Director, Patient Operations and Government Affairs

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

In 2025, we are looking to expand outside of California into the State of Montana and you will be employee #1, reporting directly to the CEO. The role owns the people‑facing and policy‑facing work streams that are critical for Day‑1 revenue under SB‑535. Engineering, construction and cGMP manufacturing oversight will be handled by a separate Facilities/Manufacturing lead.

Job Duties:

• Core Responsibilities (70 % external / 30 % internal)
1. Patient‑Pipeline Development
• Build and execute the referral network with U.S. oncologists and concierge‑medicine firms.
• Own the digital funnel (webinars, targeted advertising, lead‑qualification).
1. Patient On‑Boarding & Monitoring
• Stand‑up remote‑monitoring tech stack (EHR integrations, wearables, tele‑oncology).
• Chair weekly Multidisciplinary Tumor Board; ensure data flow into Real‑World Evidence (RWE) database for DPHHS.
1. Government & Stakeholder Relations
• Primary liaison to DPHHS, State Legislature health committees, and Governor’s Office of Economic Development.
• Draft and deliver Annual Safety & Outcomes Report; coordinate facility tours and testimony.
1. Community & Foundation Interface
• Manage CSBio Foundation subsidy programme; identify and onboard 10+ Montana residents in the pilot year.
• Lead rural‑access initiatives with local hospitals.
1. Programme Management (Non‑Construction)
• Track timelines for licensure, treatment‑center fit‑outs, and concierge‑care rollouts using Agile/Kanban toolset.
• Run cross‑functional war‑room calls (clinical, finance, legal). Escalate risks to executive team.
1. Finance & Incentive Coordination
• Partner with CFO to secure and service the Montana Facility Finance Authority below‑market loan (covenant tracking, community‑impact reporting).
• Prepare grant/credit applications (workforce training, rural‑health funds).
1. Brand & Reputation Safeguard
• Establish Code‑of‑Conduct for marketing claims; monitor competitors and flag “bad actors” to DPHHS.
• Represent CSBio on state Right‑to‑Try working groups to advocate higher compliance standards.

Competencies:

• To perform the job successfully, an individual should demonstrate the following competencies:
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Supports everyone's efforts to succeed.
• Organizational Support - Follows policies and procedures; Completes tasks correctly and on time; Supports organization goals and values.
• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

• 10+ yrs in clinical‑operations or patient‑services leadership (oncology, specialty pharmacy, or concierge medicine).
• Demonstrated success in government affairs or public‑health policy—ideally at the state level.
• Proven track record hitting patient‑acquisition or revenue targets in a regulated setting.
• PMP or equivalent programme‑management certification preferred.
• Comfort with financial modeling & loan‑covenant reporting.
• Superb public‑speaking and stakeholder‑management skills.
• Thorough understanding of problem-solving, safety and quality improvement tools and techniques
• Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• 401k 10% 1:1 match
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• PTO policy. 10 days PTO
• Cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities