We Put People First

• 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 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 25%.

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
• 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 apply via Linkedln or submit your resume and cover letter to careers@autobahntx.com referencing CLINMGR in the subject line.

Key Responsibilities

• Establishes and implements a Medical Affairs strategy through each stage of clinical development for new products in Major Depressive Disorder, Bipolar Disorder Depression, and other CNS diseases.
• Identifies, prioritizes, and engages with key external stakeholders amongst medical, healthcare, and patient organizations.
• Supports the development of key scientific and medical messages and participates in company presentations to key external audiences, including research analysts, investors, and strategic partners.
• Leads the development and implementation of medical and patient education strategies, with an emphasis on addressing unmet medical needs in target patient populations within neuropsychiatry and neuroimmunology.
• Provides leadership to the Medical Affairs organization; evaluates the function and sub-functions, determines required core capabilities, future team structure and development.
• Develops and refines Medical Affairs policies and procedures and SOPs.
• Develops strategic imperatives and tactical plans to enhance healthcare practitioner education to improve patient outcomes.
• Works closely with clinical development/regulatory in designing and implementing strategies and tactics to prepare for potential future commercial activities, and lifecycle planning.
• Provides input to the publication strategy, developed with discovery, commercial and clinical development/regulatory.
• Oversees the execution of publication plans emanating from company activities, and which may require internal resources, external collaborators, and external writers to generate posters, presentations, abstracts, and papers for scientific communication.
• Leads and oversees scientific efforts at relevant medical and scientific conferences to support sponsored speakers and presenters, ensures success of publication/communication goals.
• Participates in the collection and reporting of competitive intelligence within company guidelines.
• Gains and provides medical insights and works closely with the commercial leadership team and health outcomes requirements to bring a medical perspective to commercial strategies and tactics
• Provides strategic input to clinical development and commercial functions on the planning steps for post-marketing clinical development requirements.
• Leads and ensures proper strategic input, alignment and oversight of Investigator Sponsored Trials, publication plans, KOL/advisory board plans, continuing medical education plans to optimize the product profile to build product awareness and gain strategic insights for marketing and development strategy.
• Fosters research relationships with key research centers in the US and OUS.
• Lead Health Economics and Outcomes Research (HEOR) strategic planning and execution.
• Responsible for corporate level influence and is considered a key opinion leader and resource both internally and externally.
• Provides input on assessments of new internal and external product opportunities.

Education

• MD, PhD, PharmD or equivalent degree, Neuroscience required, psychiatry strongly preferred.

Experience

• Eight years progressively responsible and relevant experience within the pharmaceutical industry with at least 6 years in CNS.
• Successful track record of leading a medical or scientific affairs department.
• Experience planning and directing strategies for engagement with key opinion leaders.
• Experience interfacing with key opinion leaders and leading scientific researchers in collaboration with biopharmaceutical companies.
• Experience establishing strong interpersonal relationships with industry/academic collaborations in support of biopharmaceutical development.
• Experience providing medical/clinical/scientific information and expertise to internal departments and externally to key stakeholders, including both healthcare professionals and research analysts, investors, and strategic partners.
• Experience establishing and leading a Scientific Advisory Board and implementing a global publication strategy for a biopharmaceutical company.
• Knowledge and expertise of adverse event reporting and drug-safety surveillance.
• Knowledge of the regulatory framework (FDA, DDMAC).
• Experience with literature information databases.
• Strong verbal and written communication skills at a professional medical level.
• Management and supervisory experience (minimum 5 years) including experience with contractors and medical information service providers.
• Leadership, coaching and mentoring skills.
• Ability to manage moderate budgets, multiple projects, and timelines.
• Ability to collaborate cross-functionally across teams across the organization (clinical, discovery, commercial).

Desired Experience

• Full understanding of all stages of pharmaceutical drug development process.
• Neuropsychiatry therapeutic experience.
• Publication and manuscript preparation experience.

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

The salary range for this position is $280,000 to $380,000 per year, which factors in various geographic regions. The actual compensation and seniority level for this position will be determined based on relevant experience and qualifications. In addition to a competitive base salary, this position is also eligible for equity awards, plus a discretionary bonus based on factors such as individual and organizational performance.

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 apply submit your resume and cover letter to careers@autobahntx.com referencing VPMEDAFFAIRS [055] in the subject line.