Associate Director, Strategic Planning & CMC Program Lead

Job Description: The Associate Director, Strategic Planning and CMC Program Lead position plays a key role in shaping product development and commercialization strategy. Accountable for driving execution of key Technical Operations deliverables to advance Atara pipeline programs. Responsible to lead a cross-functional team within Tech Ops (including Manufacturing, Process Sciences, Finance, Supply Chain, Engineering and Quality) to facilitate the creation and execution of product development and commercialization plans for Atara pipeline products. Works closely with other functions on the Product Team (Clinical Operations, Clinical Sciences, Translational Sciences, Regulatory) to shape product strategy and manage program deliverables.

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Work Location*: Thousand Oaks, CA
Reports to: Director, Operations Strategic Planning
Travel required: Up to 10%

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Primary Responsibilities: *

• Leads cross-functional initiatives that advance Atara’s Technical Operations network.

Coordinates and oversees execution of product CMC commercialization strategy through key regulatory filings (IND, BLA, etc).

• Represent Technical Operations on cross-functional product team and provide key input to help shape product strategy.
• Leverage input from critical functions to develop integrated strategic development plan for program.
• Work with key functions to develop CMC timelines to identify key interdependencies and critical path for program deliverables.
• Develops tracking dashboards to communicate program updates and identify any critical issues that can play or impact program.
• Leads and manages day to day operations of a cross functional program teams.
• Generates analysis and develops business case(s) to support decisions regarding prospective opportunities consistent with the strategic direction of Technical Operations.
• Engages stakeholders, ensures cross-functional alignment, and facilitates internal and external communication.
• Responsible for timely identification of critical path risks and for escalating issues to line leaders and project team representative for resolution.
• Ensures all team members understand project goals and objectives, current project plan and schedule, critical path activities and risks.
• Recommends and implements innovative process ideas that impact execution and cost efficiency.
• Acts as cross-functional liaison to ensure project plans remain aligned with current business development strategies.
• Partners with Plant Manager, Quality Site Head, Manufacturing, Supply Chain and Engineering leaders to assure timely facility qualification and licensure.
• Ascertains product requirements from internal sources and external partners, translates into specific goals, and ensures the delivered products will meet the expectations of customers, stakeholders, and external collaborators.
• Applies decision analysis tools to analyze complex situations and recommend defensible actions and solutions.
• Exercises good judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Builds and maintains relationships with key personnel.
• Organizes and facilitates team meetings and presentations; generate meeting minutes.
• As a key interface between different groups, ensures timely communication of changes or updates on timelines and deliverables.
• Leads or participates in other cross-departmental or cross-functional operations development projects as needed.
• Effectively interfaces with other line functions (e.g. Regulatory Affairs, Commercial, etc.) and function autonomously as a Product Development Project Leader.

Qualifications:

• BS minimum, MBA preferred, in pharmaceutical science or related field.
• 12 years of related pharmaceutical, biopharmaceutical industry.
• Proven success in project management in the pharmaceutical or biopharmaceutical industry.
• Strong understanding of phase-appropriate CMC requirements for product development
• Strong understanding of biopharmaceutical commercialization process (cell therapy commercialization experience)
• Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.
• Strong understanding of pharmaceutical and/or biopharmaceutical manufacturing.
• Knowledge of GxP’s, FDA guidelines, and other relevant international and domestic relations.
• Advanced MS Project skills.
• Solid experience in facilitation and project team management, with demonstrated excellence in communication, presentation, analytical thinking and problem-solving skills and organizational improvement.
• Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
• Proven success influencing teams in a matrix management environment.
• Recent experience with a smaller entrepreneurial environment.
• Good decision making with strong judgment through collaboration and consideration of others point-of-view.
• Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
• Excellent management skills-hiring, recruiting, training, performance management, planning, prioritization, objective setting, meeting management and plan execution.
• Role model for Atara’s values.

More about Atara Bio: We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.

We’re proud of our team of 425+ Atarians co-located by design in 4 different locations including South San Francisco (corporate headquarters), Thousand Oaks (R&D and manufacturing headquarters), Zug, Switzerland (european headquarters) and a R&D site in the Denver, Colorado area. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility.

Our mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence.”

Our vision - “T-Cell Immunotherapy for every patient, any time.”

Atara offers a competitive benefits packages that includes medical/dental/vision benefits, life and disability, retirement and stock program, as well as a generous paid time off and wellness plan that supports the well-being of our staff. Visit www.atarabio.com/careers to learn more.
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Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group._

We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.

Job Type: Full-time