Vice President/Senior Vice President, Clinical Operations
Join Autobahn Therapeutics! We are seeking high-performing individuals who are passionate about science and excited to work in a collaborative environment with an experienced team fueled by a rigorous and entrepreneurial culture. Take part in our mission to restore hope for people affected by CNS disorders.
Company Overview
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 major depressive disorder (MDD).
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
Position Summary
The successful candidate will identify, lead and oversee operational resources related to CNS-driven drug development programs, including managing direct reports and vendors. The VP/Senior Vice President, Clinical Operations will develop clinical operations strategy and be accountable for the efficient planning, execution, oversight, and delivery of the highest quality clinical trials according to required standards and regulations (SOPs, ICH GCP, regulations, data privacy, etc.) This person will be a key member of the executive team.
Key Responsibilities
- Build, lead and support the CMO in Clinical Operations (e.g. governance, resources, budget, SOPs, vendors, etc.)
- Develop the clinical operations strategy to include risk management and contingency planning
- Alongside HR, direct and oversee recruitment, hiring, onboarding, and provides line management and mentoring of direct reports.
- Identify, qualify and oversee additional resources required to deliver projects compliantly, effectively and efficiently (i.e. CROs, vendors, consultants/medical writers, Key Opinion Leaders, etc.)
- Utilize best practice operational, project, change and risk management strategies to plan, oversee and report timely, high quality programs/projects (trials), ensuring regulatory compliance and ongoing audit/inspection readiness
- Drive development of and/or, provide expertise, to generate operationally feasible organizational, program and trial level documentation and procedures (e.g. SOPs, protocol, Investigators’ Brochure, consent/patient information, monitoring plans, safety review committee charters, etc.)
- Evaluate the health and success of program/project deliverables (time, budget, scope) to ensure they remain on track, making adjustments where necessary (applying appropriate company resources/systems/tools as needed)
- For all programs/projects, proactively identify and manage ‘issues that matter’ and address noncompliance, applying judgement to ensure appropriate issue responses, escalations and timely resolution. Perform root cause analyses and take corrective and preventive actions, where necessary
- Proactively collaborate with stakeholders to communicate information effectively. Prepare and present updates and reports, as required
- Liaise with regulatory agencies to support filing/application activities, review and approval process (IND, etc.)
- Maintain awareness of current and evolving industry trends, regulations and best practices to ensure that company continually improve and adapt accordingly
- Continually evaluate lessons learned and assess the impact on company infrastructure and address potential gaps and identify improvement opportunities
- Represent the company as the senior clinical operations spokesperson before appropriate scientific, medical, and regulatory professional meetings and with the Board of Directors.
- Apply commercial, financial and business acumen skills to all endeavours
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations
Qualifications
Education
- Bachelor’s degree is required.
- Master’s degree or higher degree is welcome.
Experience
- 10+ years of US clinical operations/project management experience in the biopharmaceutical industry is required, including direct experience in biotech and clinical development (Phase I/II/III clinical trials.)
- CNS and/or rare disease experience is required. Psychiatry experience is highly desired.
- Deep knowledge of drug development, ICH/21CFR/EMA clinical trials regulations and clinical operations roles and responsibilities is required.
- Previous line management and hiring experience
- Experience selecting, qualifying and overseeing CROs/vendors/consultants
- Experience and knowledge of FDA/EMA IND/NDA submission and approval process
- Early development clinical monitoring experience is desired
- Systematic, analytical and critical thinker – able to evaluate complex information and apply data-driven approaches to ensure effective decision making and solutions.
- Advanced program/project management skills
- Ability to provide flexible and scalable operational solutions to aid effective planning and implementation of governance/systems/programs/trials
- Ability to proactively evaluate and communicate the impact of risk and change on organisations, projects and deliverables - proficient in application of best practice project and risk based quality management approaches
- Advanced verbal and written communication and negotiation skills, with an ability to build effective relationships across international cultures and organizations
- Advanced presentation skills – able to simplify and distill complex information for stakeholders at all levels to enable efficient and effective decision making
- Ability to build and sustain a team of direct reports and contractors - develop, coach, train and mentor others
Attributes
- Transparency, humility, accountability, collaborative, inclusive leadership, high level of EI/adaptability/resilience - awareness of unconscious bias, uses influencing skills to remove barriers, agile, promotes sharing and applying lessons learned, change champion, big picture thinker, flexible, self-motivated
- Shows willingness to ‘jump-in’ and get the work done when/where it’s needed,
- Ability to function effectively in an organization where there is very little infrastructure in place (has worked in biotech before).
- Critical thinking - Asks the right questions at the right time and understands how RBQM can be applied within early development.
- Knows what regulatory changes are coming and can keep up to date/assess impact on wider organization.
- Strives for excellence (rather than perfection).
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
- Autobahn Perks (gym membership, discounts to Alexandria restaurants, free lunch twice weekly, company-sponsored events, etc.)
- 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 submit your resume and cover letter referencing job VPCLINOPS [055] to careers@autobahntx.com
