Senior Director, Program Management
Location: South San Francisco, California, United States
As we build a solid and differentiated portfolio and a development centric organization, its ability to manage complex R&D programs, including clinical and product development, in an effective and efficient manner is of critical importance. The primary role of this leadership position in Program-Management is to deliver program success including facilitating the success of the assigned development programs to deliver commercially viable products.
The role interfaces with the Portfolio Management Team to ensure project and program success and will be responsible for translating the cross-functional, integrated Program Team (PT) strategy into an efficiently executable plan; predict and plan solutions to achieve program goals and objectives; drive clarity and remove barriers to ensure team success; interface with executive management and influence decision-making, proactive management and mitigation of development risks, and ensure appropriate communication and interface with internal governance.
Key Responsibilities include:
- Work with the leadership team to develop pipeline strategies and build high-performing teams that can deliver defined business solutions
- Develop and deliver on project plans to guide programs while managing risk, contingencies and/or corrective actions
- Leads and manages project management function
- Define and direct the technical approach to project management
- Lead and provide effective project/program leadership of the development team to deliver high-quality projects/programs with clear boundaries and outcomes on time and within budget
- Work in partnership with the Portfolio Management Team to develop and implement overall project/program strategy
- Present projects/programs to the Portfolio Management Team and Executive Team, representing the interests of the overall project / program (aligned across organizations and departments)
- Align development plans across Regulatory, Clinical, R&D, Pharmacology-Toxicology and CMC
- Interface with Regulatory Affairs to develop global regulatory strategy and plans
- Provide cross-functional leadership for the strategic planning of integrated development plans for programs starting at first-in-human through registration
- Co-chair cross-functional project/program team meetings to ensure appropriate action plans are created and implemented
- Set realistic yet aggressive timeframes for achieving objectives with team buy-in and alignment
- Lead cross-functional project/program team(s) to prepare Target Product Profile and global development plan to deliver differentiated products leveraging the scientific and medical leadership of Portfolio Management Team
- Define and implement a communication strategy / plan for the program that supports the most effective team empowerment and progress
- Act as an appropriate role model / coach / mentor to facilitate the success and development of individuals within the teams and the team as a whole
Preferred Qualifications include:
- Minimum education is Bachelor degree: preferably an advanced Degree (MBA, MS, PhD) and PMP certification
- 15 years or more experience in drug development especially with project/program leadership of cross-functional teams
- Demonstrated experience planning, managing and completing one or more large complex projects with teams of 30+, 18+ month duration and cost to implement of $20M+ engaging varied functional stakeholders
- Deep experience in the Pharmaceutical industry drug development process and regulations all along the R&D value chain (preferably in a function such as research, clinical, preclinical, CMC or regulatory affairs) with significant exposure to global teams in addition to Project/Program Leadership is considered as a plus
- Experience with viral hepatitis and Asia regulatory would be a plus
- Ability to travel as required
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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