- Accountable for the oversight and execution of multiple clinical trials.
- Member of core team(s) 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 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.
- Remains current with therapeutic areas under study, industry practices / trends and FDA requirements. Applies this knowledge to current programs.
- Partners with and maintains regular contact with key stakeholders including Regulatory, 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.
Key Qualifications - Experience leading clinical trial operations as an Associate Director, Director or Senior Director level role including multinational/multisite clinical studies with experience in ophthalmology drug development.
- Associate Director: Typically requires BS/BA degree + 14 years of related experience, or MS/MA degree + 12 years of related experience, or PhD + 8 years of related experience.
- Director: Typically requires BS/BA degree + 15 years of related experience, or MS/MA degree + 13 years of related experience, or PhD + 10 years of related experience.
- Senior Director: Typically requires BS/BA degree + 17 years of related experience, or MS/MA degree + 15 years of related experience, or PhD + 12 years of related experience.
- Strong leadership skills with ability to be hands-on and lead/ manage the clinical team. Experience with direct line-management of clinical operations staff.
- Has a thorough knowledge of the clinical development process, FDA, EMA and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelines.
- Has demonstrated success identifying, negotiating and overseeing outsourced clinical operations services and vendors.
- Experience with financial budgeting or reporting.
- Experience with Opthalmology.
- Ability to interact with investigators, vendors, and individuals at all levels of the organization.
What Annexon offers - Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. To learn more about our diversity commitment, culture and values, visit
- A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
- We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry.
- Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.
CompensationThe anticipated salary range for the Associate Director, Clinical Operations position is $171,000 to $190,000 per year; Director, Clinical Operations position $209,700 to $233,000 per year; Senior Director, Clinical Operations position $256,500 to 285,000. The starting salary for this position will be determined based on the candidate's education, experience, transferable skills, licenses/certifications, location, and will be reviewed on a case-by-case basis to determine the final compensation. The starting salary does not include any other potential components of the total compensation package, including bonus, equity, employer provided benefits, and perks.
Company Summary
Annexon Biosciences (Nasdaq: ANNX) is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Annexon's novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington's disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. To learn more visit
EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging
Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.
Staffing Agencies
Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences. Please do not send agency CVs/resumes through Annexon's website or Annexon Employees. Inquiries must be sent to with the Subject Heading: Staffing Agency Request.
-
Associate Director/Director/Senior Director
1 week ago
Annexon Bioscience South San Francisco, United StatesWork Location · Corporate Headquarters (South San Francisco, CA) · Position Summary · This position reports into the Vice President / Executive Director of Global Clinical Operations. The Associate Director/Director/Sr. Director - Clinical Operations (Ophthalmology) will contr ...
-
Activities Director
1 day ago
San Bruno Skilled Nursing San Bruno, United StatesWe are seeking an experienced and enthusiastic Activities Director to join our team. As the Activities Director, you will be responsible for planning, organizing, and implementing a variety of engaging activities for our residents. · Your role will be crucial in promoting social ...
-
Associate Director/Director/Senior Director
1 week ago
Annexon Brisbane, United StatesAssociate Director/Director/Senior Director - Clinical Operations (Ophthalmology) · Work Location · Corporate Headquarters (South San Francisco, CA) - Hybrid · Position Summary · This position reports into the Vice President / Executive Director of Global Clinical Operations. The ...
-
Director of It
1 week ago
Giularos Search Firm San Francisco, United States**$4,000 Relocation** · Giularos Five Star Hospitality has an AMAZING opening for a Director of IT for a hotel management company in San Francisco This position is in office and relocation to San Fran is required. · AMAZING PERKS: · - PTO + 8 Holidays · - Medical, Vision, Dental, ...
-
Senior Director
2 days ago
Human Immunology Biosciences South San Francisco, United StatesJOB TITLE: Director/Senior Director, Medical Affairs · DEPARTMENT: Clinical Development · LOCATION: South San Francisco, California · TYPE: Full-Time (Hybrid) · Are you a medical affairs leader with late stage into commercialization experience in kidney and/or immune-mediated dis ...
-
Senior Director
1 day ago
HI-Bio South San Francisco, United StatesJOB TITLE: Director/Senior Director, Medical Affairs · DEPARTMENT: Clinical Development · LOCATION: South San Francisco, California · TYPE: Full-Time (Hybrid) · Are you a medical affairs leader with late stage into commercialization experience in kidney and/or immune-mediated ...
