Cmc In Biotech Jobs in California (NOW HIRING)

The Senior Program Management Director is a key leadership role with substantial strategic input and demonstrates a mastery of core and technical competencies, navigating myriad of complex and ambiguous therapeutic area scenarios. This position plays a pivotal role in managing development of program strategies ensuring design of a TPP. Serves as a key leader in the Program Management function. The Senior Program Management Director partners with Team Leaders and cross-functional teams to manage multiple highly complex Discovery and Translational Research (DTR), CMC and Development programs, spanning from Discovery to Phase 1 to 3 development, CMC, NDA/BLA filings and approvals. This position plays a critical role in the development and execution of program strategy and leads the creation and implementation of team processes to enable the timely delivery of program goals and deliverables. Develops and maintains integrated project plans, Gantts/timelines, status reports, strategic development and filing plans in collaboration with team leaders and cross-functional team members. Oversees and manages the operational aspects of ongoing drug development projects to ensure goals and objectives are met. Acts as a strategic thought partner to the Project Leaders and teams in the definition of product development strategy.

• Oversees multiple highly complex projects or a portfolio of discovery and translational research (DTR), CMC, Phase 1 to 3 clinical development, NDA/BLA filings/approvals and/or post approval programs; leads and ensures alignment across cross-functional teams.
• Develops detailed cross-functional integrated project plans, Gantt charts, status reports in collaboration with cross-functional teams.
• Ensures timelines accurately capture dependencies for key milestones and critical path.
• Critically assess project plans to foresee risks and evaluate opportunities for efficiencies impacting success of established TPP.
• Drives project execution through the development and implementation of high quality, integrated cross-functional project plans, in collaboration with Team Leaders and cross-functional teams.
• In collaboration with Finance and team leader, keeps track of project resources and budget and schedules appropriate governance approvals.
• Oversees risk management and contingency planning for the team, ensuring proactive identification and resolution of issues; navigates uncertainties with agility and accountability.
• Communicates effectively with executive leadership and governance bodies, providing clear, concise updates and recommendations; sets clear meeting agendas, facilitates meetings, writes clear minutes, assigns action items, follows up on action resolution.
• Leads department-level or cross-functional initiatives to establish best practices or improve processes and ways of working.
• Proactively identifies gaps in processes, develops proposals and implements solutions to address as needed.
• Maintains strong external awareness of scientific, regulatory and commercial trends to inform and adapt development strategies.
• Communicates relevant information, highlighting relevance to departmental or cross-functional team.
• Performs other duties as assigned.
• Complies with all policies and standards.

SUPERVISORY RESPONSIBILITIES None.

Education BS/BA degree in STEM with a minimum of 15 years relevant experience; or, MS/MA degree in STEM, biological or pharmaceutical sciences with a minimum of 13 years relevant experience; or, PhD in STEM, biological or pharmaceutical sciences with a minimum of 12 years of relevant experience; or, Equivalent combination of education and experience.

Experience 12-15 years of experience managing cross-functional teams in biotech/pharma industry, including CMC, discovery or development. Possesses relevant managerial experience. Experience managing small molecules/biologics in cancer immunology and/or oncology fields is preferred. Experience working with corporate partners and alliance management or working with business development or alliance management on a deal is a plus.

Knowledge, Skills and Abilities Required: Extensive understanding or experience of the full drug development process (oncology is preferred) including discovery, CMC, development and filing. Experience in at least two different functions or phases of development preferred. Excellent analytical skills with an ability to summarize and present complex information in a clear and concise manner. Excellent verbal and written communications, presentation, collaboration and negotiation skills. Strong leadership and influencing skills at departmental, organizational and cross-functional levels. Shows excellent drive and self-motivation, sets a fast pace for self and teams while maintaining strong relationships. Strong organizational skills, highly efficient, strong attention to detail. Able to process significant amount of information within multiple projects simultaneously. Models leadership behaviors, articulates and demonstrates a firm commitment to Exelixis' vision and values. High proficiency with MS Office Suite, Planisware, MS Project or equivalent project management software.

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $204,500 - $290,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

• 401k plan with generous company contributions
• Group medical coverage
• Dental coverage
• Vision coverage
• Life insurance
• Disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Sales-based incentive plan (if field sales staff)
• Opportunity to purchase company stock
• Long-term incentives
• 15 accrued vacation days in first year
• 17 paid holidays including a company-wide winter shutdown in December
• Up to 10 sick days throughout the calendar year

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: ApplicantAccommodations@exelixis.com.

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future.

After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too.