Director, Non-Clinical Operations

Alector, Inc. South San Francisco , CA 94080

Posted 5 months ago

At Alector, our mission is to develop therapies that empower the immune system to cure neurodegeneration. Our team is solely focused on developing cures for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and board members, leading healthcare investors and some of the most innovative pharma companies.

Would you like to take part in creating new therapies that really make a difference in patients' lives? Are you motivated by opportunities to make operations run smoothly? Do you derive satisfaction from anticipating and preventing issues that could derail outcomes or timelines? Would you like to be part of a talented team where everyone has a voice, and where innovation flourishes?

Use your hard-earned non-clinical operations, project management, and outsourced contractor management skills to help us achieve our mission of saving lives by curing neurodegenerative diseases.

As Director of Non-Clinical Operations for Alector, you'll closely collaborate with research biologists, assay development scientists, clinical scientists, regulatory and operations managers and the project team leaders. You will provide technical and operational support for the development of all Alector's products, which includes study design, protocol development in collaboration with functional representatives to support IND filing, and comprehensive CRO oversight. You'll be able to contribute across a variety of programs and have broad involvement in work central to Alector's strategic goals.

During the first year, your goals will include:

  • Oversee the development of toxicology package to support IND filing for multiple programs

  • Support multiple programs to conduct pharmacology and PK/PD studies at CROs with a good understanding of disease indication, MOA, clinical strategy, and target profile

  • Facilitate planning, development, tracking, and study timelines of nonclinical outsourced studies. Edits and reviews documents for consistency, completeness, and accuracy with minimal supervision

  • Collaborate closely with research teams and project teams, directly contribute to and represent non-clinical operations on internal and external project teams

  • Draft and review the Non-Clinical sections of new INDs and IBs

  • Demonstrates clear and concise verbal and written communication

  • Facilitates open communication across all departments

  • Possesses a solid understanding of GLP regulations, program science, and CRO landscape

We'd love to hear from you if:

  • You take pride in being persistent, self-motivated, and efficient

  • You thrive in an environment where we work independently and on teams

  • Bachelor's degree in life science or quality-related field and at least 8 years of experience in toxicology, pharmacology, pharmacokinetics, immunology, biological sciences or related discipline. MS or PhD preferred

  • You have hands-on experience with non-clinical toxicology studies to support regulatory filings

  • You possesses a solid understanding of GLP regulations, program science, and CRO landscape

  • You demonstrate a track record of managing relationships with vendors, suppliers, and contract organizations effectively

  • You have excellent communication skills, including the ability to influence cross-functionally and articulate complex issues clearly to drive understanding and decision-making

  • You have a point of view but are low ego

At Alector, we believe that high-performing teams include people from a wide variety of backgrounds and experiences who can challenge each other's assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a cure, where you'll drive growth, this is the role for you. There is no limit to how far you can go with us.

Benefits

While we've focused on what to look forward to during the first year and beyond, Day One is great, too: committed and driven colleagues, a bold and important company goal, state-of-the-art brand-new brightly-lit offices in the heart of the biotech area, competitive compensation and benefits. But these matter only if you're excited to build and own something great, and tackle these challenges with us. Come join us.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Director Clinical Operations

Cytomx Therapeutics

Posted 2 days ago

VIEW JOBS 12/7/2019 12:00:00 AM 2020-03-06T00:00 Sr. Director, Clinical Operations About CytomX Therapeutics: CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody™ therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.com The Opportunity: Reporting into the Vice President of Clinical Operations, the Sr. Director, Clinical Operations will be contributing to the development and implementation of strategic direction in the conduct of multiple clinical studies. Responsibilities include providing leadership to staff and study teams to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements. Establish and lead Governance meetings with CRO's and other trial vendors and serve as a key escalation point for teams and vendors. The Sr. Director will contribute Clinical Operations expertise in cross-functional meetings and develop and implement department initiatives. Management and mentoring of direct reports (Director through entry level) is expected. Professional Responsibilities: * Accountable for the oversight and execution of multiple clinical trials including: * Member of Development and Global Product Teams providing strategic direction to study teams to meet corporate goals and timelines. * Develop, implement, and provide oversight of vendor budgets and contracts * Tracking and reporting of study metrics * Identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion * Develop and manage effective working relationships with Principal Investigators and other key clinical opinion leaders. * Provides technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct * Partners with and maintains regular contact with key stakeholders including Regulatory Affairs (RA), Biometrics, Clinical Development, Legal, Finance, and others as necessary * Leads the team in the selection of Contract Research Organizations (CROs) for both large budget and small budget * Attends CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals * Contributes to definition, development, and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices * Travel may be required up to 30% in support of clinical study activities Education/Experience: * BS/BA or MS/MA degree in related discipline or equivalent combination of education and experience * Typically requires a minimum of 8-10 years of related experience or a minimum of 12 years combined education/training and experience. * Extensive Clinical operations experience in the CRO/pharmaceutical/biotech industry with a proven track record as a leader in clinical trials * Direct and in-direct management experience * Experience leading programs from preclinical to IND submission preferred * Oncology/ immuno-oncology experience required * Experience leading process changes and writing SOPs and other controlled documents Professional Requirements: * Has extensive experience in relevant industry/profession * Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways * Develops technical and/or business solutions to complex problems * Identifies and applies advanced practices, technical principles, theories and/or concepts, and contributes to the development of new principles and concepts; has a comprehensive understanding of current approaches in industry and ability to incorporate them into CytomX' s programs * Guides the successful completion of major programs, projects and/or functions. Has extensive experience leading multiple projects involving complex issues and decision-making * Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing * Independently interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company * Develops departmental policies and oversees and/or authorizes their implementation. Establishes organizational policies in a major segment of the company * Has extensive knowledge of other related disciplines * Applies strong analytical and business communication skills CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. Cytomx Therapeutics South San Francisco CA

Director, Non-Clinical Operations

Alector, Inc.