John C. Email & Phone Number

Foster City, Ca, Us

Hellerup, Capital Region Of Denmark, Dk

Boston, Ma, Us

Paris, France, Fr

Paris, France, Fr

Responsible for the drug development safety strategy and develops/maintains risk management plans. Manages the day-to-day operations and provides medical guidance and clinical expertise to safety physicians to improve consistency/accuracy of benefit/risk assessment and safety management. Member of the Shire Drug Safety Surveillance Team Leadership. Collaborates with Clinical Development Teams, Regulatory Affairs, Licensing and Marketing, and provides therapeutic knowledge and ongoing assessment of competitive therapies safety profiles. Serves a Shire representative to IQ-DILI initiative and lead the first in Shire initiative for a Patient Preference Safety Program to support development and approval of a novel compound.

Recruited to lead the medical and development strategy for biosimilars. Chaired the Biosimilars R&D leadership team to address cross-functional efficiencies and support regulatory/medical tactics. Oversight of $2M budget with a team of eight. Responsible for successful design, submission and deployment of medical affairs and clinical programs, as well as submission oversight and leadership, clinical platforms, customer-facing engagement, publications, and launch plans and support of HEOR and market-access strategy. Reported to the EVP and President of Biosimilars & Launch Excellence; Member of the R&D Extended leadership team and R&D Scientific Review Committee.• Drove medical tactical plans realignment and was key medical decision-maker on the evaluation of potential BD&L opportunities. • Key Member of JSC, JCC and JDC for partnered assets and appointed to Shire–Baxalta integration team for Clinical Research and Development. Member of Joint Operating Committee with CRO partners.• R&D partner for patient centricity initiatives.• Post-Shire acquisition responsibilities focused on the leadership/delivery of the Biosimilars portfolio, including global regulatory interactions as well as the tactical and strategic support of the corporate decision process on the evolution of the assets.

Brussels, Be

• Streamlined clinical processes, reducing early development time by up to 2.5 years utilizing mini proof-of-concept studies in translation programs to issue key decisions on compounds. • Drove cross-partnership realignments of initial product placement strategy and post-launch activities with regulatory mandates, unmet patient needs and payer expectations. • Optimized recruitment and retention of subjects in pivotal program to ensure targeted timelines for BLA approval.

• Decreased R&D costs by $4M within initial 2 months in position while streamlining operations to generate synergies. • Attained Q2 financial targets by maintaining tight control of vendor contracts and expenses. • Spearheaded expansion of lead program into EU and performed due diligence for partner CRO.

Rockaway, New Jersey, Us

• Rightsized organization from 80 team members to 24 cross-functional specialists across medical writing, clinical data management, biostatistics, and programming delivering cost savings to company. • Contributed to flagship assets in dermatology and infectious disease, projected to generate over $250M; leveraged 505b pathway to maintain sustainability throughout product’s lifetime. o Attained lead line extension program to sNDA 4 months ahead of schedule. • Maintained global alignment of research by co-chairing Alliance R&D Committee along with Sanofi-Aventis; ensured continuity of Sanofi-Aventis partnership with P&G. • Launched company’s first process for internal DMC review and reduced analysis time for interpretation of clinical and efficacy data.

• Established high-performance MSL specialty team to support Cystic Fibrosis studies. • Salvaged label enhancement study for flagship product for treatment of Endocrine Pancreatic Insufficiency and Cystic Fibrosis working closely with top U.S. KOLS to drive success.

Bedminster, New Jersey, Us

• Played key role in securing $35M from alliance partner Nycomed for Gattex and Preotact studies. • Delivered 5 clinical studies including 2 Phase I, 2 Phase III, and 1 confirmational study. • Resolved backlog of 6 Clinical Study Reports with data certification/validation for 3 compounds and 4 indications. • Created business case strategy and patient needs evidence to maintain development of flagship asset. • Accelerated awareness and advocacy among KOLs and positioned products with competitive therapies via development of medical messaging and data for publication program.

Basel, Baselstadt, Ch

• Received 2 Presidential Awards for contributing to defense of product safety for bone metastasis and osteoporosis products. • Instrumental in expanding claims for bone metabolism/osteoarthritis drug; led Novartis Post-Menopausal Osteoporosis indication trials in bone metabolism and 2 in osteoarthritis. Served as Clinical Indication Leader for large-scale osteoporosis studies with 11K+ patients. • Drove continuous improvement across clinical processes. • Supported U.S. MSL team in introduction and support of KOL interactions.• Selected to represent Novartis on steering committees for pivotal studies, National Space Biomedical Research Institute, and International Society of Clinical Densitometry industry forum.

Switzerland 🇨🇭 , Ch

• Directed U.S. Medical Excellence Team for core medical bone team in Oncology and Osteoporosis. • Played instrumental role in 2 NDAs in osteoporosis and virology as Medical Reviewer.

Doctor Of Medicine (M.D.), Medicine

Master Cert. Pm, Project Management

Bsc, Biological Science