Autobahn Therapeutics is seeking a Manager/Senior Manager, Clinical Operations to join its team to oversee clinical pharmacology (BE, DDI, Mass Balance and SAD/MAD) studies.
About Us
Autobahn Therapeutics is focused on improving life health for people affected by CNS disorders. Autobahn is leveraging a deep understanding of validated human biology coupled with its brain-targeting chemistry platform to develop thyroid hormone receptor beta agonist therapies that harness the regenerative power of the human body. The company's pipeline is led by ABX-002 for the treatment of treatment resistant depression (TRD) and other affective disorders. The research pipeline is focused on CNS immunology.
Autobahn Therapeutics has a deep investor base, anchored by ARCH Venture Partners, and is located in San Diego, for more information, visit www.autobahntx.com.
Summary
The Manager/Senior Manager of Clinical Operations will report directly to the SVP Global Clinical Operations and work closely with the Program Management, Regulatory, CMC and Quality. The position will be responsible for clinical trial conduct of assigned clinical studies in support of our product development portfolio and will lead the cross-functional clinical trial team including our CRO and vendor partners. They will work with key internal stakeholders ensuring alignment of activities with study projects and timelines.
The title for this position may range from Manager to Sr Manager, based upon experience and career accomplishments.
Key Responsibilities
Responsible for providing sponsor oversight of clinical study conduct (start-up through database lock and reporting) in compliance with Autobahn SOPs, HREC/FDA/EMA/ and other RA regulations, ICH/GCP guidelines and applicable local laws, including review of study documents (protocol, ICF), study presentations, study tools, and study plans (e.g. RBM, IRT, EDC, ePRO, SRM, Recruitment, Laboratory Manuals, etc) Coordinating cross-functional efforts to achieve study objectives with a focus on quality.
Provide oversight of clinical pharmacology (BE, DDI, Mass Balance and SAD/MAD) studies. Includes activities associated with the implementation, management and monitoring of clinical trials including but not limited to review of monitoring reports, site recruitment efforts and maintaining timelines.
Oversees data discrepancy management and assists with mapping as needed, routine review of risk management plans, protocol deviations lists, ongoing data cleaning, listing review and TLFs (when available). Provides input/reviews clinical study report, DSUR, and regulatory annual and periodical reports.
Informs leadership on overall clinical trial progress, recruitment status, and raises potential risks with eye towards creating potential mitigation plans, real time as needed.
Oversees TMF set-up, ongoing quality review, and final reconciliation.
To varying degrees and based on level and experience: Manages vendor relationships (selection through execution of contract/timelines) to achieve project goals and ensure that performance expectations are met. Manages vendor agreements, change orders and site budgets to meet clinical operations specifications. Identifies and communicates in a timely manner study issues that will impact budget, resources, and timelines.
Work with Autobahn QA to review CRO Quality Systems and perform audits as required
Encourages others to consider new approaches and ideas. Models and promotes positive team behaviors in a cross-functional setting by inspiring and holding others accountable for accomplishing goals, building a culture of energy and commitment that challenges people to excel. Recognizes and rewards accomplishments, proactive management of issues, and providing guidance/feedback on performance.
May participate in company initiatives, company policies/procedures, continuous improvement initiatives, and shares knowledge where applicable.
The candidate must be on the West Coast (Pacific Time) and be able to visit the San Diego office 3-4 days/month for key meetings and activities.
May require travel up to 20%.
Qualifications
Education
Bachelor's Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study
Experience
Minimum of 4 years of relevant and progressive clinical trial management experience and proven track record of successful management of global clinical research studies in the small company biotech industry.
Demonstrated expertise in with Phase 1, clinical pharmacology studies in Healthy Volunteers required. Experience with Phase 2 and 3 trial oversight desirable.
CNS experience is highly desired. Experience beyond oncology and rare disease is required.
Deep knowledge of FDA and EMA drug development and clinical trial regulations (21 CFR Parts 11,50,54,56, 312 and 312 and ICH/GCP/GDPR)
Experience selecting, qualifying, and overseeing CROs/vendors/consultants
Experience and knowledge of FDA/EMA IND/NDA submission and approval process
Advanced program/project management skills
Ability to provide flexible and scalable operational solutions to aid effective planning and implementation of programs/trials
Software proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, MS Project, Teams) and document sharing sites (e.g., SharePoint)
Experience with electronic quality, compliance, EDMS and CTMS systems
Attributes
Results driven in alignment with the company culture of spirited collaboration and integrity
Systematic, analytical, and critical thinker - able to evaluate complex information and apply data-driven approaches to ensure effective decision making and solutions
Strong interpersonal skills with highly effective written and verbal communication skills.
Team player who understands the nuances and importance of relationship management.
Transparency, humility, accountability, collaborative, inclusive leadership, high level of El/adaptability/resilience - awareness of unconscious bias, uses influencing skills to remove barriers, agile, promotes sharing and applying lessons learned, change champion, big picture thinker, and flexible.
Self-motivated individual who can prioritize work.
Willingness to 'jump-in' and get the work done, when needed
Ability to function effectively in an organization where infrastructure and processes are still under development.
Compensation and Benefits
In addition to a competitive compensation package with stock options, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
Competitive compensation package including bonus opportunities and stock options
Medical, Dental & Vision Plans
401(k) Plan, including company match with immediate vesting
Unlimited Paid Time Off
11 paid company holidays
An opportunity to do truly meaningful work to make a lasting impact
Flexible spending account for medical and dependent care
Life insurance, short and long term disability plans
We foster an environment where all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation or expression, age, disability or veteran status or any other characteristics protected by law.
For consideration, please apply via LinkedIn or submit your resume and cover letter to careers@autobahntx.com referencing CLINPHASE1 in the subject line.