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Senior Director, Business Development & Alliance Quality

Summit, NJ Full Time Posted by: Bristol-Myers Squibb Posted: Wednesday, 15 May 2024
 
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job.

But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.

We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.Position Summary:The Head, Senior Director, of Business Development & Alliance Quality will be responsible for (1) formulating and executing strategies that position BMS as the preferred Quality partner for potential BD opportunities, (2) creating a consolidated Quality vision for the BD space, (3) developing asset-specific Quality strategies to meet BMS's BD plans/objectives, and (4) leading/creating and delivering comprehensive Quality specific guidance documents such as play books, decision trees, and check-lists. The incumbent will conceive strategy at both the micro and macro levels and implement change at scale and new ways of working within the BD space.

The position will be a people manager and will report to the Vice President of Product Quality.Key Responsibilities:To ensure that Quality is actively engaged and represented in the BD space through PD, GPS, and/or R&D.To be a single point of contact within BMS from GQ for BDPartners with various functional specific BD groups (PD, GPS, Enterprise, and R&D as appropriate) to foster collaboration across diverse teams.

Create a RACI, decision tree, or something similar to ensure inclusion of GQ into the BD process.Support or lead BD evaluations and activities (from the perspective of Quality) associated with bringing in new assets and will partner with alliance management as necessary.Work closely with multiple cross-functional leaders within BMS to ensure Quality's support for BD activities.

Work closely with GQ leaders and teams (global, sites, and R&D-Quality) for creating processes and systems (eg, workflow, templates, playbooks, communication) for business development opportunities for smooth transition of external assets into BMS ways of working.Responsible for clearing roadblocks within GQ before the start of transition of BD asset specific activities into BMS ways of working.Responsible for evaluation of business development opportunities (CMC activities) for compounds in development (small molecule and biologics).

Assesses risks and communicates/escalates appropriately.Member of BD & Alliance Teams providing Quality (QA) input for assets from pre-clinical to late-phase development (until start of PPQ) through commercial product life cycle. Partners with technical SMEs to develop and approve the CMC strategy for incoming assets.

Support creation of quality agreements keeping structuring of transactions in mind (eg, license deals, out license, joint venture, divestments etc.).Manage stakeholders, present to internal leadership teams, and drive internal consensus on opportunities from the perspective of Quality.Responsible for ensuring the existence of change management throughout the asset acquisition to include impact assessments, tracking, and implementation.

Also, as appropriate, responsible Quality member for oversight of all key Quality System deliverables associated with the asset.Work with CMC Teams to conduct risk assessments, as required, for CMC activities. Responsible for communicating Quality risks within the Quality organization.

Collaborate with Regulatory to track/own Quality input for assets and updates to Health Authorities (eg, IND/IMPD/BLA/NDA) including specifications, shelf-life extensions, country specific trial approvals, etc.Carry out day to day project management, resource allocation, managing across matrixed functions, timeline adherence, internal and external communications, leading & working effectively in x-functional teams and oversee the management and development of direct reports as appropriate.Adherence to and role models BMS Values.

Qualifications & Experience:Bachelor of Science in Chemistry, Biochemistry, or a similar Scientific field; master's degree preferred.Minimum of 15 years' experience in pharma and at least ten years of experience in Quality In addition, several years of experience/exposure in Pharma business development and alliance landscape is needed.Thorough understanding of pharma business development activities from the perspective of manufacturing, testing, packaging/labeling, and clinical/commercial supplies.

Thorough understanding of pharma drug development (from discovery to end of product life cycle) and the inter-dependencies across different functions.Thorough knowledge of the Product Development processes as evidenced by bringing multiple INDs through to successful BLA/NDA approval.Recognized as a CMC expert with an ability to introduce best practices into the quality management systems.

Thorough understanding of cGMPs and regulatory requirements (eg, FDA, EU, ICH).Well-versed in relevant CMC area, with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes.Excellent investigational and QA problem-solving skills.

Analytical mindset, with an ability to assess new situations to define and implement the appropriate QA action plan.Proven attention to detail, excellent review skills, and the ability to organize and manage multiple tasks in a fast-paced environment.Enterprise mindset with proven ability to work across R&D and GPS with strong stakeholder management skills.

Excel as negotiator and an attentive listener, adept at steering conversation toward mutually beneficial results.Ability to gauge the situation and manage discussions to yield positive outcomes is exceptional.Continuous improvement mindset and self-motivated.

you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary.

Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

Summit, NJ, USA
Science
Bristol-Myers Squibb
AJF/707497218
15/05/2024 00:25

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