-
Senior Director, IT
3 weeks ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · Are you ready to shape the future of technology in the dynamic world of biotechnology? As the Senior Director of IT at Maze, you'll spearhead strategies that power our technology applications, platforms, and infrastructure. In this role, you'll be at the forefront ...
-
Senior Director, IT
6 days ago
Maze Therapeutics South San Francisco, United StatesJob Description · Job DescriptionThe Position: · Are you ready to shape the future of technology in the dynamic world of biotechnology? As the Senior Director of IT at Maze, you'll spearhead strategies that power our technology applications, platforms, and infrastructure. In this ...
-
Creative Director
6 days ago
Meta Burlingame, United States**Creative Director Responsibilities**: · - Oversee the strategy and creative direction of consumer facing Meta Quest · - Further develop the Meta Quest brand · - Manage development of creative executions across all channels that strongly resonate with the local market while main ...
-
senior director
1 week ago
Insitro South San Francisco, CA, United StatesThe Opportunity · The heart of insitro's strategy is the combination of novel, cutting edge methods in machine learning, biology at scale and small molecule discovery that address key bottlenecks in the drug development pipeline. To accomplish that, we are putting together an inc ...
-
BioSpace South San Francisco, United StatesJob Details · Work Location · Corporate Headquarters (South San Francisco, CA) Onsite - Hybrid · Position Summary · This position reports into the Vice President of Global Clinical Operations. The Director/Sr. Director will contribute to the development and implementation of cl ...
-
Director/Senior Director, Clinical Operations
2 weeks ago
Annexon, Inc. South San Francisco, United States Full timeWork Location · Corporate Headquarters (South San Francisco, CA) Onsite - Hybrid · Position Summary · This position reports into the Vice President of Global Clinical Operations. The Director/Sr. Director will contribute to the development and implementation of clinical studies. ...
-
Director/Senior Director, Medical Writing
5 days ago
BioSpace South San Francisco, United StatesJob Details · IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach ...
-
Director / Senior Director, Medical Writing
3 days ago
BioSpace South San Francisco, United StatesJob Details · Work Location · Corporate Headquarters (South San Francisco, CA) - Hybrid · Position Summary · The Director / Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in p ...
-
Annexon Bioscience South San Francisco, United StatesWork Location · Corporate Headquarters (South San Francisco, CA) Onsite - Hybrid · Position Summary · This position reports into the Vice President of Global Clinical Operations. The Director/Sr. Director will contribute to the development and implementation of clinical studie ...
-
BioSpace South San Francisco, United StatesJob Details · IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach ...
-
It, Director
12 hours ago
YugabyteDB Sunnyvale, United StatesAt Yugabyte, we are on a mission to become the default transactional database for the cloud. We are well underway on this journey with YugabyteDB, the open source, high-performance, distributed SQL database that runs on any cloud and enables developers to get instantly productive ...
-
Director / Senior Director, Medical Writing
5 days ago
Annexon, Inc. Brisbane, United StatesDirector / Senior Director, Medical Writing · Work Location · Corporate Headquarters (South San Francisco, CA) - Hybrid · Position Summary · The Director / Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmac ...
-
Septerna South San Francisco, United StatesTHE ROLE · The Director/Senior Director of Clinical Operations is a critical leadership position and is responsible for leading all clinical operations activities within the organization. This individual will be primarily focused on managing and executing domestic and internatio ...
-
Senior Director/Director
1 week ago
Kearns & West Inc San Francisco, CA, United StatesJob Description · Job Description · Kearns & West · Senior Director/Director · San Francisco, California · About the Job · THE ORGANIZATION · Kearns & West, Inc. is a stakeholder engagement, communications, and collaborative solutions firm. Our staff is passionate about en ...
Associate Director/Director/Senior Director - South San Francisco, United States - Annexon, Inc.
Description
Work Location
Corporate Headquarters (South San Francisco, CA)
Position Summary
This position reports into the Vice President / Executive Director of Global Clinical Operations. The Associate Director/Director/Sr. Director - Clinical Operations (Ophthalmology) will contribute to the development and implementation of 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 meetings with CROs and other trial vendors and serve as a key escalation point for teams an
Associate Director/Director/Senior Director professionals in South San Francisco
-
Kuo-Ching Chang
Data Scientist
-
Sanjay M. Satav
Sales & Business Development Manager