- Develops, agrees and aligns on hepatology program strategy with R&D Leadership and Brand Team
- Leads risk mitigation and contingency planning; escalates risks as needed.
- Provides scientific, technological and medical knowledge and expertise for the clinical research aspects of registration activities with a working knowledge of regulatory affairs, in the development of the project strategy and the clinical development plan (CDP).
- Plays a primary role in identifying key opinion leader(s)/principal investigators for the program to ensure adequacy of the program's scientific basis and obtain endorsement on the assumptions related to medical needs and clinical utility represented in the project development strategy.
- Provides medical and scientific interpretation of efficacy and safety data; and to seek advice of other experts as required.
- Accountable for the clinical study reports including expert reports, integrated summaries, and other regulatory documents, etc.
- Plays a key role in the interactions with regulatory authorities (e.g., US Food and Drug Administration [FDA], European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA] meetings). This includes developing key documents, participating in the preparation for meetings with the health authorities, and participating in the meetings and interactions with the health authorities. To serve as the main scientific/medical representative during these interactions, with support from other project team members as needed.
- Provides input for a project publication plan; may author/review/approve content used for publications and promotions.
- Liaises with commercial on launch activities, if applicable
- Keeps abreast of current medical/scientific progress and actively develops and maintains relationships with outside experts aligned with the scientific and business objectives of assigned therapy area.
- Represents the company with outside groups. Works to understand the evolving healthcare environment (provider/expert) and payer landscapes and translates that working knowledge into a plan.
- Contributes to Medical aspects of Regulatory issues related to development compounds or marketed products including labeling discussions/updates, interactions with Regulatory Agencies, and Annual NDA and IND Report submissions.
- Participates in the Promotional Review Committee, Medical Review Committee, Grant Review Committee and Scientific Review Committee.
- Manages the respective budgets for assigned CDMA activities.
- Advanced degree (PhD, PharmD, MD) with specialty in hepatology/nephrology /critical care required.
- 10+ years' pharmaceutical experience in Program Management, Clinical Development and/or Medical Affairs.
- Experience in clinical study/protocol/program design and execution.
- Ability to work effectively in a multidisciplinary team.
- Experience working with global regulatory agencies.
- Demonstrated business acumen with ability to balance need for maintaining high scientific standards with business relevance and impact.
- Excellent communication, interpersonal and leadership skills.
- Ability to quickly and comprehensively learn about new subject areas and environments and effectively communicate that information.
- Demonstrated ability to establish strong customer relationships.
- Focus on patient and external customers.
- Committed to full compliance with company SOPs, all applicable laws and regulations.
- Experience with medical device/drug device combination products.
- Proven track record of successfully leading clinical development programs from concept to regulatory approval.
-
Medical Affairs Assistant
1 week ago
National Organization f Boston, United States**About NORD** · **Position Summary** · NORD has an exciting opportunity for a Medical Affairs Assistant to work collaboratively with the Rare Disease Centers of Excellence Team to provide ongoing support to the Rare Disease Center of Excellence Working Groups. Each Working Group ...
-
Medical Affairs Lead, NA
6 days ago
Sanofi Group Bridgewater, United States**Medical Affairs Lead - OTC Brands and HCP Strategy, NA** · **Location:** Bridgewater, NJ · **Remote Work:** Hybrid working model · **Travel Expected:** <10% · **Job Type:** Full time · **About the Job** · _At Sanofi Consumer Healthcare, we have one shared mission - we work pass ...
-
Medical Affairs Lead, NA
1 week ago
Sanofi Group Bridgewater, United StatesMedical Affairs Lead - OTC Brands and HCP Strategy, NA · Location: Bridgewater, NJ · Remote Work: Hybrid working model · Travel Expected: <10% · Job Type: Full time · About the Job · At Sanofi Consumer Healthcare, we have one shared mission we work passionately, every day, ...
-
Mallinckrodt Pharmaceuticals Bridgewater, United StatesJob Title · Senior Director, Clinical Development and Medical Affairs · Requisition · JR Senior Director, Clinical Development and Medical Affairs (Open) · Location · US Specialty Brand Headquarters - USA501 · Additional Locations · Bridgewater, NJ · Job Description · The Senior ...
-
Green Key Resources Bridgewater, United StatesSummary:The Senior Director of Clinical Development Medical Affairs (CDMA) is tasked with spearheading the strategy and oversight for the hepatology drug program, ensuring alignment with brand objectives, incorporation of relevant insights, and the generation of a robust R&D plan ...
-
Medical Director, Medical Affairs
1 week ago
Blueprint Medicines Corporation Cambridge, United StatesHow will your role help us transform hope into reality? · The Medical Director, Medical Affairs will be responsible for development and execution of the Ayvakit / Systemic Mastocytosis medical plan and future potential allergy/immunology launches of pipeline assets as well as sub ...
-
Medical Director, Medical Affairs
2 weeks ago
Editas Medicine Cambridge, United StatesAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...
