Senior Medical Director Therapeutic Area Leader
Deerfield, IL
Req ID 49985BR
Business Title
Senior Medical Director, Therapeutic Area Leader
Business
Medical Products
Sub-Business
Research & Development
Country
US
State/Province
Illinois
Location of Position
Deerfield, IL
Shift_
1st
Job Description
Business Title
Senior Medical Director, Therapeutic Area Leader - Anesthesia/Critical Care/Brevibloc
Job Description
The Senior Medical Director will play a key leadership role in the development of clinical and business strategies for the TA. Participate in development of Global Business Strategies to explore/expand new medical use or market expansion. This position is a senior role which will provide overall medical perspective, expertise and direction for the global Therapeutic Area.
1. Oversee clinical strategy, including phase I-IV clinical trial design and execution for drugs and possibly devices. Participate in developing strategies for supporting in-house and investigator initiated clinical studies. Collaborate closely with the Research & Development and Regulatory teams to ensure effective clinical strategy, design, execution of trials, and regulatory submissions. Participate in business development initiatives for the assessment and integration of clinical candidate molecules and devices. Lead the clinical component of product life cycle management. Participate in development of global business strategy. Share medical/clinical expertise with colleagues in other functional areas such as marketing, manufacturing, quality assurance, regulatory affairs, R&D, and legal. Keep the concept of protection of patient safety at the forefront of all team activities.
2. Design, manage and develop a professional clinical development team. Ensure team integrates well with other functional areas. Ensure mandated team training is competed in a timely manner and ensure activities are compliant with all relevant Laws and Regulations.
3. Liaise effectively with multiple internal functions, particularly Medical Affairs, Regulatory Affairs, Product Therapy Teams, Legal, Manufacturing, Quality Assurance, Pharmacovigilance etc.
4. Ensure high quality clinical input to the Product Therapy Teams to ensure global strategies best meet the needs of the business.
5. Design and provide ongoing medical input to clinical trials and assist in meeting challenging timelines and keeping to agreed budgets, whilst maintaining high quality.
6. Work closely with the Clinical Operations team to develop protocols, identify and recruit qualified investigators and institutions, monitor studies to ensure compliance with protocol and integrity of data, analyze results, and prepare the clinical section of regulatory submissions.
7. Develop and maintain relationships with key external subject matter experts and serve as the clinical lead for advisory meetings. Attend medical and scientific symposia to remain conversant with the newest scientific developments, maintain awareness of research activities in area of expertise, network with subject matter experts and identify and evaluate potential commercial opportunities from companies that have potentially attractive assets.
8. Take a leadership role in interactions with appropriate Regulatory Agencies and provide medical and scientific direction on clinical matters affecting the preparation and submission of timely and sound information to the Regulatory Authorities.
9. Review and support development of appropriate product labeling and advertising activities to provide medical perspective and maintain compliance.
10. Contribute to the training, leadership and continuing education for all departmental staff.
11. Provide medical and specialty expertise for safety surveillance of clinical studies.
12. Provide strong ethical and moral leadership relative to standards of medical, nursing, and pharmacy practice and patient advocacy.
13. Assume other duties as assigned by the VP, R&D Franchise Lead, Specialty Pharmaceuticals.
Business
Specialty Pharmaceuticals
Req ID
40594BR
Recruiter Contact
Kevin Carlson
Supervisor Name
Stuart Atkinson
Supervisor's Position
Vice President, R&D Franchise Lead, Specialty Pharmaceuticals
Job Requirements
1. MD degree, with specialty training in anesthesiology / critical care or equivalent experience; BE/BC preferred.
2. Minimum of five years of clinical practice experience; minimum of ten years of applicable industry experience in a biotechnology or pharmaceutical company performing most or all of the responsibilities of this position.
3. Demonstrated experience in successfully leading clinical development of drug candidates from pre-clinical activities through clinical trials and successful product approval(s).
4. Demonstrated expertise in managing complex collaborations and teams in support of design and execution of clinical trial programs effectively, including management of projects and timelines and interpretation/evaluation of clinical data
5. Solid knowledge of FDA/EMEA requirements, GCP, and pharmaceutical clinical development; previous experience working with regulatory authorities.
6. Excellent leadership capabilities; teamwork oriented; interested in working in a multicultural and cross-functional environment; demonstrated leadership success, including excellent analytical, planning, and communication skills in a dynamic environment.
7. Track record of recruiting and developing high performing clinical staff and taking on increasing responsibility in a high growth environment.
8. Strong management skills; decisive; resourceful and well-developed interpersonal skills; able to deliver education and direction on complex scientific/clinical issues in a crisp and clear manner to both peer and larger audiences.
9. Excellent verbal and written communication skills, public speaking and teaching skills, relevant Microsoft Office skills.
Job Requirements
1. MD degree, with specialty training in anesthesiology / critical care or equivalent experience required; BE/BC preferred.
2. Minimum of five years of clinical practice experience; minimum of ten years of applicable industry experience in a biotechnology or pharmaceutical company performing most or all of the responsibilities of this position.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
