Vice President of Medical Affairs Americas
Location: Remote or in Corp HQ in Woburn, MA
Posted Date: 09/14/2022
Who We Are
Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. We’re a fast growing; dynamic organization and we seek an experienced Vice President of Medical Affairs-Americas to help us with our growth. In this role, work location can be remote to our Corporate Headquarters in Woburn, MA or in HQ.
What You’ll Do
The Vice President of Medical Affairs Americas (US, LATAM and Canada) will fulfill an important strategic leadership role reporting into the CMO. He/ she has high visibility in the organization, participating with senior management in developing strategic objectives and implementing functional Medical Affairs plans for assets with the benefit of the patient at the forefront.
You'll lead key Medical Affairs projects that require breadth of experience and strong business acumen. He/she brings innovation and critical thinking to planning Medical Affairs related processes, determines organizational structures, influences or directs cross-functional teams (including medical, scientific & commercial directors, biostatistics, clinical operations, safety, regulatory, marketing planning, business development and corporate communications) and assures optimal partnership for products developed in an alliance setting.
The VP plays a critical role in establishing/maintaining professional relationships with key medical experts in the field of Interventional Radiology and Oncology. The VP ensures that all activities, internal and external adhere to rigorous corporate standards and government/industry regulations & compliance standards. The main responsibilities:
- Direct, develop and enhance one or more critical functions within the medical affairs department.
- Ensure that strategic long term and execution of Americas and Global Medical Affairs plans are appropriately aligned with corporate strategies.
- Plan strategically and executes, through line management where in place, appropriate medical support for product(s) and candidates which includes, but is not limited to the following responsibilities:
- Development and oversight of implementation of Americas and globally focused medical strategy and tactics, including internal/ external disease area/ product training, annual medical planning, scientific communications, and collaborations with experts.
- Application of therapeutic/disease area expertise and addressing current and future medical needs in clinical practice to inform medically appropriate use of investigational therapies.
- Provide strategic leadership and providing therapeutic area and medical affairs expertise for assets in development phases and post-marketing commitments.
- Oversight and hands on support in management, generation and dissemination of clinical and non-clinical data that supports the medical strategy and results in high quality publications.
- Leadership to ensure an aligned and effective collaboration between internal business partners including the Clinical Affairs and Commercial teams.
- Stand or ad-hoc membership for various cross-functional and cross-alliance teams; providing medical perspectives to the global and Americas strategic and medical organizations.
- Work closely with clinical sciences colleagues to optimize the development of post-marketing and registrational trials.
- Oversee design, approval process, conduct, analysis and reporting of Medical Affairs studies. Provides oversight to ensure timely submission and delivery of high-quality clinical trial documentation, implementation, and execution. This will include Interventional and Non-interventional Trials/Studies, traditional and real-world evidence, company-sponsored studies
- Development and cultivation of long-term strategic partnerships with clinical experts, societies, collaborative groups, advocacy groups, and other external stakeholders representing Sirtex.
- Champion of high standards of compliance, ethics and patient safety, putting patients at the center of all actions.
- Stay abreast of current developments within pertinent medical and scientific therapeutic area through familiarity with current literature, attendance at medical society meetings, professional associations and other.
- Accountability for creating and managing resources within annual Medical Affairs budget, and expenses.
- Perform oversight of medical monitoring of post-registrational trails and is the final signatory of documents related to interpretation of patient level data where necessary, if in possession of a medical degree
Managerial responsibility and related expectations:
- Directs, through line and matrix management, multiple functions and therapeutic areas within Medical Affairs.
- Determines organizational structures and operational direction for one or more critical functions within medical affairs.
- Is accountable for the overall organizational morale, team effectiveness and talent management
- Leads by example and is viewed across the organization as a role model
- Serves as principal spokesperson for the Medical Affairs function on highly significant matters
- Interacts internally and externally with senior management and/ or functional heads requiring negotiation of difficult matters.
- Takes on a positive leaderships role when there is ambiguity and little or no direction.
- Provides guidance and fosters professional development and growth of direct reports.
- Plays a key role in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
- Speaks as principal spokesperson for the function or organization on significant matters.
- Works in a goal/objective-oriented manner within formalized process to plan and execute annual goals in alignment with the corporate annual goals and core business strategy.
- Demonstrates excellent people management skills, as well as collaborative efforts with relevant stakeholders within and outside Sirtex.
Who You’ll Be
Because our patients deserve the highest caliber of people who work at Sirtex, we seek someone with:
- Advanced degree (MD, PhD or PharmD), MD (Radiology, IR, Oncology, or Immunology) preferred however not mandatory
- 14+ years total experience post (medical) degree, with at least ten years progressive experience in Pharmaceutical or Biotech Industry working in Medical Affairs and/or Clinical Research & Development or related fields.
- Industry experience in planning, executing and reporting clinical trials with post-marketing experience required.
- Prior experience working in a matrix organization as well as cross-functional collaboration with Clinical Development, and Commercial/Marketing departments strongly desired.
- Prior experience with working in an alliance setting strongly preferred.
- Experience working with field-based colleagues/MSLs required.
- Americas and global experience, including launch experience strongly desired.
- Experience working collaboratively and coordinating with external partners
- Demonstrates strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships.
- Demonstrates a strong ability and desire to collaborate with the commercial/marketing organization in an appropriate manner to ensure commercial strategy, plan and execution incorporate medical input and direction. Ensure that all medical affairs activities in support of the product adhere to all relevant industry regulations.
- Ability to lead business and technical discussions internally and externally and explain scientific/medical concepts to all levels.
- Strong leadership and management skills.
- Strong presentation and communication skills; must be able to provide succinct, strategic, and actionable insights to senior management.
- Thorough understanding of the healthcare environment including all external stakeholders.
- The ideal candidate will demonstrate the following competencies:
-Ability to work effectively in a fast paced, rapidly changing and expanding environment and juggle multiple projects.
-Outstanding work ethic and integrity, including high ethical and scientific standards
-Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by ability to lead teams.
-Deals with scientific concepts and complexity with confidence.
-Ability to engage in collaborative decision making to complete tasks in a timely fashion, and function in a rapid-paced environment. Must be a practical thinker, able to identify simple, realizable solutions.
-Makes the best decision possible based on a mixture of data analysis, wisdom, experience and judgement.
-Creates a climate in which people want to do their best and can motivate many kinds of direct reports and team or project members.
-Can deal comfortably with senior management.
-Knows how to get things done both through formal channels and the informal network and can inspire and motivate teams across the organization
-Sense of Humor: We take our patients and science seriously, just not ourselves.
What to expect from Sirtex
If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:
- Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives.
- A working culture of respect, diversity, and performance to help facilitate an inclusive culture.
- Attractive compensation and benefit packages which are practical, robust, fair, and equitable.
- A place to grow through career development and training opportunities.
Conditions of Employment
- Sirtex Medical has implemented a mandatory vaccination policy effective November 1, 2021, requiring the COVID 19 vaccination for all employees. In accordance with Sirtex’s duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees and their families, and the community at large from infectious diseases that may be reduced by vaccinations.
- Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department.
- Sirtex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.