-
director, medical affairs
1 week ago
Apellis Pharmaceuticals, Inc. Waltham, MA, United StatesPosition Summary: · The Director of Global Medical Affairs Strategy, Ophthalmology is a key member of the global medical affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of the global medical affairs strategy for o ...
-
Director, Medical Affairs
4 days ago
Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · The Director of Global Medical Affairs Strategy, Ophthalmology is a key member of the global medical affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of the glob ...
-
Director, Medical Affairs
2 days ago
Verve Therapeutics, Inc. Boston, United StatesJob Description · Job DescriptionThe CompanyVerve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, ...
-
Director, Medical Affairs
2 weeks ago
Apellis Waltham, MA, United StatesJob Description · Job Description · Position Summary: · The Director of Global Medical Affairs Strategy, Ophthalmology is a key member of the global medical affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of th ...
-
Medical Affairs Director
3 days ago
Ironwood Pharmaceuticals Boston, United States Full timeIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription ...
-
Director, Medical Affairs
1 week ago
Apellis Pharmaceuticals, Inc. Waltham, MA, United StatesPosition Summary: · The Director of Global Medical Affairs Strategy, Ophthalmology is a key member of the global medical affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of the global medical affairs strategy for ...
-
Director of Medical Affairs
2 weeks ago
Empatica Boston, MA, United StatesJob Description · Job Description · Empatica · Empatica is a full-stack digital healthcare company and a pioneer in digital biomarker development and continuous patient monitoring driven by AI. Our platform consists of medical-grade smartwatches, software, and physiological an ...
-
Medical Affairs Director
1 week ago
Ironwood Pharmaceuticals, Inc. Boston, MA, United StatesIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription ...
-
Medical and Clinical Affairs Specialist
1 day ago
Med Device, Biotech and Pharma Consulting Raynham, United StatesJob Description · Job Description A premiere Medical Device company is looking for a Medical/ Clinical Affairs Specialist to assist on a long term contract. · Requirements for the position include: · -Clinical Document Review Experience · -Evidence of Data and Claims · -experienc ...
-
Medical Affairs Medical Director, Pain
2 weeks ago
Vertex Pharmaceuticals Boston, MA, United StatesMedical Affairs Medical Director, Pain page is loaded · Medical Affairs Medical Director, Pain · Apply locations Boston, MA time type Full time posted on Posted 30+ Days Ago job requisition id REQ-20050 Job Description · The Medical Affairs Medical Director will provide medic ...
-
Medical Affairs Medical Director, Pain
1 week ago
Vertex Pharmaceuticals, Inc Boston, MA, United StatesJob Description · The Medical Affairs Medical Director will provide medical leadership for the Medical Department in the Pain therapeutic area. This role will be accountable for working with the medical team for North America, for the development and implementation of the North ...
-
Medical Affairs Medical Director, Pain
2 weeks ago
Vertex Pharmaceuticals Boston, MA, United StatesMedical Affairs Medical Director, Pain page is loaded · Medical Affairs Medical Director, Pain · Apply locations Boston, MA time type Full time posted on Posted 30+ Days Ago job requisition id REQ-20050 Job Description · The Medical Affairs Medical Director will provide medic ...
-
Head of Global Medical Affairs
5 days ago
Bicycle Therapeutics Cambridge, United StatesBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small mole ...
Senior Director, Clinical Development and Medical Affairs - Bridgewater, United States - Mallinckrodt
Description
Job TitleSenior Director, Clinical Development and Medical Affairs
Requisition
JR Senior Director, Clinical Development and Medical Affairs (Open)
Location
US Specialty Brand Headquarters - USA501
Additional Locations
Bridgewater, NJ
Job Description
The Senior Director, Clinical Development Medical Affairs (CDMA) drives strategy and accountability for the hepatology drug program execution, ensuring alignment with brand team objectives, incorporation of relevant internal and external insights and the generation of an R&D plan that delivers for unmet patient need, generates competitive differentiation, and prepares for new indication/label approvals. The Senior Director, CDMA leads a multi-disciplinary program team effectively and efficiently through the Stage Gate process as required.
This leader is responsible for the strategic direction, planning, execution, and oversight of our clinical development programs, ensuring they meet the highest scientific and regulatory standards. They will also play a key leadership role in developing and implementing medical affairs strategies to support product launches and lifecycle innovation.
Continually seeks to increase clinical/scientific awareness and expertise by fostering relationships with outside organizations/experts to support research programs and licensed product maintenance and optimization. This includes leading Advisory Board and Expert Panel meetings, and providing strategic direction on Medical Education Grants, External Collaborative Research and Medical Publications.
Essential Functions
This position reports to VP, CDMA with a dotted line reporting relationship to the CSO. The Senior Director CDMA will interact with internal colleagues in Research and Development (Clinical Development & Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management, Commercial and Operations functions. External collaboration includes trade associations, professional societies, payers, clinicians, and policy thought leaders, and various government personnel and agencies.
Working Conditions:
Usual office conditions in a hybrid environment (2 days/in office, 3 days remote); both domestic and international travel, 20-30%.
**Will consider Remote candidates.**
