Senior Director, Clinical Development

$336k - $374k USD

AnnexonbioscienceSan Francisco Bay Area3h ago

Company:  At Annexon Biosciences we are 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. Our 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, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.    For more information on Annexon and our pipeline, check out our site <a href="https://annexonbio.com/">Annexon Biosciences</a> & <a href="https://annexonbio.com/pipeline/">Annexon Pipeline</a>. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.  We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company <a href="https://annexonbio.com/our-culture/">culture</a>!  Position:  The Sr. Director of Clinical Development will serve as a key leader in driving the clinical strategy and execution of one or more development programs. This role will be responsible for the end-to-end design and execution of clinical programs, from Phase I through Phase III, ensuring scientific integrity, regulatory compliance, and alignment with corporate objectives. The Sr. Director will collaborate with cross-functional teams, lead regulatory submissions, and establish critical partnerships with key opinion leaders and external stakeholders to advance clinical initiatives. The ideal candidate will bring a strategic vision, proven expertise in clinical trial design and execution, and the ability to manage complex programs in a fast-paced environment. This individual will play a crucial role in translating innovative therapeutic concepts into real-world treatments, shaping the company’s success in the rapidly evolving field of neurology.  Responsibilities include:  <ul> <li>Lead the strategic direction and execution of clinical development programs, from early-phase through late-stage clinical trials ensuring they are scientifically robust and meet regulatory requirement. </li> <li>Collaborate cross-functionally with teams in clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics to ensure the successful execution of clinical development plans.  </li> <li>Drive the preparation, submission, and management of regulatory filings, including clinical trial applications, investigator brochures, and study protocols, ensuring alignment with global regulatory guidelines (FDA, EMA). </li> <li>Analyze, interpret, and communicate clinical trial data to inform key decisions, providing clear recommendations to guide clinical development strategy.   </li> <li>Establish and maintain strategic relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives.  </li> <li>Manage clinical trial budgets, timelines, and resources, ensuring the delivery of high-quality results aligned with corporate objectives.  </li> <li>Regularly present clinical progress, data outcomes, and strategic recommendations to executive leadership, stakeholders, and external partners.  </li> <li>Stay at the forefront of industry trends, scientific advancements, and regulatory developments to ensure the company remains competitive in the clinical development strategies.  </li> <li>Identify potential risks in clinical development timelines, budgets, or regulatory pathways, and develop contingency plans to mitigate them. </li> </ul> Education, Experience, and Skills:  Required:  <ul> <li>MD or PhD in Neurology, Neuroscience, or a related field.  </li> <li>Over 10 years of experience in clinical development, with a focus on CNS-related indications.  </li> <li>Proven leadership in designing, managing, and executing clinical trials from early phase through late-stage development.  </li> <li>Demonstrated experience in leading clinical development teams at a senior or executive level, ideally within a high-growth biotech or pharmaceutical environment. </li> <li>In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA) and clinical development processes, including Experience in HA meetings, writing briefing books, attending/supporting meetings.  </li> <li>Exceptional leadership, strategic thinking, and communication skills with a proven ability to influence across functions and levels.   </li> <li>Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities.  </li> <li>Strong analytical and problem-solving skills, with a data driven approach to decision making.   </li> <li>Demonstrated success in building collaborations with cross-functional teams and external partners in a dynamic, fast paced environment.  </li> </ul>  Preferred:   <ul> <li>Experience with regulatory submissions and clinical trial oversight in a biotech or pharmaceutical setting. </li> <li>Familiarity with emerging trends in neurology, including cutting-edge therapeutic modalities. </li> </ul> Salary Range: $336,000 - $374,000 Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area.  Benefits:  <ul> <li data-leveltext="" data-font="Symbol" data-listid="17" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.</li> <li data-leveltext="" data-font="Symbol" data-listid="17" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Shuttle service from BART, CalTrain and the Ferry.</li> <li data-leveltext="" data-font="Symbol" data-listid="17" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">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, and other benefits. </li> </ul> Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.  #LI-DM1