Vp, Commercial Supply Chain

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Lexington, MA.

Culture is key and all Bicycle employees actively embrace and role model our company values:

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.
• We are One Team. We only succeed when we work together.
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination.

Current Supply Chain Business Requirements

The company is successfully developing drug products targeting specific cancer types that - even in the clinical trials - are already seeing direct patient benefit (as well as the indirect benefit of less burden on local healthcare systems).

This ongoing success has generated an increased interest in the rapid commercialization of the first product, and as such, the company needs to have operational processes in place to support a likely accelerated timeline.

The company intends to utilize Contract Manufacturer Organizations (CMOs) for production, packaging and distribution steps; including for the drug substance and drug product manufacture.

The company also has longer-term aspiration to manufacture their portfolio themselves. How much of the production process and any target timelines are yet to be determined, but this should be a consideration when establishing what supply chain systems and processes are to be introduced to the company.

It is key that any candidate considering this role has had the experience of E2E Supply Chain build within a business structure that relies on CMO’s.

JOB PURPOSE

The VP of Commercial Supply Chain will be responsible for both establishing and leading the E2E commercial supply chain activities (reporting into the Senior VP, CMC Development & Manufacture)

The role will act as the operational link for the Bicycle Therapeutics portfolio; to actively support each product’s evolution from clinical development into commercial supply operations.

The role will personally assess and recruit the experienced personnel needed (within their team) to manage each of the defined roles/areas within the E2E commercial supply chain organisation.

The role will establish processes and cadence (within the E2E commercial supply chain) that will both complement and enhance the defined commercial strategy of Bicycle Therapeutics.

The role will utilize a network of Contract Manufacturing Organizations (CMOs)/3PLs for each step in the production, packaging and distribution process.

The role will lead an integrated launch programme that delivers medicines to patients on time, of a high quality and at a cost effective price. The role will coordinate with the Global Project Team to integrate all launch activities into an overall company project delivery plan.

The role will actively engage with each function in the company, both commercial and technical, and lead the introduction of an S&OP cadence to enable Bicycle’s senior management to make informed decisions (with regards to demand and supply).

KEY RESPONSIBILITIES

• Lead the design and development of cGMP and cGDP supply chain management processes and procedures, including the introduction of electronic systems.
• Lead the identification and qualification of targeted second source CMOs (to mitigate supply risk).
• Design, develop and maintain a world class E2E commercial supply chain which includes the following functions: Customer Service, Planning, Launch Management, Procurement, Distribution and Logistics. Ensuring the timely delivery of high-quality products to the customer base.
• Align with key business partners in Quality, CMC, Regulatory, Commercial and Finance to establish clear lines of communication into Supply Chain and their respective inter-dependencies.
• Lead the introduction of an S&OP process across the company that will include the key areas of demand management, supply capability (incl. CMO capacity), inventory management and product distribution.
• Recruit and manage an initial team of 6 persons to oversee these functions – rising to 9 as more markets and products are launched
• Build strategic partnerships with CMOs at a senior level to ensure mutual value and growth are able to be achieved from these long-term, critically-commercial relationships.
• Following each product launch, continue to ensure product supply for commercial ramp-up and distribution across the customer base.
• Lead on all operational aspects of the RFP process for the acquisition of an MRP/ERP system and actively support the subsequent program of events to embed the software and processes across the supply chain and wider functions of the company.
• Oversee product launch activities for the Bicycle Therapeutics portfolio, including the generation of a robust delivery plan (with key milestone tracking) for each new product introduction.
• Oversee the creation of a product supply plan and take full responsibility for its successful implementation to maintain on time, high quality supply of products across the customer base.
• Oversee all aspects of CMO contract management including; planning, interpretation, negotiation, sign-off and ongoing maintenance (in close alignment with legal)
• Design and introduce a CMO performance management system to drive mutual collaboration across the CMO network; enabling the timely delivery of all high quality Bicycle Therapeutics products at an acceptable cost.

• Resilient and able to work effectively in a demanding and fast-paced environment
• Extensive experience of leading on numerous pharmaceutical new product launches, with evidence of close alignment with each of the technical functions (ie. CMC, Quality, Regulatory)
• Proven ability to drive operational excellence within your sphere of direct influence
• Proven and demonstrable experience of leading end-to-end pharmaceutical supply chain functions within complex contract manufacturing networks
• Highly collaborative, with strong relationship building skills with a high level of integrity
• Extensive experience of designing and implementing pharmaceutical supply chain processes
• Clear communicator – with a proven ability to adapt your style when speaking to either your team, your peers or to senior management
• Extensive experience of directly managing CMOs across a global footprint for pharmaceutical manufacturing, packaging and distribution (incl. 3PL/4PL)
• Strong influencing capability and demonstrable experience of influencing across a range of stakeholders, both internally and externally as well as across different geographies
• Extensive experience of designing & implementing MRP/ERP systems in a pharmaceutical environment

• Employee assistance program
• 401(k) plan with a 4% Company match and immediate vesting
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
• Employee recognition schemes
• 10 Company holidays
• Competitive Family Leave Policy
• Competitive reward including annual company bonus
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
• Flexible working environment
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
• Health and Dependent Care Flexible Spending Accounts

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.