Bachelor's Degree in the life sciences, (advanced degree preferred; PMP Certification is a plus)
- Have a minimum of 6 years of relevant experience, including a minimum of 4 years of project management experience in development function(s) in the biotech/ pharmaceutical industry
- Have a strong understanding in translational sciences and preclinical development
- Have working knowledge of bioanalytical assay development and qualification/validation requirements, ICH GLP, and GCP guidelines.
- Excellent interpersonal, influencing and communication skills. Be able to distill the right amount of information and present the right level of detail to various audiences
- Be persistent, meticulously organized, proficient and strive for excellence
- Ability to work both independently and collaboratively in a fast-paced, interdisciplinary research team.
- MS/PhD in life sciences, project management certification desirable
- Previous experience or exposure to biomarker/diagnostics development in both preclinical and clinical development
- Familiarity with CRISPR technologies and therapeutic approaches is a plus
- Previous experience in startup companies
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Sr. Manager, Translational Sciences Project Management - Alameda, United States - Scribe Therapeutics
Description
Job Description
Job DescriptionScribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl, David Savage, and Jennifer Doudna, Scribe is overcoming the limitations of current genome editing technologies by developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by DesignTM platform for CRISPR-based genetic medicine.
We are seeking a highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of CRISPR-based therapeutics. The current role is for an experienced Project Manager to join our Program Management team to support our Translational Sciences (TS) operations to advance our platform and expanding pipeline.
The candidate should be a well rounded scientist with a passion of working collaboratively with other scientists to build the necessary processes to drive the new frontier of CRISPR-based therapeutics into the clinic. The candidate will partner with the Head of Translational Sciences, TS functional leads and other cross-functional leads to organize and execute on tactical plans related to departmental operations and bioanalytical outsourcing. The position will require the candidate to wear both a scientist and a project manager hat in order to be successful in this role.
The candidate will have opportunities for professional growth in a rapidly growing biotechnology company, which includes growing into a leadership role of increasing responsibilities and the ability to get hands-on experience in various phases of development.
If you are seeking a role to wear multiple hats, not afraid to get your hands dirty, to be involved in cutting-edge science, and to drive changes to make things happen, this position is for you
Key Responsibilities:
Required Skills and Background:
Preferred Skills and Background:
Salary will be commensurate with experience. We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to engineer the future of therapeutics, then we are excited to hear from you Visit us at
We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.
At the time of posting, the base pay wage range for this role is $150,000-190,000 per year. The offered pay range will depend on internal equity and the candidate's relevant skills, experience, qualifications, training, and market data. Additional incentives are provided as part of the complete package in addition to comprehensive medical and other benefits.