Associate Director, Clinical Sciences Helsingborg - Johnson & Johnson

About The Johnson & Johnson Consumer Helsingborg
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.


With $81.6 billion in 2018 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world.


At Johnson & Johnson Consumer Nordic, we have a truly unrivalled brand portfolio, with power brands across multiple categories, including Neutrogena, Natusan, Piz Buin, o.b, Imodium, Ipren, Livostin and Nicorette. In Helsingborg we manufacture Nicorette and Rhinocort products for the global market. Our Nicorette products - found in over 80 countries - help people around the world to quit tobacco and live healthier lives. In addition to manufacturing, we also have a global research and development unit working in three areas: Smoking Cessation, Digestive Health and Cough & Cold. With around 650 employees we are one of the region's largest companies.


Introduction And Overview
The Associate Director, Clinical Science serves as a medical/clinical strategy lead for NPD and clinical programs in all phases of product development. This position works closely with cross-functional teams to evaluate innovation opportunities within their assigned need states. This position supports JJCI’s Cough/Cold need state and may provide support to other need states as appropriate.


This position represents the clinical strategies during health authority interactions and negotiations in support of NPD for their assigned need states. In collaboration with clinical operations and in compliance with department, Company, and regulatory standards, this position is responsible for the planning, design, directing, and reporting of clinical studies for their assigned Need State(s). This role involves extensive cross-functional and global/cross-regional team matrix interactions.


The Associate Director, Clinical Science


Objectives of the Position
Manage direct reports as appropriate.
Serve as Clinical lead on cross-functional NPD project teams in assigned Need States.
Responsible for designing clinical development programs in support of NPD. As appropriate, also supports phase 4 claims studies and other scientific research.
Lead cross-functional clinical teams responsible for planning, design, execution and reporting of clinical studies for assigned Need States.
Assure timely and quality completion of investigator brochures, study protocols, clinical study reports, and any documents needed for regulatory filing.
Responsible for timely and accurate publication of completed research.
Develop and maintain positive relationships with scientific leaders and medical/clinical consultants.
Understand and shape Clinical Model development and knowledge in assigned Need State.
Support the overall clinical/research strategy in assigned need states by evaluating global innovation and NPD opportunities.
Serve as a Medical Monitor ensuring the safety of participants in assigned clinical studies.
Responsible for clinical evaluation reports for devices in development and for Post-market clinical follow-up Studies for in-market devices in their assigned need state.
Provide medical/clinical support to business and competitive intelligence activities for assigned need states.
Support medical affairs activities as needed including, but not limited to, Safety Management Teams, Core Data Sheet/Labeling Working Group activities, Review of periodic safety reports, ingredient/product issue management and benefit/risk challenges.
Act as Study Director for assigned studies.
Author/contribute to study documents (eg, synopsis, protocol, ICF, CSRs, CT.gov, medical safety oversight plans).
Author/contribute to regulatory documents (eg, IND, CTA, NDA, MA) as needed.
Collaborate with regional and local medical and regulatory colleagues to ensure development plans meets local regulatory and commercial needs.
Support claims activities and related data-mining in support of need state claims innovation.
Support RX to OTC switches if appropriate.
Support design and execution of post-authorization safety or efficacy studies as appropriate.
Ensure that all activities are in compliance with department safety practices, policies, and procedures.
Participate on cross-functional teams for evaluation of ideas, clinical development of new products, and implementation of business strategies.
Report study findings to senior management.
Handle project budgets and projections.


What You Will Need To Succeed
Lead and work with cross-functional teams.
Lead multiple projects and mentor team members.
Understand Quality, Compliance and Regulatory requirements.
Understand business context and work closely with commercial business partners in the development of self-care products.
Develop and work within agile processes and business frameworks.
Partner efficient across a diverse set of business partners and stakeholders to deliver process improvements and NPD.


Qualifications
A minimum of a Doctor of Medicine or equivalent (required).
5+ years related experience (required).
Experience of Good Clinical Practices and Regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings (required).
Proficient in Microsoft Suite of software products including Excel and Word (required).
Proficient in English language, verbal and written (required).
Helsingborg location (required).



Application
If you are interested in this position, please apply with an updated CV and Cover letter. The selection process will start during the 14-day posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.


We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.