Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients withcal complement-mediated disorders of the body, brain and eye. The Company’s pipeline is based on its platform technology addressing well-researched cal complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of thecal complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.
As the leader of one of our therapeutic franchises, the Project Team Leader will provide strategic scientific, business and operational leadership and direction of the R&D development and advancement of Annexon’s portfolio. In addition to developing and driving a comprehensive lifecycle portfolio strategy, the Project Team Leader shall be responsible for leading a cross functional leadership team of both internal and external resources in all aspects of development pre-IND stage through late stage development, ensuring consistent high quality output from the team and achievement of program goals and objectives as well as drive effective execution of such strategies by leading the cross functional team’s engagement, integration, coordination and communication across functional lines. Duties for this role also include managing R&D partnerships, helping to build necessary infrastructure for the R&D organization and working with the executive leadership to create an environment that supports rapid and high-quality decision making (both for the portfolio and the organization) and to identify, evaluate and find solutions for key issues facing the programs on an ongoing basis. The Project Team Leader will report into the SVP, Portfolio Strategy & Operations.
- Partnering with internal and external stakeholders to drive the development of a comprehensive strategic plan through registration and pre-commercialization preparation, including goals, budget and risk assessment. Includes developing program vision, strategy, scope/focus, milestones, risk assessment and management strategies, as well as project investment requirements.
- Leading cross-functional Project Team focused on the development of Annexon’s clinical candidates, from pre-IND through late stage clinical development and NDA submission for multiple indications. Project Team shall include representation from Research, Development, CMC, Regulatory, Quality, Commercial and Finance.
- Providing effective leadership and direction to the cross functional Project Team, including scientific and operational oversight of activities, budgeting and planning.
- Utilizing his/her understanding of disease biology, global drug development and portfolio management within the field of Neuroscience and/or Autoimmune disorders to effectively lead the Project Team.
- Partnering with executive team to develop operating framework within R&D, including with regard to the Project Team to clarify and facilitate decision-making and escalation around strategic direction, resource allocation, etc.
- Partnering with functional areas to identify and ensure adequate resources for timely completion of goals and objectives. Ensuring team members understand program objectives, specifications, deliverables, timelines, and tasks.
- Driving the development and implementation of lifecycle portfolio strategy and follow-on drug candidates for multiple diseases.
- Managing and communicating program progress on a continual basis, identifying both cross-program and cross-functional issues, resource issues, timeline issues, and budget issues.
- Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles
- Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results
- Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people
- Ensures budgets and schedules meet corporate requirements
- Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major internal and external customers
- Works on abstract problems across functional areas of the business.
- Identifies and evaluates fundamental issues for major function areas through assessment of intangible variables. In-depth knowledge of functional areas, business strategies and company goals.
- Interacts internally and externally with executive level management requiring negotiation of matters to influence policymaking bodies both internally and externally.
- Anticipates potential roadblocks and issues of conflict and maintains open lines of communication in problem solving and resolving issues and conflict.
- The successful candidate should have an advanced degree in life sciences or medicine (PhD or MD) and/or commensurate experience.
- He/she will have at least 10 years of industry experience in drug development, including experience in early phase non-clinical and clinical drug development, regulatory knowledge and pre-commercial market preparation.
- Prefer scientific or industry experience within the autoimmune, neurology and/or ophthalmology field.
- Will have a proven track record of being a results-oriented leader and will have 5+ yrs. leading, managing, and developing program related teams; prefer direct Project Team Leader experience.
- Leadership: Experience leading and motivating teams in a matrix environment is required. Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams.
- Strategic Agility: Ability to develop and execute complex strategies.
- Collaboration/Relationship Management/Influencing: Ability to effectively collaborate in and across multiple functions, and with internal and external stakeholders of various backgrounds and skill sets. Skilled in establishing a collaborative and respectful environment. Demonstrated skills in persuading senior leadership on strategy, initiative(s) implementation, and decision-making. Influences and motivates others to achieve objectives.
- Decision Making: Strong decision-making skills taking multiple perspectives into account and analytical skills are required; exercises sound business judgment that has broad organizational impact.
- Communication: Excellent communication skills (both orally and written) is critical to the success of the role.
- Business Excellence: good at developing the processes necessary to get things done, knows how to organize people and activities and knows what to measure and how to measure. Demonstrated ability to interpret data into actionable items.
- Negotiation: Proven negotiation skills that effectively drive discussions and decisions to desired end-results that have broad organizational impact.