Senior Director, Strategic Therapeutic Area Lead, Autoantibody Pipeline, US Medical Affairs- Immunology

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Job Function: Medical Affairs Group Job Sub Function: Medical Affairs Job Category: People Leader

All Job Posting Locations: Horsham, Pennsylvania, United States of America

Job Description:

We are searching for outstanding talent to serve as Senior Director, Strategic Therapeutic Area Lead, Autoantibody Pipeline in our US Immunology Medical Affairs organization based in Horsham, PA.

About Immunology

Our expertise in Innovative Medicine is informed and inspired by patients and healthcare professionals, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

The USMA Immunology- Autoantibody (AAb) TA franchises are currently focused on supporting Nipocalimab, an FcRn inhibitor, which reduces IgG antibody levels including pathogenic IgG antibodies thought to be relevant in the pathogenesis of a number of important autoimmune diseases which represent important medical unmet needs. Recently approved for generalized myasthenia gravis (gMG), Nipocalimab is also under study and development in a number of (unapproved) indications including Warm Autoimmune Hemolytic Anemia (WAiHA), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and the Maternal Fetal Conditions of Hemolytic Disease of the Fetus and Newborn (HDFN), Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), and Sjogren's Disease.

Purpose:

In this role, the candidate will be responsible for supervising a team of direct reports and serve as a leader of matrixed teams advancing the scientific strategy, pre-launch preparation, and planning for these indications within the Autoantibody Therapeutic Area (TA). Specific TA indication accountability and responsibilities will include pipeline indications such as Warm Autoimmune Hemolytic Anemia (WAiHA), and the Maternal Fetal Conditions of Hemolytic Disease of the Fetus and Newborn (HDFN), Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), and other future non-neuroimmunology indications, and partner with other TALs to support other indications (such as gMG and Sjogren's syndrome).

Universally, the strategic aims and ambition is to strive for Medical Affairs scientific leadership in relevant therapeutic areas, e.g. by identifying and addressing key stakeholders' needs, and generating robust plans for data generation, data dissemination, and prelaunch and other initiatives supporting these indications, which may be the first approved therapy in these disease states.

Reporting to the VP of US Medical Affairs, Gastroenterology & Autoantibody- Immunology this individual will be accountable for the execution and attainment of key medical objectives in compliant alignment with the business strategy and lead the team to deliver high-quality communications regarding the science and clinical applications of our products and/or the disease states to external stakeholders on a regional and national level.

The ideal candidate will have a record of strong leadership combined with exceptional business acumen and clinical expertise as this individual is expected to build strong cross-functional relationships with internal colleagues as well as external relationships with HCPs.

Responsibilities:

• Leading a team of multiple AAb Medical Affairs team direct reports in developing a scientifically, strategically, and competitively strong strategy(s) around pre-launch support and related activities, including HCP and expert/opinion leader engagement, which are anticipated to require substantial effort in developing strategy for new indications which are anticipated to be First-in-Disease approved therapies.
• Lead the US MA AAb Pipeline Therapeutic Area team and matrixed team partners in developing sophisticated and innovative scientific strategies, data generation activities and subsequent tactics. Create opportunities for key talent to assume future leadership roles.
• Identify, prioritize, and oversee the implementation of innovative and compliant data dissemination approaches and data generation strategies, with cognizance of the continually changing healthcare environment and clinical practice patterns.
• Drive the execution of the Autoantibody Therapeutic Area strategies through collaboration with cross-functional partners (including R&D, MSLs, RWVE, Field V&E, Global and other region MA, market access, and US Commercial teams) and ensure the strategy is aligned and successfully executed across these stakeholders.
• Supervise the planning and execution of Phase 3b and 4 clinical trials, as needed, to address key data gaps and/or post marketing commitments, and drive the development of other evidence generation activities (such as those using RWE approaches), and the assessment, coordination and prioritization of collaborative and IIS studies.
• Actively contribute as a disease-specific TA subject matter expert and manage expertise on to provide advice and input to and support the Global Medical Affairs, R&D, Marketing, Sales, Market Access, New Business Development, Real World Value & Evidence, autoantibody MSL, Medical Information and Communications teams, shaping and influencing the collective strategy based on sound scientific principles, available data, and strategic insights.
• Lead the relevant AAb Therapeutic Areas in annual business planning and be responsible for budget decisions within boundaries allocated by the Medical Affairs Leadership Team. Serve as a core member of Medical Affairs Leadership Team, US Immunology Business Development, US commercial integrated strategic teams, Operations Teams, and Integrated Evidence Team(s).
• Represent US Medical Affairs in various interactions with the global functions including clinical R&D, translational medicine, regulatory affairs/labelling, and global medical safety. This includes providing data, responses, and subject matter expertise for regulatory requests and documents, directly and through the team.
• Serve as a key driver of strategy and execution of publications from both the global and US perspectives. Provide strategic and scientific input on business development opportunities, pipeline assets (and related supportive clinical studies) to ensure necessary scientific rigor in study design and endpoints, as well as alignment with US strategic requirements.

Qualifications / Requirements:

• An advanced degree (MD/DO, PhD, PharmD, DNP, etc.) required
• A minimum of 10 years of combined clinical and/or industry experience is required, of which at least 5 years must be industry experience
• Experience in Medical Affairs is highly preferred
• Clinical or industry experience or expertise in the Hematology (particularly benign) or OB-GYN therapeutic areas is highly preferred
• Experience in Rare Disease, Neuromuscular or Immunology Therapeutic Areas is also relevant beneficial experience
• Significant launch experience highly preferred
• The successful candidate must have strong leadership skills with highly collaborative instincts and previous direct people management experience is highly preferred
• Experience in a multi-functional matrix organization is preferred
• Ability to communicate clearly and effectively with basic and clinical scientists, as well as with regulatory and commercial colleagues is required
• Excellent oral and written communication and presentation skills are required
• Up to 25% travel (primarily domestic & limited international) is required

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

• Preferred Skills:

• Strong leadership skills

• Excellent communication and presentation skills

• Ability to work in a fast-paced environment

• Strong analytical and problem-solving skills

• Ability to build and maintain strong relationships with internal and external stakeholders

• Experience with data analysis and interpretation

• Strong business acumen

• Ability to work in a matrix organization

• Experience with regulatory affairs

• Strong project management skills

• Ability to prioritize and manage multiple projects simultaneously

• Experience with clinical trials and evidence generation

• Strong scientific knowledge in immunology and autoantibody pipeline