Who We Are
Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer.
The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such non-responsiveness or acquired and intrinsic resistance.
Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule drug candidates as part of the Kinnate Discovery Engine.
The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines. Come join us to help improve lives.
For more information, visit www.kinnate.com and follow us on LinkedIn.
Your Impact at Kinnate
We are seeking a Director Clinical Supply Management (CSM) to lead the CSM function. This position reporting to the Head of Pharmaceutical Development and Manufacturing (CMC) will be responsible for the CSM team and all related functions. The individual will develop and implement strategies to ensure uninterrupted drug supply for US and global clinical trials, covering primarily small molecule drug product and comparators. The individual will lead the team for drug product packaging, labeling, and distribution at drug depots and IRT system development and maintenance with vendors. The individual will collaborate cross-functionally with the Clinical Operations, Quality, Regulatory, and CMC team members and external vendors. The individual will manage the supply chain for a portfolio of global clinical studies across all phases of development, as well as direct line management of supporting clinical supply team members. New oncology therapy breakthroughs await your creative spirit and ‘roll-up your sleeves’ approach because #patients are waiting.
Key Responsibilities:
Provide strategic direction and shape the Clinical Supply Management (CSM) group to support early and late-stage clinical trials.
Responsible for outsourced packaging, labeling and distribution of Clinical Trial Material (CTM) at drug depots to support global clinical trials, and IRT system development and maintenance with vendors.
Partner with CMC, Clinical Operations, Quality, and Regulatory Affairs to ensure timely delivery of CTM to clinical sites in compliance with global regulatory requirements.
Translate clinical study requirements into demand and supply of drug product to ensure a timely study start and uninterrupted global clinical supply.
Ensure management of clinical trial materials inventory at multiple study depots, and work closely with Clinical Operations team to ensure sufficient inventory at clinical sites.
Develop budget and timing forecast for clinical packaging, labeling, and distribution.
Responsible for procurement of comparator or commercial products to support clinical trials.
Create and manage CTM forecasting across all clinical programs.
Manage global clinical supply logistics and distribution activities.
Work closely with QA and regulatory to ensure vendor compliance including investigational global labeling process.
Collaborate with internal CMC functions for CTM expiry date management at clinical sites and depots.
Serve as the primary point of contact for all CTM supply chain activities, internally and externally to clinical supply vendors.
Listed responsibilities are an essential, but not exhaustive, list of the expected initial duties associated with the position. The role will evolve over time and changes to individual responsibilities may occur due to business needs.
The Right Stuff
A degree in supply chain or drug development-related discipline or equivalent qualification, with 12+ years’ experience working in a Clinical Supply Management function.
Prior experience working with various clinical supply CMOs and understanding of their capabilities and limitations.
Experience in independently leading all aspects of clinical supplies management for trials from early to late phase, including global trials.
Strong understanding of Clinical Protocols and Study Designs, and leading implementation of IRT systems.
Thorough knowledge of global regulatory requirements around labeling, handling, and distribution of investigational products.
Good knowledge of drug supply forecasting, supply, and demand calculations.
Competencies:
Ability to proactively identify and manage risks, and excellent project management and organizational skills.
Good knowledge of GMP regulations, ICH guidelines, 21CFR and Annex 13 requirements as they relate to clinical supplies.
Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment, and respond to changing priorities in a positive and creative manner.
Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment.
Positive, adaptable, can-do attitude with quick learning ability.
Demonstration of past experiences in a leadership role with a strong track record of achievement through pivotal trials.
Excellent interpersonal skills with ability to effectively communicate and collaborate with cross functional teams, the senior management, and outside CROs and collaborators.
Ability to lead the team in prioritization of activities and programs.
Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Ability to travel (up to 20%) and work flexible hours, as required.
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
We offer a competitive total rewards package that provide our employees with the resources to pursue their goals, both at work and in their personal lives. The salary reasonably expected to be paid for this role is $196,000 - $205,000. The actual compensation and seniority level for this position will be determined based on relevant experience and qualifications. This position is eligible for an annual cash bonus and equity awards. Our employees are also eligible to receive other benefits including:
· Unlimited Paid Time Off
· 11 Company Paid Holidays - plus 2 annual paid “Refresher Days”
· Wide variety of comprehensive health, dental, and vision packages – most with minimal to no out-of-pocket expenses for employees
· Company contribution to 401k plan
· Employee stock purchase program
· Annual Massage Days
· Free local gym memberships
· Healthy Lifestyle Reimbursement Program
· Home Office Reimbursement Program
Kinnate is proud to be responsible members of our communities. Subject to applicable law, we require all our employees to be fully vaccinated and boosted against the COVID-19 virus. Therefore, all applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.
EEO & Employment Eligibility. Kinnate Biopharma Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Kinnate Biopharma Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of applicable law.