Job Code: USRA03
Position: Program Management (Executive Director/Senior Director)
Department: Regulatory Affairs
Reports to: VP, Regulatory Affairs
Location: Remote- West Coast based
Connect Biopharma (Nasdaq: CNTB) is a global, clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research. With operations and expertise in China, the United States and Australia and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology.
The Head of Program Management will be responsible for establishing the Program Management function and providing expertise to Connect Biopharm to ensure milestones and deliverables are met for global programs and that tasks are well executed in a timely manner. The ideal candidate will partner with the Project Team and Senior Leadership to create the global development plan as well as manage day-to-day planning by coordinating and tracking of critical activities. Additionally, a successful candidate will build strong working relationships across departments, with key stakeholders, and other members of the executive management team to ensure transparency and facilitate communication.
- Direct global development and implementation strategy to optimize team effectiveness and decision-making for global programs in immunology disease area, including both large and small molecules
- Facilitates highly effective team building and communication by leading global teams to establish development strategy and meet corporate development goals and oversight of clinical, preclinical, CMC, and publication planning for Connect Biopharm programs.
- Creates and drives timelines to keep programs on schedule; develops annual project and program goals in alignment with corporate goals and track progress using program timelines (Gantt chart) identifying all significant activities, dependencies, resources and milestones; performs continual review and analysis of critical path activities to manage risk and communicate mitigations.
- Perform End-to-end review of lead development programs to make recommendations for development priorities including determination of risks for the clinical development plans and potential differentiation in target product profiles
- Proactively and independently identifies and resolves program team challenges; conducts scenario planning, establishes resolution/mitigation plans, and ensures alignment across multiple functional groups
- Drives information flow and communicates program status to all stakeholders in collaboration with the team. Produces regular status reports (milestones, status, issues, decisions) for executive and senior management to communicate risks and plan mitigation as needed.
- Develop annual project and program goals in alignment with corporate goals and track progress including detailed project plans, timelines, resources, and identification of critical path activities.
- Work closely with CMC group and contract manufacturers to assess challenges for manufacturing plans, process optimization, and scale up to ensure timelines are appropriate to support clinical plans; supports development of drug supply forecasts for both clinical and commercial products, as needed.
- Consolidates and reports on program budget. May work with the team and functional areas to prepare the annual (and longer range) program budget. May participate with budget forecasts as requested; in cooperation with functional managers, ensures that resources assigned to the program are adequate to meet program objectives and identifies resource constraints.
- Creates and maintains easily accessible, high level program documents in electronic format; identifies, develops and/or maintains an appropriate electronic platform for maintaining documentation of relevant program information and plans.
- Interfaces internally by acting as a liaison and facilitator of cross functional teams (i.e. Clinical Development, Clinical Operations, Technical Operations, Regulatory, Quality Assurance, Finance, etc.) in planning and executing Phase 1-4 clinical trials and regulatory filings.
- Interfaces externally with collaborators, vendors, contractors, and consultants to ensure communication and deliverables in accordance with planned program objectives.
- Assists team members in preparing for advisory board activities, scientific meetings, and other external meetings/conferences, as appropriate.
- Contributes to the development of the Program Development Department through introduction of new tools and processes for continuous improvement. May manage and develop other Program Management staff.
- Minimum of a BA/BS is required, an advanced degree and Project Management certification is highly desirable.
Qualifications And Requirements
- Minimum of 15 years of pharmaceutical industry experience, with at least 10 years of Program/Project Management experience within a matrixed pharmaceutical, biotechnology or medical device organization.
- Thorough understanding drug development and lifecycle management from Discovery through Launch; experience with post marketing commitments, pediatric studies, and medical affairs a plus.
- Project planning experience required, particularly an understanding of strategic decision-making to drive clinical development and product commercialization processes.
- Prior experience in leading and managing interdisciplinary or cross functional pharmaceutical or biotech teams is required.
- Ability to drive program plans and timelines (across multiple functional areas) is essential. Proven success in goal setting, prioritization and time management is required.
- Understanding of FDA and EMA quality and regulatory requirements and processes for conducting clinical trials and marketing pharmaceuticals is required.
- Prior experience with regulatory filings (IND, BLA, NDA) and agency interactions is required.
- Experience working with global partners, scientific advisory boards, and vendors with an understanding of alliance management is preferred.
- Familiarity with due diligence activities for in-licensing and out-licensing opportunities with an understanding of co-development and marketing partnerships in pharmaceuticals is preferred
- Proactive mindset with strong formal and informal leadership, facilitation, teamwork and influence management/negotiation skills.
- Must have excellent verbal and written communication skills as well as exceptional organizational capability.
- Proven ability to build strong working relationships across functions, with key stakeholders, and other members of the executive management team to ensure transparency and facilitate communication
- Ability to work independently in decision-making and resolution of program obstacles and conflicts.
- Familiarity with developing budgets and budget/resource forecasting is desirable.
- Keen insight, independent judgment and tactful discretion are required.
- Must be able to demonstrate strong analytical and problem-solving capabilities.
- Proficiency with Microsoft Suite, MS Project, Sharepoint, and other software as needed.